Latest News - Neuro NewsBIBA Medical Ltd2015-08-28T12:40:40Z Neurovascular launches Neuroform Atlas Stent System in Europe<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;">Stryker Neurovascular has announced that it has received the CE mark for the Neuroform Atlas Stent System. The Neuroform Atlas Stent is a new 4<sup>th</sup>-generation adjunctive stent, pushing forward the adjunctive stent landscape which previously included woven, closed-cell, and open-celled stents. According to Stryker Neurovascular, the Neuroform Atlas Stent features an innovative adaptive cell architecture that is designed to optimise conformability and stability when treating wide-neck intracranial aneurysms. Physicians can deliver all sizes of the Neuroform Atlas Stent, from 3.0mm up to 4.5mm in diameter, through a low-profile Excelsior SL-10 microcatheter.</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Professor Ansgar Berlis, from the Zentralklinikum Augsburg, Germany, was one of the first neuro-interventionalists in the world to use this new stent technology. &ldquo;The Neuroform Atlas Stent allows me to smoothly track all sizes of the stent through a low-profile SL-10 microcatheter. Being able to use the same 10-size microcatheter to deliver coils and the stent makes the access easier and shortens the procedure time, and thus reduces the risk of complications. This stent is available without a distal delivery wire tip, which facilitates stent delivery. The cell structure can be easily recrossed, which allowed me to deploy the Neuroform Atlas Stent in a y-configuration. In my experience, the Neuroform Atlas Stent provides very good&nbsp;vessel wall apposition and stability in both curved and tapered vessels. These improvements have made Neuroform Atlas a great addition to my practice,&rdquo; said Professor Berlis.</span></p> <p><br /><span style="font-size: 10pt;"> Joost de Vries from Radboudumc, Nijmegen, The Netherlands, experienced that &ldquo;The Neuroform Atlas Stent is easy to deliver and that stent and microcatheter are very stable during deployment. The Atlas Stent displays a consistent and reliable opening without kinking of the stent at sharp bends of the parent artery resulting in good wall apposition&rdquo;.</span></p> <p><span style="font-size: 10pt;">The company says that the Neuroform Atlas Stent is designed for optimised vessel wall conformability and coil scaffolding to help treat complex intracranial aneurysms, and the adaptive cell structure enhances stent opening and apposition to allow for accurate placement while maintaining the recrossability. </span><br /> <br /><span style="font-size: 10pt;"> Stryker Neurovascular will present and launch the Neuroform Atlas Stent at the 7<sup>th</sup> ESMINT Congress (10&ndash;12 September, Nice, France).</span></p></div>2015-08-27T13:16:00Z2015-08-27T13:16:00Zwebeditor@bibamedical.com and efficiency of single-layer WEB device comparable to that of dual-layer WEB<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;">In a 10-site European study reported in the<em> American Journal of Neuroradiology</em>, the safety and efficiency of the single-layer Woven EndoBridge (WEB-SL) device was found to be comparable to that of the older double-layer device. According to the authors, this study is the largest WEB study undertaken to date where WEB-SL devices were used to treat aneurysms that would normally be considered difficult to treat with traditional endovascular approaches.</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">While the safety and efficiency of the dual-layer WEB device has already been established, Jildaz Caroff and others sought to evaluate the safety of the single-layer device, which is the newest generation of the WEB intrasaccular flow-disrupter family. According to the manufacturer (Sequent Medical) the new WEB-SL has been designed to offer smaller-sized devices with a lower profile to optimise navigability and delivery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study authors write that with the WEB-SL improved microbraiding technology allows a reduction in device size and profile, which optimises navigability (through smaller catheters) and delivery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To conduct the study, data from all consecutive patients treated with a single-layer WEB device in 10 centres from June 2013 to May 2014 were included. Clinical presentations, technical details, intra and perioperative complications and outcomes at discharge were recorded. Clinical and angiographic data at last follow-up were also analysed when available.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors report the results of 90 patients (60 women) with 98 WEB-treated aneurysms. In 93 cases, WEB placement was possible. Complete occlusion at the end of the procedure was obtained in 26 instances. Additional treatment during the procedure (coiling and/or stent placement) was necessary in 12 cases. Procedure-related complications occurred in 13 cases, leading to permanent neurologic deficits in four patients. Early vascular imaging follow-up data were available for 44 patients, with an average time interval of 3.3 months. Treatment-related morbidity and mortality rates at last follow-up were 2.2% and 1.1%, respectively.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />They conclude stating, &ldquo;In this study, the feasibility and safety of the single-layer WEB device was comparable with that of the double-layer device.&rdquo; They caution however, that further studies are needed to evaluate the long-term efficacy.</span></p></div>2015-08-27T12:35:00Z2015-08-27T12:35:00Zwebeditor@bibamedical.com device effective and safe in treatment of acute stroke<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;">In a multicentre study, the Aperio thrombectomy device (Acandis) demonstrated safety and efficacy as a tool for reopening occluded cerebral arteries in the setting of an acute ischaemic stroke.</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to study authors, Kallenberg <em>et al</em>, &ldquo;Aperio is a newer thrombectomy device which was found to remove blood clots as effectively as the market leading product in an experimental study, and faster and will less distal embolisation than the other devices tested.&rdquo; What they aimed to evaluate therefore, was the practicability and effectiveness of Aperio in an &lsquo;everyday anywhere clinical setting&rsquo;: in multiple centres, applied by neurovascular interventionalists with differing levels of experience.</span></p> <p><span style="font-size: 10pt;"><br />Aperio is a non-detachable mechanical thrombectomy device with a hybrid cell design. It has an outer diameter of 4.5mm and a usable length of 30&ndash;40mm, depending on the vessel diameter. For radio-opacity the device has two elongated wire markers to support the positioning of the device and three distal device markers to indicate the distal device end and the grade of expansion.</span></p> <p><span style="font-size: 10pt;"><br />In the study, a total of 119 patients (68 women) with acute stroke were treated at nine centres. Kallenberg and others report in the <em>Journal of NeuroInterventional Surgery</em> (<em>JNIS</em>) that the median thrombus length was 15mm and the average time from device insertion to recanalisation was 30 minutes. Blood flow restoration (TICI 2&ndash;3) was achieved in 85% of patients. In the majority of cases complete clot removal was achieved (TICI 0, 12%; TICI 1, 2%; TICI 2a, 14%; TICI 2b, 18%; TICI 3, 53%), and the median number of deployments was two.</span></p> <p><span style="font-size: 10pt;"><br />Twelve procedural complications occurred, including one vessel perforation with subarachnoid haemorrhage, one subarachnoid haemorrhage of unknown cause, four cases of vasospasm, one device rupture, one case with subarachnoid contrast agent in post-interventional angiographic CT of unknown cause and three dissections. Embolisation of previously unaffected territories by fragmented or lost clots was not reported in any case.</span></p> <p><span style="font-size: 10pt;"><br />The authors report some difference between this study and previous thrombectomy studies. &ldquo;In this study we report the use of the Aperio thrombectomy device with its distal portion mainly deployed in vessels of &le;2mm diameter with fewer intracranial haemorrhages than with rtPA alone or with previous studies applying retrievable stent systems to treat acute stroke. In MR CLEAN there was no difference in the overall risk of any serious adverse event between the intervention group and the control group, but the risk was considerably higher than in the present study,&rdquo; they write. &nbsp;</span></p> <p><span style="font-size: 10pt;"><br />They add that the recanalisation rate (&ge;TICI 2a) of 85% is similar to that of other stent retriever trials&mdash;SWIFT (Solitaire 89%, Merci 67%); SWIFT PRIME, 88%; Trevo, 92%; Trevo II (Trevo 92%, Merci 77%); and IMS III, 73%. The difference between this Aperio study and those studies however, was that neurointerventionalists in the in those studies had to fulfil certain qualification criteria in order to participate, whereas the experience of the physicians who used the Aperio device was quite inhomogeneous.</span></p> <p><span style="font-size: 10pt;"><br />Kallenberg <em>et al</em> conclude stating that the Aperio device &ldquo;seems to be an effective and adequately safe tool for reopening occluded cerebral arteries in the setting of acute stroke&rdquo;.</span></p></div>2015-08-27T12:22:00Z2015-08-27T12:22:00Zwebeditor@bibamedical.com study finds that Cefaly has high efficacy for migraine prevention<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A new study finds that Cefaly, the first US Food and Drug Administration (FDA)-approved transcutaneous electrical nerve stimulation device specifically authorised for use prior to the onset of migraine pain, provides relief for 81% of migraine sufferers who use it.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The results of the clinical trial, published in <em><a href="">The Journal of Headache and Pain</a></em>, found 24 migraine sufferers who frequently suffered episodic migraines without aura, experienced a very high efficacy when using the headband-like device, for 20 minutes per day, at least two-thirds of the required 60-day consecutive treatment period. The entire study was conducted from January 2013 to October 2014. The test group matched the category of patients in a 2,313 person study used to gain the approval of the FDA in March 2014. Those results were also published in <em>The Journal of Headache and Pain</em> in December 2013.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is great confirmation on what we thought about the high efficacy of Cefaly,&rdquo; said Pierre Rigaux, chief executive officer of Cefaly Technology, the maker of the device. &ldquo;We knew Cefaly to be very safe and with minimal side effects, but now we learn that it is not just the frequency of migraine days that has reduced for every four out of five patients, but the intensity of pain during a migraine attack is reduced as well.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The new study is the first to reveal the intensity of headache pain during a migraine attack is significantly reduced using the Cefaly device. Previous studies only focused on migraine prevention.</span></p> <p><br /><span style="font-size: 10pt;">Antonio Russo and Alessandro Tessitore, with the Headache Center, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences at the Second University of Naples, Italy, two of the authors that conducted the study, concluded that the technology used in Cefaly is &ldquo;a first choice therapy in selected migraine populations due to the high level of efficacy and safety.&rdquo; They also find Cefaly to be an efficient option for the preventative treatment of migraine attacks&mdash;particularly in patients who cannot, or choose not, to take daily medications.</span></p> <p><br /><span style="font-size: 10pt;">While Cefaly does require a prescription, it is not a drug. It is the only device of its kind approved by the FDA and it uses tiny electrical impulses to stimulate the trigeminal nerve and reduce the frequency and intensity of migraines.</span></p></div>2015-08-27T10:09:00Z2015-08-27T10:09:00Zwebeditor@bibamedical.com Hospital La Timone is world's first to treat patients with Leksell Gamma Knife Icon<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Doctors at University Hospital La Timone, Marseille, France, have used their new Leksell Gamma Knife Icon system to treat a metastasis in the brain of a 71-year-old female patient.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This single-session treatment was the first time La Timone physicians had harnessed the system&rsquo;s advanced motion management and imaging capabilities to enable therapy using mask-based head fixation instead of the traditional rigid stereotactic frame. With Icon, La Timone physicians are predicting a significant increase in the volume of patients suitable for frameless Gamma Knife radiosurgery.</span><br /><br /></p> <p><span style="font-size: 10pt;">In the days following, doctors treated three additional patients with metastases using the same method. The hospital then achieved another Icon milestone&mdash;its first patient to begin frameless, multi-session (hypofractionated) treatment of a benign tumour.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This 77-year-old female patient had a cavernous sinus meningioma that was too close to the optic nerve and chiasm to treat with a single high dose&mdash;it would have been too high of a dose to avoid threatening these sensitive structures,&rdquo; says professor Jean Regis, a neurosurgeon and programme director for University Hospital La Timone&rsquo;s Gamma Knife programme, which launched traditional frame-based Gamma Knife radiosurgery treatments with Icon in mid-July. &ldquo;Therefore, she received a hypofractionated treatment, which divided her therapy into five sessions over five days to decrease the risk of injuring visual pathways.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">When performing frameless Gamma Knife radiosurgery with Icon, it is crucial that patient motion be managed and that the patient&rsquo;s position can be precisely reproduced in hypofractionated treatments.</span></p> <p><br /><span style="font-size: 10pt;">Gamma Knife Icon addresses both of these imperatives. Icon provides an integrated cone-beam computed tomography (CBCT) workflow that enables doctors to check the patient&rsquo;s position against planning images. After a thermoplastic mask is custom-fitted to the patient&rsquo;s head, an initial CBCT is performed to obtain a reference image, which is then fused with a magnetic resonance imaging (MRI) image to enable the clinician to develop the plan. The patient is then placed on the treatment couch with the mask.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Because the patient is never precisely in the same position as in these first scans, you acquire a new CBCT scan,&rdquo; Regis explains. &ldquo;In a few seconds, the GammaPlan software automatically adapts the plan to the new position of the patient&rsquo;s head and displays the dose distribution before and after this automated recalculation. This allows the physician to identify any discrepancies between the initial plan and the recalculated plan according to the new patient position. It is important to reiterate that this is a plan correction, not physically correcting the patient&rsquo;s position. So far, the differences in the plan&mdash;before and after adaptation to the patient&rsquo;s latest position&mdash;have been clinically insignificant, so we have not rejected any of the adapted plans.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">During treatment, patient motion is managed through the high-definition motion management system, which monitors the patient&rsquo;s head position via infrared tracking of markers.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;If the patient coughs or moves her head and that motion exceeds a safety threshold, the system automatically stops delivering the radiation,&rdquo; he observes. &ldquo;This is critical feature for patient safety in these frameless treatments. The on-the-fly intrafraction, automated adaptation of the planning to patient position is a new and interesting capability of Icon.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Hospital La Timone has so far used Leksell Gamma Knife Icon to treat a total of 33 patients using either frame-based or frameless methods.</span></p></div>2015-08-26T09:45:00Z2015-08-26T09:45:00Zwebeditor@bibamedical.com Jude Medical receives CE mark for MRI conditional labelling of the Prodigy MRI system<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>St Jude Medical has received CE mark approval for magnetic resonance imaging (MRI) conditional labelling for the company&rsquo;s Prodigy MRI chronic pain system with select leads.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A company press release states that upon its launch, the Prodigy MRI system will become the market&rsquo;s smallest MR-conditional rechargeable implantable pulse generator (IPG), as well as the industry&rsquo;s sole MR-conditional spinal cord stimulation system capable of delivering both St Jude Medical&rsquo;s proprietary Burst stimulation and traditional tonic stimulation.</span><br /><br /></p> <p><span style="font-size: 10pt;">In addition to the approval of Prodigy MRI, all Octrode percutaneous and Penta 5-column paddle leads have received MR-conditional labelling and are approved for use with Prodigy MRI. The Penta lead is the industry&rsquo;s only five-column paddle lead, which offers unmatched lateral coverage to finely control current and stimulate spinal nerves based specifically on patient need.</span></p> <p><br /><span style="font-size: 10pt;">Nearly 95 million Europeans suffer from chronic pain, and the condition costs European health care systems a combined total of &euro;300bn annually due to associated medical costs, lost work days and social security and welfare payments. Spinal cord stimulation therapy can offer many patients meaningful pain relief and improvements in quality of life, yet for some patients the need for future MRI scans can act as a barrier to such therapy.</span></p> <p><br /><span style="font-size: 10pt;">The new Prodigy MRI system will ensure patient access to St Jude Medical&rsquo;s portfolio of chronic pain solutions, such as the company&rsquo;s Burst stimulation, while maintaining the option for patients who may need future head and extremity MRI scans. In addition to the approval of the Prodigy MRI system, St Jude Medical has announced plans to seek updated labelling in key markets around the world for additional chronic pain products, and plans to submit testing data to support full-body MR-conditional labelling for their future spinal cord stimulation systems.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Clinical experience suggests that while relief from chronic pain remains the primary need for patients seeking spinal cord stimulation therapy, some patients who may benefit from it may also need future MRI scans,&rdquo; said Athanasios Koulousakis, head of Department Functional Neurosurgery, Spasticity and Pain, University Hospital in Cologne, Germany. &ldquo;So while the number of spinal cord stimulation patients requiring future MRIs may be limited, it is still critical to remove barriers to diagnostic options. Yet just as critical is providing MRI capability in spinal cord stimulation solutions that provide access to new therapy options, such as St Jude Medical&rsquo;s Burst stimulation. The new Prodigy MRI system helps put all such requirements into one package for our patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">St Jude Medical is the only company approved to offer patients Burst stimulation, which the company introduced to the market in 2014 with the launch of the original Prodigy chronic pain system. The therapy was introduced after nearly a decade of research and study in collaboration with Dirk De Ridder, who filed the therapy&rsquo;s initial patents in 2005.</span></p> <p><br /><span style="font-size: 10pt;">The addition of Burst stimulation to St Jude Medical&rsquo;s chronic pain portfolio offered patients access to a therapy proven to relieve pain more effectively than traditional spinal cord stimulation while also significantly reducing or eliminating paraesthesia for most patients. Clinical studies have also shown Burst stimulation can also offer pain relief to patients who may have become unresponsive to traditional spinal cord stimulation.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;MRI compatibility in our Prodigy system answers a growing market demand for devices that enhance patient access to new stimulation modes and therapy options,&rdquo; said Eric S Fain, group president of St Jude Medical. &ldquo;MRI compatibility for head and extremity will reduce treatment limitations or restrictions for chronic pain patients who may have future MRI needs. We want patients to have access to the most advanced therapies and technologies to effectively and safely reduce their chronic pain.&rdquo;</span></p></div>2015-08-24T13:26:00Z2015-08-24T13:26:00Zwebeditor@bibamedical.com number of people with dementia in some Western European countries could be stabilising<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>In a Policy View published in <em><a href="">The Lancet Neurology</a></em> journal, a group of leading experts on the epidemiology of dementia state that the number of people with dementia&mdash;both new cases and total numbers with the disease&mdash;in some Western European countries is stabilising despite population ageing, in direct contrast to the &ldquo;dementia epidemic&rdquo; reported in some recent studies.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Policy View discusses data from five large epidemiological studies done in Sweden, the Netherlands, the UK, and Spain that compare dementia occurrence in old people across two periods of time using the same methods of diagnosing dementia in the same geographical regions. The findings suggest that prevalence and incidence of dementia in specific age groups are falling across time and generations.</span></p> <p><br /><span style="font-size: 10pt;">Estimates of the proportion of dementia cases within countries are needed to plan for the provision of care, yet much of the evidence used at both national and local levels (such as the UK&rsquo;s NHS primary care targets) is based on research started in the 1980s. &ldquo;These old studies support the idea of a continuing &lsquo;dementia epidemic&rsquo;, but are now out of date because of changes in life expectancy, living conditions, and improvements in health care and lifestyle,&rdquo; says Carol Brayne, lead author and professor of public health medicine at the Cambridge Institute of Public Health (CIPH), University of Cambridge, UK.</span></p> <p><br /><span style="font-size: 10pt;">Findings from four of the five studies analysed in the Policy View showed non-significant changes in overall dementia occurrence over the past 20 to 30 years. The UK study showed a significant reduction (about 22%) in overall prevalence in people aged 65 years in 2011 than the predicted estimates in 1990, resulting in stabilisation of estimated numbers of people with dementia. Results from the study done in Zaragoza, Spain, showed a significant decline in dementia prevalence in men aged 65 and older (about 43%) between 1987 and 1996. The studies done in Stockholm, Sweden, and Rotterdam, the Netherlands, showed that the age-specific incidence of dementia is falling in these regions.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The suggested decrease in dementia occurrence coincides with improvements in protective factors, such as education and living conditions, for dementia and a general reduction in risk factors such as vascular diseases over recent decades,&rdquo; explains Brayne. &ldquo;Incidence and deaths from major cardiovascular diseases have decreased in high-income countries since the 1980s. We are now potentially seeing the results of improvements in prevention and treatment of key cardiovascular risk factors such as high blood pressure and cholesterol reflected in the risk of developing dementia.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to the researchers, although the decrease in dementia occurrence is a positive sign, dementia care will remain a crucial challenge for many years because of population ageing. &ldquo;It is important to remember that the number of people over age 85 is the fastest growing age demographic, with about 40% currently estimated to be affected by dementia,&rdquo; says co-author Yu-Tzu Wu from CIPH, University of Cambridge.</span></p> <p><br /><span style="font-size: 10pt;">Brayne concludes, &ldquo;Our up-to-date evidence suggests a relatively optimistic picture of possible future trends in dementia occurrence and strengthens the need to shift more of our societal and research focus to primary prevention across the lifecourse, with a rebalancing from what could be seen as the current overemphasis on diagnostics and drug interventions for dementia (which detect early or later assumed pathology). Policies which address determinants of health in earlier life stages and enhance cognitive reserve for populations may have the greatest long term impact on reduction of dementia risk at given ages in later life as well as on population health more generally.&rdquo;</span></p></div>2015-08-21T10:09:00Z2015-08-21T10:09:00Zwebeditor@bibamedical.com“We all need the strength” to challenge unacceptable behaviour<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The editor-in-chief of <em><a href="" target="_blank">Annals of Internal Medicine</a></em>, Christine Laine, and her fellow editors have called for doctors to confront colleagues who act in a disrespectful manner towards patients after an anonymous essay in the journal highlighted incidences in which unprofessional behaviour was condoned. Laine <em>et al</em> claim that doctors owe it to themselves, their profession, and their patients to address inappropriate actions. </strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In <em>Annals of Internal Medicine</em>, for a &ldquo;On being a doctor&rdquo; essay, an anonymous author recounts the story of a medical student who laughed along when his senior colleague made a crude remark while prepping a woman for vaginal hysterectomy&mdash;the colleague apparently suggested the women (who was under general anaesthetic at the time) was &ldquo;enjoying&rdquo; him cleansing and scrubbing her labia and inner thighs. The author writes that the student told them: &ldquo;Yeah, I laughed but what was I supposed to do? Have you ever been in a situation like that?&rdquo;, which prompts the author to admit that they also joined in when a colleague acted in a manner that, according to Laine <em>et al</em>, had &ldquo;heavy overtones of sexual abuse and racism&rdquo;.</span></p> <p><span style="font-size: 10pt;"><br />They then describe a case in which a physician named as &ldquo;Dr Canby&rdquo; saved the life of a patient (&ldquo;Mrs Lopez&rdquo;) by performing an internal bimanual uterine massage (with the patient under general anaesthetic) to stop excessive bleeding after a vaginal delivery. However, the author reports that Dr Canby subsequently&mdash;keeping his left hand in the woman&rsquo;s vagina&mdash;started to sing dance so that it looked like he was &ldquo;dancing with her&rdquo;. They add: &ldquo;He keeps dancing. And then he looks at me. I begin to sway to his beat. My feet shuffle. I hum and laugh along with him. Moments later, the anaesthetist yells &lsquo;Knock it off assholes!&rsquo; And we stop.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Laine <em>et al</em> write in an accompanying editorial that they published the essay because they hope it will &ldquo;gnaw on the consciences of readers who may recall an instance of their own repugnant behaviour&rdquo;. They add that they believe those who read the essay, upon realising how such behaviour appears to others, will &ldquo;hopefully think twice before acting in a manner that demeans patients and make trainees and colleagues squirm&rdquo;. Furthermore, the editors state that they want the essay to not only dissuade doctors from acting in such a manner but also &ldquo;call out our colleagues who do&rdquo;. &ldquo;We all need the strength to act like the anaesthesiologist in this story and call our colleagues &lsquo;assholes&rsquo; when that label is appropriate. We owe it to ourselves, to our profession, and especially to our patients,&rdquo; Laine <em>et al</em> write. &nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the editors, this is only the second time that the author of an article published in the <em>Annals of Internal Medicine</em> has been allowed to be anonymous. They explain: &ldquo;Then, as now, we did so to protect the identity of any person who might be identified, most importantly the patients.&rdquo;</span></p></div>2015-08-20T08:28:00Z2015-08-20T08:28:00Zwebeditor@bibamedical.com Pharmaceuticals initiates phase 2A study of Cirara in spinal cord injury<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A prospective multicentre open-label pilot study of Remedy Pharmaceuticals&rsquo; Cirara drug in patients with acute traumatic cervical spinal cord injuries has been initiated.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Up to five Level I trauma centres will be involved in the trial, including University of Ohio Wexner Medical Center, USA, as the principal site. The study&rsquo;s Principal Investigator is H Francis Farhadi, clinical assistant professor, Department of Neurological Surgery and Director, Spinal Surgery Fellowship Program at The Ohio State University, USA.</span></p> <p><br /><span style="font-size: 10pt;">According to the World Health Organization, annually there are between 133,000 and 226,000 cases of spinal cord injury worldwide, with approximately 12,000 new cases each year in the USA. Presently, over 250,000 people in the USA are living with a spinal cord injury.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There are currently no standard of care pharmaceutical strategies for the treatment of acute traumatic spinal cord injury,&rdquo; notes Sven Jacobson, chief executive officer of Remedy Pharmaceuticals. &ldquo;There remains a dire need for new therapies that will give hope to these patients and their families, who otherwise face years, even a lifetime of painful recovery, and often full paralysis.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Spinal cord injury causes progressive haemorrhagic necrosis, leading to devastating loss of spinal cord tissue. Emerging evidence points to the Sur1&ndash;Trpm4 channel as the molecular precursor of progressive haemorrhagic necrosis. Data from preclinical and human clinical studies has suggested that Remedy Pharmaceuticals&rsquo; drug candidate, Cirara, closes this channel, inhibiting spinal cord oedema and micro haemorrhage formation.</span></p> <p><br /><span style="font-size: 10pt;">The study will enrol and treat up to a maximum of 10 patients who will be matched in a 1:3 ratio with historical controls. Patients with cervical (C4&ndash;C8) level complete or incomplete injuries who are aged 18&ndash;70 years old will be eligible for inclusion in the study.</span></p> <p><br /><span style="font-size: 10pt;">The data obtained from this pilot study should inform the design of further multicentre phase II/III clinical studies evaluating the efficacy of Cirara in improving functional outcomes following spinal cord injury.</span></p></div>2015-08-19T09:04:00Z2015-08-19T09:04:00Zwebeditor@bibamedical.com ALS patients consume more calories but have lower BMIs than the general population<div style="clear:both;"><p><strong><span style="font-size: 11pt;">Presymptomatic patients with amyotrophic lateral sclerosis (ALS) consumed more daily calories but had lower body-mass index (BMI) than those individuals without ALS, reports a Dutch study that also looked at risk for the disease and associations with food and alcohol intake. The study was detailed in an article published online by <em><a href="">JAMA Neurology</a></em>.</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The cause of ALS is poorly understood. Diet is highly modifiable but previous studies have not identified a consistent nutrient that modifies susceptibility to ALS and contradictory results exist for the association with fat intake.</span><br /><br /></p> <p><span style="font-size: 10pt;">Jan H Veldink, of the University Medical Centre Utrecht, the Netherlands, and colleagues used a 199-item food frequency questionnaire to study premorbid (pre-illness) dietary intake and the risk of ALS.</span></p> <p><br /><span style="font-size: 10pt;">The study was conducted from 2006 to September 2011 and included all patients with a new diagnosis of ALS. The final analysis included 674 patients and 2,093 control patients without ALS.</span></p> <p><br /><span style="font-size: 10pt;">The authors found presymptomatic total calorie intake in patients was higher compared with those individuals in the control group (average 2,258 vs 2,119 kcal/day) and presymptomatic BMI was lower in patients (25.7 vs 26).</span></p> <p><br /><span style="font-size: 10pt;">The study analysis also suggests that higher premorbid intake of total fat, saturated fat, trans-fatty acids and cholesterol was associated with an increased risk of ALS, while higher alcohol intake was associated with a decreased risk. No significant associations were found between dietary intake and survival.</span></p> <p><br /><span style="font-size: 10pt;">The authors note limitations in their study that include the use of a questionnaire, which is prone to recall bias by participants.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The combination of independent positive associations of a low premorbid body mass index and a high fat intake together with prior evidence from ALS mouse models&hellip;and earlier reports on premorbid body mass index support a role for increased resting energy expenditure before clinical onset of ALS,&rdquo; the study concludes.</span></p></div>2015-08-18T11:05:00Z2015-08-18T11:05:00Zwebeditor@bibamedical.com of US emergency services for stroke differs by race and sex<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>During a&nbsp;stroke, slightly more than half of patients use emergency medical services to get to the hospital, with white women the most likely, and Hispanic men the least likely to use emergency transport, according to new research in&nbsp;<em><a href="">Journal of the American Heart Association</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Between October 2011 and March 2014, researchers analysed medical records from nearly 400,000 stroke patients admitted to more than 1,600 hospitals participating in the American Heart Association/American Stroke Association&rsquo;s&nbsp;&ldquo;Get With The Guidelines-Stroke&rdquo;, a quality initiative to improve stroke treatment. Fifty per cent of stroke patients were women, 69% were white, 19% were black, 8% were Hispanic and 3% were Asian. Average age was 71, and most had the most common type of stroke which is caused by a blocked blood vessel.<br /><br /></span></p> <p><span style="font-size: 10pt;">Researchers found:</span></p> <ul> <li><span style="font-size: 10pt;">Women were overall more likely than men to use emergency services in the event of a stroke, with 62% of white women being transported by emergency services.</span></li> <li><span style="font-size: 10pt;">About 58% of black women and men used emergency services.</span></li> <li><span style="font-size: 10pt;">About 57% of Asian women and white men used emergency services.</span></li> <li><span style="font-size: 10pt;">About 55.5% of Hispanic women and Asian men used emergency services.</span></li> <li><span style="font-size: 10pt;">The group least likely to use emergency services was Hispanic men, at a little more than 52%.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;These findings are critically important because a significant predictor of stroke-related disability is the time interval between symptom onset and medical treatment,&rdquo; said Heidi Mochari-Greenberger, lead author of the study and an associate research scientist at Columbia University Medical Center in New York, USA. &ldquo;The use of emergency medical service transport is associated with shorter hospital arrival times.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Fast treatment&nbsp;is critical during a stroke to restore blood flow to the brain and prevent tissue damage, and limit disability. Despite this, many people experiencing stroke symptoms do not receive timely treatment. Evidence shows that black people are more likely to die from a stroke than white people and that blacks and other minorities have more disability after a stroke than non-Hispanic whites. Since the reasons for these differences are unclear, the researchers sought to determine whether they might be related to emergency services use.</span></p> <p><br /><span style="font-size: 10pt;">In other findings that confirm previous research, the researchers found that patients with well-recognised stroke symptoms, such as weakness, speech difficulty, or altered consciousness, were much more likely to use emergency medical services than people with less well-known symptoms.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This information highlights a need for healthcare providers to educate patients and their families about stroke warning signs and taking action to call 9-1-1,&rdquo; Mochari-Greenberger said. &ldquo;Calling 9-1-1 at the time of stroke onset not only may increase the likelihood of one&rsquo;s own survival, but those who are educated may also be in a position to save a life if they observe stroke symptoms in someone else and call emergency medical services immediately.&rdquo;</span></p></div>2015-08-14T15:10:00Z2015-08-14T15:10:00Zwebeditor@bibamedical.com Cell Therapeutics completes enrolment in phase 2 trial of NurOwn in amyotrophic lateral sclerosis<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>BrainStorm Cell Therapeutics has completed enrolment in its ongoing randomised, double-blind placebo-controlled phase 2 clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS).&nbsp; The targeted enrolment of 48 subjects has been achieved.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Completion of enrolment in this phase 2 trial is a major corporate milestone for BrainStorm,&rdquo; stated chief executive officer Tony Fiorino. &ldquo;We continue to expect the last subject to be treated early in the fourth quarter of this year and top line results to be available shortly after the follow-up period is complete. This study has attracted much interest from both patients and physicians, and we anticipate it to give us valuable insights into the safety and efficacy of NurOwn in ALS.&nbsp; Given the limited treatment options for patients with ALS, we are hopeful that this study will move NurOwn another step closer to becoming a treatment for ALS.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Merit Cudkowicz, professor of neurology at Harvard Medical School, director of the ALS Clinical at Massachusetts General Hospital ALS Clinic, and a principal investigator for the trial, stated, &ldquo;I want to thank the participants and their families for being part of this study and helping develop new therapies for ALS. Completion of enrolment is a very important milestone. We look forward to completing close follow-up and learning the results of this study.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">This multicentre, randomised, double blind, placebo controlled study is evaluating the safety and efficacy of a single combined intramuscular and intrathecal administration of MSC-NTF cells (NurOwn) in early-stage ALS patients. After enrolling in the study, subjects are followed for a three months run-in period, during which their bone-marrow is harvested and mesenchymal stromal cells are isolated and expanded. Subjects are then randomised to receive either NurOwn or placebo, after which they are followed for six months. The primary endpoint of the study is safety, and secondary endpoints are efficacy measures including the ALS Functional Rating Scale, slow vital capacity, and grip strength.</span></p> <p><br /><span style="font-size: 10pt;">In February 2015, the Data Safety and Monitoring Board (DSMB) overseeing the trial completed its first safety review of the trial, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern. A second and final DSMB review is planned the fourth quarter of 2015.</span></p></div>2015-08-11T13:44:00Z2015-08-11T13:44:00Zwebeditor@bibamedical.com Medical Patient Therapy Controller receives FDA approval<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Flowonix Medical&rsquo;s newest product, the Patient Therapy Controller (PTC), has been approved for US market release by the Food and Drug Administration. The PTC interfaces with the company&rsquo;s Prometra platform of intrathecal infusion devices. A small, hand-held device with a touch-screen, the PTC allows the patient to initiate a bolus delivery of medication from the implanted pump.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The new Patient Therapy Controller, or PTC, allows patients to administer a bolus of medication as needed," stated Jason Pope, president of Summit Pain Alliance in Petaluma, USA. &ldquo;Patients need only to press the Rx button and hold the PTC over the implanted pump. The PTC then communicates with the pump and the supplemental medication is delivered. It is intuitively easy to use and it provides greater flexibility for pump patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Chronic pain is estimated to affect 116 million Americans. Back pain alone is the leading cause of disability in Americans under 45 years old. Flowonix is dedicated to providing ongoing solutions designed for the relief of pain, receiving approval for three new products in 2015, including the Prometra II, the longest-lasting targeted drug delivery device available.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Breakthrough pain can be a significant problem for this patient population. Oral medications are not ideal for treating breakthrough pain because of the potential for side effects and abuse,&rdquo; stated W Porter McRoberts, medical director of Interventional Spine, Pain and Neurosurgery at Holy Cross Hospital in Fort Lauderdale, USA. &ldquo;The PTC allows a patient experiencing breakthrough pain to deliver a bolus of pain medication which provides quick and effective pain relief. Not only can the PTC help to control breakthrough pain better, it may help reduce or eliminate the need for oral analgesics.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Flowonix president and chief executive officer, Steven Adler added, &ldquo;Our new Patient Therapy Controller demonstrates our ongoing commitment to making the Prometra drug delivery system the most advanced infusion system available. This device will allow a great number of patients, specifically those with variable pain pathologies, to benefit from targeted drug delivery.&rdquo;</span></p></div>2015-08-07T13:51:00Z2015-08-07T13:51:00Zwebeditor@bibamedical.com clears Leksell Gamma Knife Icon<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;">Elekta&rsquo;s Leksell Gamma Knife Icon radiosurgery system has received 510(k) clearance from the US Food and Drug Administration, enabling US healthcare providers to offer this advanced technology to their patients. With stereotactic imaging, online Adaptive DoseControl, ultra-precise dose delivery and the availability of frameless treatments, Icon is capable of treating virtually any target in the brain, regardless of type, location or volume.</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Gamma Knife Icon represents the sixth generation of the company&rsquo;s Leksell Gamma Knife system, a technology that has been in use worldwide and continually evolving since the 1980s. Gamma Knife radiosurgery is a gentler alternative to traditional brain surgery for illnesses such as metastatic disease, which is cancer that has travelled to the brain from elsewhere in the body. With pinpoint accuracy, the system delivers up to thousands of low-intensity radiation beams to one or more targets in a single session.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Leksell Gamma Knife Icon offers a new model for the application of precise radiosurgery for a virtually unlimited range of cranial cases,&rdquo; says Bill Yaeger, executive vice president Region North America. &ldquo;Physicians have the flexibility to employ either frame-based or frameless techniques to immobilise the patient&rsquo;s head, in addition to the option to treat the patient in one session or multiple sessions. Importantly, Icon is the only system with the accuracy to enable ultra-precise microradiosurgery in cases that demand the utmost precision.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Integrated in Gamma Knife Icon are novel online Adaptive DoseControl and high-definition motion management technologies that assure the highest accuracy for all treatments, as well as an efficient workflow.</span></p> <p><span style="font-size: 10pt;"><br />Soon after Elekta CE marked Gamma Knife Icon in June 2015, the University Hospital La Timone (Marseilles, France) installed the first Gamma Knife Icon system.</span></p></div>2015-08-05T14:34:00Z2015-08-05T14:34:00Zwebeditor@bibamedical.com test predicts prognosis for traumatic brain injuries<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A new blood test could help emergency room doctors quickly diagnose traumatic brain injury and determine its severity. The findings, published in the&nbsp;<em><a href="">Journal of Neurotrauma</a></em>, could help identify patients who might benefit from extra therapy or experimental treatments.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Compared to other proteins that have been measured in traumatic brain injury, brain-derived neurotrophic factor (BDNF) does a much better job of predicting outcomes,&rdquo; says&nbsp;Frederick Korley, an assistant professor of emergency medicine at the Johns Hopkins University School of Medicine, USA, and first author of the new paper.</span><br /><br /></p> <p><span style="font-size: 10pt;">After a blow to the head or rapid whiplash, whether from a car crash, athletic event or other accident, millions of Americans develop traumatic brain injuries (TBIs) each year. TBIs can range from mild concussions causing only a headache or temporary blurred vision to much more severe injuries causing seizures, confusion, memory and attention problems, muscle weakness, or coma for many months. These symptoms, whether mild or more severe, are generally caused by damaged brain cells.</span></p> <p><br /><span style="font-size: 10pt;">Until now, most physicians have relied on computed tomography (CT) scans and patients&rsquo; symptoms to determine whether to send them home and have them resume their usual activities or take extra precautions. However, CT scans can only detect bleeding in the brain, not damage to brain cells, which can happen without bleeding.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;A typical situation is that someone comes to the emergency department with a suspected TBI, we get a CT scan, and if the scan shows no bleeding, we send the patient home,&rdquo; says Korley. &ldquo;However, these patients go home and continue having headaches, difficulty concentrating and memory problems, and they cannot figure out why they are having these symptoms after doctors told them everything was fine.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Korley and collaborators around the country wanted to know if a blood test could better predict which patients would have ongoing brain injury-related problems, to provide better treatment for them. They measured the levels of three proteins that they suspected play a role in brain cell activity in more than 300 patients with a TBI and 150 patients without brain injuries. Then, they followed those with a TBI for the next six months.</span></p> <p><br /><span style="font-size: 10pt;">Levels of BDNF protein, taken within 24 hours of a head injury, could predict the severity of a TBI and how a patient would fare, they found. While healthy people averaged 60 nanograms per millilitre of BDNF in their bloodstreams, patients with brain injuries had less than one-third of that amount, averaging less than 20 nanograms per millilitre, and those with the most severe TBIs had even lower levels, around 4 nanograms per millilitre. Moreover, patients with high levels of BDNF had mostly recovered from their injuries six months later, while in patients with the lowest levels of BDNF, symptoms still lingered at follow-up. The results suggest that a test for BDNF levels, administered in the emergency room, could help stratify patients.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The advantage of being able to predict prognosis early on is that you can advise patients on what to do, recommend whether they need to take time off work or school, and decide whether they need to follow up with a rehab doctor or neurologist,&rdquo; Korley says. In addition, it could help decide which patients to enrol in clinical trials for new drugs or therapies targeting severe TBIs.</span></p> <p><br /><span style="font-size: 10pt;">Korley would like to follow up with more research on why, at a molecular level, brain injuries lower levels of BDNF in the blood and whether things known to increase BDNF levels&mdash;including exercise and omega-3 fatty acids&mdash;could help treat TBIs. He also wants to know whether changes in BDNF levels over time can be a proxy for recovery and if they could be used to gauge the effectiveness of an intervention.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We looked at that very first blood sample obtained within 24 hours of an injury,&rdquo; he says. &ldquo;But for BDNF to be used as a surrogate outcome, we will have to see what happens to BDNF blood levels down the line, at one, three or six months after the injury.&rdquo; He and his collaborators have already started collecting data for those prospective studies, he adds.</span></p></div>2015-08-05T11:45:00Z2015-08-05T11:45:00Zwebeditor@bibamedical.com software speeds detection of brain volume changes and diagnosis of degenerative brain diseases<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Danish medical device company Brainreader has launched a new software product that has the potential to speed the detection of changes in a patient&rsquo;s brain volume&mdash;a key indicator in the diagnosis of degenerative brain diseases such as Alzheimer&rsquo;s disease, epilepsy and depression.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The software, Neuroreader, also can help identify changes in brain volume associated with concussions and other traumatic brain injuries.</span></p> <p><br /><span style="font-size: 10pt;">In use by a growing number of radiologists and neuroradiologists in the USA and Europe, Neuroreader analyses magnetic resonance imaging (MRI) scans of patients&rsquo; brain and benchmarks it against a Food and Drug Administration (FDA)-cleared database of healthy brain tissues in a matter of minutes. Neuroreader is the only service of its kind to have received FDA clearance for its normative database and for the statistical calculations resulting from comparing the measured volumes to that database. The software measures 45 specific structures within the brain.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Brain scans are typically analysed visually by radiologists in what can be a time-consuming process, especially when changes in brain volume are slight,&rdquo; said Jamila Ahdidan, founder and chief technology officer of Brainreader. &ldquo;When looking for changes as small as hundredths of a millimetre, a software-driven analysis allows for these tiny changes to be detected in minutes.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">For more than 30 years, since the development of the MRI scanner, physicians have ordered MRI scans of the brain to identify traumatised, diseased or atrophied tissue.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Radiologists rely on our human pattern recognition to identify tiny abnormalities in patients&rsquo; brains,&rdquo; said Barton Branstetter, neuroradiologist at University of Pittsburgh Medical Center, USA. &ldquo;But even the best radiologist cannot precisely determine the volume of every structure in the brain without hours of intensive manual calculations. Neuroreader gives us easy, reliable, reproducible volume measurements, and takes the guesswork out of analysing structures in our patients&rsquo; brains.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">When treating a patient with signs of neurodegenerative diseases, such as Alzheimer&rsquo;s, the physician uploads the MR image to the Brainreader server. Neuroreader then analyses the MRI scan and delivers a report in less than five minutes, indicating &nbsp;which brain structures&rsquo; volume are abnormal and to what extent. The software, which has an intuitive interface, produces an easily interpreted automated report featuring an analysis of an unprecedented number of structures within the brain, in less than five minutes. All the information presented in the Neuroreader report is FDA-cleared, unlike the information in competing software.</span></p> <p><br /><span style="font-size: 10pt;">One of those brain structures is the hippocampus, the measurement of which is vital in determining a person&rsquo;s ability to maintain strong cognitive function, according to neurologist and Alzheimer&rsquo;s disease expert Majid Fotuhi, chairman, NeuroGrow Brain Fitness Center, McLean, and Johns Hopkins Medicine, Baltimore, USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Measuring the size of the hippocampus is the single most important factor in determining a person&rsquo;s prognosis for having strong memory performance in the future,&rdquo; said Fotuhi. &ldquo;That is where the Neuroreader comes in. It is a major breakthrough in establishing an accurate measurement of this part of the brain.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to Fotuhi, the Neuroreader will help him and his colleagues diagnose patients early for degenerative brain diseases and to create treatment plans that can not only slow the loss of brain tissue, but even to build it back up. &ldquo;In the future, I believe it will become routine for patients&mdash;and their doctors&mdash;to know the volume of their hippocampus and to have it monitored regularly,&rdquo; said Fotuhi.</span></p> <p><br /><span style="font-size: 10pt;">According to Dale E Bredesen, Augustus Rose professor of neurology at UCLA, and founding president and chief executive officer of the Buck Institute for Research on Aging: &ldquo;Recent publications have offered some of the first evidence for functional, sustained improvement in neurodegenerative conditions, and the ability to quantitate multiple brain region volumes reproducibly and longitudinally will be critical as therapeutic programs are being refined.&nbsp;Neuroreader&nbsp;is perfectly suited for this.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Neuroreader, which is sold as software-as-a-service, is available to hospitals radiology and neuroradiology departments on a pay-per-use or subscription model tailored to the healthcare organisation&rsquo;s wishes.</span></p></div>2015-08-04T11:13:00Z2015-08-04T11:13:00Zwebeditor@bibamedical.com men move legs with new non-invasive spinal cord stimulation<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Five men with complete motor paralysis were able to voluntarily generate step-like movements thanks to a new strategy that non-invasively delivers electrical stimulation to their spinal cords, according to a new study funded in part by the National Institutes of Health (NIH).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The strategy, called transcutaneous stimulation, delivers electrical current to the spinal cord by way of electrodes strategically placed on the skin of the lower back. This expands to nine the number of completely paralysed individuals who have achieved voluntary movement while receiving spinal stimulation, though this is the first time the stimulation was delivered non-invasively. Previously it was delivered via an electrical stimulation device surgically implanted on the spinal cord.</span></p> <p><br /><span style="font-size: 10pt;">In the study, the men&rsquo;s movements occurred while their legs were suspended in braces that hung from the ceiling, allowing them to move freely without resistance from gravity. Movement in this environment is not comparable to walking; nevertheless, the results signal significant progress towards the eventual goal of developing a therapy for a wide range of individuals with spinal cord injury.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These encouraging results provide continued evidence that spinal cord injury may no longer mean a life-long sentence of paralysis and support the need for more research,&rdquo; said Roderic Pettigrew, director of the National Institute of Biomedical Imaging and Bioengineering at the NIH. &ldquo;The potential to offer a life-changing therapy to patients without requiring surgery would be a major advance; it could greatly expand the number of individuals who might benefit from spinal stimulation. It is a wonderful example of the power that comes from combining advances in basic biological research with technological innovation.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study was conducted by a team of researchers at the University of California, Los Angeles; University of California, San Francisco, USA; and the Pavlov Institute, St Petersburg, Russia. The team was led by V Reggie Edgerton, UCLA, and Yury Gerasimenko, director of the laboratory of movement physiology at Pavlov Institute and a researcher in UCLA&rsquo;s Department of Integrative Biology and Physiology. They reported their results in the <em><a href="">Journal of Neurotrauma</a></em>.</span></p> <p><br /><span style="font-size: 10pt;">In a study published just over a year ago, Edgerton&mdash;along with Susan Harkema and Claudia Angeli from the University of Louisville, Kentucky, USA&mdash;reported that four men with complete motor paralysis were able to generate some voluntary movements while receiving electrical stimulation to their spinal cords. The stimulation came from a device called an epidural stimulator that was surgically implanted on the surface of the men&rsquo;s spinal cords. On the heels of that success, Edgerton and colleagues began developing a strategy for delivering stimulation to the spinal cord non-invasively, believing it could greatly expand the number of paralysed individuals who could potentially benefit from spinal stimulation.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There are a lot of individuals with spinal cord injury that have already gone through many surgeries and some of them might not be up to or capable of going through another,&rdquo; said Edgerton. &ldquo;The other potentially high impact is that this intervention could be close to one-tenth the cost of an implanted stimulator.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">During this most recent study, five men&mdash;each paralysed for more than two years&mdash;underwent a series of 45 minute sessions, once a week, for approximately 18 weeks, to determine the effects of non-invasive electrical stimulation on their ability to move their legs.</span></p> <p><br /><span style="font-size: 10pt;">In addition to stimulation, the men received several minutes of conditioning each session, during which their legs were moved manually for them in a step-like pattern. The goal of the conditioning was to assess whether physical training combined with electrical stimulation could enhance efforts to move voluntarily.</span></p> <p><br /><span style="font-size: 10pt;">For the final four weeks of the study, the men were given the pharmacological drug buspirone, which mimics the action of serotonin and has been shown to induce locomotion in mice with spinal cord injuries. While receiving the stimulation, the men were instructed at different points to either try to move their legs or to remain passive.</span></p> <p><br /><span style="font-size: 10pt;">At the initiation of the study, the men&rsquo;s legs only moved when the stimulation was strong enough to generate involuntary step-like movements. However, when the men attempted to move their legs further while receiving stimulation, their range of movement significantly increased. After just four weeks of receiving stimulation and physical training, the men were able to double their range of motion when voluntarily moving their legs while receiving stimulation. The researchers suggest that this change was due to the ability of electrical stimulation to reawaken dormant connections that may exist between the brain and the spinal cord of patients with complete motor paralysis.</span></p> <p><br /><span style="font-size: 10pt;">Surprisingly, by the end of the study, and following the addition of buspirone, the men were able to move their legs with no stimulation at all and their range of movement was&mdash;on average&mdash;the same as when they were moving while receiving stimulation.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It is as if we have reawakened some networks so that once the individuals learned how to use those networks, they become less dependent and even independent of the stimulation,&rdquo; said Edgerton.</span></p> <p><br /><span style="font-size: 10pt;">The researchers also made extensive recordings of electrical signals generated in the calf muscle and the muscle directly below the calf while the men attempted to flex their feet during stimulation. Over time, these signals increased with the same amount of stimulation, further supporting the hypothesis of re-established communication between the brain and spinal cord.</span></p> <p><br /><span style="font-size: 10pt;">Edgerton has already initiated a new study to see whether these same men can be trained with non-invasive spinal stimulation to fully bear their weight, a feat that the four men with surgically implanted stimulators have already achieved. In addition, he is interested in determining whether, similar to epidural stimulation, non-invasive stimulation can help individuals regain some autonomic functions lost due to paralysis such as the ability to sweat, regulate blood pressure, and control bladder, bowel, and sexual function.</span></p> <p><br /><span style="font-size: 10pt;">The hope is that further research can help determine whether non-invasive stimulation can restore function that will truly impact patient lives.</span></p> <p><br /><span style="font-size: 10pt;">Edgerton also wants to test non-invasive stimulation on individuals who have partial paralysis. &ldquo;We have focused on individuals with complete paralysis throughout this whole process because we knew that was going to be the toughest patient population to see changes in. We have always thought, and we have every reason to believe, that those individuals with partial injuries have even more room for improvement,&rdquo; said Edgerton.</span></p> <p><br /><span style="font-size: 10pt;">Though a non-invasive stimulation could offer advantages over a surgically implanted device, Edgerton says both need to continue to be developed. For example, a non-invasive stimulator might be useful in determining whether a patient will be receptive to neuromodulation, which could then help determine whether undergoing surgery to implant a stimulator is warranted. Alternatively, Edgerton speculates it may be possible early after an injury for non-invasive stimulation to help patients achieve a certain level of motor control that then allows them to continue to improve with physical rehabilitation and avoid surgery altogether.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;All patients are going to need something slightly different, and maybe non-invasive stimulation is going to be best in some cases and epidural stimulation in others,&rdquo; said Edgerton. &ldquo;What we need to do is maximise the clinical tool box that we have so that the physician and the patient can select a therapy that is best for them.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-07-31T11:50:00Z2015-07-31T11:50:00Zwebeditor@bibamedical.com tools used to select patients for aneurysm treatment in need of further evaluation<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A study released at the Society of NeuroInterventional Surgery 12th Annual Meeting (27&ndash;30 July, San Francisco, USA), indicates that strict adherence to two commonly-used tools to weigh the risk of treating unruptured aneurysms may not prevent the majority of morbidity-mortality outcomes associated with ruptured intracranial aneurysms. Thus, the International Study of Unruptured Intracranial Aneurysms (ISUIA) criteria and the PHASES score require additional research to determine their effectiveness.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Published in 2003, the ISUIA study predicted the risk of aneurysmal rupture based primarily upon size and site of the aneurysm. Posterior circulation aneurysms larger than 7mm were reported as having the highest rupture risk when compared to their counterparts in the anterior circulation. A decade later, the PHASES score was developed to calculate aneurysmal rupture risk based upon a myriad of factors, including the patient population, history of hypertension, age, size of aneurysm, history of earlier subarachnoid haemorrhage, and site of aneurysm. With this tool, a cumulative score of 8 predicts a five-year risk of rupture of 3.2%.</span></p> <p><br /><span style="font-size: 10pt;">In the recently-released study, entitled &ldquo;A re-evaluation of the ISUIA criteria and the PHASES score for predicting intracranial aneurysmal rupture&rdquo;, these standard results were compared to an analysis of 520 ruptured aneurysms (from an institutional database) treated at Emory University Hospital. When measuring against ISUIA, the study produced different results from standard, showing that approximately 77% of ruptured aneurysms measured smaller than 7mm in their largest diameter, regardless of location in either the anterior or posterior circulations. When comparing to PHASES, results indicated that approximately 90% of study patients received a score of less than 8, putting their predicted five-year risk of rupture at 3.2%.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Despite the fact that ISUIA and PHASES standards are widely accepted and used within the field, it is important that we continue to re-evaluate them, and compare them with the data and experience at large academic centres,&rdquo; said Arsalaan Salehani, lead study author and fourth year medical student at Emory University School of Medicine in Atlanta, USA. Raul Nogueira, neuroendovascular division director at Grady Memorial Hospital, adds, &ldquo;As our database grows, we plan to continually re-analyse our findings not only to broadly contribute to the academic community, but to ultimately ensure that physicians are using the best criteria and guidelines when making decisions about patient selection for treatment.&rdquo;</span></p></div>2015-07-31T08:00:00Z2015-07-31T08:00:00Zwebeditor@bibamedical.com innovation is driving improvement in stroke treatment outcomes<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>In the last decade, intra-arterial stroke therapy (in which thrombolytic agents and devices are passed through the arteries directly to the clot site) has gained notable momentum as an effective and safe treatment option for patients. Two new studies released at the Society of NeuroInterventional Surgery 12th Annual Meeting (27&ndash;30 July, San Francisco, USA) further reinforce the value and progress of intra-arterial treatment and conclude that the new devices that facilitate this approach are reducing treatment times, improving outcomes and decreasing mortality rates.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Since Stent Retrievers&mdash;the latest evolution of devices for intra-arterial treatment&mdash;became available in 2012, no comparative analysis with pre-retriever devices has been conducted to determine differences in utilisation or clinical outcomes. In the &ldquo;Trends and outcomes of mechanical thrombectomy in patients with acute ischemic stroke: A review of national in-patient database&rdquo;, joint investigators, Srikanth Boddu and Ning Lin, at New York Presbyterian Hospital and Weill Cornell Medical Center in New York, USA, used the Nationwide Inpatient Sample database provided by the Agency for Healthcare Research and Quality to analyse outcomes across three generations of devices: 2006&ndash;2007 (post-MERCI); 2008&ndash;2011 (post-Penumbra); and 2012 (stent retrievers).</span></p> <p><br /><span style="font-size: 10pt;">Results showed that while the number of stroke cases climbed across these three time periods&mdash;from 723,327 to 738,490&mdash;the rate of deaths decreased with newer devices. In 2012, stent retrievers were associated with a mortality rate of 17.1% vs pre-retriever devices in both 2008&ndash;2011 (19.3%) and 2006&ndash;2007 (25%). Additionally, the age-specific mortality following stroke intervention decreased with newer devices for patients &ge;80 and 65&ndash;79 years of age: 2012 (20% and 14.9%, respectively) compared to 2008&ndash;2011 (25.8% and 20.5%, respectively) and 2006&ndash;2007 (26.3% and 30.2%, respectively). These findings are significant as they prove that older patients can in fact benefit from intra-arterial therapy and that age, alone, is not an exclusion criteria for interventional treatment.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It is clear that the introduction of stent retrievers for stroke treatment has been a significant game changer. Not only have these tools provided practitioners with new approaches to treatment,&rdquo; said Srikanth Boddu, lead investigator and interventional neuroradiologist at the Weill Cornell Brain and Spine Center in New York, USA, &ldquo;but we have also proven that innovation is worth the investment. With treatment advances, we are seeing increasing numbers of patients survive stroke.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In a second study, &ldquo;Implementation of new technological advances of endovascular treatment in acute ischemic stroke provides overall improvement in procedural times&rdquo;, conducted at the Swedish Medical Center in Englewood, USA, the usefulness and performance afforded by evolving devices were again the focus as investigators sought to understand if newer tools were associated with better outcomes and shorter procedural times. A data analysis was conducted across six prospective and retrospective endovascular treatment trials, with various evolutions of the Penumbra Aspiration System being used as the primary therapy. Out of a pool of 932 subjects, study results showed that the newer and larger Penumbra catheters provided a faster and more efficient method for treating acute ischaemic stroke. In turn, when considering variables including age, baseline National Institutes of Health Stroke Scale (NIHSS) score, and post-treatment status of restoration of blood flow, shorter procedural times were a significant predictor of better clinical outcomes at 90 days, as measured by the modified Rankin Scale&mdash;a standard tool used to indicate level of independence following a stroke.</span></p> <p><br /><span style="font-size: 10pt;">Donald Frei, lead author of the study, president of the Society of NeuroInterventional Surgery and neurointerventionalist at Swedish Medical Center, echoed the optimistic sentiment espoused by Boddu. &ldquo;As each new generation of devices provides improved tools for our treatment arsenal, we are able to adjust our approach to maximise efficiencies and results for our patients. Time is the most important factor when treating a stroke, so it is incumbent upon all of us to use every tool at our disposal to achieve fast and effective treatment,&rdquo; Frei said. &ldquo;Thankfully, each generation of new devices has proven to reduce procedure time, which raises the chance of a successful operation.&rdquo;</span></p></div>2015-07-29T08:45:00Z2015-07-29T08:45:00Zwebeditor@bibamedical.com Neuro launches family of coils for treatment of brain aneurysms<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Codman Neuro, part of DePuy Synthes Companies of Johnson &amp; Johnson, has introduced a new platform of embolic coils for the treatment of brain aneurysms, supported by an enhanced detachment system designed to improve microcatheter stability and provide an optimised detachment zone for coils. The announcement was made at the Society of NeuroInterventional Surgery 12th Annual Meeting (SNIS; 27&ndash;30 July, San Francisco, USA).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The family of framing, filling and finishing coils used during a minimally invasive endovascular procedure is designed to help doctors individualise intervention based on the unique anatomy of the aneurysm.</span></p> <p><br /><span style="font-size: 10pt;">Offering coils designed for each step of the procedure may help clinicians achieve aneurysm stability, effective neck coverage and the packing density needed for treatment of brain aneurysms. Codman Neuro says it is the only company to offer coil shapes for each step of the procedure&mdash;Micrusframe coils for framing, Galaxy G3 coils for filling, and Deltaxsft coils for finishing.</span></p> <p><br /><span style="font-size: 10pt;">The enhanced detachment system provides the physician with improved microcatheter stability. Tactile fluoro markers on the delivery wire improve visibility and control during the procedure, potentially reducing X-ray exposure time for patients and hospital staff.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The Codman Neuro family of coils and detachment system provide the best of both worlds; a softer detachment and three types of coils that help me individualise treatment based on the anatomy of the aneurysm,&rdquo; said Ajit S Puri, Division of Neurointerventional Surgery at UMass Memorial Medical Center in Worcester, USA. &ldquo;Also, the new fluoro markers may help tactically navigate the procedure better.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to the American Stroke Association, about 3&ndash;5 million people in the USA have cerebral aneurysms. During a coiling procedure, tiny coils are deployed directly into the aneurysm in a minimally invasive interventional procedure using a microcatheter, to induce clotting or embolisation and prevent rupture. The coils may be of various shapes, sizes and configurations and are deployed by the physician depending on the anatomy of the aneurysm.</span></p> <p><br /><span style="font-size: 10pt;">The Codman Neuro family of coils features Deltawind technology. This coil technology was designed with hundreds of natural micro-deflection points so the coils can easily change direction, which allows the coils to seek and fill open spaces and be uniformly distributed to facilitate increased packing density. High packing densities have been correlated with low patient retreatment rates.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our coils are unique because they allow the physician to truly tailor the procedure at every step,&rdquo; said P Laxmin Laxminarain, worldwide president of Codman Neuro. &ldquo;Coupled with a new, softer delivery system, our coil platform is designed to improve how aneurysms are treated, and is an example of the continued commitment of Codman Neuro to innovation in neurovascular care.&rdquo;</span></p></div>2015-07-29T08:15:00Z2015-07-29T08:15:00Zwebeditor@bibamedical.com stroke treatments proven to reduce health care costs<div style="clear:both;"><p class="p1"><span style="font-size: 11pt;"><strong>&nbsp;</strong></span></p> <p class="p2"><span style="font-size: 11pt;"><strong>Use of mechanical thrombectomy on qualifying stroke patients could result in major savings to the healthcare economy in the United Kingdom and other western countries with a similar healthcare structure, according to a new study presented at the Society of NeuroInterventional Surgery 12<span class="s2">th </span>Annual Meeting in San Francisco, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p class="p1">&nbsp;</p> <p class="p2"><span style="font-size: 10pt;">The study, <em>Developing an Interventional Stroke Service: Improving Clinical Outcomes and Reducing Cost and Delivering Great Cost Savings Benefits to Health Economy, </em>conducted at the University Hospital of North Midlands, Stoke-on-Trent, UK, found that mechanical thrombectomy (the use of a device to retrieve a clot from the vessel) in the treatment of stroke reduced the average stroke patient&rsquo;s hospital stay to 14 days when compared to previously recorded 90 days. In addition, more than nine in 10 patients were discharged to their home as opposed to a nursing home. Using this data, the study also found the use of mechanical thrombectomy produced a net savings of &pound;3.2 million (approximately US$5 million), or &pound;684,000 per 100,000 populations served (approximately US$1.1 million). The study estimates that there are around 20,000 to 25,000 potential patients that could receive mechanical thrombectomy within the UK if used as a mainstream treatment for large vessel clots.</span></p> <p class="p2"><br /><span style="font-size: 10pt;">&ldquo;It&rsquo;s quite amazing that this treatment can make such a notable impact, both medically and economically,&rdquo; said Sanjeev Nayak, the lead author of the study and a neurointerventionalist at the University Hospital of North Midlands. &ldquo;Not only are we seeing patient mortality and time in the hospital reduced dramatically when treating large vessel clots with mechanical thrombectomy, but we are saving money in the process. This procedure shows strong benefit, both for eligible patients and our healthcare system as a whole.&rdquo;</span></p> <p class="p2"><br /><span style="font-size: 10pt;">While the clot-busting drug known as t-PA (tissue plasminogen activator) had been the only medical therapy approved for treatment of acute stroke in the United States, the projected UK cost savings of mechanical thrombectomy treatment as reported in the study could correlate to the USA, making the treatment an even better option. In America, stroke is the leading cause of disability and the fourth cause of death. In 2010, stroke cost the USA an estimated US$54 billion, including the cost of health care services, medications and missed days of work. Additionally, strokes account for US$74 billion in health care expenditures annually for treatment due to disability.</span></p></div>2015-07-29T02:38:00Z2015-07-29T02:38:00Zwebeditor@bibamedical.com stroke units may improve survival rates for ischaemic stroke patients<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p class="p1"><span style="font-size: 11pt;"><strong>&nbsp;</strong></span></p> <p class="p2"><span style="font-size: 11pt;"><strong>Two new studies presented at the Society of NeuroInterventional Surgery 12th Annual Meeting in San Francisco, USA, report that Mobile Stroke Treatment Units (MSTUs) can significantly reduce the time it takes to diagnose and treat patients for stroke, greatly improving survival rates and enhancing a patient&rsquo;s chance of recovery.</strong></span></p></div><div style="clear:both; text-align:left"><p class="p1">&nbsp;</p> <p class="p2"><span style="font-size: 10pt;">There are currently four MSTUs in use worldwide. Two are in Germany and two are in the United States &ndash; one in Cleveland and one in Houston. MSTUs resemble ambulances on the outside, but contain highly specialised staff, equipment and medications strictly used for diagnosing and treating strokes. Specifically, they are equipped with diagnostic tools and telemedicine capabilities that facilitate real-time communication with hospital-based stroke specialists, enabling immediate diagnosis and the administration of IV t-PA for eligible patients while en route to the hospital.</span></p> <p class="p2"><br /><span style="font-size: 10pt;">&ldquo;Determining and facilitating the correct treatment in the shortest amount of time is the most important part of treating stroke, as any delay in treatment can be deadly,&rdquo; said Shazam Hussain, Head of the Cleveland Clinic Stroke Program. &ldquo;Time is never on our side, but it&rsquo;s clear that Mobile Stroke Treatment Units offer the best chance for patients to receive care as fast as possible, sometimes beginning before the patient even arrives at a facility.&rdquo;</span></p> <p class="p2"><span style="font-size: 10pt;"><em><br />Mobile Stroke Treatment Unit and Golden Hour Thrombolysis for Emergent Large Vessel Occlusion: Initial Experience </em>conducted at the Cleveland Clinic in Cleveland, Ohio, examined patients who received IV t-PA from MSTUs and found that it improved flow restoration rates for emergent large vessel occlusion strokes (ELVO) that were treated in the &ldquo;golden hour&rdquo; following symptom onset. Additionally, MSTUs reduced time for qualifying patients to receive intra-arterial therapy (IAT), treatment that is administered through the arteries directly to the clot site, for ELVO strokes. A second study, Triage of Emergent Large Vessel Occlusion Strokes with the Mobile Stroke Treatment Unit, also conducted at the Cleveland Clinic, found that among study subjects who received intra-arterial therapy or IAT, MSTUs significantly reduced numerous time intervals along the emergency stroke care continuum in comparison to controls, including dispatch to door (19min vs. 31min, p=0.03), door to initial CT (12min vs. 32min, p=0.01), and CT to IAT (82min vs. 165min, p=0.01).</span></p> <p class="p2"><br /><span style="font-size: 10pt;">Other studies support the need for the capabilities of MSTUs. In ESCAPE, a widely recognised stroke study earlier this year, researchers found that routing patients directly to a comprehensive stroke centre may significantly decrease patient wait time for treatment. &nbsp;<br /><br />Although advances in stroke treatment over the last decade have improved patient survival rates, prompt treatment upon symptom onset is still the key to not only survival but also avoiding long-term disability.</span></p></div>2015-07-29T02:26:00Z2015-07-29T02:26:00Zwebeditor@bibamedical.com transport times for stroke patients still in need of improvement, study shows<div style="clear:both;"><p class="p1"><span style="font-size: 11pt;"><strong>&nbsp;</strong></span></p> <p class="p2"><span style="font-size: 11pt;"><strong>Despite efforts to close the time gap between symptom onset and stroke treatment &ndash; including improvements in public education, 911 dispatch operations, pre-hospital detection and triage, hospital stroke system development, and stroke unit management &ndash; a new study presented at the Society of NeuroInterventional Surgery (SNIS) 12<span class="s2">th </span>Annual Meeting suggests that delays in emergency transport are still prevalent and that improvements are needed to ensure patients can be treated within the optimal time window.</strong></span></p></div><div style="clear:both; text-align:left"><p class="p1"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p2"><span style="font-size: 10pt;">Perhaps more than any other condition, stroke requires timely diagnosis and treatment to yield the best possible outcomes for patients. Three recent stroke studies &ndash; MR CLEAN, ESCAPE and EXTEND IA &ndash; demonstrated that the success of endovascular therapy was due in part to reducing the time it took for patients to access treatment. <em>Evaluation of Transfer Times for Emergent Stroke Patients from Regional Centers to a Comprehensive Stroke Center</em>, conducted at Vanderbilt University Medical Center in Nashville, Tennessee, specifically focuses on time intervals associated with hospital-to-hospital transfer as most patients in the United States (U.S.) are transported to a regional center that is not equipped to treat all levels of stroke. Recording 70 patient transfer times within a one-year timeframe, the study found that all transfer times were significantly longer than expected driving times, with average differences per hospital ranging from 46 to 133 minutes.</span></p> <p class="p2"><br /><span style="font-size: 10pt;">&ldquo;Stroke requires a multi-disciplinary team that engages in a nuanced chain of events leading to treatment, and efficient and prompt patient transport via Emergency Medical Services (EMS) is a significant link in the process,&rdquo; said Michael Froehler, lead study author and neurointerventionalist at the Cerebrovascular Program at Vanderbilt University Medical Center. &ldquo;Within the broader stroke community, we&rsquo;ve definitely made progress in our systems of care that ensure an increasing number of patients receive treatment as quickly as possible. But we need to do more.&rdquo;</span></p> <p class="p2"><br /><span style="font-size: 10pt;">The conversation on time to treatment is not without precedent. Within the last decade, the American Heart Association/American Stroke Association has put forth guidelines designed to advocate that stroke patients receive the highest level of care in the shortest time possible. Many state legislatures have created stroke prevention task forces and developed state-wide stroke prevention plans. Individual counties and cities have established systems to ensure that emergency medical service personnel are equipped to appropriately assess patients and immediately transfer them to the closest certified stroke center. Despite these efforts, transfer times often remain beyond the preferred treatment time window.</span></p> <p class="p2"><br /><span style="font-size: 10pt;">&ldquo;The challenge to improve upon stroke systems of care is an opportunity to transform the way we approach stroke treatment, and we&rsquo;re seeing the most progress in the cities, states and regions that are engaging in collective efforts <span class="s2">to </span>ensure that patients go to the hospital that is best equipped to treat stroke,&rdquo; said Donald Frei, president-elect of SNIS. &ldquo;We have a unique responsibility to continue to invest our time, resources and best thinking to better assist our patients and to continually refine systems of care that will facilitate optimal stroke treatment.&rdquo;</span></p> <p class="p2"><br /><span style="font-size: 10pt;">Froehler pointed out that most changes in systems of care, while well-intentioned, are often not informed by evidence from trials. He has therefore initiated controlled study of stroke care systems at Vanderbilt University Medical Center by comparing different approaches to transporting stroke patients to the right hospital faster. &ldquo;It&rsquo;s important that we continue to inform best practices and evolve our&nbsp;systems for the good of patients who depend on rapid response and timely intervention. We must rigorously apply the same evidence-based standards that we use for individual patient treatment decisions to the broader systems of care in order to achieve necessary efficiencies that can make a real difference for our patients,&rdquo; said Froehler.</span></p> <p class="p2">&nbsp;</p></div>2015-07-29T02:19:00Z2015-07-29T02:19:00Zwebeditor@bibamedical.com study demonstrates high revascularisation rates, quick procedure times<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Penumbra has&nbsp;announced that the results of the European multicentre study of the company&rsquo;s ACE64 thrombectomy system were presented in the Abstract Presentations Session at the Society of NeuroInterventional Surgery (SNIS) 12th Annual Meeting in San Francisco, USA. ACE64 is the most recent innovation in mechanical thrombectomy technology since the landmark MR CLEAN and subsequent confirmatory trials demonstrated the efficacy of endovascular treatment for patients with acute ischaemic stroke.</strong></span></p></div><div style="clear:both; text-align:left"><p class="p1"><span style="font-size: 10pt;">&ldquo;We were able to show that ACE64 achieved high revascularisation rates, particularly TICI 3 scores,&rdquo; explained Professor Werner Weber, director of the Institute for Diagnostic and Interventional Radiology, Neuroradiology and Nuclear Medicine at the University Hospital Knappschaftskrankenhaus Bochum, Germany, and investigator in the study.&nbsp;&ldquo;In Europe, my colleagues and I have long used many different variations of stent retrievers.&nbsp;ACE64 offers improvements over earlier technology by quickly removing clot en masse, often in a single attempt, to increase TICI 3, reduce procedure time and minimise the need for adjunctive devices.&nbsp;Working proximal to the occlusion, ACE64 also decreases clot disruption to create a favourable safety profile.&rdquo;</span></p> <p class="p1"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><br /><span style="font-size: 10pt;">In the ACE64 study, acute ischaemic stroke patients with large vessel occlusions achieved high revascularisation rates of 96%&nbsp;<span class="s1">Thrombolysis in Cerebral Infarction (TICI) </span>2b/3, with complete revascularisation at 62% TICI 3, a fast procedure time of 35 minutes and modified Rankin Scale (mRS) &le;2 at discharge of 46%.&nbsp;</span></p> <p class="p1"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><br /><span style="font-size: 10pt;">The study enrolled 117 patients at nine centers in Germany, the<span class="s1"> Netherlands, Switzerland, Spain, Denmark and Italy.</span></span></p> <p class="p1"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><br /><span style="font-size: 10pt;">&ldquo;The multicentre European experience has demonstrated the effectiveness of ACE64,&rdquo; said Blaise Baxter, Chief of Radiology at Erlanger Hospital in Tennessee, USA. &ldquo;The innovative technology of the ACE64 allows reliable, easy tracking of a large bore aspiration catheter. By using ACE64 direct aspiration frontline, we achieve high revascularisation rates and save on procedural cost while still maintaining the option to use adjunctive devices if needed.&nbsp;ACE64 is not only effective but also a very versatile stroke platform.&rdquo;&nbsp;</span></p> <p class="p1">&nbsp;</p> <p class="p1"><br /><span style="font-size: 10pt;">Penumbra&rsquo;s aspiration thrombectomy devices use a minimally invasive &ldquo;vacuum&rdquo; inside the artery to remove blood clot en masse. ACE64 features a 0.064&rdquo; distal inner diameter and a 0.068&rdquo; proximal inner diameter that is designed to evacuate large clot burdens from the neurovasculature. Built on the innovative ACE tracking technology platform, ACE64 accomplishes exceptionally easy delivery, enabling optimal clot engagement for even faster and more complete clot removal. ACE64 received CE Mark in December 2014 and 510(k) clearance from the U.S. Food and Drug Administration in May 2015. ACE64 provides a very versatile platform for intra-arterial stroke therapy, working easily with adjunct devices, if needed, to simplify procedures and lower procedural costs.</span></p></div>2015-07-28T20:02:00Z2015-07-28T20:02:00Zwebeditor@bibamedical.com results published in Anesthesiology<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Nevro Corp has announced the publication of the SENZA-RCT results in the Online First edition of Anesthesiology, the official Journal of the American Society of Anesthesiologists.</strong></span></p></div><div style="clear:both; text-align:left"><p class="p1"><span style="font-size: 10pt;">The SENZA-RCT pivotal study was a ground-breaking study that was the first to directly compare spinal cord stimulation (SCS) therapies. &nbsp;The multicenter study compared the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients across 11 US clinical trial sites (171 patients received SCS implants at 10 sites), making it the largest prospective randomised SCS study ever conducted to assess the treatment of chronic back and leg pain. &nbsp;</span></p> <p class="p2"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><span style="font-size: 10pt;"><br />The Senza SCS system received FDA approval in May of 2015. The results of the SENZA-RCT, first presented at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy&rsquo;s superiority labeling from FDA, a first in the SCS space. &nbsp;Additional information, including 18-month data from the SENZA-RCT, will be presented at the Annual Scientific Meeting of the International Spine Intervention Society on 29 July, 2015.</span></p> <p class="p2"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><span style="font-size: 10pt;"><br />The full SENZA-RCT publication is available by subscription at <a href=""><span class="s1"></span></a>.</span></p> <p class="p2"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><span style="font-size: 10pt;"><br />About the Senza System and HF10 Therapy</span></p> <p class="p2"><span style="font-size: 10pt;">&nbsp;</span></p> <p class="p1"><span style="font-size: 10pt;"><br />The Senza system is the only SCS system that delivers Nevro&rsquo;s proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro&rsquo;s innovations in SCS, including the Senza system and HF10 therapy, are covered by more than 75 issued US and international patents.</span></p></div>2015-07-28T19:45:00Z2015-07-28T19:45:00Zwebeditor@bibamedical.com shows need for greater consistency in “real world” observational research<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Results from the 9th Annual Survey on Observational Research conducted by Continuum Clinical suggest that the pharmaceutical, biotech, and medical device industries are aware of the benefits of observational research in better understanding the real world value of their products. However, they also show that there is continued need to improve the design and implementation of the studies.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">While more traditional controlled clinical trials are the conventional pathway for regulatory approval of drugs, observational studies are increasingly viewed as essential for companies interested in understanding how their products perform under actual medical conditions.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Controlled clinical research remains the gold-standard for regulatory approval,&rdquo; said Jeff Trotter, president of Continuum Clinical, and author of the survey. &ldquo;But other stakeholders including payers, physicians, and patients need to understand a product&rsquo;s clinical, economic and humanistic value once it is approved and being prescribed and utilised in the &lsquo;real world.&rsquo; As a result, drug and device companies must generate these data through studies that are designed and implemented under post-approval conditions.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The survey reveals ten key findings about prospective observational studies, and identifies opportunities for drug and device companies to improve the implementation of real world research. Among the key findings were:</span></p> <ul> <li><span style="font-size: 10pt;">70% of respondents see their organisations becoming increasingly involved with observational studies, and 75% see their company &ldquo;comfort level&rdquo; improving;</span></li> <li><span style="font-size: 10pt;">Less than half of respondents indicated that their organisations had standard operating procedures specific to observational studies;</span></li> <li><span style="font-size: 10pt;">83% of respondents felt constrained in utilising vendors (for observational research) that do not understand observational research;</span></li> <li><span style="font-size: 10pt;">A vastly underutilised source for enrolling patients into observational studies was &ldquo;patients interested in but not qualifying for pre-approval clinical trials&rdquo;.</span></li> </ul> <p><span style="font-size: 10pt;">Trotter added, &ldquo;What we are seeing is that there is a strong consensus that observational research is critical, but a lot of confusion regarding how to efficiently and effectively implement the studies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Over its nine iterations, approximately 2,000 respondents worldwide have participated in the survey, representing a cross-section of the pharmaceutical industry and job functions.</span></p></div>2015-07-28T08:00:00Z2015-07-28T08:00:00Zwebeditor@bibamedical.com may impact men and women differently<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>New research suggests concussion may not significantly impair symptoms or cognitive skills for one gender over another, although women may still experience greater symptoms and poorer cognitive performance at preseason testing. The study was presented at the Sports Concussion Conference (24&ndash;26 July, Denver, USA), hosted by the <a href="">American Academy of Neurology</a>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study involved 148 college athletes from 11 sports at the University of Michigan in Ann Arbor, USA. All had taken tests of learning and processing along with other measures of the brain&rsquo;s abilities, such as attention and working memory speed. Of the participants, 45% were female, 51% played a contact sport and 24% had experienced a concussion.</span><br /><br /></p> <p><span style="font-size: 10pt;">They had an average of 0.3 concussions, ranging from zero to four. Men and women were equally likely to have a history of concussion, even after researchers adjusted for the percentage who played contact sports.</span></p> <p><br /><span style="font-size: 10pt;">Women who have had a history of at least one concussion do not score lower on computerised cognitive baseline testing. However, all women, regardless of concussion history, had greater symptoms, symptom severity and poorer cognitive performance than men at baseline. Women reported on average 1.5 more symptoms and scored three points higher on symptom severity than men. On a clinical reaction time task, women were 19 milliseconds slower to react than men.&nbsp;On cognitive tasks assessing processing speed, attention and working memory speed women scored on average 7% below men with the greatest difference on processing speed (8.5%).</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;More research is needed to confirm these results and to understand why women may have lower performance at preseason baseline. The difference in performance between genders should be of great interest to athletes, coaches, athletic trainers, and doctors who utilise baseline assessments to aide recovery protocols,&rdquo; said study author Kathryn L O&rsquo;Connor of the University of Michigan and a member of the American Academy of Neurology.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This finding that cognitive skills were not significantly affected by having a concussion for either gender should be reassuring to athletes who have experienced a concussion and wonder about its later effects,&rdquo; O&rsquo;Connor said.</span></p></div>2015-07-27T10:51:00Z2015-07-27T10:51:00Zwebeditor@bibamedical.com in older smokers may increase stroke risk<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>New research suggests older people who experience migraines may have an increased risk of stroke, but only if they are smokers. The study is published by <em><a href="">Neurology</a></em>, the medical journal of the American Academy of Neurology.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Our findings may provide more evidence as to why quitting smoking is important for people who experience migraine,&rdquo; said study author Teshamae Monteith, of the University of Miami Miller School of Medicine in Miami, USA, and a member of the American Academy of Neurology. &ldquo;While this investigation of migraine and vascular events in older people found that only smokers with migraine have an increased risk of stroke, earlier studies have shown that women younger than 45 who have migraine with aura are also at an increased risk of stroke, whether or not they smoke.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">For the study, 1,292 people from the Northern Manhattan Study with an average age of 68 who reported migraine were followed for an average of 11 years to see who developed heart attacks or stroke. Of those, 187 had migraine without aura and 75 had migraine with aura. During the study, a total of 294 strokes, heart attacks and deaths occurred.</span></p> <p><br /><span style="font-size: 10pt;">The study did not find an association between migraine with or without aura and the risk of either stroke or heart attacks. However, among smokers, migraine was associated with a three-fold increased risk of stroke, whereas among smokers, migraine was not associated with a stroke risk.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Statistically, we could not rule out the possibility that the relationship between migraine and stroke in smokers was due to chance, however, we believe the association is consistent with other studies,&rdquo; Monteith said.</span></p> <p><br /><span style="font-size: 10pt;">The collaborative study of investigators from the University of Miami and Columbia University was supported by the National Institute of Neurological Disorders and Stroke.</span></p></div>2015-07-23T11:00:00Z2015-07-23T11:00:00Zwebeditor@bibamedical.com often overestimate their ability to deliver fast stroke care<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Hospitals often overestimate their performance in providing fast delivery of anti-clotting medication to&nbsp;stroke&nbsp;patients, according to new research in the&nbsp;<em><a href="">Journal of the American Heart Association</a>.</em></strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Researchers surveyed staff in 141 hospitals that treated 48,201 stroke patients in 2009 and 2010. They found that hospital staff perception did not match up with stroke care performance.</span><br /><br /></p> <p><span style="font-size: 10pt;">Data on patients&mdash;including the onset of their stroke symptoms, hospital arrival time, treatments, initiation of the intravenous drug called&nbsp;tissue plasminogen activator (tPA), and complications from the drug&mdash;were compared with hospital staff survey responses. Hospitals were categorised as high-, middle- or low-performing based on the percentage of time they appropriately administered tPA.</span></p> <p><br /><span style="font-size: 10pt;">Hospital performance was based on &ldquo;door-to-needle&rdquo; time&mdash;how quickly the drug is administered from the time the patient arrives at the hospital. Guidelines recommend delivering tPA within 60 minutes of the patient&rsquo;s arrival to the hospital as the drug has proven to reduce both the short- and long-term effects of a stroke.</span></p> <p><br /><span style="font-size: 10pt;">Among the researchers&rsquo; findings were that:</span></p> <ul> <li><span style="font-size: 10pt;">Only 29% of hospital staff accurately identified their door-to-needle performance.</span></li> <li><span style="font-size: 10pt;">Forty-two per cent of middle-performing hospitals and 85% of low-performing hospitals overestimated their abilities to quickly administer tPA.</span></li> <li><span style="font-size: 10pt;">Nearly 20% of low-performing hospitals believed their door-to-needle time was above the national average.</span></li> <li><span style="font-size: 10pt;">Hospitals that overestimated their performance had lower volumes of tPA administration.</span></li> </ul> <p><span style="font-size: 10pt;">The surveyed hospitals all participated in the American Heart Association&rsquo;s&nbsp;Get With the Guidelines-Stroke&nbsp;national quality improvement program designed to ensure consistency in timely stroke care.</span></p> <p><br /><span style="font-size: 10pt;">Factors affecting the disparity between hospital perception and performance included stroke patient volume, whereas hospital size or region did not appear to be a major factor.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Institutions at any performance level could benefit from making protocol changes that would better align performance with perception&rdquo; said Cheryl Lin, lead study author and a former researcher at Duke Clinical Research Institute in Durham, USA. &ldquo;This would have a significant impact on the quality of stroke care delivered across the USA.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Stroke is now the fifth-leading cause of death in the USA, claiming a life once every four minutes.</span></p></div>2015-07-23T10:41:00Z2015-07-23T10:41:00Zwebeditor@bibamedical.com leading researchers in Alzheimer’s disease receive 2015 MetLife Foundation Awards for Medical Research<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>MetLife Foundation&nbsp;today announced the two recipients of the 2015<em>&nbsp;</em>MetLife Foundation Awards for Medical Research&mdash;Randall Bateman, Charles F and Joanne Knight distinguished professor of neurology, Washington University School of Medicine, St Louis, USA, and Christian Haass,&nbsp;professor of biochemistry, Ludwig Maximilians University M&uuml;nchen, and German Center for Neurodegenerative Diseases, Munich, Germany.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Bateman and Haass have now joined a roster of past winners whose work has gone onto receive Noble prizes.</span></p> <p><br /><span style="font-size: 10pt;">The winners were first announced during a session at the Alzheimer&rsquo;s Association International Conference (18&ndash;23 July, Washington DC, USA) and later celebrated at&nbsp;a scientific briefing and awards ceremony. Organised by the American Federation for Aging Research, the evening awards ceremony included a researching briefing featuring each awardee as well as special remarks by Marie Bernard, deputy director of the National Institute on Aging.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;MetLife Foundation is proud to present these major awards to Bateman and Haass for their exceptional scientific research contributions, which help bring us closer to finding a cure for Alzheimer&rsquo;s disease,&rdquo; said A Dennis White, president and chief executive officer, MetLife Foundation. &ldquo;Their outstanding contributions, recognised around the world, have helped us better understand this devastating illness, and both awardees have laid the groundwork leading to effective treatments.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to recent estimates, without the development of treatments that either delay the onset or slow the progression of Alzheimer&rsquo;s disease, by 2050 as many as 200 million people worldwide will be living with the disease.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Even modest advances in preventing or delaying Alzheimer&rsquo;s disease, championed by recipients of the MetLife Foundation Awards for Medical Research, will have a huge global public health impact,&rdquo; White shared.</span></p></div>2015-07-20T15:09:00Z2015-07-20T15:09:00Zwebeditor@bibamedical.com approves MR-conditional paddle lead for management of chronic pain<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>St Jude Medical has announced&nbsp;US Food and Drug Administration (FDA) approval of MR-conditional labelling for the company&rsquo;s&nbsp;Penta five-column paddle lead&nbsp;for spinal cord stimulation (SCS) therapy to manage chronic pain. The Penta lead, which will be available for use with the company&rsquo;s Prot&eacute;g&eacute; MRI system in the USA, is the only five-column paddle lead on the market that will allow patients to safely undergo head and extremity MRI scans.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">For some chronic pain patients, the potential need for future MRI scans has historically acted as a barrier to SCS therapy. Throughout 2015,&nbsp;St Jude Medical&nbsp;has introduced a series of MR-conditional implantable pulse generators (IPGs) and leads designed to improve patient access to the latest chronic pain therapy options while preserving the ability to undergo head and extremity MRI scans.</span></p> <p><span style="font-size: 10pt;"><br />With the newly approved updated labelling, the Penta paddle lead will be available for use with the Prot&eacute;g&eacute; MRI system, which is the smallest upgradeable MR-conditional SCS IPG available in the USA.</span></p> <p><span style="font-size: 10pt;"><br />The Penta paddle lead is designed to provide physicians the broadest area of lateral stimulation coverage available (9mm), which supports selective stimulation of nerve fibres associated with a patient&rsquo;s pain without needlessly stimulating other areas. The broad coverage of the Penta five-column paddle ensures sufficient stimulation when physicians are faced with anatomical asymmetries or in cases where stimulation is needed in very specific clusters of nerve fibres. Such specific targeting allows physicians to tailor therapy to a patient&rsquo;s unique pain pattern.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited to receive MR-conditional labelling approval for our Penta paddle lead alongside the recent approval of the Prot&eacute;g&eacute; MRI system and MR-conditional labelling for our Octrode percutaneous leads,&rdquo; said&nbsp;Eric S Fain, group president of&nbsp;St Jude Medical. &ldquo;When taken together, the approvals of these products in our chronic pain portfolio represent a critical component to growing our neuromodulation business and improving access to our industry-leading chronic pain therapies for patients who may need future head and extremity MRI scans.&rdquo;</span></p></div>2015-07-20T13:20:00Z2015-07-20T13:20:00Zwebeditor@bibamedical.com study finds DRG superior to conventional stimulation across all endpoints<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>At the International Neuromodulation Society&rsquo;s 12<sup>th</sup> World Congress (INS; 6&ndash;11 June, Montreal, Canada) principal investigator, Timothy Deer, presented the three-month data (ie.&nbsp;the FDA defined primary endpoint for safety and efficacy)&nbsp;of the ACCURATE trial for the first time. He reported that dorsal root ganglion (DRG)&nbsp;stimulation showed not only non-inferiority, but also superiority over conventional spinal cord stimulation across all primary endpoint analyses.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Although dorsal root ganglion stimulation is approved and has been in use in Europe and Australia for some time, in the United States, DRG stimulation remains under investigation. The US-based ACCURATE study is the first largescale, prospective randomised clinical trial of dorsal root ganglion stimulation versus conventional spinal cord stimulation for patients with complex regional pain syndrome and peripheral causalgia.</span></p> <p><br /><span style="font-size: 10pt;">Giving some background into the premise of dorsal root ganglion stimulation, Robert Levy (Marcus Neuroscience Institute at Boca Raton Regional Hospital, Boca Raton, USA) explained that the dorsal root ganglion is a simple spinal structure that is bounded by the dura and it is where the cell bodies of the peripheral nociceptors live. He said, &ldquo;As an intradural structure it is in the neuroaxis, and for neurostimulation purposes, it is important to recognise that unlike the dorsal columns where there is a large layer of cerebrospinal fluid between the epidural space where we put our lead and where our current is targeted and we lose 80&ndash;90% of our current in the low-resistant cerebrospinal fluid pathways and only 10&ndash;20% of our current gets to the target fibres where we are trying to stimulate, here there is minimal cerebrospinal fluid and an epidural lead laying over the dorsal ganglion is very efficient, using about 5% of the total energy we use for dorsal column stimulation. It is a target that has been used for a number of different interventions and it is accessible via an intraspinal approach.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The primary objective of the ACCURATE study is to assess the safety and efficacy of dorsal root ganglion stimulation (delivered by the Axium device from Spinal Modulation, recently acquired by St Jude Medical) compared to a commercially available spinal cord stimulation device. The multicentre, prospective, randomised trial was designed with significant input from the US Food and Drug Administration (FDA). It was a non-inferiority study design, but it had power with a sufficiently robust effect, to demonstrate superiority as well. Importantly, once patients were randomised to one or another therapy arms, the people who were responsible for that therapy were the representatives from that company. </span><br /><br /><span style="font-size: 10pt;">Therefore, if patients were randomised to the spinal cord stimulation arm, the devices were maintained, programmed and optimised by representatives from that company, and similarly, patients randomised to DRG therapy were maintained by Spinal Modulation, providing for an equal bias to optimise the stimulation and prove best effect.</span></p> <p><br /><span style="font-size: 10pt;">There were 152 subjects enrolled, randomised 1:1 between DRG and dorsal column traditional stimulation at 22 sites with a three-month primary endpoint. Included were patients with chronic intractable pain in their legs and who carried a diagnosis of complex regional pain syndrome or peripheral causalgia.</span></p> <p><br /><span style="font-size: 10pt;">The primary endpoint was a composite endpoint where all patients had to have a greater than 50% pain relief at the trial, greater than 50% pain relief at the time of their three-month follow-up and be free of any stimulation-induced neurological deficits. If they met all three of those criteria, they were considered successful. Secondary endpoints included an evaluation of both paraesthetic intensity and the positional effects on paraesthetic intensity between spinal cord and dorsal root ganglion stimulation. The tertiary endpoints were the specificity of stimulation&mdash;that is the overlap of paraesthesias and the patient&rsquo;s pain, quality-of-life, psychological disposition, functional status and patient satisfaction.</span></p> <p><br /><span style="font-size: 10pt;">During the presentation at INS, it was reported that in the modified intent to treat group (made up of the 152 patients randomised) 55.7% of patients treated with conventional spinal cord stimulation met the primary endpoint of 50% or more pain relief, while in the DRG group, 81.2% of patients had relief. Superiority of dorsal root ganglion stimulation as compared to conventional spinal cord stimulation was shown, with a superiority p value of 0.0004.</span></p> <p><br /><span style="font-size: 10pt;">Further, in the primary endpoint sub-analysis (those who went to permanent implant and then met the three-month endpoint) 72.2% of patients in the conventional group met the primary endpoint at three months post-implant, while in the dorsal root ganglion group, 93.3% of patients met the primary endpoint&mdash;indicating non-inferiority and superiority &nbsp;(p=0.0011) of DRG stimulation.</span></p> <p><br /><span style="font-size: 10pt;">In terms of high responders, 52% of patients in the conventional group versus 70% of patients in the DRG group saw 80% or more improvement (p=0.055). Additionally, in terms of secondary endpoints, patients receiving DRG stimulation reported no differences in paraesthesia intensity due to changes in body position (postural effects) when compared to conventional spinal cord stimulation. A statistically significant result was found between the two groups studied. Also, patients in the DRG stimulation group were significantly less likely to report feeling stimulation outside their area of pain, compared to the control group. As it relates to safety, there was no reported deficit in either group.</span></p> <p><br /><span style="font-size: 10pt;">Overall, at three months, the ACCURATE study demonstrated that the DRG group was statistically non-inferior and then superior in the composite endpoint of safety and efficacy as compared to the spinal cord stimulation control group. The DRG group demonstrated a comparable safety profile to the commercially available technology that was used as a comparator, DRG showed a greater percentage of patients that responded to therapy overall, produced less positional effects comparing&nbsp; stimulation groups, and also had more specific paraesthesia as compared to conventional stimulation.</span></p> <p><br /><span style="font-size: 10pt;">According to, the ACCURATE study&rsquo;s estimated final data collection date for primary outcome measure is December 2015 and the estimated study completion date is December 2018. </span></p></div>2015-07-20T09:01:00Z2015-07-20T09:01:00Zwebeditor@bibamedical.com lessens severity of tinnitus<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Individuals with chronic tinnitus who received treatment that involved the delivery of electromagnetic pulses had a greater improvement in tinnitus severity compared to a placebo group, according to a study published online by <em><a href="">JAMA Otolaryngology-Head &amp; Neck Surgery</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Tinnitus is perceived by 10&ndash;15% of the adult population. Of those individuals who experience chronic tinnitus, approximately 20% consider it to be a &ldquo;clinically significant&rdquo; problem. Because chronic tinnitus is a condition that negatively affects the quality of life for millions of people worldwide, a safe and effective treatment has been sought for decades, according to background information in the article.</span></p> <p><br /><span style="font-size: 10pt;">Repetitive transcranial magnetic stimulation (rTMS) is non-invasive and involves delivering electromagnetic pulses through a coil to the patient&rsquo;s scalp. Low-frequency rTMS is known to reduce brain activity in directly stimulated regions and has been proposed as an innovative treatment strategy for medical conditions associated with increased cortical activity, including tinnitus.</span></p> <p><br /><span style="font-size: 10pt;">Robert L Folmer, of the Portland Veterans Affairs Medical Center and Oregon Health &amp; Science University, Portland, USA, and colleagues randomly assigned 70 study participants with chronic tinnitus to receive 2,000 pulses per session of active or placebo rTMS on 10 consecutive workdays. Follow-up assessments were done at one, two, four, 13 and 26 weeks after the last treatment session. Sixty-four participants were included in the final analyses. No participants withdrew from the study because of adverse effects of rTMS. Severity of tinnitus was measured with the Tinnitus Functional Index (TFI).</span></p> <p><br /><span style="font-size: 10pt;">The researchers found that the active rTMS group as a whole exhibited a 31% reduction in the TFI at the 26-week follow-up compared with baseline and the placebo rTMS group as a whole exhibited a 7% reduction. Overall, 18 of 32 participants (56%) in the active rTMS group and 7 of 32 participants (22%) in the placebo rTMS group responded to rTMS treatment (defined as participants who improved a certain amount on the total TFI from baseline to the end of their last rTMS session).</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;If rTMS continues to demonstrate efficacy as a treatment for tinnitus, future investigations should include multisite clinical trials. If these larger clinical trials replicate efficacy of rTMS that has been demonstrated in the present study, then steps should be taken to implement the procedure as a clinical treatment for chronic tinnitus,&rdquo; the authors write.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We do not believe that rTMS should be viewed as a replacement for effective tinnitus management strategies that are available now. Instead, rTMS could augment existing tinnitus therapies and provide a viable option for patients who do not respond favourably to other treatments.&rdquo;</span></p></div>2015-07-17T13:45:00Z2015-07-17T13:45:00Zwebeditor@bibamedical.com supports use of local anaesthesia during endovascular treatment of stroke<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A study published in the journal <em><a href="" target="_blank">Stroke</a></em>&nbsp;has added to the evidence supporting the use of local anaesthesia when possible during endovascular treatment of acute ischaemic stroke. The question of improved outcome associated with the use of local anaesthesia has been one increasingly being raised since the release of overwhelmingly positive results in favour of endovascular treatment of acute stroke in five stroke trials around the world.</strong> </span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Alex Abou-Chebl (Baptist Health Louisville, Louisville, USA) and others analysed patients in the Interventional management of stroke III (IMS III) trial which randomised patients within three hours of acute ischaemic stroke onset to intravenous tissue-type plasminogen activator &plusmn; endovascular treatment. General anaesthesia use within seven hours of stroke onset was recorded per protocol. Good outcome was defined as 90-day modified Rankin Scale &le;2. A multivariable analysis adjusting for dichotomised National Institutes of Health Stroke Scale (NIHSS; 8&ndash;19 versus &ge;20), age, and time from onset to groin puncture was performed.</span></p> <p><span style="font-size: 10pt;"><br />Abou-Chebl <em>et al </em>report that 434 patients were randomised to endovascular treatment, 269 (62%) were treated under local anaesthesia and 147 (33.9%) under general anaesthesia; 18 (4%) were undetermined. The two groups were comparable except for median baseline NIHSS (16 local anaesthesia versus 18 general anaesthesia;&nbsp;p&lt;0.0001).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The general anaesthesia group was less likely to achieve a good outcome (adjusted relative risk, 0.68; confidence interval, 0.52&ndash;0.90;&nbsp;p=0.0056) and had increased in-hospital mortality (adjusted relative risk, 2.84; confidence interval, 1.65&ndash;4.91;&nbsp;p=0.0002). Those with medically indicated general anaesthesia had worse outcomes (adjusted relative risk, 0.49; confidence interval, 0.30&ndash;0.81; p=0.005) and increased mortality (relative risk, 3.93; confidence interval, 2.18&ndash;7.10;&nbsp;p&lt;0.0001) with a trend for higher mortality with routine general anaesthesia. There was no significant difference in the adjusted risks of subarachnoid haemorrhage (p=0.32) or symptomatic intracerebral haemorrhage (p=0.37),&rdquo; the authors write.</span></p> <p><span style="font-size: 10pt;"><br />They conclude stating that general anaesthesia was associated with worse neurological outcomes and increased mortality in the endovascular therapy arm. &ldquo;Relative risk estimates, though not statistically significant, suggest reduced risk for subarachnoid haemorrhage and symptomatic intracerebral haemorrhage under local anaesthesia. Although the reasons for these associations are not clear, these data support the use of local anaesthesia when possible during endovascular therapy,&rdquo; the authors add.</span></p> <p><span style="font-size: 10pt;"><br />This study supports the results of a post hoc-analysis of the use of general anaesthesia in the ground breaking MR CLEAN trial (Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands) where investigators reported that the subgroup of patients treated without general anaesthesia benefited more from the endovascular treatment than the subgroup treated under general anaesthesia.</span></p> <p><span style="font-size: 10pt;"><br />In the MR CLEAN post-hoc analysis, of the 233 patients allocated to intra-arterial treatment, 79 were treated under general anaesthesia, and 137 using local anaesthesia. Using the modified Rankin Scale score to assess patient outcome at 90 days, study author Olvert Berkhemer (Academic Medical Center, Amsterdam, the Netherlands) said, &ldquo;We noticed that patients treated without general anaesthesia have a higher chance of a functional independent lifestyle. They did better after 90 days.&rdquo; Intra-arterial treatment without general anaesthesia resulted in 38% good outcome, compared to 23% in the under general anaesthesia group.</span></p></div>2015-07-17T10:50:00Z2015-07-17T10:50:00Zwebeditor@bibamedical.com clears St Jude Medical Invisible Trial System<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><strong><span style="font-size: 11pt;">St Jude Medical has received Food and Drug Administration (FDA) approval of the Invisible Trial System. The system, which received CE mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The company says that the system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">For some patients, complex controllers and bulky programming cables can disrupt the SCS trial experience and act as barrier to the therapy. With the Invisible Trial System, St Jude Medical believes it has removed these barriers, allowing patients to more effectively evaluate their therapy.</span></p> <p><br /><span style="font-size: 10pt;">The system relies on Bluetooth wireless technology to provide patients with a safe, secure and entirely wireless SCS trial experience. The system provides patients with an iPod touch digital device as a controller, while physicians utilise an iPad mini digital device to programme and evaluate their patient&rsquo;s therapy.</span></p> <p><br /><span style="font-size: 10pt;">The programmer also displays trial usage data from a small external pulse generator (EPG) and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both issues. These hindrances may impede the integration of the technology into their daily activities, which shifts their focus away from evaluating the effectiveness of SCS therapy,&rdquo; said pain specialist Jason E Pope, president of Summit Pain Alliance in Santa Rosa, USA. &ldquo;By providing a discreet trial system, St Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">One of the key system features of the St Jude Medical system is the use of EPG as the system&rsquo;s power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient&rsquo;s iPod touch controller and the stimulation system, the overall device profile has been reduced so the system can be worn discreetly under a patient&rsquo;s clothing. The effect is that the system feels essentially invisible to the wearer, resulting in a more comfortable trial experience.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy,&rdquo; said Eric S Fain, group president of St Jude Medical. &ldquo;By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they are receiving from spinal cord stimulation.&rdquo;</span></p></div>2015-07-17T10:33:00Z2015-07-17T10:33:00Zwebeditor@bibamedical.com’s may affect the brain differently in African-Americans than European-Americans<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Alzheimer&rsquo;s disease may cause different pathologies in African-Americans than in white Americans of European descent, according to a study published in an online issue of the medical journal of the <em><a href="">American Academy of Neurology</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Because some studies suggest that Alzheimer&rsquo;s disease is more common among older African-Americans than European-Americans, we wanted to see whether the brain changes caused by Alzheimer&rsquo;s are different in these two racial groups,&rdquo; said study author Lisa L Barnes, Rush University Medical Center, Chicago, USA. &ldquo;Studying how Alzheimer&rsquo;s disease looks in the brain in individuals of different races may help us to further understand the disease and pinpoint strategies for prevention and treatment.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study included 41 African-Americans with a clinical diagnosis of Alzheimer&rsquo;s dementia from the memory clinic, who had an autopsy of their brain performed after death. They were then compared to 81 deceased European-Americans who had Alzheimer&rsquo;s dementia with the same level of disease severity and were of the same age, sex and education level. Researchers looked for typical signs of Alzheimer&rsquo;s disease (plaques and tangles) as well as other brain changes that can cause dementia, such as infarcts (changes associated with stroke) and Lewy bodies (associated with Lewy body or Parkinson&rsquo;s disease). They noted whether people had one pathology or more than one. They also looked at small and large blood vessel disease.</span></p> <p><br /><span style="font-size: 10pt;">Almost all participants in the study had Alzheimer&rsquo;s disease in their brain. Only about half of the European-Americans had pure Alzheimer&rsquo;s disease pathology (no additional pathologies contributing to dementia) whereas the rest had Alzheimer&rsquo;s disease pathology with either infarcts or Lewy bodies. In contrast, less than 25% of the African Americans had pure Alzheimer&rsquo;s disease pathology. On the other hand, almost three-quarters (71%) of African-Americans had Alzheimer&rsquo;s disease pathology mixed with another type of pathology, compared to 51% of European-Americans. Clinical Alzheimer&rsquo;s disease in African-Americans was much more likely to involve pathologies other than Alzheimer&rsquo;s disease pathology. African-Americans also had more frequent and severe blood vessel disease. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our study has important clinical implications because it may suggest a need for different types of Alzheimer&rsquo;s prevention and treatments in African-Americans. Indeed, current Alzheimer&rsquo;s drugs primarily target specific Alzheimer pathologies in the brain. Given the mixed pattern of disease that we see in African-American brains, it will be important to develop new treatments that target these other common pathologies, particularly for African-Americans,&rdquo; said Barnes.</span></p></div>2015-07-16T11:19:00Z2015-07-16T11:19:00Zwebeditor@bibamedical.com Medical awarded US patent for composite wire implant designs<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Sequent Medical has been granted a new patent from the US Patent and Trademark Office covering many versions of Sequent&rsquo;s Web aneurysm embolisation system.&nbsp;</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Web is a braided implant that includes composite drawn filled tube wires, ie. an external nitinol tube and a highly radiopaque material disposed within the tube. The devices utilise this technology for enhanced visualisation while preserving desired mechanical properties. Web is braided from numerous wires, which in some cases are less than one-quarter of the diameter of a human hair.</span></p> <p><br /><span style="font-size: 10pt;">The company has previously developed and introduced enhanced visualisation versions of Web in single-layer Web SL and SLS configurations in Europe. In the USA, enrolment in an investigational device exemption clinical study called WEB-IT is underway, with WEB EV designs now being implanted in the study.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Improving the visualisation of Web proved to be a significant engineering challenge,&rdquo; said Tom Wilder, president and chief executive officer. &ldquo;Enhanced visualisation technology is the latest demonstration of Sequent&rsquo;s robust innovation capability, and further extends our leadership of the intrasaccular flow disruption category. The utility of Sequent&rsquo;s proprietary technology extends beyond the neurovascular field, and has the potential to address a number of unmet clinical needs.&rdquo;</span></p></div>2015-07-15T14:20:00Z2015-07-15T14:20:00Zwebeditor@bibamedical.com Medical announces two additional US patents<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Mainstay Medical has announced the issuance of two new US patents for the treatment of chronic low back pain. One patent regards restoring muscle function to the lumbar spine, while the other regards anchoring electrode leads for use with an implantable neuromuscular electrical stimulator. Corresponding applications have been made in other countries.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Most people with chronic low back pain have exhausted conventional treatments, are not candidates for surgery or spinal cord stimulation, and in the prime of their lives face a future of continuing pain and disability. For many of these people the root cause of their pain is a disruption in the control of the muscles that stabilise the lumbar spine. The approach of Mainstay Medical&rsquo;s ReActiv8 is to use electrical stimulation to elicit repetitive contractions of the key stabilising muscles of the lumbar spine to reactivate the body&rsquo;s control over these muscles allowing recovery from chronic low back pain.</span><br /><br /></p> <p><span style="font-size: 10pt;">Clinical trials with ReActiv8 are ongoing in Europe and Australia, and the company recently announced US Food and Drug approval to start a clinical trial of ReActiv8 under an investigational device exception.</span></p></div>2015-07-15T13:40:00Z2015-07-15T13:40:00Zwebeditor@bibamedical.com European health centres to use Elekta’s Leksell Gamma Knife Icon for cranial radiosurgery<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Three medical centres in the UK&nbsp;and Germany have ordered and are now planning upgrades to Elekta&rsquo;s latest generation stereotactic radiosurgery system for the brain, Leksell Gamma Knife Icon, to provide advanced brain radiosurgery treatments for their patients.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The centres are University Medical Centre Mannheim, Mannheim, Germany, Bristol Gamma Knife Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK, and the Leeds Gamma Knife Centre at St James&rsquo;s Institute of Oncology, Leeds, UK.</span></p> <p><br /><span style="font-size: 10pt;">Leksell Gamma Knife Icon integrates advanced motion management, dose delivery and imaging technologies, enabling clinicians to treat a wider variety of tumour types and sizes. Elekta says that the system provides caregivers increased flexibility in how radiosurgery is delivered, by allowing doctors to choose either frame-based or frameless methods to immobilise the patient&rsquo;s head, in addition to the option to perform the treatment in a single session or multiple sessions. Icon also permits physicians to choose the degree of precision needed for each patient case, ranging from traditional high radiosurgery accuracy to ultra-precise microradiosurgery.</span></p> <p><br /><span style="font-size: 10pt;">The ability to deliver multi-fraction Gamma Knife radiosurgery to spare organs-at-risk was important to clinicians at University Medical Centre Mannheim, according to Frederik Wenz, professor and chairman, Department&nbsp;of Radiation Oncology.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The steep dose gradients and mechanical stability offered by Gamma Knife Icon allow sparing of normal tissue adjacent to the target,&rdquo; he says. &ldquo;In clinical situations with sensitive structures within the target volume, sparing of organs-at-risk can only be achieved by fractionation. By fractionating the dose, we can use Icon in many clinical scenarios in which the tumour is infiltrating normal tissue.&rdquo; Wenz anticipates treating the first patients with Gamma Knife Icon in late August.</span></p> <p><br /><span style="font-size: 10pt;">Alison Cameron, clinical lead for the Bristol Gamma Knife, says: &ldquo;Icon will allow Bristol to offer an intracranial stereotactic service without any compromises. The system has the flexibility to ensure that the patient receives the level of radiosurgery that they require clinically, whilst optimising their experience through flexibility in immobilisation, scheduling and treatment. This will lead to increased efficiency with improved quality, a truly transformational service development.&rdquo; The team in Bristol expect to treat the first patient in September.</span></p> <p><br /><span style="font-size: 10pt;">At the Leeds Gamma Knife Centre, Paul Hatfield, consultant clinical oncologist, observes that the frameless immobilisation and accurate intrafraction monitoring of patient position are particularly valuable features of Icon.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These features will enable fractionated treatment for targets that would normally be too large to treat, or where dose reductions would typically be required, for safety reasons, that could potentially compromise treatment effect,&rdquo; Hatfield says. &ldquo;The cone beam CT also will allow confirmation of setup, which is an important part of modern radiotherapy. All of these benefits combined will undoubtedly enhance the patient experience.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The Leeds Gamma Knife Centre, as part of Nova Healthcare, has always been integrated within our busy radiotherapy and neuroscience department,&rdquo; adds Nick Phillips, consultant neurosurgeon. &ldquo;We operate as a close collaboration between oncology, neurosurgery, medical physics and radiographers. Our department is a leader in many stereotactic radiotherapy techniques and we are keen to push forward this technology in the UK.&rdquo; The Gamma Knife Icon system is expected to be operational at the Leeds Gamma Knife Centre by the end of 2015.</span></p></div>2015-07-13T13:20:00Z2015-07-13T13:20:00Zwebeditor@bibamedical.com acid may lessen women’s disability after stroke<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Uric acid&mdash;a chemical that at high levels can lead to serious illness&mdash;may lessen women&rsquo;s disability after&nbsp;stroke, according to new research in the American Heart Association&rsquo;s journal&nbsp;<em>Stroke</em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">High levels of uric acid can lead to kidney stones or the inflammatory arthritic condition known as gout and is linked with heart and vascular problems and&nbsp;diabetes. However, in a new study, 42% of women treated with uric acid therapy following a stroke had little to no disability after 90 days compared to 29% of women treated with a placebo. Women also had less dead tissue resulting from lack of blood supply after receiving uric acid. Among men, there was essentially no difference between uric acid treatment and placebo.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Women fare better with uric acid therapy because they tend to have less uric acid in their bodies,&rdquo; said &Aacute;ngel Chamorro, study lead author and director of Barcelona&rsquo;s Comprehensive Stroke Center, Hospital Clinic Chamorro, Spain. &ldquo;While high levels of uric acid can lead to other health problems, uric acid also helps protect tissue from harmful molecules known as free radicals.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Researchers re-analysed 2014 data based on URICO-ICTUS, a randomised, double-blind trial of patients admitted to stroke centres in Spain. Participants included 206 women and 205 men. All participants were given&nbsp;therapies to remove the clots, while half in each gender group were also given either 1000mg of uric acid therapy or a placebo through IV infusion.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In&nbsp;ischaemic stroke&nbsp;a clot lodges in an artery supplying oxygen to the brain. When doctors successfully remove a clot, oxygen re-enters the brain, but it also releases free radicals, which may damage surrounding tissue. Uric acid counteracts the release of the free radicals, minimising the damage.</span></p> <p><span style="font-size: 10pt;"><br />Women in the study were, on average, seven years older than the men, and they were more likely to have&nbsp;irregular heartbeat, high blood pressure and other conditions. As younger, healthier stroke victims are treated, the results should be even more impressive, &Aacute;ngel said.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />More data are needed before uric acid becomes standard clinical practice. Among other directions, researchers want to determine whether uric acid also could benefit men&mdash;perhaps those with naturally lower levels of uric acid or high levels of blood sugar and other metabolic conditions that fuel the release of free radicals.</span></p> <p><span style="font-size: 10pt;"><br />The Institute of Health Carlos III of the Spanish Ministry of Health and Fundaci&oacute;n Doctor Melchor Colet supported the study.</span></p></div>2015-07-10T13:24:00Z2015-07-10T13:24:00Zwebeditor@bibamedical.com Foundation study shows brain activity changes after cognitive rehabilitation for TBI<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Kessler Foundation researchers published results of their TBI-MEM trial, the first study to demonstrate significant changes in cerebral activation after memory retraining in individuals with traumatic brain injury (TBI). The article was published by the <em><a href="">Journal of Head Trauma Rehabilitation</a></em>. The authors are&nbsp;Nancy Chiaravalloti, Ekaterina Dobryakova, Glenn Wylie and&nbsp;John DeLuca, of&nbsp;Kessler Foundation.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Eighteen participants with moderate to severe TBI were assigned to either the treatment (n=9) or placebo group (n=9). All underwent neuropsychological assessment, cognitive ability assessment and functional magnetic resonance imaging (fMRI) during a learning task before and after treatment. The treatment group was administered the modified Story Memory Technique (mSMT), a 10-session memory retraining protocol based on visualisation and context; the placebo group underwent memory exercises without visualisation or context training.</span></p> <p><br /><span style="font-size: 10pt;">fMRI findings showed a pattern of changes in cerebral activation in the mSMT treatment group. This is consistent with the researchers&rsquo; findings in a prior study of mSMT in patients with multiple sclerosis, which provided the first class I evidence for the efficacy of cognitive rehabilitation in multiple sclerosis.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is the second study we have conducted that shows significant changes in activation patterns on neuroimaging after behavioural memory intervention,&rdquo; said Nancy Chiaravalloti, director of neuroscience and neuropsychology and TBI research at Kessler Foundation. &ldquo;These changes likely reflect increased brain efficiency and decreased task difficulty after training with mSMT. Memory deficits are a major cause of disability after TBI. Identifying effective cognitive interventions is critical to improving quality of life in this population.&rdquo;</span></p></div>2015-07-09T13:53:00Z2015-07-09T13:53:00Zwebeditor@bibamedical.com shows long-term effects of type 2 diabetes on the brain, thinking<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>In just two years, people with type 2 diabetes experienced negative changes in their ability to regulate blood flow in the brain, which was associated with lower scores on tests of cognition skills and their ability to perform their daily activities, according to a new study published in the 8 July, 2015, online issue of <em>Neurology</em>, the medical journal of the American Academy of Neurology.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Normal blood flow regulation allows the brain to redistribute blood to areas of the brain that have increased activity while performing certain tasks,&rdquo; said study author Vera Novak of Harvard Medical School in Boston, USA. &ldquo;People with type 2 diabetes have impaired blood flow regulation. Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study involved 40 people with an average age of 66. Of those, 19 had type 2 diabetes and 21 did not have diabetes. Those with diabetes had been treated for the disease for an average of 13 years. The participants were tested at the beginning of the study and again two years later. Tests included cognition and memory tests, MRI scans of the brain to look at brain volume and blood flow, and blood tests to measure control of blood sugar and inflammation.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />After two years, the people with diabetes had decreases in their ability to regulate blood flow in the brain. They also had lower scores on several tests of memory and thinking skills. People with lower ability to regulate blood flow at the beginning of the study had greater declines in a measure of how well they could complete daily activities such as bathing and cooking.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Higher levels of inflammation were also associated with greater decreases in blood flow regulation, even if people had good control of their diabetes and blood pressure, Novak said.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />On a test of learning and memory, the scores of the people with diabetes decreased by 12%, from 46 points to 41 points over the two years of the study, while the scores of those without diabetes stayed the same, at 55 points. Blood flow regulation in the brain was decreased by 65% in people with diabetes.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills,&rdquo; Novak said.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />She said additional studies involving more people and extending for a longer time period are needed to better understand the relationship and timing with blood flow regulation and changes in thinking and memory skills.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by the National Institute on Aging, American Diabetes Association, Harvard Clinical and Translational Science Center and National Center for Research Resources.</span></p></div>2015-07-09T13:13:00Z2015-07-09T13:13:00Zwebeditor@bibamedical.com Davis researchers find key mechanism that causes neuropathic pain<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Scientists at the University of California, Davis, USA, have identified a key mechanism in neuropathic pain. The discovery could eventually benefit millions of patients with chronic pain from trauma, diabetes, shingles, multiple sclerosis or other conditions that cause nerve damage.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A biological process called endoplasmic reticulum stress, or ER stress, is the significant driver of neuropathic pain, said lead researchers Bora Inceoglu of the UC Davis Department of Entomology and Nematology and UC Davis Comprehensive Cancer Center, and Ahmed Bettaieb, Department of Nutrition. The work is published in the journal <em><a href="">Proceedings of the National Academy of Sciences</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is a fundamental discovery that opens new ways to control chronic pain,&rdquo; said co-author Bruce Hammock, distinguished professor at the UC Davis Department of Entomology and Nematology and the UC Davis Comprehensive Cancer Center.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We can now specifically search for agents to control ER stress and its downstream pathways,&rdquo; Hammock said. &ldquo;This search is already underway in a number of laboratories working on cancer and other diseases.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Working with Fawaz Haj of the UC Davis nutrition department, Bettaieb found that key molecular signatures associated with diabetes and diabetic pain were linked to ER stress. Neuropathic pain is a common consequence of both type 1 and type 2 diabetes, affecting up to 70% of patients.</span></p> <p><br /><span style="font-size: 10pt;">Inceoglu, working in Hammock&rsquo;s laboratory, showed that neuropathic pain could be initiated by compounds that cause ER stress and reversed by agents that block it.</span></p> <p><br /><span style="font-size: 10pt;">The researchers had previously shown that a class of natural bioactive lipids has powerful analgesic effects in the body. These analgesic lipids are broken down in the body by an enzyme, soluble epoxide hydrolase. The team was able to show that blocking soluble epoxide hydrolase blocks ER stress and associated neuropathic pain.</span></p> <p><br /><span style="font-size: 10pt;">The work sheds new light onto at least one biological process that mediates neuropathic pain, Inceoglu said. With this knowledge, researchers can now test ER-stress blocking drugs in the clinic, and carry out fundamental research on how different types of pain grouped under the name &ldquo;neuropathic&rdquo; differ from each other and respond to new drugs.</span></p> <p><br /><span style="font-size: 10pt;">The study provides convincing evidence for a novel concept as to what causes neuropathic pain said John Imig, professor of pharmacology and toxicology at the Medical College of Wisconsin, Milwaukee, USA, who was not involved in the study. The work provides new opportunities for drugs or drug combinations to treat chronic pain, he said.</span></p></div>2015-07-08T14:24:00Z2015-07-08T14:24:00Zwebeditor@bibamedical.com can now be identified, say researchers in neuroimaging study<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>After comparing more than 20,000 brain scans, researchers have identified differences between traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) despite both conditions sharing common symptoms.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This discovery is breakthrough information for anyone diagnosed with either TBI or PTSD or both,&rdquo; said&nbsp;Theodore Henderson, a co-author of the study, published in&nbsp;<em>PLOS One</em>. &ldquo;Now that we can tell the difference between TBI and PTSD, clinicians can apply more targeted and appropriate treatments, and achieve advances with their patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Believed to be the largest functional neuroimaging study (<em>&ldquo;Functional Neuroimaging Distinguishes Post traumatic Stress Disorder from Traumatic Brain Injury in Focused and Large Community Datasets&rdquo;</em>), researchers used single photon emission computed tomography (SPECT) to obtain biological differences between TBI and PTSD in the brain. This neuroimaging method and landmark study &ldquo;demystify&rdquo; these two conditions that both may appear with symptoms like anxiety, depression, mood dysregulation, irritability and other cognitive breakdowns, according to Henderson.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study contained a subset of closely matched patients and a larger dataset of real world patients with multiple psychiatric or neurological conditions. The accuracy of the closely matched study was 100% which replicates our research on veterans with TBI or PTSD (wherein the accuracy was 94%). It clearly delineates the potential of SPECT as a biomarker in differentiating TBI from PTSD&mdash;a critical issue for anyone suffering from symptoms with no answers,&rdquo; said Henderson, a&nbsp;Denver-based psychiatrist specialising in treating complex conditions.</span></p> <p><span style="font-size: 10pt;"><br />Henderson emphasised the importance of obtaining an accurate diagnoses for TBI or PTSD. &ldquo;They may have similar symptoms, but treatments are very different,&rdquo; he said.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;For example, some treatments for PTSD can actually be useless and possibly even harmful for TBI,&rdquo; said Henderson. &ldquo;Plus, TBI can refer to injury to any part of the brain, which would require different treatments as well.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />One of the latest treatments for TBI includes applying infrared laser directly to the skull of the injured area of the brain. Called transcranial near infrared light therapy (NILT), Henderson has seen clinical improvements among his patients, as&nbsp;this study reports.</span></p></div>2015-07-08T12:00:00Z2015-07-08T12:00:00Zwebeditor@bibamedical.com stroke damage may be next application for OCT technology<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>An optical technology already widely used in ophthalmology and other medical fields holds potential to reveal how blood flows in the brain during stroke, providing information that could someday guide new treatments and reduce stroke-induced damage to the brain.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A new article published in the journal&nbsp;<em>Neurophotonics</em>&nbsp;describes work at the University of Washington, USA, using optical coherence tomography (OCT) to render high-resolution images and information about blood-flow dynamics over a broad region of the brain before, during, and after stroke-like states.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;OCT is a well-established medical imaging technique that uses light waves to generate three-dimensional pictures of tissue structure,&rdquo; said&nbsp;Ruikang Wang, professor of bioengineering and ophthalmology at the University of Washington. &ldquo;Widely applied over the past two decades in clinical ophthalmology, it recently has been adapted for brain vascular imaging.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />In &ldquo;Vasodynamics of pial and penetrating arterioles in relation to arteriolo-arteriolar anastomosis after focal stroke,&rdquo; Wang and co-authors&nbsp;Utku Baran and&nbsp;Yuandong Li&nbsp;describe using OCT-based optical microangiography to reveal brain-vessel dynamics in tremendous detail during real-time experimental stroke.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Wang has been a leader in developing OCT to measure microvascular angiograms and is now applying the methodology to explore the microvascular dynamics of blood vessels in the brain during stroke. This enables the imaging of far more vessels in a shorter period of time, and offers a greater depth penetration,&rdquo; noted&nbsp;<em>Neurophotonics</em>&nbsp;editor-in-chief David Boas&nbsp;of the Massachusetts General Hospital and Harvard Medical School, USA.</span></p> <p><span style="font-size: 10pt;"><br />Not only were the University of Washington researchers able to achieve high-resolution images of in vivo vascular networks across a large area, but they also were able to evaluate the vessel diameters, red-blood-cell velocity, and total blood-flow change across the area. In doing so, Wang said, they demonstrated a biologically initiated rescue mechanism in response to stroke. The new information could potentially provide guidance to clinicians treating stroke patients.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our key finding uncovers a non-uniform regulation event in penetrating arterioles&mdash;variance in the dilation among important vessels circulating blood throughout the brain,&rdquo; Wang said. &ldquo;Specifically, active dilation of penetrating arterioles during stroke requires strong connections&mdash;anastomosis presence&mdash;and dilation and therefore blood flow fail in the areas farther away from an anastomosis. Abundance of anastomoses may prevent or delay permanent neural damage by supplying blood to penetrating arterioles and recovering rescuable tissue called penumbra.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />With the enhanced imaging capability, Wang and his colleagues may discover as-yet-unknown mechanisms by which the brain regulates blood flow to brain tissue, Boas said. &ldquo;OCT, which already is a billion-dollar industry, is likely to go on to play an increasingly important role in the neurosciences,&rdquo; he said.</span></p> <p><span style="font-size: 10pt;"><br />The work was supported in part by National Institutes of Health grants.</span></p></div>2015-07-08T11:43:00Z2015-07-08T11:43:00Zwebeditor@bibamedical.com clinical trial harnesses the power of the immune system to fight brain cancers<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Already pioneers in the use of immunotherapy, City of Hope researchers are now testing the bold approach to cancer treatment against one of medicine&rsquo;s biggest challenges: brain cancer. This month, they will launch a clinical trial using patients&rsquo; own modified T cells to fight advanced brain tumours.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">One of but a few centres in the United States offering human studies in chimeric antigen receptor or CAR&ndash;T cell therapy, City of Hope (California, USA) is the only centre investigating CAR-T cells in injection form administered directly to brain tumours. In this first-in-humans study, patients with advanced brain tumours will receive injections&mdash;directly at the tumour site&mdash;of immune cells genetically modified to recognise certain markers on cancer cells.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;The data from our preclinical studies makes us confident that this treatment has the potential to be very powerful and last longer than previous attempts at immunotherapy for brain cancer,&rdquo; said Behnam Badie, chief of neurosurgery at City of Hope. &ldquo;This could take the treatment of brain tumours to the next level, and open up a new avenue of treatment to patients who badly need it.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The safety trial will evaluate the therapy in patients with inoperable glioblastomas and advanced gliomas and in those who have had their tumours surgically removed. The goal is to determine a safe therapeutic dose.</span><br /> <br /><span style="font-size: 10pt;"> City of Hope has been offering CAR-T cell immunotherapy in clinical trials for several blood cancers. This trial will extend the exciting therapeutic approach to the fight against solid tumours.</span><br /> <br /><span style="font-size: 10pt;"> T cells are cells in the immune system that recognise threats to the body, then mount an attack. Because cancer can hide from the immune system, CAR-T cell therapy modifies a patient&rsquo;s T cells to recognise cancer cells. First, a sample of a patient&rsquo;s T cells are extracted then genetically modified to recognise receptors on cancer cells.</span><br /> <br /><span style="font-size: 10pt;"> This City of Hope trial will use a type of T cell known as memory T cells, meaning they replicate in the body and &ldquo;remember&rdquo; diseases they have fought previously. These memory cells give rise to &ldquo;soldier&rdquo; T cells that fight disease. The hope is that the immune system will mount an attack on the existing cancer&mdash;then do the same should the cancer recur.</span><br /> <br /><span style="font-size: 10pt;"> The CAR-T cell research is overseen by Christine Brown, associate director of the T Cell Therapeutics Research Laboratory, and Stephen J Forman, Francis &amp; Kathleen McNamara Distinguished chair in Hematology and Hematopoietic Cell Transplantation.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;CAR-T cell therapy has significant potential to fight not just blood and bone marrow cancers, but a wide range of diseases for which patients need better treatment,&rdquo; Forman said. &ldquo;City of Hope is committed to maximising the potential of this revolutionary therapy for the sake of patients here and around the world.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The research is being funded through grants from the California Institute of Regenerative Medicine and the Gateway for Cancer Research Foundation.</span></p></div>2015-07-08T11:30:00Z2015-07-08T11:30:00Zwebeditor@bibamedical.com starts work to provide prosthetic hands with sense of touch<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Despite recent advances in technology for upper-limb prostheses, artificial arms and hands are still unable to provide users with sensory feedback, such as the &ldquo;feel&rdquo; of things being touched or awareness of limb position and movement. Without this feedback, even the most advanced prosthetic limbs remain numb to users, a factor that impairs the limbs&rsquo; effectiveness and their wearers&rsquo; willingness to use them. In a step toward overcoming these challenges, DARPA has awarded prime contracts for Phase 1 of its Hand Proprioception and Touch Interfaces (HAPTIX) programme.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">As part of DARPA&rsquo;s commitment to help restore full and natural functionality to wounded Service members and veterans, and in support of the White House brain initiative, HAPTIX seeks to create a prosthetic hand system that moves and provides sensation like a natural hand. Sensory feedback, especially from the hand, is vitally important for many functions, and HAPTIX seeks to create a sensory experience so rich and vibrant that users would want to wear their prostheses full time. By restoring sensory functions, HAPTIX also aims to reduce or eliminate phantom limb pain, which affects about 80% of amputees.</span></p> <p><span style="font-size: 10pt;"><br />Speeding development of vastly improved upper-limb prostheses has become a national priority. President Obama&nbsp;referred to DARPA&rsquo;s numerous advanced prosthetics programs in his 2015 State of the Union address&nbsp;when he said the US government is interested in &ldquo;creating revolutionary prosthetics, so that a veteran who gave his arms for his country can play catch with his kids again&rdquo;. &nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The ultimate goal for HAPTIX is to create a device that is safe, effective and reliable enough for use in everyday activities,&rdquo; said&nbsp;Doug Weber, DARPA programme manager. &ldquo;DARPA is partnering with scientists at the Food and Drug Administration to help develop standards for verifying safety and quantifying benefits of this new class of advanced technologies. We hope to streamline the process of validating technologies that can help our military Service members and veterans who have been injured while serving our country.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />DARPA is evaluating several distinct technical approaches in Phase 1. Those that prove successful would continue into Phase 2, which would integrate selected technology components into a complete HAPTIX test system. The agency plans to initiate take-home trials of a complete, FDA-approved HAPTIX prosthesis system within four years.</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The name HAPTIX is a play on the word haptics, referring to the sense of touch. The programme plans to adapt one of the prosthetic limb systems developed recently under DARPA&rsquo;s&nbsp;Revolutionizing Prosthetics&nbsp;programme to incorporate interfaces that provide intuitive control and sensory feedback to users. These interfaces would build on advanced neural-interface technologies being developed through DARPA&rsquo;s&nbsp;Reliable Neural-Interface Technology (RE-NET)&nbsp;programme.</span></p> <p><br /><span style="font-size: 10pt;">Where appropriate, HAPTIX teams intend to leverage commercially available technologies such as intramuscular electrodes and lead technologies developed initially for cardiac pacemakers and now used in several modern implantable medical devices. The programme also plans to test advanced microelectrode array and nerve cuff electrode technologies that have been developed over the past two decades with support from the National Institutes of Health, the Department of Veterans Affairs and DARPA.</span></p> <p><br /><span style="font-size: 10pt;">DARPA is working with teams led by the following institutions:</span></p> <ul> <li><span style="font-size: 10pt;">Case Western Reserve University</span></li> <li><span style="font-size: 10pt;">Cleveland Clinic</span></li> <li><span style="font-size: 10pt;">Draper Laboratory</span></li> <li><span style="font-size: 10pt;">Nerves Incorporated</span></li> <li><span style="font-size: 10pt;">Ripple LLC</span></li> <li><span style="font-size: 10pt;">University of Pittsburgh</span></li> <li><span style="font-size: 10pt;">University of Utah</span></li> <li><span style="font-size: 10pt;">University of Florida</span></li> </ul> <p><span style="font-size: 10pt;">To help the performers more quickly and cost-effectively conduct their research, DARPA is providing prosthetics simulation software for testing designs. The software includes a variant of the DARPA Robotics Challenge (DRC) Simulator from the June 2013&nbsp;Virtual Robotics Challenge, which helped to expedite the initial design and evaluation of semi-autonomous robots that could aid in emergency response efforts.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The DARPA Robotics Challenge Simulator was a big help for DRC and we immediately saw how adapting its virtual testing environment could benefit HAPTIX research,&rdquo; Weber said. &ldquo;The simulator will enable rapid and low-cost development of the HAPTIX technology and also provide amputees with a realistic experience for learning to use their physical prosthesis.&rdquo;</span></p></div>2015-07-08T11:22:00Z2015-07-08T11:22:00Zwebeditor@bibamedical.com Therapeutics reports significant improvement of two Neuro-Spinal Scaffold patients<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>InVivo Therapeutics has announced a one-month post-implant update for the third study patient and a six-month post-implant update for the second study patient in the company&rsquo;s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from complete AIS A spinal cord injury to incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.</span></p> <p><br /><span style="font-size: 10pt;">The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.</span></p> <p><br /><span style="font-size: 10pt;">The Neuro-Spinal Scaffold was implanted in both patients by Dom Coric of Carolina Neurosurgery and Spine Associates, chief of neurosurgery at the Carolinas Medical Center in Charlotte, USA. The study is being led by Coric and William Bockenek, chief medical officer of Carolinas Rehabilitation and chairman of the Department of Physical Medicine and Rehabilitation at the Carolinas Medical Center.</span></p> <p><br /><span style="font-size: 10pt;">Coric said, &ldquo;I am very encouraged with the third patient&rsquo;s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.&rdquo; Bockenek further stated, &ldquo;It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer, said, &ldquo;We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10&ndash;T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury.</span></p> <p><br /><span style="font-size: 10pt;">To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure.</span></p></div>2015-07-07T08:53:00Z2015-07-07T08:53:00Zwebeditor@bibamedical.com Hermann completes first NeuroPace RNS system procedure for epilepsy patient<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Nitin Tandon, UTHealth neurosurgeon and director of Epilepsy Surgery at the Memorial Hermann Mischer Neuroscience Institute at the Texas Medical Center, USA, has successfully implanted NeuroPace&rsquo;s RNS system technology into a 36-year-old epilepsy patient to help reduce the frequency of seizures&mdash;the first time this procedure has been done at Memorial Hermann.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Our patient was a severe case with a 10-year history of seizures that were uncontrollable, frequent and affecting both his left and right hippocampi and ultimately causing short-term memory loss,&rdquo; Tandon explained.</span></p> <p><br /><span style="font-size: 10pt;">Epilepsy is a common but chronic condition, and while many people can treat their seizures with medications, some 30&ndash;40% of patients are severely affected and experience uncontrolled, disabling seizures. The NeuroPace RNS system is the first closed-loop responsive brain stimulation to treat adults with partial onset seizures that cannot be controlled with antiepileptic medications.</span></p> <p><br /><span style="font-size: 10pt;">The technology, approved by the Food and Drug Administration in 2013, automatically provides treatment when it detects brain electrical activity that could lead to a seizure. The neurostimulator is placed under the scalp and into the skull, and its two leads are tailored to monitor brain activity specific to a patient while detecting patterns and delivering brief pulses of stimulation to help normalise before they experience seizures.</span></p> <p><br /><span style="font-size: 10pt;">External components to the RNS system include a NeuroPace programmer and a NeuroPace remote monitor. These devices track and analyse the data stored in the neurostimulator to assist with ongoing patient treatment. On average, NeuroPace patients have seen a 50% reduction in seizures after the first year, and up to a 70% reduction by year two.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;NeuroPace&rsquo;s two-lead system was a perfect solution for this patient, as it was essential that we monitor both sides of his brain activity,&rdquo; added Tandon. &ldquo;Just two months post-surgery, the patient has seen a significant reduction in the amount of seizures experienced and an added benefit of some improved cognitive ability. We are encouraged by these numbers and outcomes and excited for the future of this treatment for epilepsy, especially given the lack of other options in some of these cases.&rdquo;</span></p></div>2015-07-06T10:17:00Z2015-07-06T10:17:00Zwebeditor@bibamedical.com nerve stimulation can reverse spinal cord injury nerve damage in patients<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Approximately 12,000 spinal cord injuries (SCI) happen every year in the USA alone, the majority caused by car accidents, falls, sporting accidents and gunshot wounds. Better emergency care and therapy have made SCI manageable, but researchers continue to investigate approaches to make it repairable.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A new study in&nbsp;<em><a href="">Journal of Neurophysiology</a> </em>reports that peripheral nerve stimulation therapy can reverse SCI-associated nerve deterioration, potentially improving the benefits of current and emerging rehabilitation treatments.</span></p> <p><br /><span style="font-size: 10pt;">Muscles contract when the nerves controlling them are activated by electrical impulses from the brain. The brain loses control of the muscles after SCI because injured nerves do not excite easily, or at all. In addition to the nerves in the spine, the peripheral nerves&mdash;nerves going to the limbs&mdash;downstream of the injury site are also compromised after SCI, worsening muscle atrophy and other health complications that follow the injury. This secondary nerve deterioration also limits the benefits of rehabilitation therapy and the possibility of spontaneous recovery.</span></p> <p><br /><span style="font-size: 10pt;">According to the researchers, maintaining peripheral nerve function soon after SCI may lessen health complications and &ldquo;lead to better functional and rehabilitation outcome later on.&rdquo; In this new study, the research team from The University of Sydney in Australia examined if an intensive, short-term nerve stimulation treatment could improve peripheral nerve function after SCI.</span></p> <p><br /><span style="font-size: 10pt;">Patients with SCI underwent 30 minutes of electrical nerve stimulation therapy five days a week for six weeks on one limb. The other limb remained untreated. All subjects started the therapy within six months of injury.</span></p> <p><br /><span style="font-size: 10pt;">Patients with SCI had less excitable nerves with altered responses to electrical stimulation, indicating nerve dysfunction. After six weeks of therapy, the nerves in the treated limb responded to electrical stimulation more like nerves in healthy subjects. Nerve function in the untreated limb did not change over the six-week period. &ldquo;The present study has clearly demonstrated that an intensive six-week peripheral nerve stimulation programme was beneficial in improving nerve excitability parameters toward the normal range,&rdquo; the researchers wrote. Moreover, the improvements stayed if the patient continued with the stimulation therapy, the researchers said.</span></p> <p><br /><span style="font-size: 10pt;">According to the researchers, short-term peripheral nerve stimulation may be a new approach to preventing long-term changes in nerve and muscle function and improving rehabilitation outcomes. &ldquo;Therapies that help to maintain peripheral nerve function, such as the peripheral nerve stimulation paradigm used in the current study, need to be incorporated into the mainstream neuro-rehabilitation program in the early phases of SCI,&rdquo; the researchers wrote.</span></p></div>2015-07-06T10:02:00Z2015-07-06T10:02:00Zwebeditor@bibamedical.com response to children's stroke symptoms may speed diagnosis<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>An emergency room rapid response plan for children can help diagnose&nbsp;stroke symptoms&nbsp;quickly, according to new research in the American Heart Association journal&nbsp;<em><a href="">Stroke</a>.</em></strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Just as there are rapid response processes for adults with a possible stroke, there should be a rapid response process for children with a possible stroke that includes expedited evaluation and imaging or rapid transfer to a medical centre with paediatric stroke expertise,&rdquo; said Lori Jordan, study senior author and an assistant professor of paediatrics and neurology at Monroe Carell Jr Children&rsquo;s Hospital at Vanderbilt in Nashville, USA. &ldquo;We need the emergency department, radiology, critical care medicine and often many other specialists to work quickly and efficiently together to treat paediatric patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Researchers reviewed quality improvement data from Vanderbilt&rsquo;s paediatric stroke programme. They established a stroke alert plan in the emergency room which requires a neurology resident to see a child with stroke symptoms within 15 minutes and for most children, quickly obtain a magnetic resonance imaging scan (MRI).</span></p> <p><br /><span style="font-size: 10pt;">Using the method for 124 children (average age 11) with stroke-like symptoms between April 2011 and October 2014, researchers found:</span></p> <ul> <li><span style="font-size: 10pt;">24% suffered strokes and 2% had&nbsp;transient ischaemic attacks&nbsp;(TIA);&nbsp;</span></li> <li><span style="font-size: 10pt;">17% had complex migraine (associated with neurological symptoms),</span></li> <li><span style="font-size: 10pt;">15% suffered seizures, and</span></li> <li><span style="font-size: 10pt;">14% were diagnosed with critical illnesses such as meningitis, encephalitis or tumours.</span></li> <li><span style="font-size: 10pt;">Of the confirmed stroke/TIA patients, 13% had&nbsp;sickle cell anaemia&nbsp;or&nbsp;congenital heart disease.</span></li> <li><span style="font-size: 10pt;">The most common presenting symptoms were weakness (65%), altered mental status (44%) and headache (37%).</span></li> </ul> <p><span style="font-size: 10pt;">The&nbsp;median time between emergency department arrival and neurology consultation was 28 minutes, and the median time from consultation to neurologist at-bedside was 7 minutes researchers said. About 94 minutes elapsed between emergency department arrival to MRI and 59 minutes between arrival and computed tomography.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Rapid evaluation and appropriate testing is critical,&rdquo; said Jordan, who also is director of the Vanderbilt Pediatric Stroke Program. &ldquo;Prior studies have suggested that stroke in children often takes a long time to diagnose due to delays in imaging. In one recent Canadian study, in-hospital delay was 12.7 hours for children with stroke. We were able to initiate the most accurate type of brain scan, a MRI of the brain, within 94 minutes on average.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Know the symptoms of stroke and consider the possibility of a stroke no matter what a person&rsquo;s age and have your child rapidly evaluated.&rdquo;</span></p></div>2015-07-03T15:28:00Z2015-07-03T15:28:00Zwebeditor@bibamedical.com survival in adult patients with low-grade brain tumours<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Using clinical data collected over the past decade through a US cancer registry, researchers at the University of California, San Diego School of Medicine, USA, demonstrated that significant strides have been made in improving the survival of adult patients with low-grade gliomas, a slow-growing yet deadly form of primary brain cancer. The findings are published by&nbsp;<em><a href="">Neuro-Oncology: Clinical Practice</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Because of the rarity of low-grade gliomas, the disease remains understudied. The optimal management strategies for these tumours also remain controversial. Decisions of when and whether to administer radiation, what type of surgery to perform, and what type of chemotherapy to use, if any, varies widely among physicians.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;An understanding of how our treatments affect the survival of low-grade glioma patients will better enable us to help these patients,&rdquo; said senior author Clark C Chen, vice chairman of research and academic development, Division of Neurosurgery, UC San Diego School of Medicine.</span></p> <p><br /><span style="font-size: 10pt;">Using the Surveillance, Epidemiology, and End Results (SEER) database, a national cancer registry sponsored by the National Cancer Institute, Chen&rsquo;s team demonstrated that the median survival of patients afflicted with low-grade gliomas increased from 44 months (in 1999) to 57 months (in 2010). This is the first time that such increased survival has been reported.</span></p> <p><br /><span style="font-size: 10pt;">The study suggests that the survival improvement is due to the development of more effective chemotherapies. Interestingly, the improved survival occurred despite a decreased use of radiation therapy at the time when low-grade glioma is first diagnosed.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The decrease in the use of radiation started in 2005, concomitant to the publication of an important European randomised control study that demonstrated no significant survival benefit whether radiation was delivered at the time of diagnosis or later in the clinical course,&rdquo; said Xuezhi Dong, the study&rsquo;s first author.</span></p> <p><br /><span style="font-size: 10pt;">While many previous studies suggest that complete excision of low-grade gliomas is associated with longer patient survival, this latest study found that only about a third of US patients underwent complete surgical resection. Notably, this number remained unchanged throughout the past decade.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The lack of improvement in surgical resection is likely limited by the availability of technologies, such as intra-operative magnetic resonance imaging, to allow surgeons to perform maximal surgical resection,&rdquo; said Bob S Carter, chief of neurosurgery at UC San Diego Health. &ldquo;The completion of an advanced surgical suite with an intra-operative MRI at Jacobs Medical Center in 2016 at UC San Diego Health will afford us an unprecedented opportunity to achieve maximal surgical resection of low-grade glioma and set forth new surgical standards for the care of this patient population.&rdquo;</span></p></div>2015-07-03T15:10:00Z2015-07-03T15:10:00Zwebeditor@bibamedical.com makes a significant difference in stoke treatment in the USA<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A new map of emergency stroke care in the USA illustrates the patchwork system in place for delivering the most effective treatment. In the journal&nbsp;<em>Stroke</em>, University of Michigan Medical School researchers report the results of a study that for the first time shows wide geographic variation in use of &ldquo;clotbuster&rdquo; treatments for stroke.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Only 4.2% of more than 844,000 stroke victims received the tPA drug or another urgent stroke treatment, the study found. If given in the first hours after a stroke, tPA and other treatments can restore blood flow in the brain and prevent the damage that causes stroke-related disability and drives up the long-term cost of caring for stroke survivors.</span><br /><br /></p> <p><span style="font-size: 10pt;">When the researchers looked at how tPA was used&mdash;or not used&mdash;in Medicare participants who had strokes in each of the USA&rsquo;s 3,436 hospital markets between 2007 and 2010, deep divides emerged. In one-fifth of these regions, no patients received tPA.</span><br /><br /></p> <p><span style="font-size: 10pt;">Meanwhile, in some places, as many as 14% of stroke patients received tPA through an intravenous line, or a intrarterial treatment that involved tPA or another strategy.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These results scream that a major opportunity exists to improve emergency stroke care, if only we can understand how these differences arise and how to eliminate them,&rdquo; says James Burke, the study&rsquo;s senior author and an assistant professor in neurology at the University of Michigan and the VA Ann Arbor Healthcare System. &ldquo;If we had a perfect system in place nationwide, which delivered treatment at the highest rates seen in this study, thousands of patients could be spared disability.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">When the researchers grouped the regions from best-performing to poorest-performing and looked at them closely, they found more surprises. In the top fifth, an average of 9% of patients received clot-busting treatment, while in the bottom fifth, no patients received it.</span></p> <p><br /><span style="font-size: 10pt;">Even after they adjusted for the number of strokes that each region reported during the four years, there was a wide gap in the use of emergency stroke treatment. In addition, older patients, women, and members of racial and ethnic minority groups were less likely to receive tPA regardless of&nbsp;where they lived.</span></p> <p><br /><span style="font-size: 10pt;">While patients were somewhat more likely to receive tPA if they had their strokes in regions where hospitals were certified as primary stroke centres, which can deliver tPA around the clock, or where ambulance companies had a policy of driving stroke patients further to get to a stroke centre, those factors did not make a major difference.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We can clearly do much better, but existing policy solutions are only going to get us so far,&rdquo; says Burke. &ldquo;In our findings, we do see positive results from primary stroke centre designation and ambulance bypass, but we are talking about a complex mix of hospital, EMS, and individual response to stroke. We need to understand better what the areas with the highest rates of use are doing differently.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">At the time of the study&rsquo;s data, comprehensive stroke centre designation, which indicates the most advanced level of stroke care including intrarterial tPA, was not yet in use.</span></p> <p><br /><span style="font-size: 10pt;">The researchers calculated that if all regions achieved the same rates of tPA use as the Stanford region, more than 92,800 people would get treated, and 8,078 people would survive their stroke disability-free. Even if all regions doubled their current tPA use, 7,206 people would be spared disability.</span></p> <p><br /><span style="font-size: 10pt;">Variation in tPA use was associated with lower&nbsp;average levels of education and income, and higher unemployment, in hospital service areas, and use was slightly higher across all densely populated areas compared with more sparsely populated areas. The top 20 areas for tPA use are scattered across the country, in urban and rural areas, rich and poor.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;By studying communities that treated a lot of stroke patients, we may learn how best to help low-performing communities treat more acute stroke patients in their community,&rdquo; says lead author Lesli Skolarus, a stroke neurologist and assistant professor at the University of Michigan.</span></p></div>2015-07-01T11:28:00Z2015-07-01T11:28:00Zwebeditor@bibamedical.com and spine surgery no riskier when physicians-in-training participate<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>An analysis of the results of more than 16,000 brain and spine surgeries suggests patients have nothing to fear from having residents assist in their operations. The contributions of residents do nothing to increase patients&rsquo; risks of postoperative complications or of dying within 30 days of the surgery, the analysis showed. A&nbsp;report on the study&nbsp;appears in the <em><a href="">Journal of Neurosurgery</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Patients often ask whether a resident is going to be involved in their case, and they are usually not looking to have more residents involved,&rdquo; says&nbsp;Mohamad Bydon, himself a resident in neurosurgery at The Johns Hopkins Hospital, Baltimore, USA. &ldquo;Some people have a fear of being treated in a hospital that trains doctors.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">To see whether that fear is borne out by real-world outcomes, Bydon worked with&nbsp;Judy Huang, a professor of neurosurgery and director of the neurosurgery residency program at the Johns Hopkins University School of Medicine, and other collaborators to analyse data from the American College of Surgeons National Surgical Quality Improvement Program database. Specifically, they examined outcomes for all patients who had brain and spine surgeries between 2006 and 2012&mdash;16,098 in total.</span><br /><br /></p> <p><span style="font-size: 10pt;">The initial analysis appeared to affirm the fear, showing that patients operated on by a fully trained physician plus a resident had a complication rate of 20.12%, while patients with only an attending had a complication rate of 11.7%. The patients operated on by attendings plus residents also had a slightly higher risk of death within 30 days after the surgery.</span><br /><br /></p> <p><span style="font-size: 10pt;">However, the research team suspected that the difference might not be caused by the participation of the residents. Residents are most often found in teaching hospitals associated with academic medical centres, and such hospitals are also the most likely to treat higher-risk, more complicated cases. The team undertook a deeper analysis of the data, one that took into account patients&rsquo; conditions and severity of illness prior to surgery. That analysis showed that having a resident present in the surgery had no effect on patients&rsquo; risks for postsurgical complications or death.</span><br /><br /></p> <p><span style="font-size: 10pt;">Having a resident present is likely to benefit patients, Huang says. &ldquo;It means that there is an extra pair of hands, an extra pair of eyes,&rdquo; she explains. The experience is also essential for training the next generation of surgeons. &ldquo;It is not just about the physical performance of the procedure,&rdquo; she says. &ldquo;It is also about the reasoning involved, the understanding of what the pitfalls are and how to avoid complications. That thought process is something that can only occur in the setting of the operating room when a trainee and a teacher work side by side together.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Bydon agrees. &ldquo;When you are in the operating room, you see how senior surgeons approach the simpler cases and how they approach the more complex cases, and it is really invaluable, because that is how you learn to one day become an attending yourself,&rdquo; he says.</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors say the study&rsquo;s results may help physicians reassure nervous patients about the prospect of having a trainee assist with a surgery. Huang explains: &ldquo;It allows us to say, &lsquo;Not only do we believe this, but it has also been shown in a population of patients across the country who undergo neurosurgery that there is no downside.&rsquo;&rdquo;</span></p></div>2015-07-01T10:32:00Z2015-07-01T10:32:00Zwebeditor@bibamedical.com retrievers now recommended for some stroke patients<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>For the first time, the American Heart Association/American Stroke Association recommends using a stent retrieval device to remove blood clots in select stroke patients who have clots obstructing the large arteries supplying blood to the brain, according to a new focused update published in the American Heart Association journal <em><a href="" target="_blank">Stroke</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The optimal initial treatment for a&nbsp;clot-caused (ischaemic) stroke&nbsp;remains intravenous delivery of the clot-busting medication&nbsp;tissue plasminogen activator (t-PA). When given within a few hours after stroke symptoms, t-PA can dissolve the clot and re-establish blood flow to the brain, limiting stroke disability.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;What we have learned in the last eight months, from six new clinical trials, is that some people will benefit from additional treatment with a stent retrieval device if a clot continues to obstruct one of the big vessels after t-PA is given,&rdquo; said William J Powers, lead author of the focused update and H Houston Merritt distinguished professor and chair of the department of neurology at the University of North Carolina at Chapel Hill.</span></p> <p><span style="font-size: 10pt;"><br />The focused update on endovascular treatment of acute ischaemic stroke analyses results from randomised clinical trials published since 2013, when the last treatment guidelines were issued.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This additional treatment is more difficult than t-PA, which can be given by most doctors in the emergency room,&rdquo; Powers said.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Clot removal with a stent retriever requires a specialised centre, such as&nbsp;comprehensive stroke centres,&nbsp;or other healthcare facilities with specially trained people including some primary stroke centres. This treatment has to be done within six hours of the onset of stroke, so in some areas it can be tricky to get you to an appropriate hospital in time.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The focused update recommends that stroke patients have their clots removed with a stent retriever if they:</span></p> <ul> <li><span style="font-size: 10pt;">have no significant disability prior to the current stroke;</span></li> <li><span style="font-size: 10pt;">received t-PA within 4.5 hours of symptom onset;</span></li> <li><span style="font-size: 10pt;">have a clot blocking a large artery supplying blood to the brain;</span></li> <li><span style="font-size: 10pt;">are at least 18 years old;</span></li> <li><span style="font-size: 10pt;">had an acute, severe stroke;</span></li> <li><span style="font-size: 10pt;">have imaging showing more than half of the brain on the side of the stroke is not permanently damaged; and</span></li> <li><span style="font-size: 10pt;">can have the procedure start within six hours after symptom onset.</span></li> </ul> <p><span style="font-size: 10pt;">The evidence backing this new recommendation received the highest rating based on the scientific evidence reviewed, and suggests the benefits substantially outweigh the potential risks in these patients.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Evidence-based guidelines are based on clinical trials, which tell you that if you have a patient with the same characteristics of those in the trials, on average they will do much better with the treatment than if you treat them another way,&rdquo; Powers said.</span></p> <p><span style="font-size: 10pt;"><br />The focused update states that the use of stent retrievers is indicated in preference to other mechanical thrombectomy devices, but notes that the use of mechanical thrombectomy devices other than stent retrievers may be reasonable in some circumstances based on a physician&rsquo;s clinical judgment.</span></p></div>2015-06-30T12:04:00Z2015-06-30T12:04:00Zwebeditor@bibamedical.com Medical and Alliance Spine and Pain Centers announce first Prometra II implant<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Flowonix Medical and Alliance Spine and Pain Centers have announced the first implant of the Prometra II intrathecal infusion pump in Georgia, USA. The intrathecal infusion device was implanted in a 56-year-old female suffering from severe chronic pain due to multiple sclerosis. The patient has been unable to get pain relief from oral pain medications due to severe adverse effects. The procedure was performed by David Rosenfeld.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Prometra pump offers clinicians an important option for treating patients suffering from chronic pain. In addition to the economic and clinical advantages of implantable pump therapy, the Prometra pump contains innovative technology for very accurate drug delivery and increased device longevity,&rdquo; stated Rosenfeld.</span></p> <p><br /><span style="font-size: 10pt;">Prometra II builds on the technology of the Prometra family. The most significant advancement in the Prometra II device is its proprietary flow-activated safety valve (FAV) technology, which is designed to allow patients to safely undergo magnetic resonance imaging (MRI). MRIs can be contraindicated for patients with implanted devices because of the strong electromagnetic energy from these systems which can interfere with proper device function. The Prometra II system is labelled as MR-conditional and can safely undergo such scans providing specific conditions are followed. These specific steps are described in the instructions for use supplied with the product.</span></p> <p><br /><span style="font-size: 10pt;">Over 100 million people suffer from some form of chronic pain caused by injury or disease in the USA alone, and in some cases the pain is severe enough that it interferes with the person&rsquo;s ability to work or lead a normal life. For such individuals, conventional pharmacological therapy or other pain strategies are often insufficient to control their pain. Implantable intrathecal drug pumps can help alleviate pain by automatically delivering pain medicine directly to the intrathecal space around the spine. In many cases, pain relief can be obtained with much less pain medication than conventional drug therapy.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We realise this is an important milestone in the therapy for this patient, but it is also an important milestone for us as this is the first implant of the Prometra II system in Georgia,&rdquo; stated Steven Adler, president and chief executive officer of Flowonix.</span></p></div>2015-06-29T14:09:00Z2015-06-29T14:09:00Zwebeditor@bibamedical.com University Hospital utilises 3D Systems’ simulator for life-saving team training in acute stroke<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Southend University Hospital has established an innovative interventional stroke service using 3D Systems&rsquo; ANGIO Mentor Suite simulator at Anglia Ruskin University for efficient and realistic team training for endovascular stroke treatment.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the American Heart Association Annual Statistical Update based on data compiled from over 190 countries, stroke remains the number two cause of death in the world. In the USA, stroke is the number four cause of death, killing nearly 129,000 people a year.</span><br /><br /></p> <p><span style="font-size: 10pt;">Recent clinical studies have demonstrated for the first time that endovascular treatment can improve stroke patient outcome.&nbsp;Currently, only 1% of ischaemic stroke patients receive this costly but potentially life-saving treatment but, based on the positive outcome of these studies, this number is expected to increase to 10%.</span><br /><br /></p> <p><span style="font-size: 10pt;">Southend University Hospital found that running dedicated training courses in a true-to-life cath lab environment using a virtual reality simulator, enhanced understanding of high-risk stroke procedures, strengthened collaboration and increased communication skills across the various clinical teams involved in this complex procedure.</span></p> <p><br /><span style="font-size: 10pt;">Iris Grunwald, diagnostic and interventional neuroradiologist at Southend University Hospital and director neuroscience and vascular simulation at Anglia Ruskin University said, &ldquo;In order to provide timely regional coverage for endovascular stroke treatment, more hospitals and physicians will need to provide endovascular stroke services. To practice this high risk procedure, I believe procedural training on a virtual reality simulator such as the ANGIO Mentor Suite should be mandatory to provide an environment that is as close as possible to the actual setting when treating a patient.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">3DS will exhibit its full range of advanced healthcare training solutions including a selection of virtual reality simulators and 3D printed models at the upcoming SESAM conference (24&ndash;26 June, Belfast, UK).</span></p></div>2015-06-22T13:57:00Z2015-06-22T13:57:00Zwebeditor@bibamedical.com announces €19m in financing to advance innovative minimally invasive stroke therapy<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p style="text-align: center;">L to R: Justin Lynch, partner, Fountain Healthcare Partners, Eamon Brady, chief executive officer, Neuravi and John O&rsquo;Shaughnessy, chairman, Neuravi</p> <p style="text-align: center;">&nbsp;</p> <p><span style="font-size: 11pt;"><strong>Neuravi has completed a Series B financing of &euro;19m (US$21m) to advance the company&rsquo;s minimally invasive thrombectomy device for acute ischaemic stroke, the EmboTrap revascularization device. The round was led by European private equity firm Life Sciences Partners (LSP), with participation from returning Series A investors Fountain Healthcare Partners, Delta Partners and the Western Development Commission.&nbsp;</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The funding will support European commercialisation of the EmboTrap device, as well as Neuravi&rsquo;s clinical trial, ARISE II, which will begin enrolling patients this year at select centres in the USA and Europe.</span></p> <p><br /><span style="font-size: 10pt;">Ischaemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischaemic strokes each year.</span></p> <p><br /><span style="font-size: 10pt;">Following a stroke, rapid intervention is critical. Minimally invasive thrombectomy devices, also known as stent retrievers, are used by physicians in an acute intervention to remove a clot and reopen cerebral blockages to immediately restore blood flow to the brain. A series of recent highly positive multinational clinical trials have demonstrated that patients treated with thrombectomy have better outcomes than those treated with medical therapy alone.</span></p> <p><br /><span style="font-size: 10pt;">Based on a foundation of clot mechanics research, Neuravi&rsquo;s technology is designed to capture and remove clots while reducing the opportunity for embolisation of clot particles that could potentially cause a new stroke in another territory, contributing to poor patient outcomes. In a case series presented at the European Stroke Organisation Congress (17&ndash;19 April, Glasgow, UK) evaluating use of the EmboTrap device in 42 stroke patients at two European centres, treatment with the device restored significant blood flow in 86% of patients, with the majority of patients recovering to be able to function independently.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is an exciting time to be backing a company dedicated to improving stroke therapy, given the recent series of positive trial results that have decisively demonstrated the value of endovascular treatment for large vessel occlusions. These are the most devastating types of stroke, creating a tremendous social and economic burden for patients, and improved treatment has the potential to both save lives and improve quality of life,&rdquo; said Anne Portwich, partner, LSP. &ldquo;The Neuravi team has impressed us tremendously with its thorough approach, from the clot research that informs the company&rsquo;s technology development, to collaborations with leading experts in the treatment of stroke.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">As part of the financing, Anne Portwich and Ren&eacute; Kuijten, partner, LSP, will join Neuravi&rsquo;s board of directors.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We look forward to working closely with the clinical community as we make the EmboTrap commercially available in Europe, and gather more data through ARISE II to support the device&rsquo;s use clinically in the USA,&rdquo; said Eamon Brady, Neuravi&rsquo;s chief executive officer.</span></p></div>2015-06-17T13:48:00Z2015-06-17T13:48:00Zwebeditor@bibamedical.com approves Brio neurostimulation system<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The US Food and Drug Administration (FDA) has approved the Brio neurostimulation system (St Jude Medical), an implantable deep brain stimulation device to help reduce the symptoms of Parkinson&rsquo;s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio neurostimulation system can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;There are no cures for Parkinson&rsquo;s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,&rdquo; said William Maisel, acting director of the Office of Device Evaluation at the FDA&rsquo;s Center for Devices and Radiological Health.&nbsp;&ldquo;This new device adds to the array of treatment options to help people living with Parkinson&rsquo;s and essential tremor enjoy better, more productive lives.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The Brio neurostimulation system consists of a small (1.9in x 2.1in x 0.4in) battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat Parkinson&rsquo;s disease or essential tremor. The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain. Healthcare providers make adjustments to the pulse generator to optimise the effects of the Brio neurostimulation system.</span></p> <p><span style="font-size: 10pt;"><br />Data supporting the safety and effectiveness of the device system included two clinical studies. One study included 136 patients with Parkinson&rsquo;s disease and the other included 127 patients with essential tremor. In both studies, patients had symptoms, including tremors, that were not adequately controlled with drug therapy.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Brio neurostimulation system was used in addition to medication for patients with Parkinson&rsquo;s disease and the majority of patients with essential tremor who used the device were able to control their symptoms without the need for medications. Researchers implanted the Brio neurostimulation system in all patients and assessed effectiveness for Parkinson&rsquo;s disease patients at three months and essential tremor patients at six months.&nbsp;Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis or death.&nbsp;Other device-related adverse events included infection and dislocation of the device lead under the skin.</span></p> <p><span style="font-size: 10pt;"><br />The Brio neurostimulation system is the second device approved by the FDA for Parkinson&rsquo;s and essential tremor. The first device, Medtronic&rsquo;s Activa deep brain stimulation therapy system, was approved in 1997 for tremor associated with essential tremor and Parkinson&rsquo;s disease. In 2002, the indications were expanded to include the symptoms of Parkinson&rsquo;s disease.</span></p></div>2015-06-13T09:05:00Z2015-06-13T09:05:00Zwebeditor@bibamedical.com find way to disrupt brain tumour stem cells<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Some brain tumours are difficult to treat. Whether surgically removed, treated by radiation or infiltrated by chemotherapy drugs, they can find a way to return. The ability of many brain tumours to regenerate can be traced to cancer stem cells that evade treatment and spur the growth of new tumour cells.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">But some brain tumour stem cells may have a weakness, scientists have found, and reported in <em><a href="">Cell Reports</a>.</em> The cancer stem cells&rsquo; abilities have to be maintained, and researchers at Washington University School of Medicine in St Louis, USA, have identified a key player in that maintenance process. When the process is disrupted, they found, so is the spread of cancer.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This discovery may help us attack the root of some of the deadliest brain tumours,&rdquo; said senior author Albert H Kim, assistant professor of neurological surgery. &ldquo;A successful brain cancer treatment will very likely require blocking the tumour stem cells&rsquo; ability to survive and replenish themselves.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Kim&rsquo;s focus is on glioblastomas. Scientists have discovered in recent years that some cancer cells in glioblastomas and other tumours are more resistant to treatment than others. Those same, more defiant cells also are better at re-establishing cancer after treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These tumour stem cells are really the kingpins of cancers&mdash;the cells that direct and drive much of the harm done by tumours,&rdquo; said Kim, who treats patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, USA.</span></p> <p><br /><span style="font-size: 10pt;">Kim and his colleagues identified a protein, known as SOX2, that is active in brain tumour stem cells and in healthy stem cells in other parts of the body.</span></p> <p><br /><span style="font-size: 10pt;">The researchers found that the tumour stem cells&rsquo; ability to make SOX2 could be modified using another protein&mdash;CDC20. Increasing SOX2 by boosting levels of CDC20 also increased a tumour&rsquo;s ability to grow once transplanted into mice. Eliminating CDC20, meanwhile, left tumour stem cells unable to make SOX2, reducing the tumour stem cells&rsquo; ability to form tumours.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The rate of growth in some tumours lacking CDC20 dropped by 95% compared with tumours with more typical levels of CDC20,&rdquo; Kim said.</span></p> <p><br /><span style="font-size: 10pt;">When the scientists analysed human tumour samples, they found that a subset of patients with glioblastomas that had the highest CDC20 levels also had the shortest periods of survival after diagnosis.</span></p> <p><br /><span style="font-size: 10pt;">Kim&rsquo;s lab is exploring methods to block CDC20 in brain tumours, including RNA interference, an approach in which the production of specific proteins is blocked. That general approach is in clinical trials as a therapy for other cancers, viral infections and other illnesses.</span></p></div>2015-06-12T15:56:00Z2015-06-12T15:56:00Zwebeditor@bibamedical.com injectable electronics system holds promise for basic neuroscience and neuro-degenerative diseases<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A team of international researchers, led by Charles M Lieber, the Mark Hyman, Jr Professor of Chemistry, has developed a method for fabricating nano-scale electronic scaffolds that can be injected via syringe. Once connected to electronic devices, the scaffolds can be used to monitor neural activity, stimulate tissues and even promote regenerations of neurons. The study is described in <em><a href="">Nature Nanotechnology</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;I do feel that this has the potential to be revolutionary,&rdquo; Lieber said. &ldquo;This opens up a completely new frontier where we can explore the interface between electronic structures and biology. For the past thirty years, people have made incremental improvements in micro-fabrication techniques that have allowed us to make rigid probes smaller and smaller, but no one has addressed this issue&mdash;the electronics/cellular interface&mdash;at the level at which biology works.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The idea of merging the biological with the electronic is not a new one for Lieber. In an earlier study, scientists in his lab demonstrated that the&nbsp;scaffolds could be used to create &ldquo;cyborg&rdquo; tissue&mdash;when cardiac or nerve cells were grown with embedded scaffolds. Researchers were then able to use the devices to record electrical signals generated by the tissues, and to measure changes in those signals as they administered cardio- or neuro-stimulating drugs.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We were able to demonstrate that we could make this scaffold and culture cells within it, but we did not really have an idea how to insert that into pre-existing tissue,&rdquo; Lieber said. &ldquo;But if you want to study the brain or develop the tools to explore the brain-machine interface, you need to stick something into the body. When releasing the electronics scaffold completely from the fabrication substrate, we noticed that it was almost invisible and very flexible like a polymer and could literally be sucked into a glass needle or pipette. From there, we simply asked, would it be possible to deliver the mesh electronics by syringe needle injection, a process common to delivery of many species in biology and medicine&mdash;you could go to the doctor and you inject this and you are wired up.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Though this does not represent the first attempts at implanting electronics into the brain&mdash;deep brain stimulation has been used to treat a variety of disorders for decades&mdash;the nano-fabricated scaffolds operate on a completely different scale.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Existing techniques are crude relative to the way the brain is wired,&rdquo; Lieber explained. &ldquo;Whether it is a silicon probe or flexible polymers&hellip;they cause inflammation in the tissue that requires periodically changing the position or the stimulation. But with our injectable electronics, it is as if it is not there at all. They are one million times more flexible than any state-of-the-art flexible electronics and have subcellular feature sizes. They are what I call &lsquo;neuro-philic&rsquo;&mdash;they actually like to interact with neurons."</span></p> <p><br /><span style="font-size: 10pt;">Despite their enormous potential, the fabrication of the injectable scaffolds is relatively simple. That&rsquo;s the beauty of this&mdash;it is compatible with conventional manufacturing techniques,&rdquo; Lieber said.</span></p> <p><br /><span style="font-size: 10pt;">The process is similar to that used to etch microchips, and begins with a dissolvable layer deposited on a substrate. To create the scaffold, researchers lay out a mesh of nanowires sandwiched in layers of organic polymer. The first layer is then dissolved, leaving the flexible mesh, which can be drawn into a syringe needle and administered like any other injection.</span></p> <p><br /><span style="font-size: 10pt;">After injection, the input/output of the mesh can be connected to standard measurement electronics so that the integrated devices can be addressed and used to stimulate or record neural activity.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These types of things have never been done before, from both a fundamental neuroscience and medical perspective,&rdquo; Lieber said. &ldquo;It is really exciting&mdash;there are a lot of potential applications.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Going forward, Lieber said, researchers hope to better understand how the brain and other tissues react to the injectable electronics over longer periods.</span></p> <p><br /><span style="font-size: 10pt;">Harvard&rsquo;s Office of Technology Development has filed for a provisional patent on the technology and is actively seeking commercialisation opportunities.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Having those results can prove that this is really a viable technology,&rdquo; Lieber said. &ldquo;The idea of being able to precisely position and record from very specific areas, or even from specific neurons over an extended period of time&mdash;this could, I think, make a huge impact on neuroscience.&rdquo;</span></p></div>2015-06-12T15:35:00Z2015-06-12T15:35:00Zwebeditor@bibamedical.com names Walter J Koroshetz director of the National Institute of Neurological Disorders and Stroke<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>National Institutes of Health director Francis S Collins has announced the selection of Walter J Koroshetz, as the Director of the National Institute of Neurological Disorders and Stroke (NINDS). He has served as acting director of the NINDS since October 2014.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;I am very pleased that Koroshetz has accepted the enormous responsibility of being the NINDS director,&rdquo; said Collins. &ldquo;His deep grounding in clinical neurology and basic neuroscience research makes him the ideal candidate to lead NINDS into the future and to fulfil the Institute&rsquo;s mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In announcing the appointment, Collins recognised Koroshetz&rsquo; role in the creation of the StrokeNet, a national clinical trial network for research in stroke treatment, prevention, and recovery as well as his role as point person for traumatic brain injury research at the NIH, and co-founder of the NIH-Uniformed Services Center for Neuroscience and Regenerative Medicine (TBI research centre).</span><br /><br /></p> <p><span style="font-size: 10pt;">Koroshetz serves as co-chair of the NIH BRAIN Initiative. He was instrumental in establishing the NIH Office of Emergency Research and is the NINDS representative to the federal Interagency Autism Coordinating Committee; chair of the Interagency Pain Research Coordinating Committee and the NIH Pain Consortium, and co-chair of the Common Fund Undiagnosed Disease programme.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;I am delighted to have the opportunity to lead the NINDS when there is such an enormous potential for unlocking the mysteries of brain function. Since the president&rsquo;s announcement of the BRAIN Initiative, all eyes have been on the efforts to uncover the circuits and connections in the brain that make us who we are. NINDS grantees are passionate about understanding how the brain develops and functions to enable human behaviour, and learning how to treat disabling disorders,&rdquo; said Koroshetz.</span></p> <p><br /><span style="font-size: 10pt;">As the new director of the NINDS, Koroshetz will oversee an annual budget of US$1.6bn and 1,141 scientists, physician-scientists, and research administrators.</span></p> <p><br /><span style="font-size: 10pt;">Before coming to NIH as the NINDS deputy director in 2007, Koroshetz was a Harvard professor of Neurology, vice chair of Neurology at Massachusetts General Hospital, director of Stroke and Neurointensive Care, and a member of the Huntington&rsquo;s disease unit.</span></p></div>2015-06-12T14:47:00Z2015-06-12T14:47:00Zwebeditor@bibamedical.com noninvasive brain stimulator may ease Parkinson’s symptoms<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Parkinson&rsquo;s disease patients whose symptoms such as tremor, muscle stiffness and slowed movement make it difficult to hold an eating utensil steady have few options for relief outside of a hospital or clinic. Medication can help, but over time it tends to become less effective.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">To give these patients another in-home option, Johns Hopkins graduate students have invented a headband-shaped device to deliver noninvasive brain stimulation to help reduce the symptoms.</span><br /><br /></p> <p><span style="font-size: 10pt;">The students&rsquo; prototype, developed during a year-long biomedical engineering master&rsquo;s degree programme, has not yet been tested on humans, but it is viewed as a promising first step toward helping Parkinson&rsquo;s patients safely relieve their own symptoms at home or elsewhere without going to a hospital or doctor&rsquo;s office.</span><br /><br /></p> <p><span style="font-size: 10pt;">The design has already received recognition at several prominent competitions, winning the US$5,000 second-place prize in VentureWell&rsquo;s BMEidea national design contest for biomedical and bioengineering students. In May, the invention earned first-place honours in the People&rsquo;s Choice Award competition at Johns Hopkins&rsquo; Biomedical Engineering Design Day 2015. Earlier, it was a finalist in the Rice University Business Plan Competition.</span><br /><br /></p> <p><span style="font-size: 10pt;">The five student team members were inspired to build the new device last summer after observing neurosurgery being performed on Parkinson&rsquo;s patients at the Johns Hopkins Hospital.</span><br /><br /></p> <p><span style="font-size: 10pt;">For patients in advanced stages, one treatment option is deep brain stimulation, using thin electrical leads into the region of the brain that controls movement. The leads are connected to a pulse generator placed under the skin below the collarbone which sends electrical signals to the brain to help curb some symptoms caused by Parkinson&rsquo;s.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We saw that this procedure is really invasive and can take 10 to 15 hours to complete,&rdquo; said Shruthi Rajan, a team member from Charlotte, USA. &ldquo;It is also very expensive, and not all patients qualify for the surgery. We asked if there was a way to provide the same treatment in a less invasive way that does not require brain surgery.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The students were referred to Yousef Salimpour, a Johns Hopkins Medicine postdoctoral research associate who has been studying a noninvasive Parkinson&rsquo;s therapy called transcranial direct current stimulation. In this painless treatment, low-level current is passed through two electrodes placed over the head to tweak the electrical activity in specific areas of the brain. The technique can be used to excite or inhibit these nerve cells. The treatment is still considered experimental, but it has attracted much attention because it does not require surgery and is inexpensive, safe and relatively easy to administer without any side effects.</span><br /><br /></p> <p><span style="font-size: 10pt;">The biomedical engineering students met with Salimpour to learn about the research he conducts in a clinical setting. &ldquo;We told him we had an idea for a portable home version of this equipment,&rdquo; Rajan said. &ldquo;But we planned to add safety measures to make sure the patient used it properly without a doctor or nurse being present.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The students aimed for a prototype that would enable a patient to activate the battery-powered treatment by touching a large easy-to-press button. With patient safety in mind, the students designed their prototype to deliver current for only 20 minutes daily and only at a doctor-prescribed level.</span><br /><br /></p> <p><span style="font-size: 10pt;">To help fine-tune their design, the students met with dozens of Parkinson&rsquo;s patients over a four-month period. Although the students did not administer the actual brain treatment, the patients helped them craft the critical headband component so that it would be easy to put on, comfortable to wear and positioned so that the electrodes would remain stable and properly target the motor cortices areas of the brain.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;For a comfortable fit, we put an elastic band in the back and told the patients to put it on like a baseball cap,&rdquo; said team member Ian Graham of Old Saybrook, Conn. &ldquo;The interaction with the patients was really helpful. In our usual college classes, we are just given a textbook problem to solve. In this programme, being able to find a real-life biomedical problem and figure out how to address it was huge. And we even received letters of encouragement from some of the patients we met.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">In addition to the assistance from neuroengineer Salimpour, the student inventors received guidance from other members of an interdisciplinary team of Johns Hopkins medical researchers that includes neurologist Zoltan Mari, neurosurgeon William Anderson and neuroscientist Reza Shadmehr.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Our preliminary results were promising&rdquo;, Salimpour said. &ldquo;Patients keep asking us for more of this treatment. But we could not provide the treatment for them because there is no portable and FDA-approved device like this for Parkinson&rsquo;s patients that is on the market at this time. The biomedical engineering students then approached us with the idea of designing the home-based treatment device. They did a great job, and made a fascinating prototype. We hope that based on their preliminary work, Parkinson&rsquo;s patients will receive the benefit of this new technique at home very soon.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">With help from the Johns Hopkins Technology Ventures staff, the student inventors obtained provisional patents covering the design of the device, dubbed the STIMband. Another Johns Hopkins student team is set to take over the project in September to further enhance the design and move it closer to patient availability. One addition may be a wireless connection to allow a doctor to adjust a home patient&rsquo;s treatment level from a remote location.</span></p></div>2015-06-12T13:39:00Z2015-06-12T13:39:00Zwebeditor@bibamedical.com education helps patients recognise stroke symptoms; encourages fast response<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Intense education can help stroke survivors quickly recognise symptoms of a subsequent stroke and seek prompt treatment, according to a study in&nbsp;<em>Stroke</em>, Journal of the American Heart Association.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Few stroke patients arrive at an emergency department within three hours of symptom onset. The FDA has approved the clot-busting drug tissue plasminogen activator, or t-PA, to be given within three hours of symptom onset, while the American Heart Association/American Stroke Association suggest it can be given up to 4.5 hours in some patients.</span></p> <p><span style="font-size: 10pt;"><br />A study called Stroke Warning Information and Faster Treatment (SWIFT) compared interactive intervention with enhanced educational materials on recurrent stroke arrival times in patients with mild&nbsp;stroke&nbsp;or&nbsp;transient ischaemic attack&nbsp;(TIA).</span></p> <p><span style="font-size: 10pt;"><br />Both intervention groups received standardised packets of material focused on being prepared to recognise and react to stroke symptoms plus a medical alert bracelet so medical professionals would recognise them as SWIFT participants. The interactive intervention group also received in-hospital group sessions featuring role-playing techniques to describe stroke symptoms to EMS workers and video presentations from stroke survivors on preparedness.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The single-centre randomised trial included 1,193 mild stroke or TIA survivors, average age 63. Half were women, 51% were Hispanic, 26% were white and 17% were black. During the five-year study, 224 patients experienced a recurrent stroke or stroke-like symptoms. Researchers found that an unprecedented 42% of these patients arrived to the emergency room within three hours compared to only 28% at baseline, a 49% increase in the proportion of all patients arriving within three hours of symptom onset. Among Hispanics, there was a 63% increase.</span></p> <p><span style="font-size: 10pt;"><br />This may be the first stroke intervention to reduce racial and ethnic disparities in hospital arrival times. &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Racial-ethnic minorities suffer more strokes and worse stroke outcomes than white Americans and they often show up later to an emergency room to seek critical treatments,&rdquo; says Bernadette Boden-Albala, lead author and professor of public health, Dentistry and Neurology and Associate Dean of Program Development, at Global Institute of Public Health at New York University in New York, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our study is the first to show that culturally tailored, health literature educational materials can decrease these racial disparities in stroke preparedness outcomes.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Both the intensive intervention and the culturally tailored educational messages were likely to decrease time to emergency room arrival, however, the intensive intervention appeared to be more beneficial in those with early recurrent events within the first 30 days, researchers said.&nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The continued low rates of people arriving to the emergency department within three hours of stroke symptoms suggests that we may not be effectively disseminating existing materials on stroke preparedness,&rdquo; Boden-Albala says. &ldquo;Our findings suggest that at minimum clear, simple, preparedness-focused messages before hospital discharge&mdash;and possibly follow-up reinforcement&mdash;results in greater proportion of early emergency room arrivals.&rdquo;</span></p></div>2015-06-12T13:38:00Z2015-06-12T13:38:00Zwebeditor@bibamedical.com International Neuromodulation Society names a Giant of Neuromodulation<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The International Neuromodulation Society (INS) recognised its third Giant of Neuromodulation at its 12th World Congress (6&ndash;11 June, Montreal, Canada)&mdash;the first such awardee who is renowned for work in neuromodulation for movement disorder.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The honour was given to Alim-Louis Benabid, board chairman of the biomedical research centre Clinatec in Grenoble, France. His clinical work in the 1980s helped usher in the modern era of using deep brain stimulation (DBS) to manage motor symptoms of Parkinson&rsquo;s disease, essential tremor and dystonia.</span><br /><br /></p> <p><span style="font-size: 10pt;">The award has been presented at biennial congresses of the nonprofit medical society since 2011, reflecting the growth and maturity of the field.</span></p> <p><br /><span style="font-size: 10pt;">Neuromodulation therapy stimulates specific areas in the nervous system to relieve symptoms and help restore function. It has been used over the last four decades to manage symptoms of chronic conditions such as neuropathic pain or movement disorder.</span></p> <p><br /><span style="font-size: 10pt;">Benabid, a neurosurgeon and emeritus professor of biophysics at Joseph Fourier University in Grenoble, France, reflected recently that he was drawn to the field not just for the insights it offered into neurological systems, but also for the potential to directly treat problems through functional neurosurgery.</span></p> <p><br /><span style="font-size: 10pt;">Benabid has pointed out that newly developed methods have helped to address serious clinical conditions in a process that has led to new branches and applications of neurostimulation.</span></p> <p><br /><span style="font-size: 10pt;">In his breakthrough in 1987, Benabid adapted deep brain stimulation leads that had already been introduced for deafferentation pain. He discovered in pre-surgical probing that high-frequency stimulation mimicked the effect of the only surgical treatment available at the time to control severe involuntary tremor, ablation of a small brain area. He began to offer movement disorder patients who were referred for a second, bilateral ablation to have deep brain stimulation instead, since it is reversible and adjustable and does not destroy brain tissue.</span></p> <p><br /><span style="font-size: 10pt;">In the years since he published his finding with neurologist Pierre Pollak in 1987, DBS has largely replaced ablation as a treatment for movement disorder. Some 100,000 patients with Parkinson&rsquo;s disease, essential tremor or dystonia have received DBS therapy to improve their function and quality of life. New potential indications and stimulation targets are being actively researched. In addition to helping limit motor symptoms of movement disorder, DBS also has a humanitarian device exemption from the FDA for obsessive compulsive disorder.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Alim-Louis Benabid&rsquo;s work offers hope that we may increasingly relieve suffering from a widening scope of brain disorders, through having formed the foundation to gaining a greater understanding of the dynamics of neural circuits, and their impact on function and symptoms,&rdquo; said Andres Lozano, a professor and chair of neurosurgery at the University of Toronto, Canada. Lozano presented the award at the congress.</span></p> <p><br /><span style="font-size: 10pt;">A member of the French Acad&eacute;mie des Sciences, Benabid received the Robert A Pritzker Prize for Leadership in Parkinson&rsquo;s Research in 2013; shared the Lasker-DeBakey Clinical Medical Research Award in 2014 with Mahlon Delong; received a lifetime achievement award from the North American Neuromodulation Society in 2014; and is a recipient of the 2015 Breakthrough Prize in Life Sciences.</span></p></div>2015-06-10T16:30:00Z2015-06-10T16:30:00Zwebeditor@bibamedical.com CE marks Leksell Gamma Knife Icon<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Elekta has CE marked its Leksell Gamma Knife Icon precision radiosurgery system, making this latest generation Leksell Gamma Knife platform available in the European market.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With stereotactic imaging, online Adaptive DoseControl, ultra-precise dose delivery and the availability of frameless treatments, Elekta says that Icon is capable of treating &ldquo;virtually any target in the brain, regardless of type, location or volume&rdquo;. The company also announced that University Hospital La Timone, Marseille, France, had installed the first Icon and will use the system to treat the first patients in July.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Leksell Gamma Knife Icon is a new concept for performing precision radiosurgery for all types of cranial cases with unlimited clinical and workflow flexibility,&rdquo; says Tomas Puusepp, president and chief executive officer of Elekta. &ldquo;Clinicians can choose either frame-based or frameless methods to immobilise the patient&rsquo;s head, as well as the option to perform the treatment in a single session or in multiple sessions. Icon is also based on the only technology available that can perform ultra-precise Microradiosurgery or the cases where this is required.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Puusepp adds that the system&rsquo;s online Adaptive DoseControl and high-definition motion management features ensure the most precise treatments possible, whether frame-based or frameless, as well as an efficient workflow thanks to the complete system and workflow integration.</span></p> <p><br /><span style="font-size: 10pt;">Jean Regis, a neurosurgeon and programme director for University Hospital La Timone&rsquo;s Gamma Knife programme, says that Icon presents physicians with two significant opportunities related to the ability to use frameless immobilisation.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The first will be to enlarge the scope of indications by permitting hypofractionation [multiple treatment sessions] to be performed more readily, and also treatment of lesions in additional anatomical sites. This is by virtue of the capability to perform frameless treatments with much better technical control,&rdquo; he says. &ldquo;The second opportunity is the ability to evaluate shifts in the patient&rsquo;s position and to adapt the dose proactively to account for these movements. This in particular, will push frameless, hypofractionated radiosurgery to a level that does not exist today.&rdquo;</span></p></div>2015-06-10T15:56:00Z2015-06-10T15:56:00Zwebeditor@bibamedical.com of dystonia symptoms is sustained in paediatric patients undergoing deep brain stimulation<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Children and adolescents who received deep brain stimulation for generalised dystonia maintained significant symptom relief for up to eight years, according to a study presented at the 12th World Congress of the International Neuromodulation Society (6&ndash;11 June, Montreal, Canada).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The results reinforce the observation that patients with a shorter duration of symptoms, and a younger age at implantation, experience better outcomes, said Fabi&aacute;n Piedimonte, of the Argentinean chapter of the International Neuromodulation Society&mdash;Sociedad Argentina de Neuromodulaci&oacute;n (SANE), the CENIT Foundation, and Buenos Aires Provincial Program of Neuromodulation. The study was presented as an oral abstract at the 12th World Congress by co-author and SANE president Juan Carlos Andreani, of the CENIT Foundation and Buenos Aires Provincial Program of Neuromodulation.</span><br /><br /></p> <p><span style="font-size: 10pt;">Dystonia is considered the third most-common movement disorder after essential tremor and Parkinson&rsquo;s disease. Its symptoms include twisting and repetitive motions or abnormal posture, which can be frustrating and painful. While there are many types and causes, one of the most severe types of dystonia can begin in childhood and become severe before the end of the teen years.</span><br /><br /></p> <p><span style="font-size: 10pt;">Previous experience in Parkinson&rsquo;s disease has suggested that if conservative measures do not adequately control dystonia symptoms, deep brain stimulation to the globus pallidus interna (Gpi) may be effective.</span><br /><br /></p> <p><span style="font-size: 10pt;">This study confirms growing evidence that deep brain stimulation to the Gpi is most effective in patients with primary dystonia (not secondary to some other condition or lesion), particularly in patients with primary dystonia who have a hereditary component, and carry the DYT1 mutation.</span><br /><br /></p> <p><span style="font-size: 10pt;">The 16 patients in the study were treated at medical centres in Buenos Aires, Argentina. Their average age of onset was 9 years old (between 1 and 14 years of age) and the median age at surgery was 12 years (between 8 and 19 years of age). On average, patients&rsquo; motor symptoms improved 69% and their disability sub-scores improved 60%, while some patients even saw complete symptom relief. In four of the 16 patients, the motor-symptom improvement was less than 50%. Half of those patients did not carry the DYTI mutation.</span><br /><br /></p> <p><span style="font-size: 10pt;">The patients were seen every few months to adjust their stimulation parameters, since the natural evolution of the disease can cause new symptoms to develop. The paediatric patients were operated on under general anaesthesia in a single-stage procedure, using microelectrode recordings to map the best path to guide the stimulation leads to the stimulation target structure. As rechargeable pulse generators became available, they were preferentially used to provide the therapeutic stimulation, since they do not require replacement surgery every few years.<br /><br /></span></p> <p><span style="font-size: 10pt;">In dystonia, initial symptom relief from deep brain stimulation appears in weeks, with settings being optimised over the first two or three months. The best relief generally develops during the first year post-surgery.</span><br /><br /></p> <p><span style="font-size: 10pt;">In addition to helping reduce patients&rsquo; symptoms, other important benefits of adequately managing dystonia include allowing the children&rsquo;s bones to continue growth with less risk of deformity from ongoing muscle contraction, and enabling ease of hygiene through better voluntary movement.</span></p></div>2015-06-10T14:06:00Z2015-06-10T14:06:00Zwebeditor@bibamedical.com cord stimulation for chronic pain led to decreased healthcare costs and improved functional measures<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both; text-align:left"><p><span style="font-size: 11pt;"><strong>A study presented at the International Neuromodulation Society 12th World Congress (6&ndash;11 June, Montreal, Canada) showed that hospitalisation costs for a set of pain patients at the Vancouver Island Health Authority fell after receiving spinal cord stimulation treatment.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study was initiated by the health authority&rsquo;s interdisciplinary pain programme. British Columbia&rsquo;s Ministry of Health had funded a 160% increase in the number of spinal cord stimulation (SCS) implants annually for several years. In turn, the ministry requested patient-reported outcome measures, said Carla Service, authority manager of the regional pain programme at Royal Jubilee Hospital, Canada.</span></p> <p><br /><span style="font-size: 10pt;">The pain programme created a neuromodulation patient database in 2010 of patients who received SCS implants from 2007 to the present, which tracked baseline measures as well as functional and clinical outcome measures. Patients who received their implants from 2008 to 2013 were asked to participate in a research study that used the database and Ministry of Health data to assess patient outcome. Forty patients (a 40% response rate) participated. Eleven of the patients also reported functional outcomes.</span></p> <p><br /><span style="font-size: 10pt;">The study was presented by principal investigator Nouri Najjar, a PhD student in economics at the University of British Columbia, Canada.</span></p> <p><br /><span style="font-size: 10pt;">Mean annual expenditures increased in each of the three years before SCS treatment, and decreased in each of the three years after, Najjar, said, with hospitalisation more probable prior to SCS. Trends in hospitalisation contributed to changes in the overall expenditures.</span></p> <p><br /><span style="font-size: 10pt;">Total mean expenditures fell by 29% overall, he said, when all three years before treatment and all three years after were compared. Comparing all three years before and after treatment, pharmaceutical costs went down by 31% and non-pharmaceutical costs went down by 29%.</span></p> <p><br /><span style="font-size: 10pt;">As the study was underway, Krishna Kumar, of the Division of Neurosurgery at the Regina General Hospital, was co-authoring a paper published in 2014 in&nbsp;<em><a href="">Neuromodulation: Technology at the Neural Interface</a></em>&nbsp;that summarised his earlier findings in which data from 15 years or more indicate that effective pain management from SCS is inversely proportional to wait times.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Najjar&rsquo;s fellow researcher on the project, physician investigator Alan Berkman, of Nanaimo Regional General Hospital, mentioned Kumar&rsquo;s long-term findings when describing the value of the current study.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This research is a very useful tool to show the funding authority that neuromodulation saves money in the short term with regards to overall health care dollar costs,&rdquo; Berkman said. &ldquo;It has been shown to continue to save money after this period by Kumar. It confirms the value of this very important modality in the treatment of patients suffering with pain.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">For the 11 patients who reported functional outcomes, Najjar found they had statistically significant post-procedure improvements in all functional measures except the Tampa Scale for kinesiophobia.</span></p> <p><br /><span style="font-size: 10pt;">In his 2014 paper, Kumar and colleagues wrote that SCS success has come to be considered an improvement in functional outcome more than strictly a reduction in the perception of pain, which is &ldquo;now regarded as highly variable and subjective, arbitrary, and a poor correlate of a patient&rsquo;s quality of life.&rdquo; Instead, the focus has shifted to how SCS permits patients to resume activities of daily life and participate in work, domestic pursuits, or social endeavors. &ldquo;Ultimately, it is on this metric that SCS therapy should be judged by patients, society, and payers alike,&rdquo; Kumar and colleagues state.</span></p> <p><br /><span style="font-size: 10pt;">They add that the cost-effectiveness of SCS is demonstrated in studies that show post-implant healthcare savings offset the initial expenditure of an SCS implant, with implantation within two years of symptom onset appearing to offer the greatest success rate.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-10T13:59:00Z2015-06-10T13:59:00Zwebeditor@bibamedical.com data demonstrate greater pain relief with Boston Scientific Precision Spectra spinal cord stimulator system<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Boston Scientific presented new data demonstrating that the Precision Spectra spinal cord stimulator system provided 1.5 times better overall pain relief and 2 times better low back pain relief than the previous generation Precision Plus system. The improved outcomes with Precision Spectra were achieved in conjunction with the use of the proprietary Illumina 3D neural targeting software, designed to target pain with point-and-click simplicity. Results from the LUMINA cohort of the Precision Spectra observational study were presented at the International Neuromodulation Society 12th World Congress (6&ndash;11 June, Montreal, Canada).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The LUMINA cohort includes three patient groups:&nbsp; 213 consecutive patients treated with the Precision Spectra system for up to 24 months post-implant; 130 consecutive patients treated with the previous generation system, Precision Plus, in a comparative evaluation with the Precision Spectra System; and 25 consecutive patients treated with Precision Spectra and the new CoverEdge 32 surgical leads for up to six months post-implant.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The results are exciting because we looked at consecutive patients, some with only low back pain, in a real-world setting,&rdquo; said Julie Pilitsis, associate professor, Albany Medical College, USA, and one of the lead investigators for this study. &ldquo;This is strong clinical evidence of the effectiveness of the Precision Spectra system in treating the types of challenging chronic pain patients that physicians see every day.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Key findings of the study included:</span></p> <p><br /><span style="font-size: 10pt;">LUMINA Spectra group:</span></p> <ul> <li><span style="font-size: 10pt;">Sustained and highly significant reduction in overall pain from an average baseline score of 7.17 to 2.98 at 24 months post-implant (n= 117), as measured on the 0-10 numeric rating scale (NRS).</span></li> <li><span style="font-size: 10pt;">In a subset of patients with only low back pain (n=51), a sustained and highly significant reduction from an average baseline score of 7.21 to 3.20 at 24 months post-implant.</span></li> <li><span style="font-size: 10pt;">Significant reduction in disability (n=51), maintained out to 12 months, as measured by the Oswestry Disability Index.</span></li> <li><span style="font-size: 10pt;">Responder rates (greater than or equal to 50% pain reduction) at 12 months post-implant for the Precision Spectra system were 72% for overall pain, 82% in leg pain only patients and 71% in low back pain only patients. For low back pain, the improvement with Spectra was more than twice that of the Precision Plus system group.</span></li> </ul> <p><span style="font-size: 10pt;">LUMINA Surgical group:</span></p> <ul> <li><span style="font-size: 10pt;">Highly significant reduction in overall pain from an average baseline score of 7.7 to 2.7 at six months post-implant (n=23).</span></li> <li><span style="font-size: 10pt;">In a subset of patients with only low back pain (n=9), 90% responder rate and a highly significant reduction from an average baseline score of 7.8 to 1.6 at six months post-implant.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;We designed the Precision Spectra to achieve even better outcomes when treating low back pain,&rdquo; said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. &ldquo;These real-world clinical data demonstrate that Precision Spectra with our proprietary neural targeting software is a significant scientific advancement in pain management.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The LUMINA cohort is part of the Boston Scientific PRO observational study.</span></p></div>2015-06-10T13:59:00Z2015-06-10T13:59:00Zwebeditor@bibamedical.com receives FDA approval for IDE trial of Freedom system<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Stimwave Technologies has received US Food and Drug Administration investigational device exemption (IDE) approval to launch an 80-patient clinical trial utilising the company&rsquo;s Freedom spinal cord stimulation system.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Stimwave says that its Freedom system is the &ldquo;smallest neuromodulation device ever commercialised&rdquo;. It is now available in an eight-electrode array, which provides additional programming and placement options for patients, including the use of high-frequency stimulation.</span></p> <p><br /><span style="font-size: 10pt;">The FDA has also approved Stimwave&rsquo;s high frequency study using an external pulse generator. The randomised study will compare conventional stimulation programming settings of five to 1,500Hz frequencies to those of a higher 10,000Hz frequency to measure pain relief outcomes, patient preferences, reduction in opioid usage, and reduction in adverse events, compared with conventional internal pulse generator (IPG) products. Recent studies have shown that high frequency has a greater effect on pain relief and quality of life, and it is expected to be effective in providing therapeutic, long-term pain relief for chronic back pain.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This study will represent for the first time an injectable high frequency platform utilised with different parameter settings to truly assess the patient response and the best mechanism to enable long-term control of chronic pain and ability to reduce opioid dependency,&rdquo; said Porter McRoberts, Holy Cross Hospital, from Fort Lauderdale, USA, the principal investigator of the study. The study will begin enrolment this summer at sites throughout the USA.</span></p> <p><br /><span style="font-size: 10pt;">Stimwave&rsquo;s electroceutical device is based on an injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves. The device will be used in both cohorts of the study. It is implanted in an outpatient procedure through a standard needle with no need for general anaesthesia or a large surgical incision, which has distinct advantages over conventional IPGs, which are both more expensive and significantly more invasive.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This device is capable of a multitude of programming options and configurations, high frequency, tonic stimulation, multiple approaches to placement due to the small size; furthermore, there is no limit on how many electrodes can be powered utilising this technology from a single outside source,&rdquo; said Laura Tyler Perryman, chief executive officer and chairman of Stimwave.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The unique Stimwave platform provides greater versatility for chronic pain patients with additional options for treatment all within one system. Since each patient is unique and each case presents with different issues, the ability to customise the device placement and programming features to the needs of the patient is a capability that the industry has been in great need of,&rdquo; said David Kloth, medical director of the Connecticut Pain Care Center. &ldquo;Coupled with the minimally-invasive nature of Stimwave products and the patient&rsquo;s greater acceptance of an implant that is 95% smaller than other options, the Freedom system is a welcome addition to the tools available to manage long term, chronic pain.&rdquo;</span></p></div>2015-06-10T09:27:00Z2015-06-10T09:27:00Zwebeditor@bibamedical.com space programme researchers develop potential nano-tools for deep brain stimulation<div style="clear:both;"><p><strong><span style="font-size: 11pt;">Applying nanotechniques developed in the US space programme may help physicians to better understand the electrochemical dynamics of deep brain stimulation in order to fine-tune the therapy, according to a presentation by NASA Ames Research Center scientist Russell J Andrews, at the International Neuromodulation Society&rsquo;s 12th World Congress (6&ndash;11 June, Montreal, Canada).</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Can we realise truly neuroregenerative neuromodulation through nanotechnology?&rdquo; Andrews asked delegates.</span><br /><br /></p> <p><span style="font-size: 10pt;">In collaboration with the Mayo Clinic since 2011, NASA Ames researchers have applied their expertise in growing and coating new carbon nanofiber materials for more sensitive, selective, and specific means to efficiently stimulate and detect activity of neural circuits.</span></p> <p><br /><span style="font-size: 10pt;">Using carbon nanofiber pads that are just tens of microns across and coated with the standard biomedical polymer polypyrrole, the team demonstrated bench-top success in detecting changes in concentration of both dopamine and serotonin in a mixture simulating chemical conditions in the brain. A proof-of-principle device was patterned with nine sensing pads that can each be individually addressed with the intent of detecting different analytes.</span></p> <p><br /><span style="font-size: 10pt;">Andrews, a neurosurgeon, has collaborated with Kendall Lee, a Mayo Clinic neurosurgeon who, with Kevin Bennet, chair of the Mayo Division of Engineering, is developing analytical tools that have been used intraoperatively during deep brain stimulation surgery to detect neurotransmitter release.</span></p> <p><br /><span style="font-size: 10pt;">The ultimate vision is to be able to wed chemical and electrical analysis to get a better picture of what occurs during deep brain stimulation, whose therapeutic effect is known, but mechanisms are not fully understood.</span></p> <p><br /><span style="font-size: 10pt;">Animal studies indicate that deep brain stimulation to the subthalamic nucleus is linked to release of the neurotransmitter dopamine. In the neurodegenerative disorder Parkinson&rsquo;s disease, the loss of dopamine-producing cells leads to motor symptoms of stiffness and slow movement.</span></p> <p><br /><span style="font-size: 10pt;">In addition, the neurotransmitter adenosine is thought to halt pathological synchrony in epileptic seizures.</span></p> <p><br /><span style="font-size: 10pt;">If these neurotransmitter releases could be monitored in real time and with high spatial resolution while functional magnetic resonance imaging tracks metabolic activity during deep brain stimulation, clinical investigators would have a much better sense of how electrical stimulation and the chemical communication of neural circuits are interconnected.</span></p> <p><br /><span style="font-size: 10pt;">Such understanding could assist with programming stimulation systems and limit the iterative process that is currently used. Also, it is hoped that nanosensor feedback about neurotransmitter activity could aid development of deep brain stimulation for refractory disorders such as treatment-resistant epilepsy or severe depression.</span></p> <p><br /><span style="font-size: 10pt;">These systems would use on-board computational analysis to deliver therapeutic stimulation to persuade errant cells to resume normal relations with their neighbours, Andrews said.</span></p> <p><br /><span style="font-size: 10pt;">In the long term, he envisions a day when neurosurgeons might say they have restored a damaged nervous system to its full potential through use of such a &ldquo;smart&rdquo; neuroprosthetic system.</span></p> <p><br /><span style="font-size: 10pt;">One of the first steps to getting there, he believes, is to operate at the same scale as biological systems&mdash;the micron or submicron level, about one-tenth or less the size of current therapeutic neurostimulation leads. At that level, he hopes, the pathological basis of a condition might actually be corrected rather than focusing on limiting the symptomatic effects.</span></p> <p><br /><span style="font-size: 10pt;">Carbon nanotubes, which were first described in 1991, have attracted interest as biosensors due to their favourable biological and bioelectrical properties, their structure having been compared to the structure of bamboo.</span></p> <p><br /><span style="font-size: 10pt;">While the biocompatibility of carbon nanofiber over the long term remains to be determined, Andrews said the polymer coating is biocompatible and larger carbon microfiber electrodes have been shown to function up to four months in laboratory animals before the electrode surface becomes fouled by adsorption of biological compounds.</span></p> <p><br /><span style="font-size: 10pt;">The sensing capabilities demonstrated by NASA in a 20-micron-by-80-micron &ldquo;nanotrode&rdquo; and the electrochemical analysis development by the </span><span style="font-size: 10pt;">Mayo Clinic are in their early stages.</span></p> <p><br /><span style="font-size: 10pt;">At the 11th World Congress of the International Neuromodulation Society in 2013, Lee, the principal investigator on the collaboration, presented his research into creation of analytical tools that send up to 100,000 neurochemical readings per second via an optical/wireless link to a nearby laptop computer where the signals are analysed with custom software and displayed in near-real time. The system, Harmoni, detected dopamine release in a rat evoked by brain stimulation using a carbon fiber microelectrode.</span></p> <p><br /><span style="font-size: 10pt;">Meanwhile, potential neural interface materials have been under development at NASA Ames for about a decade by researchers in its Smart Systems group and Center for Nanotechnology. The centre formed in the 1990s when the space programme redirected its efforts toward &ldquo;faster, better, cheaper&rdquo; technological approaches to such missions as exploring the origins of life through astrobiology or developing autonomous networked planetary probes.</span></p> <p><br /><span style="font-size: 10pt;">The carbon nanofibers are grown through vapour deposition on lithographically patterned catalysts and coated with the conductive polymer through electrochemical deposition. That combination of materials has less impedance and greater capacitance at several orders of magnitude beyond the charge-transfer performance of conventional deep brain stimulation leads&mdash;properties that enhance performance.</span></p> <p><br /><span style="font-size: 10pt;">Beyond deep brain stimulation, this and related technologies are being considered for retinal, cochlear and cardiac implants as well as guided </span><span style="font-size: 10pt;">drug delivery systems.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-09T15:31:00Z2015-06-09T15:31:00Zwebeditor@bibamedical.com scientific abstracts win inaugural competition at the International Neuromodulation Society 12th World Congress<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The International Neuromodulation Society (INS) has announced winners of its inaugural best abstract competition at the 12th World Congress (6&ndash;11 June, Montreal, Canada).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The scientific programme committee selected the five winning abstracts, out of more than 350 received, for their quality, originality and ingenuity.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We felt it was important to acknowledge the full range of basic and clinical science in this honour,&rdquo; said scientific programme chair and INS president-elect Timothy Deer. &ldquo;Our field is evolving so rapidly that not only is it helping patients who are living with chronic disease today, but also shedding light on underlying mechanisms. Together, this growing understanding can spur advances in emerging bioelectronic medicine and current neuromodulation therapies.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The top five abstracts represent a range of conditions addressed by neuromodulation; neural prosthesis and restoration for central nervous system injury, symptom management for incurable and progressive neurological disorder, and drug-free analgesia for neuropathic pain.</span><br /><br /></p> <p><span style="font-size: 10pt;">The five winning submissions are:</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Neural bypass</strong>&nbsp;&ndash; A collaboration by Chad Bouton and team members at Battelle in Columbus, USA, with physicians at The Ohio State University Wexner Medical Center. A tetraplegic patient demonstrated the ability to use a neuroprosthetic brain implant system to intentionally move his hand and wrist. The implant, a 96-electrode array, was surgically placed on his motor cortex by OSU&rsquo;s Ali Rezai. A Battelle-built multichannel stimulator relayed signals to nerves in his arm governing muscle control. Neural activity detected by the cortical array was processed by Battelle&rsquo;s algorithms and encoded patterns sent to the stimulator to activate muscles. The demonstration showed the system could bypass the injury in the spinal cord and link brain activity in his motor cortex to voluntary muscle activity in his arm, hand and wrist, so that he was able to make voluntary motions in real time with high accuracy. The patient has spent seven months with the research team, who collected 300 hours of data in developing their custom algorithm. The study protocol has been approved for up to five participants.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>&lsquo;Biometric&rsquo; movement disorder index</strong>&nbsp;&ndash; Stephanie Tran, a neuroscience undergraduate who participated in a project at the Movement Disorders Centre of Western University in London, Canada, presented findings of a research team that quantified the effects of deep brain stimulation in Parkinson&rsquo;s disease patients. The team used a motion-capture suit to assess the slow, stiff movements of bradykinesia, which is commonly experienced by all Parkinson&rsquo;s disease patients. Seven patients were assessed while performing a simple clinical test of their voluntary movement. For comparison, seven healthy control subjects were recorded performing the same exercise. Each patient was assessed at three pre-defined device settings used in common practice. The team defined a &ldquo;B-Index&rdquo; for bradykinesia based on range of motion, angular velocity, and variability in time and amplitude. The group found that at six months post-implant, patients&rsquo; bradykinesia was reduced to the point that their B-Index was not statistically different from healthy controls under a stimulation setting that involved decreasing pulse width while using medium frequency and voltage.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Stroke damage repair</strong>&nbsp;&ndash; A preclinical investigation lead by Andre Machado, at the Cleveland Clinic, that suggests deep brain stimulation may aid the brain&rsquo;s plasticity and ability to form new neural connections during recovery from stroke. The team&rsquo;s research in rats showed that DBS promoted growth of neurons that specialize in release of the neurotransmitter glutamate, which aids learning and memory. The group had previously shown that deep brain stimulation enhanced motor recovery after stroke. This abstract built on that earlier work by showing the effect was linked to enhanced formation of new neural connections and blood vessels in the damaged area. They believe this is the first time that a deep brain stimulation therapy has shown the potential for selective nerve growth after focal injury, implying there may be a neurorestorative potential. As with any new finding, the research remains preliminary and the team would need to replicate these findings before expanding further on the research.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Picturing pain therapy impact on the brain</strong>&nbsp;&ndash; Imaging studies were conducted by Quinn Hogan, of the Department of Anesthesiology at the Medical College of Wisconsin, USA, and colleagues. The research team used functional magnetic resonance imaging (fMRI) to show that parts of the brain&rsquo;s so-called &ldquo;pain network&rdquo; are less activated when rats receive pain-relieving stimulation of the dorsal root ganglion (DRG), a structure at the edge of the spine. The researchers said the fMRI findings validate DRG stimulation as analgesic in rats, providing a model for future mechanistic research.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Preferred stimulation modes compared</strong>&nbsp;&ndash; Nadia Kriek and colleagues at the Center for Pain Medicine at the Erasmus University Medical Center in Rotterdam, the Netherlands, planned to present a comparison of five different spinal cord stimulation (SCS) modes, with the final data collected just prior to the meeting. They studied 43 patients who have a rare chronic pain condition, complex regional pain syndrome (CRPS), which is a leading indication for SCS since the therapy is highly effective in most CRPS patients. However, in some CRPS patients the therapeutic effect of SCS can diminish over time resulting in the loss of pain control, as shown by past studies. Some of these patients that have lost the therapeutic benefit of SCS can regain pain control if the stimulation frequency is increased to more than 250Hz. There is growing interest in new stimulation modes of SCS such as burst and high frequency. These new modes of stimulation along with conventional and sham stimulation were compared during the clinical trial. The patients began with conventional SCS of 40Hz, and after three months, were crossed over randomly into treatment groups. Each patient randomly received 40Hz, 500Hz, 1,200Hz, burst and sham stimulation, with two-day &ldquo;washout&rdquo; intervals between each stimulation mode. After 10 weeks each patient decided which mode was preferred, and continued on that mode for another three months, with an assessment taken again at the end of that period.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This final abstract was selected on the basis of its sound clinical trial design and solid patient enrolment,&rdquo; commented INS president Simon Thomson. &ldquo;Developing an evidence base and disseminating knowledge about best practices are among key objectives that our society advocates. With the advent of several new modes of stimulation for practitioners to choose between, these recent findings were expected to be of particular interest.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">All abstracts submissions accepted for presentation at the congress will be published online in the INS journal <a href=""><em>Neuromodulation: Technology at the Neural Interface</em></a>.</span></p></div>2015-06-09T14:17:00Z2015-06-09T14:17:00Zwebeditor@bibamedical.com may recur years after endovascular treatment<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Endovascular treatment of intracranial aneurysm is effective in preventing long-term bleeding, but may be followed by aneurysm recurrences in a significant proportion of cases, according to a new magnetic resonance angiography (MRA) study published online in the journal <em><a href="">Radiology</a></em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Endovascular treatment with coils was developed in the 1990s and became an established treatment for intracranial aneurysm in the early 2000s. In endovascular treatment, coils are threaded via a micro-catheter through a blood vessel in the groin to the location of the aneurysm. The coils expand and cause formation of a clot in the aneurysm that provides a seal, or occlusion, to prevent further bleeding.</span><br /><br /></p> <p><span style="font-size: 10pt;">The main drawback of endovascular treatment is recanalisation, or a return of blood flow into the original aneurysm. Previous studies on the clinical significance of this have followed a limited number of patients for relatively short periods.</span><br /><br /></p> <p><span style="font-size: 10pt;">For the new study, researchers looked at the long-term efficacy of endovascular treatment in preventing aneurysm ruptures. They performed clinical examination and 3-Tesla MRA 10 years after endovascular treatment of intracranial aneurysm in a single institution. In addition, they reviewed results from the medical literature to identify studies reporting bleeding and/or aneurysm recurrence rate in patients followed beyond 10 years after the treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">Among 129 aneurysms followed for more than 10 years, 16 (12.4%) demonstrated recanalisation between midterm and long-term MRA. Incomplete occlusion on midterm MRA and retreatment within five years were risk factors for late recurrence. The literature review of 2,902 aneurysms showed that incomplete occlusion and aneurysm size of greater than 10mm were risk factors for late recurrence.</span><br /><br /></p> <p><span style="font-size: 10pt;">The results show that while endovascular treatment is effective in preventing long-term bleeding, patients with larger aneurysms or incomplete occlusion face a long-term risk of aneurysm recurrences.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This result is of importance since a large proportion of patients in the study were young, with a mean age of 47 years,&rdquo; said Olivier N Naggara, from the Centre Hospitalier Sainte-Anne, Paris, France. &ldquo;Consequently, demonstration of the efficacy of prevention of rupture more than 10 years after treatment is a crucial point.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">If supported by additional research, the findings may mean that longer follow-up protocols are necessary for some intracranial aneurysm patients who undergo endovascular treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We believe that the subgroup of patients with aneurysm size 10mm or more and patients with incomplete occlusions should be followed by non-invasive imaging exams for 10 years or more, particularly young patients,&rdquo; Naggara said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Treatment can be repeated to prevent a potential angiographic recurrence. However, more research is needed, Naggara said, to develop a clearer picture of the risks and benefits of this approach.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Retreating a recurrent aneurysm with additional coils may fail in up to 50% of cases,&rdquo; he said. &ldquo;Adjunctive techniques we add to standard coiling, such as modified coils, stents and flow diverters, have demonstrated lower recurrence rate after endovascular treatment but may involve more risks than simple treatment with platinum coils.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-09T13:41:00Z2015-06-09T13:41:00Zwebeditor@bibamedical.com embolic protection device receives US FDA clearance for carotid indication <div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Allium Medical has announced that it has received FDA clearance to market Gardia&rsquo;s Wirion system in the United States for the carotid indication.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Asaf Alperovitz, CEO of Allium Group said: "Receiving FDA clearance to market the Wirion system in the US for the carotid clinical indication is a major achievement for Allium. [&hellip;] The success in achieving all clinical endpoints [of the pivotal, multicentre trial], including the primary endpoint, based on half of the number of patients defined in the study protocol, while meeting stringent statistical criteria, is unprecedented for embolic protection devices. Meeting the clinical endpoints already at this early stage enabled us to streamline the process for obtaining FDA approval and to significantly shorten the timetable. &ldquo;The Gardia Wirion system, which has been used successfully in over 350 procedures, in a variety of clinical indications, received a very favourable feedback from leading European physicians. The system includes significant competitive advantages over other FDA cleared embolic protection devices of world leading companies."<br /><br /></span><span style="font-size: 10pt;"><strong>About the system:</strong><br /><br /></span><span style="font-size: 10pt;">A press release from the company adds that the Wirion system is a unique, patent-protected embolic protection filter-type system that protects against blood clots and emboli produced during catheterisation procedures for opening blocked blood vessels. The system has a unique locking mechanism that allows the physician to use the any guide wire of choice and to place the filter in the most suitable and desired location. The flexibility to place the filter anywhere over any guide wire simplifies and streamlines the procedure, making it safer, convenient, and simple to use thus presenting significant advantages over other protection devices in the market. The Wirion system also includes a unique retrieval catheter for easy, quick and safe filter retrieval after stent deployment.<br /><br /></span><span style="font-size: 10pt;">It is approved in the US for the clinical indication of emboli protection during carotid artery catheterisation procedures and in Israel (AMAR) and Europe (CE mark) for widespread use in all cardiovascular catheterisation procedures.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-09T10:12:00Z2015-06-09T10:12:00Zwebeditor@bibamedical.com system found to provide superior pain relief over traditional spinal cord stimulation for the treatment of chronic lower limb pain<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>St Jude Medical has announced data from the ACCURATE study shows that stimulation of the dorsal root ganglion (DRG) with the company&rsquo;s Axium neurostimulator system is associated with superior pain relief over traditional spinal cord stimulation (SCS) for the treatment of chronic pain of the lower limbs.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">St Jude Medical says that the ACCURATE study, designed to support US approval of DRG stimulation, represents the medical device industry&rsquo;s largest study to date to evaluate patients suffering from chronic lower limb pain associated with complex regional pain syndrome (CRPS) or peripheral causalgia (nerve damage)&mdash;two of the many chronic pain conditions currently underserved by traditional SCS therapy. A total of 152 patients were enrolled in the trial at 22 centres across the USA.</span></p> <p><br /><span style="font-size: 10pt;">Patients in the study were randomised to receive either DRG stimulation delivered by the Axium system or traditional SCS therapy delivered by a competitor&rsquo;s system. After three months, investigators from the ACCURATE study found the trial had met its primary endpoints for both non-inferiority and superiority over traditional SCS. Specifically, data from the ACCURATE study shows DRG stimulation delivered:</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <ul> <li><span style="font-size: 10pt;">Superior pain relief: Significantly more patients receiving DRG stimulation achieved significant pain relief and greater treatment success when compared to patients receiving traditional SCS (81.2% vs 55.7%).</span></li> <li><span style="font-size: 10pt;">Consistent therapy: Patients receiving DRG stimulation reported no differences in paraesthesia intensity due to changes in body position (postural effects) when compared to traditional SCS. A statistically significant result was found between the two groups studied. Postural effects can be a common challenge associated with traditional SCS therapy.</span></li> <li><span style="font-size: 10pt;">Precise anatomical coverage: Patients in the Axium group were significantly less likely to report feeling stimulation outside their area of pain, compared to the control group.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;Data from the ACCURATE study are exciting because they demonstrate that DRG stimulation can offer meaningful improvement over traditional spinal cord stimulation for patients suffering from chronic pain conditions that have historically been challenging to treat,&rdquo; said Mark Carlson, chief medical officer at St Jude Medical. &ldquo;We look forward to continuing to develop DRG stimulation therapy to expand availability for patients currently underserved by traditional chronic pain therapy options.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Research suggests that, in total, the condition costs the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year.</span></p> <p><br /><span style="font-size: 10pt;">Stimulation of the DRG with Axium targets nerves within the DRG, a spinal structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain. By targeting the DRG, stimulation with the Axium system has been shown in international research to be effective in treating conditions currently underserved by traditional SCS. St Jude Medical plans to explore potential pathways to further expand the availability of DRG stimulation for other hard-to-treat chronic pain conditions.</span></p></div>2015-06-09T08:40:00Z2015-06-09T08:40:00Zwebeditor@bibamedical.com non-invasive brain stimulation provides long-term relief of post-stroke pain<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Weekly sessions of non-invasive repetitive transcranial magnetic stimulation provided sufficient long-term pain relief in 61% of patients with central post-stroke pain, and delivered long-term relief for patients who continued for one year, according to a study presented at the International Neuromodulation Society 12th World Congress (6&ndash;11 June, Montreal, Canada) by Masahito Kobayashi, of the Department of Neurosurgery, Saitama Medical University &ndash; Department of Neurology, Institute of Brain and Blood Vessels, Mihara Memorial Hospital in Saitama, Japan.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Of 18 patients in the open-label series, 11 patients achieved satisfactory-to-excellent pain relief. Pain relief was sustained in six patients who continued treatment for one year. All patients received repetitive transcranial magnetic stimulation (rTMS) to their primary motor cortex once a week for at least 12 weeks.</span><br /><br /></p> <p><span style="font-size: 10pt;">Satisfactory relief was considered a 40&ndash;69% reduction in pain scores (six patients) and excellent relief, pain reduction of 70% or more (five patients). Overall, eight patients who had severe stroke-caused dysesthesias, such as uncomfortable numbness or prickling, experienced less relief than patients without severe dysesthesias, suggesting possible neural circuit damage was inhibiting response to treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study participants had all been treated medically after a blood clot or bleed in one side of the brain (unilateral ischaemic or haemorrhagic stroke). Several weeks into their recovery, they had begun to experience severe hand or leg pain as a consequence of brain damage from the stroke. Such central post-stroke pain can be extremely disabling and difficult to treat, impacting general functioning, mood, and overall quality of life.</span><br /><br /></p> <p><span style="font-size: 10pt;">Since the 1990s, Japan has been an active centre of research into the study of electrical motor cortex stimulation (EMCS) to treat post-stroke pain using surgically implanted devices. The study reported at the INS 12th World Congress builds on observations that electrical motor cortex stimulation&rsquo;s effectiveness in relieving central post-stroke pain can be predicted by rTMS, suggesting the techniques share similar pain-relief mechanisms.</span><br /><br /></p> <p><span style="font-size: 10pt;">However, Kobayashi and colleagues point out in their peer-reviewed online publication of this study, &ldquo;Repetitive transcranial magnetic stimulation once a week induces sustainable long-term relief of central poststroke pain&rdquo; that there has still been controversy about the efficacy of rTMS in post-stroke pain. Kobayashi said in comparison to EMCS, his impression is rTMS efficacy seemed almost the same, without requiring surgery.<br /><br /></span></p> <p><span style="font-size: 10pt;">In 2014, a review&nbsp;suggested that there is probable efficacy (a level A recommendation) for short-term rTMS treatment of neuropathic pain, including central post-stroke pain, but did not speak to long-term efficacy.</span><br /><br /></p> <p><span style="font-size: 10pt;">Since pain relief from rTMS increases a few days after treatment, weekly treatment sessions were selected to try to sustain pain relief at treatment intervals that could be maintained on an outpatient basis.</span><br /><br /></p> <p><span style="font-size: 10pt;">Kobayashi believes neurologists would especially have an interest in this method, which is also attractive due to its low side-effect profile. None of the 18 patients reported any serious side effects from weekly sessions of 10 trains of 10-second 5Hz rTMS, at 90% of the active motor threshold. Two patients reported transient, slight scalp discomfort after rTMS.</span></p> <p><br /><span style="font-size: 10pt;">In addition to the potential of rTMS in pain relief, there has been growing research into non-invasive stimulation to augment progress in physical rehabilitation soon after stroke. It is believed that the stimulation aids in plasticity, the ability of the brain to gradually form new neural connections to take on functions previously performed by damaged areas.</span></p> <p><br /><span style="font-size: 10pt;">A first phase of the study assessed whether rTMS had a treatment effect on pain. In it, the research team randomly assigned six patients to receive either sham or active rTMS one week and the other treatment the next, measuring pain scores before and after each session.<br /><br /></span></p> <p><span style="font-size: 10pt;">Once that phase had shown that rTMS did reduce the patients&rsquo; pain, an open-label treatment phase began. In this second phase, the 18 patients underwent 12 weekly rTMS sessions. The patients&rsquo; pain scores were measured just before each weekly session.</span></p> <p><br /><span style="font-size: 10pt;">Data were collected for eight years, ending in 2014. Kobayashi said that some patients really hoped to continue rTMS after the study because their pain worsened after rTMS treatment sessions were over, and almost all the patients said that after the study ended, their pain increased to the level before rTMS.</span></p> <p><br /><span style="font-size: 10pt;">He added that the remaining question to answer is whether the level of the patients&rsquo; severe uncontrollable pain would continue to decrease if rTMS continued for several years.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-08T14:30:00Z2015-06-08T14:30:00Zwebeditor@bibamedical.com Therapeutics announces enrolment of third patient in pilot spinal cord injury trial<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A third patient has been enrolled in InVivo Therapeutics&rsquo; ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Dom Coric, of the Carolina Neurosurgery and Spine Associates and Chief of Neurosurgery at Carolinas Medical Center, together with William Bockenek, chief medical officer at Carolinas Rehabilitation, are co-principal Investigators at this site. Coric, along with Mark Smith of the Carolina Neurosurgery and Spine Associates, performed the third-ever Neuro-Spinal Scaffold implantation into an acute spinal cord injury patient. The implantation took place about three and a half days after the injury. Coric said, &ldquo;The implantation procedure went smoothly and the patient is doing very well. It has been rewarding to be involved in this clinical study, and I look forward to following the patient&rsquo;s progress.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer and chairman, said, &ldquo;This third patient affords us the opportunity to further extend our experience with the Neuro-Spinal Scaffold and will provide us with additional data for the design of a future pivotal study.&rdquo;</span></p></div>2015-06-08T09:11:00Z2015-06-08T09:11:00Zwebeditor@bibamedical.com commences second cohort of the Pathway study in cervical spinal cord injury<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>StemCells has enrolled its first subjects in cohort 2 of its phase II Pathway study. The study is designed to assess the efficacy of the company&rsquo;s proprietary HuCNS-SC platform technology (purified human neural stem cells) for the treatment of cervical spinal cord injury. Cohort 2 will enrol 40 patients and forms the single-blinded controlled arm of the phase II study. The primary efficacy outcome being tested in cohort 2 is the change in motor strength of the various muscle groups in the upper extremities innervated by the cervical spinal cord.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Pathway study is the first clinical trial designed to evaluate both the safety and efficacy of human neural stem cells transplanted into the spinal cord of patients with cervical spinal cord injury. The trial has three cohorts. The primary cohort is cohort 2 which is being conducted as a randomised, controlled, single-blind cohort with efficacy primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The trial will follow the participants for one year and will enrol up to 52 subjects.</span></p> <p><br /><span style="font-size: 10pt;">Cohort 1 of the Pathway study is an open-label, HuCNS-SC dose-escalation arm involving six patients. Safety data from all six subjects was reviewed by an independent data monitoring committee and approval was provided to commence with cohort 2. No safety or tolerability issues were seen at any of the dosing levels. The six-month outcome from cohort 1 will be disclosed as interim data later this year.</span></p> <p><br /><span style="font-size: 10pt;">Cohort 3 is an optional open label cohort targeted to enrol six patients. This cohort is designed to assess safety and preliminary efficacy in patients with less severe injuries (AIS C).</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The initiation of Cohort 2 begins the next phase of our clinical efforts towards a potential breakthrough therapy for spinal cord injury,&rdquo; said Stephen Huhn, vice president, Clinical Research and chief medical officer at StemCells. &ldquo;This is the first blinded, controlled clinical trial to be conducted using human neural stem cells. The goal of this proof-of-concept study is to demonstrate the potential efficacy of our cells as a treatment for victims of spinal cord injury. We currently have seven sites enrolling patients and expect to reach a total of fourteen active North American sites by year end. Conducting a multicentre study on this scale should allow us to efficiently enrol the study.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The company completed enrolment and dosing in its open-label phase I/II study in thoracic spinal cord injury in April 2014 and has reported top-line results. Sustained post-transplant gains in sensory function were demonstrated in seven of the twelve patients. Two patients in the phase I/II study converted from a complete injury (AIS A) to an incomplete injury (AIS B). The final results also continue to confirm the favourable safety profile of the cells and the surgical procedure.</span></p></div>2015-06-08T08:48:00Z2015-06-08T08:48:00Zwebeditor@bibamedical.com steal eight years’ worth of brain function, new study suggests<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Having a stroke ages a person&rsquo;s brain function by almost eight years, new research finds&mdash;robbing them of memory and thinking speed as measured on cognitive tests.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In both black and white patients, having had a stroke meant that their score on a 27-item test of memory and thinking speed had dropped as much as it would have if they had aged 7.9 years overnight.</span></p> <p><span style="font-size: 10pt;"><br />For the study, data from more than 4,900 black and white seniors over the age of 65 was analysed by a team from the University of Michigan U-M Medical School and School of Public Health and the VA Center for Clinical Management Research, USA. The results will be published in the July issue of <em><a href="" target="_blank">Stroke</a></em>.</span></p> <p><span style="font-size: 10pt;"><br />Researchers married two sources of information for their analysis: detailed surveys and tests of memory and thinking speed over multiple years from participants in a large, national study of older Americans, and Medicare data from the same individuals.</span></p> <p><span style="font-size: 10pt;"><br />They zeroed in on the 7.5% of black study participants, and the 6.7% of white participants, who had no recent history of stroke, dementia or other cognitive issues, but who suffered a documented stroke within 12 years of their first survey and cognitive test in 1998.</span></p> <p><span style="font-size: 10pt;"><br />By measuring participants&rsquo; changes in cognitive test scores over time from 1998 to 2012, the researchers could see that both blacks and whites did significantly worse on the test after their stroke than they had before.</span></p> <p><span style="font-size: 10pt;"><br />Although the size of the effect was the same among blacks and whites, past research has shown that the rates of cognitive problems in older blacks are generally twice that of non-Hispanic whites. So the new results mean that stroke does not account for the mysterious differences in memory and cognition that grow along racial lines as people age.</span></p> <p><span style="font-size: 10pt;"><br />The researchers say the findings underscore the importance of stroke prevention.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;As we search for the key drivers of the known disparities in cognitive decline between blacks and whites, we focus here on the role of &lsquo;health shocks&rsquo; such as stroke,&rdquo; says lead author and U-M Medical School assistant professor Deborah Levine. &ldquo;Although we found that stroke does not explain the difference, these results show the amount of cognitive ageing that stroke brings on, and therefore the importance of stroke prevention to reduce the risk of cognitive decline.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Other research on disparities in cognitive decline has focused on racial differences in socioeconomic status, education, and vascular risk factors such as diabetes, high blood pressure and smoking that can all contribute to stroke risk. These factors may explain some but not all of the racial differences in cognitive decline.</span></p> <p><span style="font-size: 10pt;"><br />Levine and her colleagues note that certain factors&mdash;such as how many years a person has vascular risk factors, and the quality of his or her education, as well as genetic and biological factors&mdash;might play a role in racial differences in long-term cognitive performance.</span></p> <p><span style="font-size: 10pt;"><br />But one thing is clear: strokes have serious consequences for brain function. On average, they rob the brain of eight years of cognitive health. Therefore, people of all racial and ethnic backgrounds can benefit from taking steps to reduce their risk of a stroke. That includes controlling blood pressure and cholesterol, stopping or avoiding smoking, controlling blood sugar in diabetes, and being active even in older age.</span></p></div>2015-06-06T11:12:00Z2015-06-06T11:12:00Zwebeditor@bibamedical.com Trial System receives CE mark approval<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>St Jude Medical has announced CE mark approval and the European launch of the Invisible Trial System, an app-based and wireless neuromodulation programming system leveraging Apple iPod touch and iPad mini technology. Like other Apple products, the new St Jude Medical system relies on Bluetooth communication, providing a secure, safe, and wireless experience when patients trial spinal cord stimulation for the treatment of chronic pain prior to permanent implantation.</strong></span></p></div><div style="clear:both; text-align:left"> <p><br /><span style="font-size: 10pt;">&ldquo;I expect that the St Jude Medical Invisible Trial System will significantly improve the trial experience for my patients,&rdquo; said Stefan Schu, specialist for neurosurgery and senior physician for neuromodulation at the Sana Clinic in Duisburg, Germany. &ldquo;The new system will be discreet, familiar and require no cables that can be uncomfortable or potentially cause the lead to dislodge. Perhaps the most important feature is the therapy itself, which will enable a unique burst stimulation mode that will expand the range of stimulation modes available in the trial phase and thereby potentially improve the trial success rate for my patients suffering from chronic pain.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">One of the key system features of the Invisible Trial System is the use of an external pulse generator (EPG) as the system&rsquo;s power source. The EPG is small, and uses Bluetooth communication to communicate between the patient&rsquo;s iPod touch controller and the stimulation system. As a result, the system can now be worn under a patient&rsquo;s clothing, often rendering the entire system &ldquo;invisible&rdquo; and providing a more comfortable trial experience. The goal is for patients to focus more on potential pain relief and therapeutic impact during their trial and less on the trial system itself.</span></p> <p><br /><span style="font-size: 10pt;">The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient&rsquo;s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient&rsquo;s comfort.</span></p> <p><br /><span style="font-size: 10pt;">The new trial system has the capability to deliver both traditional and burst stimulation modes. Burst stimulation has been demonstrated to minimise paraesthesia in most patients. Being able to utilise the burst stimulation mode in a trial setting expands the range of available stimulation modes for chronic pain sufferers in the trial phase and in addition offers the potential to trial burst stimulation for patients who did not respond to traditional tonic stimulation previously.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We have developed our new patient-centric Invisible Trial System as a response to physician and patient feedback,&rdquo; said Eric S Fain, group president of St Jude Medical. &ldquo;The system was designed to improve the comfort and usability of our system for patients evaluating spinal cord stimulation therapy to alleviate their chronic pain without focusing on potential barriers such as programming trial cables and systems with complex trial controls.&rdquo;</span></p></div>2015-06-04T13:33:00Z2015-06-04T13:33:00Zwebeditor@bibamedical.com Scientific launches the Precision Novi spinal cord stimulator system in Europe<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Boston Scientific will announce the European launch of the Precision Novi spinal cord stimulator (SCS) system at the International Neuromodulation Society meeting (6&ndash;11 June, Montreal, Canada).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The 16-contact primary cell device has CE mark for the treatment of chronic pain, and is the smallest high-capacity primary cell device currently available. The enhanced shape of the Precision Novi implant is designed to provide a new level of comfort to patients with pain treated using primary cell therapy. Precision Novi is powered by Illumina 3D software that enables physicians to target pain precisely &ldquo;with point-and-click simplicity&rdquo;, states a company press release.</span></p> <p><br /><span style="font-size: 10pt;">Chronic pain can have a devastating impact on quality of life for many patients. Spinal cord stimulators alleviate pain by stimulating the nerve fibres in the spinal cord to reduce pain signals. While primary cell (also referred to as non-rechargeable) devices are typically larger due to limitations in technology and battery size, Boston Scientific believes that Precision Novi represents a significant technology advance, with the smallest high-capacity battery on the market, allowing effective pain relief to be delivered from a much smaller device. The Precision Novi is also the only primary cell device that couples with a wireless remote, empowering patients with flexibility and control over their pain management.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The small size and novel shape of the Precision Novi implant improves patient comfort and enables a very discreet subcutaneous placement,&rdquo; said Simon Thomson, a consultant in Pain Management and Neuromodulation at Basildon and Thurrock University Hospitals, UK. &ldquo;The simplicity of the programming software saves valuable time in the operating theatre, efficiently allowing me to achieve and maintain comfortable therapy for my patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Precision Novi intuitive Illumina 3D neural targeting software incorporates three-dimensional lead location, as well as the conductivity of the spinal cord and surrounding tissue. This &ldquo;point-and-click&rdquo; technology automatically calculates the optimal programming configuration to target the selected pain area. Further, unique for primary cell devices, Precision Novi is a MultiWave platform capable of delivering a variety of field shapes and waveforms with or without paraesthesia, including burst and higher rate frequencies.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are excited to expand upon our range of therapeutic solutions for patients suffering from chronic pain,&rdquo; said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. &ldquo;The Precision Novi system brings the power of our Illumina 3D Algorithm to the more than 60% of SCS patients in Europe who are treated with primary cell therapy.&rdquo; The Precision Novi is not available in the USA.</span></p></div>2015-06-04T13:08:00Z2015-06-04T13:08:00Zwebeditor@bibamedical.com website launches<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>For years, the radiology industry has focused on reducing, or eliminating patient exposure to radiation. Recently, the industry has shifted attention to the cumulative effect radiation exposure has over the course of a physician&rsquo;s career.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">To address this, Unfors RaySafe, a Fluke Biomedical Company, launched to enable physicians and clinical staff to educate themselves on the risks of radiation exposure and measures that can be taken to protect themselves. This first-of-its kind community delivers the most current research about radiation exposure, as well as stories and anecdotes from practicing clinical personnel. promotes peer-to-peer engagement through real-life experience sharing about the concerns of excessive and unnecessary radiation exposure.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Radiation safety awareness is key, not just for patients, but for the physicians and clinical teams treating patients,&rdquo; explains Scott Pollak, interventional cardiologist at Florida Hospital Orlando, USA. &ldquo;Before I was diagnosed with cancer, I had some awareness of the possible risks of radiation exposure, but my knowledge was limited. is an invaluable resource for physicians, technologists and nurses who are exposed to radiation on a daily basis.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Radiation exposure in cardiac catheterisation labs, interventional radiology suites and electrophysiology is a significant but often overlooked risk for medical staff. provides analysis and valuable insights to help educate physicians and clinical staff, giving them a broader perspective of what is happening in their particular specialty. The site also includes a dynamic blog with perspectives from physicians, technologists and nurses, administration and medical physics.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Radiation is an important diagnostic and interventional tool for fluoroscopy guided minimally invasive procedures, but carries with it implicit risks,&rdquo; explains Magnus Kristoferson, managing director for RaySafe. &ldquo;Physicians and their clinical teams can no longer ignore these risks. This site gives physicians and staff an opportunity to have a conversation about what is really happening and enable staff safety and protection to be as high priority and equally accepted as patient safety and protection.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Armed with information, physicians are better equipped to champion awareness and the change that is needed in the industry to protect future generations of physicians and technicians.&nbsp; Information previously scattered among medical journals, news articles and personal experiences can now be found in one place,</span></p></div>2015-06-03T15:35:00Z2015-06-03T15:35:00Zwebeditor@bibamedical.com link needed between neurologists and cardiologists<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>While physicians are generally aware that atrial fibrillation is a leading preventable cause of a recurrent stroke, there is a lack of understanding of the best ways to accurately identify atrial fibrillation in these patients. Richard Bernstein, director, Northwestern Stroke and Telestroke Program and professor of Neurology, Feinberg School of Medicine of Northwestern University, Chicago, USA, tells <em>NeuroNews</em> that a closer relationship between neurologists and cardiologists/electrophysiologists can help to improve the care of patients experiencing strokes of unknown cause.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>How often does atrial fibrillation contribute recurrent stroke?</strong></span></p> <p><span style="font-size: 10pt;"><br />The risk of a recurrent stroke in patients with a recent stroke and atrial fibrillation has been estimated as high as 15% per year, in the absence of anticoagulation. When patients are anticoagulated, that risk plummets.</span></p> <p><span style="font-size: 10pt;"><strong><br />How do heart monitors work and what exactly do they do?</strong></span></p> <p><span style="font-size: 10pt;"><br />In general, the monitors we are interested in continuously analyse the heart rhythm and automatically detect atrial fibrillation; they then notify the monitoring company who confirms the diagnosis and notifies the patient&rsquo;s doctor. What makes the current generation of monitors unique is that they can be used for months to years; much longer than we were previously able to monitor. This allows us to detect atrial fibrillation in patients in whom the abnormal rhythm is rare and brief.</span></p> <p><span style="font-size: 10pt;"><strong><br />Which patients are the ideal candidates for heart monitors?</strong></span></p> <p><span style="font-size: 10pt;"><br />Stroke patients in whom the diagnosis of atrial fibrillation would change medical management, usually from antiplatelet agents (like aspirin) to anticoagulants (like warfarin or the newer agents) are the ideal ones to monitor. These include patients with embolic stroke of unknown source, also called cryptogenic ischaemic stroke; and others in a variety of situations.</span></p> <p><span style="font-size: 10pt;"><strong><br />How can the implantation of heart monitors help to reduce recurrent stroke?</strong></span></p> <p><span style="font-size: 10pt;"><br />We think heart monitors reduce recurrent stroke by allowing us to detect rare instances of atrial fibrillation in these patients that would otherwise go undiagnosed, allowing us to put the patients on anticoagulation which is much more effective in reducing recurrence in patients with atrial fibrillation, but are not of proven benefit in patients without atrial fibrillation (with rare exceptions).</span></p> <p><span style="font-size: 10pt;"><strong><br /><br /></strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Why are heart monitors not used in more patients?</strong></span></p> <p><br /><span style="font-size: 10pt;">Most neurologists do not know about this technology; and most cardiologists do not see cryptogenic stroke patients or recognise it when they do see it. Therefore, the two specialists who need to converge on the patient to initiate this testing often do not work together.</span></p> <p><span style="font-size: 10pt;"><strong><br />How can the situation be improved? Should neurologists and cardiologists/electrophysiologists be working more closely together? </strong></span></p> <p><br /><span style="font-size: 10pt;">Yes. Cardiologists are already the most frequently called consultant on stroke patients, performing echocardiograms and helping deal with cardiac conditions that are common in stroke patients. Neurologists should now ask them to place these cardiac monitors in appropriate patients, and cardiologists need to be able to do the procedure quickly and review the output of the devices in a timely manner.</span></p> <p><span style="font-size: 10pt;"><strong><br />What would a regular collaboration between neurologists and cardiologists/electrophysiologists look like, and why is it not common now?</strong></span></p> <p><br /><span style="font-size: 10pt;">Traditionally these are disciplines that had very little in common. I do see this changing; more stroke patients are getting long-term cardiac monitoring, but educating doctors is a painfully slow process.</span><br /><br /></p> <p><br /><span style="font-size: 9pt;">Richard A Bernstein has disclosed that he is a speaker, consultant, and member of steering committees for Medtronic and was paid for his work on the steering committee of CRYSTAL-AF. He is also a researcher, consultant, and speaker for Boehringer-Ingelheim.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div>2015-06-03T14:19:00Z2015-06-03T14:19:00Zwebeditor@bibamedical.com prevention app paves the way for world-first global study<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The Stroke Riskometer app will aim to reduce the cases of stroke and several other chronic diseases such as diabetes and heart disease by collecting and sharing information from users. The global RIBURST study, which starts this month with the app&rsquo;s release, could significantly contribute to the reduction of these epidemics, saving millions of lives and billions of dollars in the process.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The app update, which is free to download for iOS and Android devices, uses mobile health technology to allow individuals to assess their risk of suffering a stroke within the next five to ten years. With input from healthcare experts across 30 countries and a large number of expected participants, the corresponding RIBURST study has been heralded as the largest international collaboration project ever undertaken.</span><br /><br /></p> <p><span style="font-size: 10pt;">Stroke Riskometer is the brainchild of stroke neuroepidemiologist Valery<strong>&nbsp;</strong>Feigin, who acknowledges current strategies are not effective enough in preventing stroke and heart disease. &ldquo;Mobile has enormous outreach and is the future of personal medicine. Non-communicable diseases constitute about 75% of the burden associated with all health conditions,"&nbsp;said Feigin. People need access to information, explains Feigin, who believes the study can significantly contribute to the reduction of these epidemics. &ldquo;Stroke causes 10% of all deaths. The only solution to this global problem is prevention on a global scale; this app is going to make a significant change in the world.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Feigin urges people of all ages to download the app, reminding users that, &ldquo;a stroke is easier to prevent than to treat.&rdquo; It is hoped that Stroke Riskometer will encourage the adoption of positive lifestyle changes and, in time, see a worldwide reduction in the occurrence of stroke. &ldquo;If you can reduce the rate of stroke by a fraction, it will have enormous impact worldwide,&rdquo; said Feigin.</span><br /><br /></p> <p><span style="font-size: 10pt;">Stroke Riskometer is based on an algorithm established by the 1940 Framingham Heart Study. The app&rsquo;s software has been updated with the 21st century user in mind; acknowledging increased stress levels, lifestyle and other risk factors changes, including and increasing rates of overweight and diabetes.</span><br /><br /></p> <p><span style="font-size: 10pt;">The app leads users through a simple interactive quiz; covering topics such as medical risk factors, diet, physical inactivity, alcohol and stress. This information is analysed to calculate a percentage likelihood of stroke within a five to ten year period; results that are then compared to those of an individual of the same age who expresses no risk factors. With this recent update, users can now anonymously submit their data to a global pool of responses for use in the RIBURST study. It is hoped that this research will allow medical professionals to better understand risk factors specific to ethnic groups and geographic regions.</span><br /><br /></p> <p><span style="font-size: 10pt;">The app has been endorsed by the World Stroke Organization, World Federation of Neurology, European Stroke Organization, International Association on Neurology and Epidemiology and was recognised by HealthTap AppRX as the Top Medical Conditions App of 2014 as voted by doctors from more than 100,000 apps. &ldquo;Stroke Riskometer is a great example of delivering research through the modern technologies of mobile health,&rdquo; suggests Kevin Pryor, chief executive officer of AUT Enterprises.</span><br /><br /></p> <p><span style="font-size: 10pt;">The &lsquo;Lite&rsquo; version of the app can be downloaded free of charge, while purchasing Stroke Riskometer Pro unlocks the ability to save and track results, and gain access to expert videos and tools to manage and reduce risk factors.</span></p></div>2015-06-03T10:50:00Z2015-06-03T10:50:00Zwebeditor@bibamedical.com study shows Cefaly returns normal metabolic activity to brain areas in migraine patients<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Cefaly Technology has released data from a new PET trial showing that the Cefaly device returns normal metabolic activity to the areas in the brain in migraine patients, namely the orbitofrontal cortex and rostral cingulate.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The positron emission tomography (PET) scan, which is an imaging test of the brain, used a radioactive substance called a tracer to show how the brain and its tissues are working under the influence of a Cefaly.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is a major breakthrough in understanding the mechanism of action of the device on the central nervous system,&rdquo; said Pierre Rigaux, chief executive officer of Cefaly Technology, the maker of the device. &ldquo;It will help us take developments in this non-invasive, drug-free, technology even further.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The study, which was conducted as part of EUROHEADPAIN, a major European research project focused on migraines, looked at 28 patients with at least four migraines per month. These patients&rsquo; brain activities were monitored as they used the Cefaly once per day for 20 minutes for a period of three months. The goal of the trial was to better understand and identify the short and medium term metabolic changes in the brain areas of those afflicted with migraines&mdash;the orbitofrontal cortex and the rostral cingulated, which are especially involved in decision-making and emotional behaviour. In patients with migraines these areas tend to be sub-metabolic in comparison to patients without migraines.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The modifications observed through the PET scan reinforce the strong clinical data on safety and efficacy that led to the Food and Drug Administration (FDA) approval,&rdquo; said Rigaux.</span><br /><br /></p> <p><span style="font-size: 10pt;">The results were presented at the EUROHEADPAIN &ndash; Midterm Meeting at the International Headache Society Congress (14&ndash;17 May, Valencia, Spain).</span><br /><br /></p> <p><span style="font-size: 10pt;">In March 2014, the FDA approved the prescription-only, headband-like, device that uses tiny electrical impulses to stimulate the trigeminal nerve to reduce the frequency and intensity of migraines. At that time, it reached its decision using data from a randomised double blinded clinical trial implemented in five university clinics in Belgium; as well as a patient satisfaction study of 2,313 Cefaly users in France.</span></p></div>2015-06-03T09:21:00Z2015-06-03T09:21:00Zwebeditor@bibamedical.com of whole brain radiation therapy and radiosurgery outweigh benefits for patients with limited brain metastases<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Whole brain radiation therapy (WBRT) is associated with significantly worse cognitive function than radiosurgery, and should no longer be used in the adjuvant setting after radiosurgery to treat cancer patients with brain metastases, according to a large study led by a researcher at&nbsp;The University of Texas MD Anderson Cancer Center, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MD Anderson&rsquo;s&nbsp;Paul Brown, professor, Radiation Oncology, presented the phase III randomised trial findings from the Alliance cooperative research group on the plenary session of&nbsp;American Society for Clinical Oncology&rsquo;s 2015 Annual Meeting (29 May&ndash;2 June, Chicago, USA).</span><br /><br /></p> <p><span style="font-size: 10pt;">More than 200,000 cancer patients in the USA alone will be diagnosed and treated for brain metastasis this year. WBRT is currently used in a variety of settings as an adjuvant therapy after surgery or radiosurgery for patients with a few metastases, as a definitive treatment for patients with a greater number of metastases and in the palliative care setting.</span><br /><br /></p> <p><span style="font-size: 10pt;">Multiple randomised trials have shown adjuvant WBRT significantly improves tumour control. However, none of the studies have shown a survival benefit, Brown explains. WBRT&rsquo;s side effects include hair loss, skin redness, dry mouth and fatigue and it is associated with significant interruptions in systemic therapy. In contrast, side effects associated with radiosurgery are minimal, and it is not generally associated with significant interruptions in chemotherapy, says Brown.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The question we were left with was how to understand the toxicities associated with whole brain radiation therapy, specifically cognitive function,&rdquo; said Brown, the study&rsquo;s corresponding author. &ldquo;We needed to understand what was worse, the cognitive impact of the whole brain radiation therapy, or, in other words, the therapy itself, or the recurrence of tumours.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Our study gives us the clearest picture of the impact of WBRT on cognitive function. To date, we have really not had that,&rdquo; Brown continued.<br /><br />The North American study enrolled 213 patients of different tumour histologies (the majority of whom had a lung primary diagnosis), from 2002&ndash;2013, all with one-to-three brain metastases. Patients were randomised to receive either radiosurgery alone, or radiosurgery followed by WBRT, and underwent cognitive testing before and after treatment. The study&rsquo;s primary endpoint was cognitive progression, defined as significant decline in any of the seven cognitive tests at three months.</span></p> <p><span style="font-size: 10pt;">At three months, cognitive progression was more frequent in the WBRT-radiosurgery arm, compared to those who received radiosurgery alone, at 92% and 64%, respectively. Specifically, in patients that underwent WBRT and radiosurgery compared to radiosurgery alone, there was more deterioration in immediate recall (30% and 8%, respectively); delayed recall (51% and 20%, respectively); and verbal fluency (19% vs. 2%).</span><br /><br /></p> <p><span style="font-size: 10pt;">Intracranial tumour control at three and six months were 75% and 65%, respectively, with radiosurgery alone, compared to 94% and 88%, respectively, with radiosurgery and WBRT. Although intracranial control was significantly better with the addition of WBRT, there was no difference in survival with a median overall survival of 10.7 months in the radiosurgery arm of the clinical trial versus 7.5 months in those who received radiosurgery and WBRT. In addition patients treated with WBRT and radiosurgery had a worse quality of life compared to those treated with radiosurgery alone.</span><br /><br /></p> <p><span style="font-size: 10pt;">The findings should serve as recognition that the deleterious impact on cognitive function outweighs any benefit associated with WBRT and tumour control, says Brown.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Overtime there has been a general shift in moving away from using whole brain radiation, in favour of stereotactic radiosurgery,&rdquo; says Brown. &ldquo;With these results and appropriate concerns for cognitive decline, it will likely be pushed even further&mdash;reserving WBRT for later in a patient&rsquo;s disease course.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">As a follow up, Brown and colleagues plan to analyse the cost effectiveness data associated with WBRT added to radiosurgery versus radiosurgery alone. Also, Brown is currently leading an Alliance trial studying WBRT use versus radiosurgery to the surgical cavity following surgical resection of a brain metastasis. This ongoing trial will determine which treatment approach is better.</span></p></div>2015-06-02T10:18:00Z2015-06-02T10:18:00Zwebeditor@bibamedical.com Medical gains approval to start US clinical trial of ReActiv8<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Mainstay Medical International plc has received approval from the US Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (IDE). ReActiv8 is an innovative implantable neurostimulation system designed to reduce the pain and disability of chronic low back pain by helping to restore control to the muscles that dynamically stabilise the lumbar spine.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The FDA approval to start a US clinical trial of ReActiv8 is a major step towards our goal of bringing ReActiv8 to the US market,&rdquo; said Peter Crosby, the chief executive officer of Mainstay Medical. &ldquo;We are impressed with the FDA&rsquo;s responsiveness during the development and review of this trial. It helped us to develop a clinical trial to meet the needs of the company, the FDA, and the millions of people who could potentially benefit from ReActiv8.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The FDA approval is for the planned ReActiv8-B trial, an international, multicentre, prospective randomised sham-controlled trial designed to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with chronic low back pain and no prior back surgery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The approval is to conduct the ReActiv8-B trial at up to 40 clinical trial sites and for 128 randomised patients to be implanted with ReActiv8 in the pivotal cohort. The IDE approval allows Mainstay Medical to engage with investigators, clinical trial sites, and Institutional Review Boards (IRBs or Ethics Committees) leading towards the first subject recruitment and implant. Upon successful completion of the ReActiv8-B trial and if the results support it, the company plans to submit an application for a Pre-Market Approval (PMA) which is required to allow the start of commercialisation in the United States.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In the approval letter, the FDA provided some helpful study design recommendations which the company is considering, and it is possible that one or more IDE supplements may be submitted in the coming months.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The principal investigator for the trial is Christopher Gilligan, chief, Division of Pain Medicine at Beth Israel Deaconess Medical Center in Boston, USA, and assistant professor of Anaesthesiology at Harvard Medical School. Gilligan is head of the Data Monitoring Committee of the ongoing ReActiv8-A trial.</span></p></div>2015-05-29T10:50:00Z2015-05-29T10:50:00Zwebeditor@bibamedical.com Road Medical appoints Andrew Davis as executive vice president of global sales<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Silk Road Medical has appointed Andrew Davis&nbsp;to the position of executive vice president of global pales. In this new role, Davis will assemble a sales organisation and lead the company&rsquo;s commercialisation efforts for the transcarotid artery revascularisation (TCAR) procedure with the Enroute transcarotid neuroprotection system and the Enroute transcarotid stent system.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Prior to joining Silk Road Medical, Davis was the vice president of sales and marketing at Acelity&rsquo;s Advanced Wound Therapy Group and previously held vice president of sales positions for Medtronic&rsquo;s CoreValve, Endovascular, Peripheral and Spinal/Biologics divisions. He has over 20 years of experience in the medical device field with deep expertise in launching innovative, minimally invasive therapies that increase patient access and solve unmet clinical needs in cardiovascular diseases historically treated with invasive surgical approaches.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Andrew is the ideal sales leader to help Silk Road redefine carotid artery revascularisation and realise its mission to beat stroke and its devastating effects on patients, families and society,&rdquo; said&nbsp;Erica Rogers, chief executive officer. &ldquo;Andrew&rsquo;s deep knowledge of endovascular surgery, extensive relationships, and track record of success will be incredibly valuable to our team as we commercialise in the USA and beyond.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Silk Road has completely changed the way we think about treating carotid artery disease,&rdquo; said Davis. &ldquo;There are known and sometimes severe complications with open carotid surgery, and transfemoral carotid stenting with current technology actually increases the stroke risk. TCAR is a clinically proven game-changer, as demonstrated by the ROADSTER trial, with the clear potential to become standard of care.&rdquo;</span></p></div>2015-05-29T10:09:00Z2015-05-29T10:09:00Zwebeditor@bibamedical.com clears Penumbra ACE64 for acute ischaemic stroke patients<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Penumbra has announced that the company&rsquo;s ACE64 aspiration thrombectomy system received 510(k) marketing clearance from the US Food and Drug Administration for the revascularisation of large vessel occlusions in patients with acute ischaemic stroke.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The efficacy and safety of mechanical thrombectomy has been demonstrated in the MR CLEAN trial and confirmed in additional randomised controlled stroke trials. According to Penumbra, ACE64 is the most advanced innovation in thrombectomy technology since these trials were conducted. With a unique construction that leverages breakthrough technology in materials science, ACE64 enables physicians to bring the most powerful clot extraction capability directly to the occlusion and remove clot en masse. Early experience from a European multicentre study, where ACE64 is already available, reported high rates of revascularisation at 96% TICI 2b/3, a fast procedure time of 37 minutes on average and mRS scores &le;2 at discharge of 48%.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;ACE64 is the latest technology improvement in mechanical thrombectomy,&rdquo; said Rob T Lo, University Medical Center Utrecht, The Netherlands, a centre in the MR CLEAN trial. &ldquo;I have used Merci and the different stent retrievers as well as the prior ACE aspiration thrombectomy system. With the new ACE64, I am achieving even higher revascularisation rates, particularly TICI 3, while reducing procedure times and minimising overall procedure costs. ACE64 is now my frontline tool for treating patients with acute ischaemic stroke.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Penumbra&rsquo;s aspiration thrombectomy devices use a minimally invasive &ldquo;vacuum&rdquo; inside the artery to remove a blood clot. The next-generation ACE64 features an even larger aspiration lumen compared with ACE to evacuate large clot burdens.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are at an exciting moment in history when the effectiveness of mechanical thrombectomy is now firmly established, allowing the stroke community to focus on optimising the delivery of care in stroke and improving patient outcomes,&rdquo; said Adam Elsesser, chairman and chief executive officer. &ldquo;At Penumbra, we are continuing the pace of innovation to bring ever more effective tools to physicians in the fight against a devastating disease affecting so many patients worldwide.&rdquo;</span></p></div>2015-05-28T08:46:00Z2015-05-28T08:46:00Zwebeditor@bibamedical.com commercial procedure of HF10 therapy performed in the USA<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Nevro has announced that the first commercial case has been performed in the United States under the company&rsquo;s 8 May, 2015 FDA approval for commercial use of the Senza spinal cord stimulation (SCS) system, which delivers Nevro&rsquo;s proprietary HF10 therapy.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is an exciting day for chronic pain patients and the physicians who treat them in the USA as they now have access to a significant advance in chronic pain management. HF10 therapy will broaden my pain practice as its superior results will allow me to treat more patients effectively. Additionally, the elimination of paraesthesia is meaningful for patient quality of life as well as predictability of the operating procedure. I am excited to bring these advances to my patients,&rdquo; said Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center, USA.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past five years. With this FDA approval, patients in the USA suffering from chronic pain will have the opportunity to experience the superior benefits of HF10 therapy. Nevro&rsquo;s Senza system is the only SCS therapy approved by FDA with superiority labelling, as demonstrated in the largest prospective randomised SCS study ever conducted to assess the treatment of chronic back and leg pain. The Senza system is also the only SCS therapy indicated by FDA to deliver pain relief without paraesthesia (a stimulation-induced sensation, such as tingling, burning, or pricking, which is the basis of traditional SCS), and to be approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy. Finally, the Senza system is the only implantable SCS system approved by FDA with labelling for 3T conditional MRI compatibility.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are pleased we are able to initiate the commercialisation of HF10 therapy so quickly after FDA approval and to broaden access to US patients in need of an effective chronic pain treatment,&rdquo; said Michael DeMane, chairman and chief executive officer of Nevro. &ldquo;The Nevro team looks forward to launching the Senza system in the USA with a deliberate and responsible commercial rollout.&rdquo;</span></p></div>2015-05-23T11:36:00Z2015-05-23T11:36:00Zwebeditor@bibamedical.com grants premarket approval for Enroute transcarotid stent system<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Silk Road Medical has announced that the company has received premarket approval (PMA) from the US Food &amp; Drug Administration (FDA) for the Enroute transcarotid stent system. The Enroute transcarotid stent is the first carotid stent that is introduced and implanted into the carotid artery through a direct common carotid access point to enable a safe and more direct approach to carotid artery stenting.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Enroute&nbsp;transcarotid stent is indicated for use in high surgical risk patients and is intended to be used in conjunction with Silk Road Medical&rsquo;s Enroute&nbsp;transcarotid neuroprotection system (NPS), which recently received 510(k) clearance by the FDA. Together the Enroute&nbsp;transcarotid NPS and stent system enables a novel hybrid procedure called transcarotid artery revascularisation (TCAR), which combines surgical principles of neuroprotection with a less invasive stenting procedure. The Enroute&nbsp;transcarotid NPS is a first in class system used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the Enroute&nbsp;transcarotid stent.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Enroute&nbsp;transcarotid stent&nbsp;was developed pursuant to a license with Cordis Corporation and leverages the micromesh design and long term durability of the Cordis PRECISE carotid stent that was clinically proven in tens of thousands of patients across multiple clinical trials including SAPPHIRE, CASES-PMS and SAPPHIRE Worldwide. The Enroute&nbsp;transcarotid stent&nbsp;has a shorter delivery system optimised for transcarotid access and was recently trialed by leading European physicians.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />"TCAR allows us to avoid potential stroke hazards at the aortic arch while placing a stent under robust flow reversal which simulates the superb neuroprotection of CEA," commented Ralf Kolvenbach, chief of Vascular Surgery at Augusta Hospital, Dusseldorf Catholic Hospital Group. "With the Enroute&nbsp;transcarotid stent&nbsp;we now have a dedicated, ergonomic stent platform for TCAR that combines the control afforded by transcarotid access with the stent&rsquo;s visibility under X-ray, allowing for confident, precise stent placement."</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The US FDA PMA was based in part on data collected from a subset (52) of 141 High Surgical Risk patients in the ROADSTER study who were treated with the Cordis PRECISE PRO RX stent system and the Enroute&nbsp;transcarotid NPS. Technical success was 100% (52/52) and the Major Adverse Event (MAE) rate at 30 days was 1.9% consisting of a single minor stroke, comparable to the overall ROADSTER results of 3.5% MAE and 1.4% stroke.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> </div>2015-05-19T17:16:00Z2015-05-19T17:16:00Zwebeditor@bibamedical.com SCS approved and first implanted in Canada<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>St Jude Medical has announced Health Canada approval and first implant in Canada of its Prodigy chronic pain system with burst technology. The Prodigy system is the only implantable spinal cord stimulation (SCS) system approved to deliver St Jude Medical&rsquo;s proprietary burst stimulation as well as traditional SCS to reduce pain, improve patient satisfaction and eliminate paraesthesia in some patients.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A 52-year-old man from Saskatoon received the Prodigy neurostimulator on 13 May due to his experience with chronic pain for several years following a successful trial experience and was performed by Ivar Mendez, from Saskatoon Health Region&rsquo;s Royal University Hospital in Saskatchewan, Canada.</span></p> <p><span style="font-size: 10pt;"><br />Chronic pain affects one in five adults in Canada and more than 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient&rsquo;s daily routine, and is a serious public health issue that remains largely under-treated and misunderstood.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Burst stimulation is a novel technology for SCS that has the potential to be effective in patients that do not respond well to traditional tonic stimulation. Studies have shown that with burst stimulation patients can experience reduced paraesthesia and pay less attention to their pain improving their overall experience with SCS therapy,&rdquo; Mendez said, who is chairman of the Department of Surgery at the University of Saskatchewan and the Saskatoon Health Region&rsquo;s Royal University Hospital. &ldquo;SCS therapy can provide significant pain relief and thus enable many patients to increase their activity levels and improve their overall quality of life. In combination with conventional tonic stimulation, burst stimulation represents a comprehensive approach to effective pain management and allows me to tailor the therapy to my patient&rsquo;s unique situation.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />SCS therapy uses an implanted pulse generator and thin wires with electrodes to deliver low levels of electrical energy to nerve fibers. These electrical pulses mask or interrupt pain signals as they travel to the brain, reducing the sensation of pain. Traditional tonic stimulation uses equally spaced electrical pulses to replace pain with a tingling sensation called paresthesia. For some patients, the stimulation sensation can fluctuate with changes in body position and paresthesia may become uncomfortable.</span></p> <p><span style="font-size: 10pt;"><br />St Jude Medical&rsquo;s burst stimulation works differently, and offers intermittent &ldquo;bursts&rdquo; of stimulation, designed to mimic the human body&rsquo;s natural design of neuron signaling and thus provide an alternative therapy method for chronic pain conditions. In addition, burst stimulation has been shown to significantly reduce or eliminate paraesthesia. The ability to support two modes of stimulation provides clinicians with the opportunity to more effectively adjust the therapy to a patient&rsquo;s unique pain condition and may be especially helpful over time.</span></p> <p><span style="font-size: 10pt;"><br />The Prodigy system features the longest-lasting battery life of all rechargeable SCS devices approved for use in Canada and, unlike some competitive devices, does not include a manufacturer-induced device shut-off. Additionally, its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.</span></p> <p><span style="font-size: 10pt;"><br />Through an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA), the St Jude Medical study called SUNBURST (Success using neuromodulation with burst) is evaluating whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. The Prodigy neurostimulator is not approved for use in the USA.</span></p></div>2015-05-19T17:01:00Z2015-05-19T17:01:00Zwebeditor@bibamedical.com SMARTer approach to stroke care<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Time is critical when it comes to stroke, and early treatment is associated with better outcomes. According to the Screening with MRI for Accurate and Rapid stroke Treatment (SMART) study, small changes in quality improvement procedures enabled clinicians to use magnetic resonance imaging (MRI) scans to diagnose stroke patients before giving acute treatment, within 60 minutes of hospital arrival.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MRI scans provide detailed images but take longer to complete than CT scans, which are commonly used in most centre. The findings, published in <em><a href="">Neurology</a></em>, were supported in part by the National Institutes of Health&rsquo;s National Institute of Neurological Disorders and Stroke (NINDS).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;By making small changes to our processes, we were able to scan suspected stroke patients with MRI and appropriately treat patients within a goal time of 60 minutes. This is an important finding for hospitals, healthcare providers and the public,&rdquo; said Amie Hsia, medical director of the Comprehensive Stroke Center at MedStar Washington Hospital Center, Washington DC, and senior author of the study. &ldquo;Not only does MRI provide more precise and complete information than the traditionally used CT scan, now we have also demonstrated that it is feasible to use from a time perspective.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">National guidelines suggest that stroke patients should receive treatment within 60 minutes of arriving at the hospital. The majority of hospitals rely on rapid CT scans to determine if an individual is eligible for intravenous tPA, the only FDA-approved treatment for ischaemic strokes, those caused by blood clots in the brain. If a CT scan shows the patient is having a bleeding, or haemorrhagic, type of stroke, tPA cannot be used as treatment. For many years CT scans were the only imaging tool available in most hospitals, but now MRIs are becoming more widely available.</span><br /><br /></p> <p><span style="font-size: 10pt;">Clinicians at MedStar Washington Hospital Center and Suburban Hospital, Bethesda, USA, routinely work with physician-scientists from NIH and have access to their cutting-edge medical protocols and technologies. The two hospitals use MRI instead of CT scans to screen stroke patients. Although MRI scans can take up to 15 minutes longer than CT scans, they provide clinicians with more detailed information about what is happening in a patient&rsquo;s brain. Using MRI, clinicians can see early changes taking place during the stroke. In this way, they can see what tissue is at risk and identify blocked blood vessels or subtle bleeding that cannot be picked up by CT.</span><br /><br /></p> <p><span style="font-size: 10pt;">To reduce the door to treatment time, multidisciplinary teams at both hospitals carefully examined the existing processes to identify time-consuming bottlenecks or duplicative methods. By using &ldquo;lean process interventions,&rdquo; they found a number of steps that could be eliminated or changed. For example, at MedStar Washington Hospital Center, a lengthy MRI screening form was simplified to three questions; at Suburban Hospital, tPA was put into the medication cart in the MRI suite so that it could be given immediately to patients after scanning instead of returning them to the Emergency Department for treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">Once the changes were implemented, Hsia&rsquo;s team examined whether they had an impact on treatment times for patients. The results indicated that door to treatment time was reduced from 93 to 55 minutes, a difference of 40%. Over a two year period, the percentage of patients treated within 60 minutes increased from 13 to 61.5%. Further analysis revealed that these changes were due to faster MRI start times.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;There was no difference in the patient characteristics. It was clear the improvements were due to the changes we made in the processes at these two hospitals,&rdquo; said Hsia.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;A number of the changes that Hsia&rsquo;s team assessed were not specific for MRI scans, but were related to general procedures of getting patients ready for imaging as quickly as possible. This suggests that these findings are relevant even in hospitals that do not have emergency access to MRI scanners,&rdquo; said Walter Koroshetz, acting director of NINDS. &ldquo;We will persist in evaluating best practices for acute stroke care to ensure that the greatest number of patients receive treatment as early as possible following stroke.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Hsia and her colleagues will continue to monitor the door to treatment times, to ensure they are sustainable. In addition, they plan to continue to evaluate best practices for acute stroke care and look for other improvements to further decrease door-to-treatment times for patients.</span></p></div>2015-05-15T14:49:00Z2015-05-15T14:49:00Zwebeditor@bibamedical.com announces launch of Neurosurgery System on 1.5T MRI platform<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Insightec has expanded its non-invasive neurosurgery system from 3T to 1.5T magnetic resonance imaging (MRI)&nbsp;systems. This launch expands the potential market for Insightec&rsquo;s ExAblate Neuro as 1.5T systems are the most common MRI systems in use today. The system is immediately available in the European market and is pending regulatory approvals in additional markets.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This product expansion is made possible by an Insightec-designed custom imaging coil that improves the intra-operative imaging performance on the 1.5T MRI to allow for this surgery. The first two treatments were successfully performed in Palermo,&nbsp;Italy,&nbsp;led by the Departments of Radiological Sciences at the University Hospital &ldquo;Paolo Giaccone&rdquo; of Palermo and Sapienza University of&nbsp;Rome, School of Medicine, with the collaboration of leading neurosurgeons from both Centro Diagnostico Italiano (CDI) and Istituto Neurologico Carlo Besta of&nbsp;Milan. The system acquisition was made through a research grant from the Italian Ministry of Education and Research.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This head coil posed quite a design challenge,&rdquo; cites Eyal Zadicario, vice president of research and development at Insightec. &ldquo;We had to create a unique coil design that was half-immersed in the water bath that surrounds our patients&rsquo; heads during treatment. It also has to be invisible to the ultrasonic acoustic beams that perform the surgery and at the same time provide the image resolution and clarity necessary to allow surgeons to make 1mm adjustments during surgery.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Being able to bring focused ultrasound neurosurgery to patients and hospitals that only have access to 1.5T MRIs is a significant step in the continuing growth of this emerging platform,&rdquo; says&nbsp;Richard Schallhorn, vice president of Neurosurgery for Insightec. &ldquo;This important technological advance, together with the growing number of clinical indications for MR-guided focused ultrasound neurosurgery, provides an opportunity to provide a safe, effective, non-invasive surgical option for a large number of patients.&rdquo;</span></p></div>2015-05-15T14:24:00Z2015-05-15T14:24:00Zwebeditor@bibamedical.com demonstrates efficacy of Brainsway’s Deep TMS for treatment of ADHD and OCD<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>New data demonstrating the efficacy of Brainsway&rsquo;s Deep Transcranial Magnetic Stimulation (Deep TMS) for the treatment of attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD) has been presented at the&nbsp;Society of Biological Psychiatry (SOBP) Annual Scientific Meeting&nbsp;(&nbsp;14&ndash;16 May, Toronto, Canada).&nbsp;</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The new data on the treatment of OCD will also be presented at the&nbsp;American Psychiatric Association (APA) Annual Meeting&nbsp;(16&ndash;20 May, Toronto, Canada).</span><br /><br /></p> <p><span style="font-size: 10pt;">Deep TMS is an outpatient therapy that utilises a coil to generate brief magnetic fields at an amplitude similar to that used in magnetic resonance imaging (MRI).&nbsp;The therapy was introduced to&nbsp;the USA&nbsp;by Brainsway for treatment of major depressive disorder (MDD) and has been used to treat more than 5,000 MDD patients in more than 70 US clinics, including&nbsp;Harvard University,&nbsp;Mount Sinai Medical School&nbsp;and UC San Diego Medical Center.</span><br /><br /></p> <p><span style="font-size: 10pt;">Brainsway&rsquo;s Deep TMS therapy is cleared by the US Food and Drug Administration (FDA) for the treatment of MDD and additional Deep TMS coils are currently being evaluated for the treatment of other indications, including ADHD and OCD. &nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The current treatments for OCD and ADHD are limited. As a result, many patients are living with distressing symptoms for which Deep TMS offers the hope of relief,&rdquo; said&nbsp;Ronen Segal, chief operating officer of Brainsway. &ldquo;The ability to treat these conditions by non-invasively stimulating deep structures of the brain is truly promising for patients who suffer from these disorders.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Brainsway&rsquo;s Deep TMS therapy is based on patents&nbsp;filed by the National Institutes of Health (NIH) and by Brainsway. Brainsway holds the exclusive license from the NIH for the patent and therapy.</span></p></div>2015-05-15T14:20:00Z2015-05-15T14:20:00Zwebeditor@bibamedical.com Therapeutics reports update of first two spinal cord injury patients implanted with Neuro-Spinal Scaffold<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>InVivo Therapeutics has announced a six-month post-implant update for the first study patient and a three-month post-implant update for the second study patient in the company&rsquo;s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the first patient in October 2014 at the Barrow Neurological Institute, Phoenix, USA, and in the second patient in January 2015 at the Carolinas Medical Center, Charlotte, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">From the three-month assessment to the six-month assessment, the first patient has demonstrated continued improvement in motor function as assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. The patient has regained partial function of knee extensors and remains classified as ASIA Impairment Scale C (AIS C) with a motor incomplete spinal cord injury. The second patient remains classified as AIS A with a complete spinal cord injury. Of note is the appreciable improvement in the second patient&rsquo;s trunk stability, self-care, mobility and bowel and bladder function at the three-month post-implant assessment. There have been no reported adverse events associated with the Neuro-Spinal Scaffold to date in either patient.</span></p> <p><br /><span style="font-size: 10pt;">Lorianne Masuoka, InVivo&rsquo;s chief medical officer, added, &ldquo;We would like to acknowledge the high level of care that our study patients are receiving by the neurosurgical and rehabilitation teams at the Barrow Neurological Institute and Carolinas Medical Center. The videos of our study patients posted on various social media outlets have proven both inspiring and scientifically valuable as we consider supplementing standard assessments with additional measures to identify motor improvement in trunk and hip muscles that are not evaluated as part of the standard ISNCSCI exam. We may add these assessments to the protocol of the ongoing pilot study or a future study to supplement the ISNCSCI exam.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I am very pleased with the improvements observed with the first two patients who have received our Neuro-Spinal Scaffold. The second patient&rsquo;s progress is encouraging since the injury and the patient&rsquo;s condition at presentation were more severe, delaying spinal stabilisation, decompression, and scaffold implantation. We look forward to following the patients&rsquo; progress over the coming months and hope that they will demonstrate continued improvement,&rdquo; said Mark Perrin, InVivo&rsquo;s chief executive officer and chairman of the board.</span></p> <p><br /><span style="font-size: 10pt;">In March, the company announced the reopening of enrolment for the remaining three patients of its pilot trial in patients with acute thoracic spinal cord injury.</span></p></div>2015-05-15T08:51:00Z2015-05-15T08:51:00Zwebeditor@bibamedical.com reduced with flow diversion for treatment of internal carotid artery aneurysms<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>According to new research, treatment of large and giant proximal internal carotid artery aneurysms using the Pipeline embolisation device (Covidien/Medtronic) requires less radiation, less fluoroscopy time, and less contrast administration than standard coiling techniques. Study authors Geoffrey Colby <em>et al</em> (Johns Hopkins University School of Medicine, Baltimore, USA) say that this further demonstrates the benefits of flow diversion for the treatment of these aneurysms. </strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors explain that since an increasing number of cerebral aneurysms are being treated by endovascular means, there has been a push to reduce radiation exposure to both the patient and the operator.</span></p> <p><br /><span style="font-size: 10pt;"> In this first of its kind study, published in the <em>Journal of NeuroInterventional Surgery</em>, Colby and colleagues retrospectively analysed radiation dose, fluoroscopy time, and contrast dye administration in 55 patients undergoing endovascular treatment of aneurysms &ge;10mm from petrous to superior hypophyseal internal carotid aneurysm segments. Thirty-seven patients were treated with the Pipeline device, and 18 patients were treated using traditional coiling techniques.</span></p> <p><br /><span style="font-size: 10pt;"> Colby <em>et al</em> reported a decrease in radiation dose, fluoroscopy time and contrast dye amounts with the Pipeline embolisation device. They write that in the Pipeline device group, average radiation dose was 2840&plusmn;213mGy, compared with 4010&plusmn;708mGy in the traditional coiling group (p=0.048; 29% decrease with the Pipeline device). Similarly, mean fluoroscopy time in the Pipeline device group was 56.1&plusmn;5 minutes versus 85.9&plusmn;11.9 minutes in the coiling group (p=0.0087; 35% decrease with the Pipeline device). Further, contrast dye amounts were also reduced by 37.5% in the Pipeline group (75&plusmn;6mL) compared with the coiling group (120&plusmn;13mL, p=0.0008).</span></p> <p><br /><span style="font-size: 10pt;"> The authors further noted that flow diversion provides additional benefits of decreased radiation exposure as it relates to retreatment.</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;This study demonstrated reduced radiation doses when the Pipeline device was used for the initial aneurysm treatment of internal carotid artery aneurysms &ge;10mm; however, there are likely extended radiation dose benefits after Pipeline device treatment. Six-month angiographic occlusion rates following Pipeline device treatment range from 81.8% to 94.4%, and there is initial evidence that similar rates can be achieved even sooner in smaller aneurysms. Additionally, once an aneurysm is occluded after Pipeline device embolisation, there has not been a single reported case of recurrence in the literature. Although long-term follow up for these devices in limited, the lack of aneurysm recurrence excludes future radiation exposure from retreatment. In contrast, aneurysms treated by coiling and stent assisted coiling can have recurrence rates of 35.9% and 15.4%, respectively. Retreatment in these cases certainly increases radiation exposure to the patient,&rdquo; Colby <em>et al</em> write.</span></p> <p><br /><span style="font-size: 10pt;"> They conclude stating that this study &ldquo;enhances the growing body of literature demonstrating the efficacy and cost effectiveness of flow diversion for the treatment of these difficult aneurysms. Although further studies are necessary, there is a potential health benefit to patients and operators secondary to these lower radiation doses.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Speaking about the future of radiation dose reduction, Colby told <em>NeuroNews</em> that &ldquo;Improvements in the devices, the delivery systems for the devices, and the experience of the operator can all expect to further reduce radiation dose/exposure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Commenting on the study, co-author, Alexander Coon said, &ldquo;This is an important analysis that demonstrates the benefit of Pipeline embolisation with regards to the very timely subject of radiation doses to patients and practitioners. I believe that it provides guidance to patients and neuro-interventionalists when selecting a treatment modality for endovascular aneurysm treatment.&rdquo;</span></p></div>2015-05-14T11:55:00Z2015-05-14T11:55:00Zwebeditor@bibamedical.com suggests feasibility of Baby Trevo for treatment of distal cerebrovascular occlusions<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Diogo Haussen and colleagues (Emory University School of Medicine, Atlanta, USA) report that their initial data suggest that treatment of distal cerebrovascular occlusions with the Trevo XP ProVue 3x20mm retriever (&ldquo;Baby Trevo&rdquo;, Stryker Neurovascular) is feasible.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this single-centre initial experience study, Haussen <em>et al</em> performed a retrospective review of their interventional database for consecutive patients who underwent treatment for acute ischaemic stroke with the Baby Trevo device between February and December 2014. The study was recently published in the <em>Journal of NeuroInterventional Surgery</em>.</span></p> <p><span style="font-size: 10pt;"><br />According to the study authors, the exisitng stent retrievers that are currently FDA-cleared (eg. Trevo Retriever, Stryker Neurovascular and Solitaire stent retriever, Covidien/Medtronic) have been shown to be safer than the older coil retriever mechanical thrombectomy technology, resulting in less vessel perforation and device-related subarachnoid haemorrhage. However, there are concerns about their use in smaller vessels.</span></p> <p><span style="font-size: 10pt;"><br />The Trevo XP 3x20 is a laser-cut, closed-cell, nitinol stent retriever specifically built to retrieve intracranial clots in patients with acute ischaemic stroke. The 3x20mm diameter device was uniquely designed to target smaller vessels.</span></p> <p><span style="font-size: 10pt;"><br />The authors explain that, according to the manufacturer, in comparison with a 4mm diameter stent retriever, the Baby Trevo was shown in bench testing to have much larger cell sizes when deployed in small vessels (217% larger cell size in a 2mm vessel and 57% larger cell size in a 3mm vessel); larger cells in smaller vessels maximise clot integration. <br /><br />Deployment and retrieval safety have also been optimised to allow for more distal use. The distal tip of the Baby Trevo is at least 48% softer then the 4x20 versions of other stent retrievers. The device also has less radial force than larger stent retrievers across all vessel diameters. &ldquo;These differences should minimise the chances of vessel perforation and endothelial damage in smaller vessels,&rdquo; they write.</span></p> <p><span style="font-size: 10pt;"><br />Of 134 patients (mean age 51&plusmn;20 years, five male treated during the study period, eight underwent treatment with the Baby Trevo for distal occlusions. The device was used for a total of 10 branches: five middle cerebral arteries, three anterior cerebral arteries, and two posterior cerebral arteries occlusions.</span></p> <p><span style="font-size: 10pt;"><br />Haussen <em>et al</em> report that all patients achieved complete recanalisation of the artery targeted by the Baby Trevo, while &ldquo;capillary-level reperfusion was noted in six (75%) cases. One pass was performed in seven vessels and two passes in three branches. Vasospasm was frequent, being noted in five (62.5%) of the vessels and fully responded to intra-arterial vasodilator infusion. Follow-up MRI revealed no infarct within the territory vascularised by the artery targeted by the Baby Trevo in four cases, partial infarct in five and complete infarct in one. No vessel perforations dissections or subarachnoid haemorrhage were noted,&rdquo; they write.</span></p> <p><span style="font-size: 10pt;"><br />The authors conclude that &ldquo;Although this device emerges as a promising technology for small and tortuous distal intracranial vessels, larger studies are still necessary to establish its safety profile and clinical benefit.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Haussen <em>et al</em> further caution that due to the small number of patients, the results should be interpreted with caution as it relates to the relatively high number of parenchymal haemorrhages as compared to other recently published thrombectomy trials.</span></p> <p><span style="font-size: 10pt;"><br />They told <em>NeuroNews</em> that, to their knowledge, there are not currently any other additional or larger studies of the Baby Trevo device for small and tortuous distal intracranial vessels ongoing.</span></p></div>2015-05-14T11:49:00Z2015-05-14T11:49:00Zwebeditor@bibamedical.com Medical announces long-term clinical data and commercial release of its WEB product<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Sequent Medica has announced the presentation of prospective long-term clinical data for the WEB aneurysm embolisation system at the Societe Francaise de Neuroradiologie (SFNR) meeting (8&ndash;10 April, Paris, France). Twelve-month data were reported from two separate prospective, multicentre, core lab reviewed studies called WEBCAST and the French Observatory.&nbsp; Results are preliminary, with full data analysis to be made available later this summer.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Safety and aneurysm occlusion rates were examined in patients with complex wide neck bifurcation aneurysms (mean neck size: 5.5mm) treated with the WEB in 15 European centres. The studies demonstrated 53% complete and 81% adequate occlusion in 96 patients with one-year imaging. As previously reported, safety results were excellent, with 2.7% procedure-related morbidity and 0% mortality at 30 days.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We are pleased to find significant and stable aneurysm occlusion rates out to one year even in these difficult to treat aneurysms. When coupled with an impressive safety profile, these results are simply outstanding,&rdquo; said Laurent Pierot, Head of the Department of Radiology, Maison Blanche Hospital, Reims, France, who presented the data at the SFNR meeting.&nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">Clinical evidence for the WEB now includes over 200 patients enrolled across four separate prospective, multicentre clinical studies. These studies are the WEB-IT investigational device exemption study in the USA and three ongoing European studies (WEBCAST, French Observatory, and WEBCAST 2). In addition to the prospective studies, there are now over 15 peer-reviewed clinical publications on the WEB and over 1,600 patients treated. &ldquo;Given this level of evidence, the WEB is an increasingly well-established therapy with an important and growing role in the management of intracranial aneurysms,&rdquo; said Pierot.</span><br /><br /></p> <p><span style="font-size: 10pt;">Sequent also announced the commercial launch of its latest WEB product, which features a reduction in delivery profile of the WEB down to .021 inches. The .021&rdquo; system also includes a downsized version of the company&rsquo;s existing VIA microcatheter. The lower profile of the new system &ldquo;will improve the deliverability of the WEB, and is designed to enable physicians to treat an even broader range of aneurysms with the WEB&rdquo;, according to a company press release.</span><br /><br /></p> <p><span style="font-size: 10pt;">The company recently completed a controlled release of the new system in select neurovascular centres that gathered initial physician feedback prior to full market release. &ldquo;I used the .021&rdquo; system in a series of recent cases and I have been extremely impressed,&rdquo; said Istvan Szikora, Head of the Department of Neurointerventions, National Institute of Clinical Neurosciences, Budapest, Hungary. &ldquo;The .021&rdquo; system represents a major advance for the WEB platform with the potential to significantly increase the number of aneurysms that I can treat with this technology.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Initially, the .021&rdquo; system will be available for all WEB implants up to 7mm in diameter, which represents a majority of WEB cases. &ldquo;The .021&rdquo; system is a breakthrough that positions us well for further adoption and growth, particularly in the ruptured segment of the aneurysm market, and we are very optimistic about the significant role the WEB can play in the treatment of intracranial aneurysms,&rdquo; said Sequent president and chief executive officer Tom Wilder.</span></p></div>2015-05-12T14:16:00Z2015-05-12T14:16:00Zwebeditor@bibamedical.com approves Senza spinal cord stimulation system delivering HF10 therapy<div style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Nevro has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation system. Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, 11 May, 2015. The company will be hosting a conference call beginning at 8:30 a.m. Eastern Time to discuss both the FDA approval and first quarter operating results in place of the conference call previously scheduled in the afternoon of the same day.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Senza spinal cord stimulation system, which delivers Nevro&rsquo;s proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Senza system delivering HF10 therapy has experienced strong adoption in Europe and Australia over the past five years. With this FDA approval, patients in the US suffering from chronic pain will have the opportunity to experience the significant benefits of HF10 therapy. FDA approval of Nevro&rsquo;s Senza system highlights the unique nature of the technological innovation:</span></p> <ul> <li><span style="font-size: 10pt;">HF10 therapy is the only SCS therapy approved by FDA with superiority labeling;</span></li> <li><span style="font-size: 10pt;">HF10 therapy is the only SCS therapy indicated by FDA to deliver pain relief without paraesthesia (a constant tingling sensation that is the basis of traditional spinal cord stimulation);</span></li> <li><span style="font-size: 10pt;">HF10 therapy is the only spinal cord stimulation therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy;</span></li> <li><span style="font-size: 10pt;">The Senza system is the only implantable spinal cord stimulation system approved by FDA with labelling for 3T conditional MRI compatibility.</span></li> </ul> <p><span style="font-size: 10pt;"><br />The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare spinal cord stimulation therapies. The multicentre study was conducted across 11 US clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomised spinal cord stimulation study ever conducted to assess the treatment of chronic back and leg pain.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;My fellow investigators and I have eagerly awaited the approval of the Senza spinal cord stimulation system,&rdquo; said Leonardo Kapural, lead investigator for the SENZA-RCT pivotal study from Wake Forest University Baptist Medical Center, USA. &ldquo;The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional spinal cord stimulation, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy I can for the first time focus on providing pain relief to my patients instead of managing paraesthesia, which is a paradigm shift for my pain practice.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The labelling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional spinal cord stimulation therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes. Superiority was demonstrated in the primary and all secondary endpoints including at every measurement time point throughout the 12-month follow up.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are grateful to the inspiring dedication of the clinical investigators, their study coordinators, and patients involved in the SENZA-RCT study, as they collectively have paved the way for this therapy to help those suffering from debilitating chronic pain,&rdquo; said Michael DeMane, chairman and chief executive officer of Nevro. &ldquo;The Nevro organisation is prepared to initiate a responsible rollout of HF10 therapy to the US pain management community and the patients they serve to ensure we deliver the clinical outcomes that are the foundation of our therapy and company.&rdquo;</span></p></div>