Latest News - Neuro NewsBIBA Medical Ltd2015-07-05T07:46:25Z 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 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 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 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>2015-05-09T08:22:00Z2015-05-09T08:22:00Zwebeditor@bibamedical.com Medical announces first implants of Prometra II<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 has announced that the first implants of its Prometra II intrathecal infusion pump took place on 5 May, 2015 at St Francis Hospital in Charleston, USA. A Prometra II pump was implanted in three patients: a 56-year-old man, a 68-year-old woman, and a 53-year-old man for chronic conditions, including neck pain and lower back pain. The procedures were all performed by Timothy Deer and Christopher Kim. The patients were reported to be doing well, and Deer and Kim considered the surgeries successful.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;These first implants of the Prometra II infusion system were successful, without any complications,&rdquo; stated Deer. &ldquo;The Prometra devices from Flowonix are very accurate intrathecal infusion systems, which are critical to improved patient safety, and Prometra II offers a proprietary flow-activated safety valve or FAV technology, designed to shut off drug flow to the patient if a high flow rate should ever occur during magnetic resonance imaging. Prometra II gives our patients added safety, in case an MRI is ever needed.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Magnetic resonance imaging (MRI) is an imaging procedure that may be contraindicated for patients with certain implanted devices because strong electromagnetic energy may interfere with device function.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The patients are doing well and will get improved pain relief,&rdquo; added Kim. &ldquo;It is a major advantage of the Prometra II system that it has such a long service life. This not only benefits our patients, but also the healthcare system. A recent retrospective study from the Cleveland Clinic found this type of drug-delivery system to be cost effective, even when looking at older and less efficient devices. With the state-of-the-art Prometra II pump, our patients can expect many years of accurate drug delivery at costs that are likely much lower than other forms of pain therapy.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The study by Bolash and colleagues found the median device longevity of these older infusion systems to be 5.4 years with a median cost per day of US$10.46. The newer Prometra devices have a 10-year service life, which is nearly double that of older systems.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Prometra II borrows from the outstanding technology of its predecessor, Prometra,&rdquo; added Steve Adler, president and chief executive officer of Flowonix. &ldquo;Like its predecessor, Prometra II is a long-lasting device with the most accurate drug delivery available today in any implantable intrathecal infusion system, but it also offers FAV technology for enhanced patient safety. These first implants of Prometra II in the United States mark another major milestone for Flowonix. All of us at Flowonix extend our congratulations to Deer and Kim on the successful implants of Prometra II and we wish the very best to their patients.&rdquo;</span></p></div>2015-05-07T10:15:00Z2015-05-07T10:15:00Zwebeditor@bibamedical.com stroke centres may improve bleeding stroke survival<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>People with haemorrhagic strokes are more likely to survive if they are treated at a comprehensive stroke centre, according to research published in the&nbsp;<em><a href="" target="_blank">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;">Haemorrhagic strokes, which account for about 13% of all strokes, are caused when a weakened blood vessel in the brain ruptures and bleeds in the surrounding brain. Comprehensive stroke centres typically have the specialists and trained personnel to deal with patients with these ruptures or other types of bleeding in the brain. They also can provide neurological intensive care and 24-hour access to neurosurgery. The American Heart Association, in conjunction with the Joint Commission, accredits&nbsp;comprehensive stroke centres&nbsp;that meet standards to treat the most complex stroke cases.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Clinicians, especially emergency-room physicians, need to be aware of the severity and potential implications of haemorrhagic stroke and try to transfer patients to the hospital most capable of providing the full complement of care. When a person is diagnosed with a haemorrhagic stroke, loved-ones should ask about the possibility of a transfer,&rdquo; said James S McKinney, lead author and assistant professor of neurology at the Rutgers-Robert Wood Johnson Medical School in New Brunswick, USA.</span></p> <p><span style="font-size: 10pt;"><br />Researchers examined the 90-day survival of 36,981 patients with haemorrhagic strokes treated at 87 hospitals in New Jersey between 1996 and 2012. Forty per cent of the patients were treated at facilities designated as comprehensive stroke centres by 2012. The remainder were treated at non-stroke centres or at hospitals designated as primary stroke centres&mdash;facilities prepared to quickly identify&nbsp;ischaemic strokes&nbsp;caused by blood clots (blocking the blood vessel to the brain) and to deliver clot-dissolving medication, but which may not be prepared for higher level acute neurosurgical emergencies. Mortality rates included deaths from all causes and were adjusted for factors such as age.</span></p> <p><span style="font-size: 10pt;"><br />Compared to primary care centres or non-stroke centres, the researchers found that treatment at comprehensive stroke centres was associated with:</span></p> <ul> <li><span style="font-size: 10pt;">a 7% reduced risk of death for patients with all haemorrhagic strokes;</span></li> <li><span style="font-size: 10pt;">a 27% reduced risk of death in patients with subarachnoid haemorrhage, bleeding onto the surface of the brain after rupture of a weakened or ballooning-out vessel (aneurysm);</span></li> <li><span style="font-size: 10pt;">no difference in risk of death for patients with intracerebral haemorrhage, a rupture of tiny arteries within brain tissue.</span></li> </ul> <p><span style="font-size: 10pt;"><br />Many patients with haemorrhagic strokes are diagnosed at a primary care centres or non-stroke centres and then transferred to a comprehensive stroke centre for more comprehensive care. This practice showed a survival advantage in the New Jersey study, with patients transferred within 24 hours 36% less likely to die within 90 days than those who remained in a primary care centre or non-stroke centre.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The most severe patients may have been more likely to be taken to a comprehensive stroke centre initially, or conversely, sicker patients at other hospitals may have been less likely to be transferred if they were already in a coma and unlikely to survive,&rdquo; McKinney said.</span></p> <p><span style="font-size: 10pt;"><br />The study is limited by looking back at years prior to the comprehensive stroke centre designation and by the lack of information on the severity of stroke or the neurological condition of the patients.</span></p></div>2015-05-07T09:50:00Z2015-05-07T09:50:00Zwebeditor@bibamedical.com biosynthesised cellulose-based dural replacement for neurosurgery launched<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>DePuy Synthes CMF has announced the launch of Synthecel Dura Repair, the first commercially available biosynthesised dural replacement derived from cellulose for use in neurosurgery. DePuy Synthes CMF is a part of the DePuy Synthes Companies of Johnson &amp; Johnson.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The dura is a tissue membrane that covers and protects the brain and spinal cord. During neurosurgery, the dura may be cut to allow surgeons to access the brain. A dural graft, which is either bovine collagen or synthetic, is often required after interdural surgery to provide a watertight seal, protect cerebral tissue and reduce the risk of infection.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />A prospective, randomised multicentre study published in the journal <em><a href="" target="_blank">Neurosurgery</a></em>&nbsp;demonstrated comparable attributes between Synthecel Dura Repair and a control group of commonly used dura substitutes made of bovine collagen and synthetic collagen. Device handling attributes such as strength and&nbsp;seal quality were evaluated by surgeons during the clinical trial. Surgeons expressed a&nbsp;statistically significant difference in favour of Synthecel Dura Repair over the&nbsp;control devices for both device strength&nbsp;and seal quality.&nbsp;In addition, six months after surgery, the cerebrospinal fluid (CSF) leak rate with Synthecel Dura Repair was zero and&nbsp;no adhesions were observed.</span></p> <p><span style="font-size: 10pt;"><sup>&nbsp;</sup></span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The ideal dural substitute should prevent cerebrospinal fluid leaks, have strength and flexibility similar to human dura mater, present little or no risk of infection and not induce a severe inflammatory response,&rdquo; said Frederick F Marciano, Barrow Neurosurgical Associates, Scottsdale Healthcare in Arizona, USA, a co-author of the randomised clinical study published in <em>Neurosurgery</em>. &ldquo;In our study, Synthecel Dura Repair delivered on all these measures, and given its excellent handling characteristics and conformability, provides an excellent choice of implant for a reliable dural repair in standard or complex procedures.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Synthecel Dura Repair is composed of naturally formed biosynthesised cellulose and water and is indicated for use as a dura replacement for the repair of dura mater in adults. The implant is non-animal derived and carries no risk of transmissible diseases. With a thickness similar to human dura,&nbsp;Synthecel Dura Repair is designed with a unique construction of non-woven, interconnected cellulose fibres that conform to the contours of the brain. Synthecel Dura Repair provides versatility with its excellent onlay or suture performance.</span></p></div>2015-05-06T09:26:00Z2015-05-06T09:26:00Zwebeditor@bibamedical.com to present breakthrough data in migraine treatment <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, the creators of the first FDA-approved transcutaneous electrical nerve stimulation device specifically authorised for use prior to the onset of migraine pain, is set to announce significant breakthroughs in migraine treatment at the EUROHEADPAIN Midterm Meeting at the International Headache Society Congress in Valencia, Spain, from 14&ndash;17 May, 2015.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">On 14 May at a meeting of EUROHEADPAIN, a major European research project focused on migraines, Cefaly Technology will present three significant patent pending systems of neuromodulation that are in development. These systems would help to alter nerve activity in migraine patients by combining different currents targeted at specific cranial zones. &ldquo;Thanks to these new systems, over the next few years, we will be able to develop the most efficient and safest treatments for migraines,&rdquo; said Pierre Rigaux, chief executive officer of Cefaly Technology.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />On 16 May, during the Late-Breaking Oral presentations, results will be released from a clinical trial on cerebral changes as demonstrated by positron emission tomography (PET) scan in migraine patients treated with a Cefaly device. The PET scan used a radioactive substance called a tracer to show how the brain and its tissues are working under the influence of a Cefaly.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;New data shows the Cefaly action on brain metabolism in specific cortical zones of migraine patients,&rdquo; said Rigaux. &ldquo;The modifications observed through brain imaging reinforce the strong clinical data on safety and efficacy that led to the FDA approval.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />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>2015-05-06T09:25:00Z2015-05-06T09:25:00Zwebeditor@bibamedical.com expanded for StealthStation electromagnetic surgical navigation 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>Medtronic plc has announced that it has received clearance from the US Food and Drug Administration (FDA) for expanded indications of specific StealthStation electromagnetic surgical navigation system instruments for paediatric and adult cranial and ENT procedures.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The clearance for these StealthStation electromagnetic instruments enables additional neurosurgical applications that can benefit from flexible, tip-tracked instruments for both pinned and pin-less procedures. The navigated instruments can be used with compatible devices to aid in the placement of ventricular catheters for adult and paediatric patients; shunt systems; connection to Ommaya reservoirs; haematoma drainage; external ventricular drainage catheters; neuroendoscope peel-away catheters; and for the placement of depth-electrodes.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This expanded indication of the StealthStation electromagnetic surgical navigation system instruments is very exciting for our business,&rdquo; said Scott Hutton, vice president and general manager of Medtronic Neurosurgery, a business in Medtronic&rsquo;s Surgical Technologies division. &ldquo;It expands the scope of neurosurgical procedures that can benefit from the unique features of electromagnetic navigation&mdash;such as depth electrode placement for epilepsy seizure monitoring, and pin-less, MRI-conditional patient tracking during intraoperative MRI imaging. This is an achievement for the neurosurgical community, and represents our commitment toward advancing this innovative technology to benefit patients.&rdquo;</span></p></div>2015-05-05T09:51:00Z2015-05-05T09:51:00Zwebeditor@bibamedical.com Jude Medical completes acquisition of Spinal Modulation<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 that it has completed the acquisition of Spinal Modulation, developer of the Axium neurostimulator system. The acquisition was completed on 1&nbsp;May, 2015.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With the closing of the acquisition,&nbsp;St Jude Medical&nbsp;has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.</span></p> <p><span style="font-size: 10pt;"><br />Commenting on the acquisition, St Jude Medical&rsquo;s chief operating officer&nbsp;Michael T Rousseau&nbsp;said: &ldquo;Completing the acquisition of&nbsp;Spinal Modulation, Inc.&nbsp;is another important step forward in building momentum and accelerating sales growth across our neuromodulation product portfolio. We are confident the&nbsp;Axium&nbsp;system will further support our goal of providing physicians multiple options to tailor treatment for patients with chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The&nbsp;Axium&nbsp;system has CE mark in the&nbsp;European Union&nbsp;for the management of chronic intractable pain and TGA approval in&nbsp;Australia&nbsp;for the management of chronic, intractable pain of the trunk and/or limbs. In&nbsp;December 2014, Spinal Modulation announced that enrolment in its ACCURATE US IDE trial had been completed and subsequently submitted its PMA application to the&nbsp;FDA&nbsp;in support of marketing approval in&nbsp;the United States. The full results from the ACCURATE Study will be presented at the 12<sup>th</sup>&nbsp;annual&nbsp;International Neuromodulation Society (INS) Congress, to be held in&nbsp;Montreal, Quebec, Canada&nbsp;from&nbsp;6&ndash;11 June, 2015.</span></p></div>2015-05-04T13:21:00Z2015-05-04T13:21:00Zwebeditor@bibamedical.com trial moves stem cell therapy for ALS patients one step closer to reality<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;">Stem cells are a safe therapy for patients with amyotrophic lateral sclerosis (ALS), according to the results of a recently completed phase 1 clinical trial. Details of the trial, conducted by scientists in South Korea, are published in <em>STEM CELLS Translational Medicine</em>.</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The trial was the next phase of research into stem cells and ALS being conducted at Hanyang University and Corestem Inc., both in Seoul, and Inje University College of Medicine in Busan. ALS is a rapidly progressive, invariably fatal neurological disease that attacks the motor nerve cells&nbsp;(neurons) responsible for controlling voluntary muscles. The Hanyang University team&rsquo;s phase 1 trial had two goals: to test whether stem cells were a safe treatment for ALS, and to learn whether two injections of the cells might prove more beneficial than a single injection.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> &ldquo;In our pilot study we followed a group of ALS patients for six months after giving them a single injection of mesenchymal stromal cells (MSCs) and found the treatment to be both safe and feasible,&rdquo; said the trial&rsquo;s co-leader, Seung Hyun Kim, director of Hanyang University Hospital&rsquo;s Cell Therapy Center and professor in Hanyang University&rsquo;s Department of Neurology. &ldquo;In this next phase, we wanted to see if two injections would prove even more beneficial, and we wanted to follow the participants for a longer period of time to determine if the treatment proved safe for a longer term than in the pilot phase.&rdquo;</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> MSCs, which are found in bone marrow, generate bone, cartilage and fat cells that support the formation of blood and fibrous connective tissue. They have emerged as a potentially promising treatment for ALS due to their ability to regenerate lost or damaged cells and for their anti-inflammatory capabilities.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> Eight patients with definite or probable ALS were enrolled in the new study, although one died shortly after enrolment. After a three-month lead-in period, MSCs were isolated from each patient&rsquo;s bone marrow two times, at an interval of 26 days, with each group of MSCs then expanded in the lab for 28 days before being injected into the donor patients. The seven patients received intrathecal (cerebrospinal fluid space) injections of their own MSCs in two separate treatments given 26 days apart. Kim said, &ldquo;Intrathecal injections have the advantages of not only avoiding invasive surgical technique that had been done in the previous other group&rsquo;s study, but also it is easy to do repeated procedures without harm to the patients.&rdquo;</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> Their ALS functional status and safety was then evaluated for 12 months after the first injection.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> &ldquo;No serious adverse events were observed during this period,&rdquo; reported co-leader Ki-Wook Oh, also of Hanyang University&rsquo;s neurology department. &ldquo;Additionally, there was no advancement in ALS symptoms in any of the patients during the 12-month period.&rdquo;</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> Kim added, &ldquo;This study shows that stem cells as a therapeutic approach for ALS are feasible and well-tolerated at least for 12 months, supporting the need for a late-stage clinical trial to examine their in-depth safety, biological effects and efficacy.&nbsp;Randomised, semi-double blind controlled phase 2 clinical data on 72 ALS patients, which recently was submitted to the Korean FDA, will be released in the near future.&rdquo;</span></p></div>2015-05-04T10:49:00Z2015-05-04T10:49:00Zwebeditor@bibamedical.com imaging can help differentiate between PTSD and traumatic brain injuries<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>By looking at the brain, scientists believe it is now possible to distinguish between two very different conditions that can have very similar symptoms. According to&nbsp;Theodore Henderson, a&nbsp;Denver, USA-based psychiatrist specialising in diagnosing complex cases,&nbsp;this study&nbsp;can help the medical community better identify the biological differences, and therefore treatment options, for post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Henderson, part of a team of brain-imaging scientists from Amen Clinics,&nbsp;UCLA,&nbsp;Thomas Jefferson University&nbsp;and&nbsp;University of British Columbia, found they could achieve 94% accuracy rate differentiating between PTSD and TBI, which both can have significant impact on behaviour and quality of life. The study was published in the&nbsp;April 2015&nbsp;special Veterans Issue of the journal&nbsp;<em>Brain Imaging and Behavior.</em></span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Now we can differentiate two common disorders which often overlap based on clinical examination in our Veteran population,&rdquo; said Henderson, president of The Synaptic Space. &ldquo;Improved diagnosis can lead to better treatment, particularly for TBI, since we have been developing specific treatments for TBI.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />More than 400,000 military personnel and veterans have been diagnosed with PTSD or TBI since 2001, and many have been diagnosed with both. Henderson said the available treatments of PTSD and TBI are vastly different. Moreover, the treatments for PTSD can be harmful, or at best, not helpful for those with TBI and vice versa.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The need for a diagnostic tool to reliably distinguish PTSD from TBI in veteran populations is urgent,&rdquo; he said. &ldquo;Prior attempts to use imaging studies such as CT scans, MRIs, and conventional X-rays have been unsuccessful. This study uses single photon emission computed tomography (SPECT) that looks directly at cerebral blood flow and indirectly at brain activity.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Henderson also said the technique of analysing the data, and developing targeted treatments, is far superior to anything previously available in&nbsp;Denver&nbsp;or nationally.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;My colleagues, here in&nbsp;Denver&nbsp;and at&nbsp;Harvard Medical School, and I have been developing a specific treatment for TBI which depends upon our ability to target the area of injury in the brain. The use of SPECT allows us to see the location of the injury and direct this treatment to those specific foci of brain injury,&rdquo; he said. &ldquo;SPECT brain imaging, a nuclear medicine technique, can show areas of over-activity and under-activity in the brain and can illustrate changes in brain function with treatment.&rdquo;</span></p></div>2015-05-04T10:06:00Z2015-05-04T10:06:00Zwebeditor@bibamedical.com Medical launches NeuroBlate SideFire Select and FullFire Select reduced diameter laser mini-probes <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>Monteris Medical has announced the launch of two new reduced diameter mini-probes for its NeuroBlate System, a minimally invasive robotic laser thermotherapy tool.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Monteris Medical&rsquo;s new mini-probes have a reduced outer diameter of 2.2mm. Each of the new FDA-cleared probes offers distinct advantages, depending on a surgeon&rsquo;s particular procedural needs: SideFire Select is a directional laser for contoured ablation of targets while preserving adjacent healthy tissue, whereas the FullFire Select is a diffusing laser designed to provide fast, volumetric ablation in a concentric zone of hyperthermia.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the company, NeuroBlate SideFire Select and FullFire Select laser mini-probes can easily be used within a standard MRI bore, and can also be used in conjunction with Monteris Medical&rsquo;s signature Robotic Probe Driver and Mini-Bolt, as well as other skull fixation devices.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The new 2.2mm probes retain outstanding target localisation and laser ablation characteristics while having less impact on intervening tissue along the trajectory,&rdquo; said Adrian W Laxton, assistant professor, Department of Neurosurgery, Wake Forest Baptist Medical Center, USA.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The NeuroBlate System employs a pulsed surgical laser to deliver targeted energy to ablate soft tissue in neurosurgery procedures. With the option of selecting 3.3mm or 2.2mm probes, Monteris offers surgeons the full spectrum of probe choice and added versatility. Each of the probes employs proprietary hyperthermia modulation and a unique sapphire capsule with high laser transparency and robust thermal properties. The probes can also be controlled remotely through Monteris Medical&rsquo;s Robotic Probe Driver.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The smaller diameter probes confer several advantages during neurosurgical procedures,&rdquo; said Alireza Mohammadi, assistant professor of Neurosurgery at a prominent Ohio academic hospital. &ldquo;The new laser probes have exactly the same efficacy of their larger counterparts, but have a lower profile design and are optimally suited for operating on lesions located in the critical areas of the brain, allowing us to perform surgery on lesions previously thought to be inoperable.&rdquo;</span></p></div>2015-05-01T11:16:00Z2015-05-01T11:16:00Zwebeditor@bibamedical.com approves world’s smallest upgradeable MR-conditional SCS 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 announced FDA approval of the company&rsquo;s Prot&eacute;g&eacute; MRI spinal cord stimulation system. In addition to the approval of the new Prot&eacute;g&eacute; MRI system, St Jude Medical has also secured FDA approval for MRI compatibility of the company&rsquo;s 60cm Octrode percutaneous leads, which has received MR-conditional labelling for use with the Prot&eacute;g&eacute; MRI system.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Prot&eacute;g&eacute; MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity MRI scans. Upgradeable technology allows patients to access future SCS technology from St Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The launch of the Prot&eacute;g&eacute; MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery,&rdquo; said Robert Levy, director of the Marcus Neuroscience Institute in Boca Raton, Florida, USA. &ldquo;The Prot&eacute;g&eacute; MRI system is an innovative technology advancement that optimises chronic pain care without compromising a patient&rsquo;s potential need for future head and extremity MRI scans.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515 million workdays annually and generates upwards of 40 million visits to physicians each year.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />SCS therapy can offer proven, meaningful chronic pain relief for many patients while improving quality of life and reducing or even eliminating a patient&rsquo;s use of pain medication. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With the approval of the Prot&eacute;g&eacute; MRI system, St Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology,&rdquo; said Eric S Fain, group president of St Jude Medical. &ldquo;Going forward, patients implanted with a Prot&eacute;g&eacute; MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In addition to the approval of the Prot&eacute;g&eacute; MRI system, St Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including their flagship Penta paddle lead, in order to allow more patients the ability to safely undergo MRI scans. St Jude Medical also plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.</span></p></div>2015-04-30T14:05:00Z2015-04-30T14:05:00Zwebeditor@bibamedical.com L Cascino elected president of American Academy of Neurology<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 American Academy of Neurology (AAN) has elected Terrence L Cascino, Mayo Clinic of Rochester, USA, as its 34th president. Cascino succeeds Timothy A Pedley, who completed his two-year term as president during the recent AAN Annual Meeting in Washington, DC, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is an opportunity of a lifetime to serve our 28,000 members with unparalleled resources to help them provide the highest quality patient-centered neurologic care for the one in six people worldwide who have a brain disease, such as Alzheimer&rsquo;s disease, stroke, epilepsy, autism, and Parkinson&rsquo;s disease,&rdquo; said Cascino. &ldquo;I am privileged to follow a long line of distinguished neurologists committed to expanding the reach of the AAN, demonstrating the value of neurologists, enhancing their career satisfaction and most importantly, being indispensable to our members.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Cascino is a career-long member of the AAN, most recently serving as president-elect and on the AAN Board of Directors.&nbsp;He has served in a multitude of other leadership positions, including serving on the AAN&rsquo;s Education and Meeting Management Committees.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Since 1982, Cascino has served as a staff consultant in neurology at the Mayo Clinic and is a professor of neurology and neuro-oncology. Cascino also served as vice chair of the Department of Neurology at Mayo Clinic in Rochester and was a leader in clinical practice at the Mayo Clinic serving as the chair of the Clinical Practice Committee. He also held a role as the Juanita Kious Waugh Executive Dean for Education, Mayo Clinic, completing his tenure in October 2012.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In addition, Ralph L Sacco will now serve as president-elect of the AAN for a two-year term.&nbsp;Sacco is the chairman of Neurology, Olemberg Family Chair in Neurological Disorders and a Professor of Neurology at the University of Miami Miller School of Medicine in Miami, USA.</span></p></div>2015-04-30T10:36:00Z2015-04-30T10:36:00Zwebeditor@bibamedical.com Neuro launches Enterprise 2 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>Codman Neuro has launched the Enterprise 2 vascular reconstruction device in Europe. The Enterprise 2 system is the latest generation of the company&rsquo;s self-expanding stent and delivery system used to treat wide-necked intracranial aneurysms and to help maintain the position of endovascular coils. Codman Neuro is a part of the DePuy Synthes Companies of Johnson &amp; Johnson.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Jan-Hendrik Buhk, from University Medical Centre, Hamburg Eppendorf, was the first interventional neuro-radiologist in EMEA to use the technology.&nbsp;&ldquo;The Enterprise 2 System provided me with predictable positioning, intraoperative control and stability once in place, and fully met my expectations of a remodelling stent,&rdquo;<em>&nbsp;</em>said Buhk<em>.</em></span></p> <p><span style="font-size: 10pt;"><br />According to Codman Neuro, the Enterprise 2 System is designed to improve vessel wall conformability in tortuous anatomy, while maintaining its ability to provide a stable structure at the neck of an aneurysm, securing the placement of coils and maintaining blood flow through the artery.&nbsp; Furthermore, the stent is more visible under fluoroscopy than the previous device and comes with device enhancements that make it easier for physicians to deploy during the procedure.</span></p> <p><span style="font-size: 10pt;"><em><br /></em>&ldquo;At Codman Neuro, we recognise the critical need for neurovascular products that more effectively target wide-neck aneurysms,&rdquo;&nbsp;said Christoph Eigenmann, marketing director DePuy Synthes Spine and Codman Neuro EMEA.&nbsp;&ldquo;We have made important design improvements to the Enterprise 2 system so that it better fits vascular anatomy, is more visible on X-Ray, and is more easily deployed.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The Enterprise 2 system is intended for use with occlusive devices in the treatment of intracranial aneurysms. More than 80,000 patients worldwide have been treated for cerebral aneurysms with the first generation of the device, which has been available worldwide since 2006.</span></p></div>2015-04-30T08:46:00Z2015-04-30T08:46:00Zwebeditor@bibamedical.com Scientific announces strategic collaboration with Brainlab<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 has announced a collaboration with Brainlab AG, a software-driven medical technology company that helps improve patient treatment planning and surgical navigation. The collaboration provides patients and physicians a comprehensive portfolio for deep brain stimulation therapy.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Deep brain stimulation is intended to treat a variety of disorders, and most commonly may help reduce symptoms for movement disorders such as Parkinson&rsquo;s disease, dystonia, and essential tremor. As part of the agreement, Boston Scientific will begin distributing the Brainlab deep brain stimulation surgical planning portfolio with the Boston Scientific Vercise deep brain stimulation system in select countries.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Planning and visualisation are important parts of the deep brain stimulation process and enable more precise placement for better patient outcomes,&rdquo; said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. &ldquo;As we continue to invest in product development, clinical science, and solutions services in the deep brain stimulation therapy space, we have found natural synergies with Brainlab. This collaboration offers physicians and their patients advanced device technology as well as sophisticated software capabilities.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> Deep brain stimulation therapy involves the placement of a device in the brain that stimulates specific areas of the brain using electrical signals. The Vercise deep brain stimulation system incorporates multiple independent current controls, which are designed to stimulate targeted areas in the brain selectively, providing physicians with precise stimulation management. &nbsp;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Our collaboration with Boston Scientific is a harmonious fit given the complementary nature of our innovative portfolios and shared passion for technology,&rdquo; said Stephan Holl, chief operating officer, Brainlab. &ldquo;Our joint solutions will streamline and integrate deep brain stimulation treatments for physicians and their patients and will also serve as a future platform to further increase the access to and consistency of care.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The Vercise deep brain stimulation system has CE mark approval and is available in Europe, Israel, Australia and certain countries in Latin America and Asia Pacific for the treatment of Parkinson&rsquo;s disease, tremor and/or dystonia. In the USA, the Vercise deep brain stimulation system is investigational and not available for use or sale. The INTREPID clinical trial is currently enrolling patients in the USA, evaluating the safety and effectiveness of the Vercise deep brain stimulation system for the treatment of Parkinson&rsquo;s disease.</span></p></div>2015-04-28T10:05:00Z2015-04-28T10:05:00Zwebeditor@bibamedical.com announces consent decree with FDA for the SynchroMed drug infusion system and the Neuromodulation quality system<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Medtronic plc has announced that it has reached agreement on the terms of a consent decree with the US Food and Drug Administration (FDA) specific to the company&rsquo;s SynchroMed drug infusion system and the Neuromodulation quality system. The agreement is subject to approval by the US District Court for the District of Minnesota. Medtronic will be contacting physicians to ensure they have information about the agreement and the steps the company will be taking to continue to provide access to the SynchroMed drug infusion system.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The agreement between the FDA and Medtronic imposes certain restrictions on the company and outlines the steps it must take to address the FDA&rsquo;s expectations. The company&rsquo;s efforts are focused on the implementation of design changes to the SynchroMed drug infusion pump to address issues the company has previously communicated, and on enhancing the Neuromodulation quality system. The agreement also includes a defined process by which Medtronic can continue to provide physicians with access to the SynchroMed drug infusion system for patients.</span></p> <p><span style="font-size: 10pt;"><br />The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement.&nbsp;This action is not related to Medtronic insulin pumps for diabetes. Additionally, the consent decree does not include any Medtronic businesses other than Neuromodulation. Medtronic does regularly communicate information on the performance of its products and new product safety information to physicians when available and will continue to do so in the future.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA&rsquo;s expectations,&rdquo; said Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic. &ldquo;We are confident that our efforts to date will contribute to the timely and thorough completion of these activities while preserving access to this important therapy in the interest of patients, their caregivers and physicians.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Medtronic&rsquo;s SynchroMed drug infusion system is used primarily to treat chronic, intractable pain, severe spasticity and cancer.&nbsp;The SynchroMed drug infusion system delivers medication through a catheter directly to the intrathecal space surrounding the spinal cord. Medtronic&rsquo;s intrathecal drug delivery system is an important treatment option for patients who have not had success with other therapies or who experience intolerable side effects with oral medications.</span></p></div>2015-04-27T10:58:00Z2015-04-27T10:58:00Zwebeditor@bibamedical.com Leksell Gamma Knife to benefit more patients with brain disease<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>With the introduction of Elekta&rsquo;s new Leksell Gamma Knife Icon, the benefits of precision cranial radiosurgery are now available for more patients with a wider variety of tumour types and sizes. This latest generation stereotactic radiosurgery system for the brain, integrates advanced motion management, dose delivery and imaging technologies, significantly increasing the versatility of Gamma Knife radiosurgery. Elekta unveiled Leksell Gamma Knife Icon at the 3rd ESTRO Forum in Barcelona, Spain.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is great news for patients,&rdquo; says Niklas Savander, Elekta president and chief executive officer. &ldquo;With the new functionality in Leksell Gamma Knife Icon, doctors will have even greater flexibility in how radiosurgery is delivered, in addition to more assurance about the radiation dose and how accurately it is targeted. This new Leksell Gamma Knife will further strengthen our leading position in radiosurgery and hopefully address some of the more complex brain disorders from which many people suffer.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Elekta, Icon provides this increased flexibility by allowing physicians 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 (fractions or hypofractionation). The system even enables clinicians to choose the degree of precision needed for each patient&rsquo;s case&mdash;ranging from traditional radiosurgery accuracy to ultra-precise microradiosurgery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With Leksell Gamma Knife Icon, we expect two major changes,&rdquo; says Professor Jean Regis, a neurosurgeon and Gamma Knife programme director at University Hospital La Timone (Marseilles, France). &ldquo;First, the system will increase indications in the sense that we will be able do more hypofractionation. The second great benefit of Icon is the ability to do true adaptive radiosurgery both interfraction and intrafraction. It has the capacity to detect and measure position change&mdash;to automatically propose dose planning adaptation&mdash;while providing the operator with an estimate of the influence of these corrections for validation.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Elekta developed Icon to be the preferred modality to treat almost any intracranial target. It offers new functionality familiar to radiation oncologists, such as cone beam CT, which should help increase the adoption of radiosurgery. By being attractive to more clinics, more patients will have access to the benefits of precision cranial radiosurgery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Maurits Wolleswinkel, executive vice president Neuroscience at Elekta, says: "By giving doctors greater clinical flexibility and precision, it should also give patients greater confidence and peace of mind. This system is intended to give physicians the ability and confidence to treat virtually any pathology found in the brain with the highest precision and certainty, and the efficient workflows that will allow them to do this every day in the clinic,&rdquo; he says.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Leksell Gamma Knife Icon is not for sale or distribution in the US and is not CE marked.</span></p></div>2015-04-25T09:07:00Z2015-04-25T09:07:00Zwebeditor@bibamedical.com exposure to air pollution may pose risk to brain structure, cognitive functions<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Air pollution, even at moderate levels, has long been recognised as a factor in raising the risk of stroke. A new study led by scientists from Beth Israel Deaconess Medical Center and Boston University School of Medicine, USA, suggests that long-term exposure can cause damage to brain structures and impair cognitive function in middle-aged and older adults.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Writing in the May 2015 issue of&nbsp;<em>Stroke</em>, researchers who studied more than 900 participants of the Framingham Heart Study found evidence of smaller brain structure and of covert brain infarcts, a type of &ldquo;silent&rdquo; ischaemic stroke resulting from a blockage in the blood vessels supplying the brain.</span></p> <p><span style="font-size: 10pt;"><br />The study evaluated how far participants lived from major roadways and used satellite imagery to assess prolonged exposure to ambient fine particulate matter, particles with a diameter of 2.5 millionth of a meter, referred to as PM2.5.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> These particles come from a variety of sources, including power plants, factories, trucks and automobiles and the burning of wood. They can travel deeply into the lungs and have been associated in other studies with increased numbers of hospital admissions for cardiovascular events such as heart attacks and strokes.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is one of the first studies to look at the relationship between ambient air pollution and brain structure,&rdquo; says Elissa Wilker, a researcher in the Cardiovascular Epidemiology Research Unit at Beth Israel Deaconess Medical Center. &ldquo;Our findings suggest that air pollution is associated with insidious effects on structural brain aging, even in dementia- and stroke-free individuals.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Study participants were at least 60 years old and were free of dementia and stroke. The evaluation included total cerebral brain volume, a marker of age-associated brain atrophy; hippocampal volume, which reflect changes in the area of the brain that controls memory; white matter hyperintensity volume, which can be used as a measure of pathology and aging; and covert brain infarcts.</span></p> <p><span style="font-size: 10pt;"><br />The study found that an increase of only 2&micro;g per cubic meter in PM2.5, a range commonly observed across metropolitan regions in New England and New York, was associated with being more likely to have covert brain infarcts and smaller cerebral brain volume, equivalent to approximately one year of brain aging.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These results are an important step in helping us learn what is going on in the brain,&rdquo; Wilker says. &ldquo;The mechanisms through which air pollution may affect brain aging remain unclear, but systemic inflammation resulting from the deposit of fine particles in the lungs is likely important.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study shows that for a 2 microgram per cubic meter of air (&mu;g/m3) increase in PM2.5, a range commonly observed across major US cities, on average participants who lived in more polluted areas had the brain volume of someone a year older than participants who lived in less polluted areas. They also had a 46% higher risk of silent strokes on MRI,&rdquo; said Sudha Seshadri, a professor of Neurology at Boston University School of Medicine and Senior Investigator, the Framingham Study.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is concerning since we know that silent strokes increase the risk of overt strokes and of developing dementia, walking problems and depression. We now plan to look at more the impact of air pollution over a longer period, its effect on more sensitive MRI measures, on brain shrinkage over time, and other risks including of stroke and dementia.&rdquo;</span></p></div>2015-04-24T16:07:00Z2015-04-24T16:07:00Zwebeditor@bibamedical.com Introduces new generation of volumetric arc therapy at ESTRO<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A Brainlab press release says that the &ldquo;Elements&rdquo; strategy&mdash;indication-specific focused software applications aimed at enhancing the workflow for difficult to treat indications in the brain and spine introduced in 2013&mdash;has now come full circle with the introduction of automated stereotactic radiosurgery planning tools at ESTRO 2015 (24&ndash;28 April, Barcelona, Spain), which enable improvised generation of consistent treatment plans for volumetric arc therapy delivery.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Elements are a new generation of products that are indication-specific, user-friendly, fast, automatic and flexible,&rdquo; said Stefan Vilsmeier, president and chief executive officer of Brainlab. &ldquo;Instead of competing with existing treatment planning systems, Elements complement them by providing additional treatment possibilities for difficult to treat indications.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Previously-introduced Elements for cranial radiosurgery have focused on enhancing image fusion, distortion correction of various magnetic imaging resonance sequences, interactive segmentation of tumours and vascular structures, fibretracking, dose review, and automatic segmentation of critical structures. Adaptive Hybrid Surgery tools have helped to simulate and evaluate the feasibility of radiosurgery treatments at different resection levels during surgery. Radiosurgery treatment planning for cranial indications, however, remains a manual iterative process that is highly user-dependent.</span><br /><br /></p> <p><span style="font-size: 10pt;">One of the new Elements tools Brainlab will introduce automatically generates highly conformal treatment plans for a variety of indications, locations, sizes, shapes and fractionation schemes, all with the click of a button. Instead of choosing between different delivery techniques, the Element algorithm produces an monitor unit-optimised plan for delivery as volumetric, intensity modulated arc. For treatment of spherical targets, such as singular metastases, or small functional targets, such as trigeminal neuralgia, another new Element has been designed around the challenges of these specific treatments.</span><br /><br /></p> <p><span style="font-size: 10pt;">Spinal radiosurgery represents another challenging treatment with multiple complex and manual steps. In addition to streamlining the fusion and segmentation steps, another volumetric arc therapy -based automatic planning Element for spinal stereotactic radiosurgery can generate complex yet highly conformal plans. This tool is specifically designed to address the visualisation and optimisation requirements for stereotactic treatments for spine indications.</span></p></div>2015-04-24T11:45:00Z2015-04-24T11:45:00Zwebeditor@bibamedical.com of Lemtrada on slowing brain atrophy and MRI lesion activity maintained through four years<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>Genzyme, a&nbsp;Sanofi&nbsp;company, has announced that new magnetic resonance imaging (MRI) data from the Lemtrada&nbsp;(alemtuzumab) clinical development programme will be presented at the 67th American Academy of Neurology (AAN) Annual Meeting.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In relapsing remitting multiple sclerosis (RRMS) patients treated with Lemtrada in the phase III pivotal studies, MRI effects observed in the two-year trials&nbsp;were maintained through two additional years in the extension study (years three and four). After the initial two courses of treatment in the pivotal studies, which were given at month zero and at month 12, approximately 70% of Lemtrada patients did not receive additional Lemtrada treatment during the following three years, through month 48.</span></p> <p><span style="font-size: 10pt;"><br />The phase III trials of Lemtrada were randomised, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had an inadequate response to another therapy (CARE-MS II).</span></p> <p><span style="font-size: 10pt;">Through year four, the adverse event profile of Lemtrada was consistent with that observed during the pivotal studies. The new data presented at AAN include:</span></p> <ul> <li><span style="font-size: 10pt;">The rate of brain atrophy, as measured by brain parenchymal fraction (BPF), decreased progressively over four years among Lemtrada patients in CARE-MS I. Among CARE-MS II Lemtrada patients, the rate of brain atrophy decreased progressively over three years and remained low in year four. In both studies, the median yearly brain volume loss was less than -0.20% in years three and four, which was lower than what was observed during the two-year pivotal studies.</span></li> <li><span style="font-size: 10pt;">In CARE-MS I and II, treatment with Lemtrada significantly reduced the risk of developing new lesions compared to interferon beta-1a. In the extension study, most of the Lemtrada-treated patients from CARE-MS I and II were free of new lesions and MRI activity in years three and four (approximately 70%).</span></li> </ul> <p><span style="font-size: 10pt;">Brain atrophy is a measure of the most destructive pathological processes that occur in MS.&nbsp;It is seen from the earliest stages of disease and may lead to irreversible neurological and cognitive impairment. Given its association with disability, control or prevention of brain atrophy is an important target for MS treatment. In addition, MRI measures including lesion activity are considered useful tools when evaluating the effect of MS therapies, and lesion activity is among several prognostic factors for unfavourable clinical outcomes.<sup>&nbsp;</sup></span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It is very promising that most Lemtrada patients experienced slowing of brain atrophy and remained free of new lesions despite receiving their last treatment course three years previously,&rdquo;&nbsp;says Alasdair Coles, professor, Department of Clinical Neurosciences, University of Cambridge, UK.&nbsp;&ldquo;These new MRI data are consistent with the clinical data from the extension study that provide additional evidence of the sustained efficacy of Lemtrada on both relapses and disability.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Safety results from the second year of the extension study were previously reported. No new risks were identified. The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhoea, sinusitis, oropharyngeal pain, paraesthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis. A risk management programme incorporating education and monitoring helps support early detection and management of these identified risks.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The four-year MRI data support the prolonged efficacy of Lemtrada,&rdquo; says Genzyme president and chief executive officer, David Meeker. &ldquo;These results are encouraging, as they provide further evidence of Lemtrada&rsquo;s potential to change the treatment approach for people living with relapsing forms of MS.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />More than 90% of the patients who were treated with Lemtrada in the CARE-MS Phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions. MRI scans were taken at CARE-MS baseline, and at 12, 24, 36 and 48 months.</span></p> <p><span style="font-size: 10pt;"><br />In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.<br /><br /></span></p></div>2015-04-24T10:36:00Z2015-04-24T10:36:00Zwebeditor@bibamedical.com lower-grade brain blood vessel malformations, surgery has “excellent clinical outcomes”<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>Interventional treatments&mdash;especially surgery&mdash;provide good functional outcomes and a high cure rate for patients with lower-grade arteriovenous malformations (AVMs) of the brain, reports the May issue of&nbsp;<a href="" target="_blank"><em>Neurosurgery</em></a>, official journal of the&nbsp;Congress of Neurological Surgeons.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The findings contrast with a recent trial (Treatment outcomes of unruptured arteriovenous malformations with a subgroup analysis of ARUBA (A randomized trial of unruptured brain arteriovenous malformations)-eligible patients) reporting better outcomes without surgery or other interventions for AVMs. &ldquo;On the basis of these data, in appropriately selected patients, we recommend treatment for low-grade brain AVMs,&rdquo; concludes the study by Laligam N Sekhar and colleagues of University of Washington, Seattle, USA.</span></p> <p><span style="font-size: 10pt;"><br /><strong>Good results with surgery for lower-grade brain AVMs</strong></span><br /> <br /><span style="font-size: 10pt;"> The researchers evaluated their hospital&rsquo;s experience in treating 105 patients with AVMs from 2005 to 2012. Arteriovenous malformations are congenital defects consisting of an abnormal tangle of blood vessels. When AVMs are located in the brain, there is a risk that they may rupture and bleed, causing potentially life-threatening haemorrhagic stroke.</span></p> <p><span style="font-size: 10pt;"><br />When AVMs are detected before rupture, options include medical (conservative) treatment, consisting of monitoring and follow-up; or various active treatments, including surgery, embolisation, or radiosurgery.</span></p> <p><span style="font-size: 10pt;"><br />Sekhar and colleagues were particularly interested in comparing their experience with the results of the 2014 ARUBA clinical trial. In that study, patients randomly assigned to medical treatment had a lower three-year risk of stroke or death, compared to those undergoing other surgery or other interventions.</span></p> <p><span style="font-size: 10pt;"><br />The new analysis focused on 61 adult patients with brain AVMs who would have been eligible for the ARUBA study. Sekhar and colleagues categorised the results by AVM severity: low-grade, intermediate, or high-grade. About half of the ARUBA-eligible patients had low-grade (grade I or II) AVMs. Most were treated with a combination of embolisation and surgery or with radiosurgery.</span></p> <p><span style="font-size: 10pt;"><br />At an average follow-up of two years, all outcomes were better for patients with lower-grade AVMs. Based on the same scale used in ARUBA, the rate of functional impairment was 3% in patients with grade I/II AVMs, compared with 20&ndash;25% for those with intermediate or high-grade AVMs.</span></p> <p><span style="font-size: 10pt;"><br />Overall, 22 patients with low-grade AVMs were treated with surgery, usually after embolisation. At their last follow-up, all 22 patients had normal functional status and &ldquo;radiographic cure,&rdquo; with no remaining signs of AVM on brain imaging scans. The cure rate was higher with surgery than with radiosurgery.</span></p> <p><span style="font-size: 10pt;"><br />The new findings &ldquo;challenge the assertion that medical management is superior&rdquo; to surgery or interventional treatments for unruptured brain AVMs, Sekhar and colleagues write. They highlight several important limitations of the ARUBA trial&mdash;especially the fact that patients were assigned to treatment groups regardless of the grade of their AVM.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study shows that grade I/II ARUBA-eligible patients can have excellent clinical outcomes after treatment and confirms the challenges of treating higher-grade, unruptured brain AVMs,&rdquo; the researchers write. They add that the results &ldquo;highlight the need for prospective, multicentre data to identify patients who may benefit most from treatment compared with medical management.&rdquo;</span></p></div>2015-04-24T10:23:00Z2015-04-24T10:23:00Zwebeditor@bibamedical.com phase II study with NeuroSTAT for traumatic brain injury passes safety evaluation<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The independent safety committee has endorsed moving on to the next dose level without any safety issues, following the treatment of 10 of 20 patients in the ongoing clinical phase IIa study for traumatic brain injury with NeuroVive&rsquo;s drug candidate NeuroSTAT. Consequently, the study will continue as planned and move on to the next dosage group.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The ongoing CHIC study (Copenhagen Head Injury Ciclosporin Study) is an open-label, non-comparative clinical phase IIa study enrolling a total of 20 patients divided into two different dosage groups, where NeuroVive&rsquo;s drug candidate NeuroSTAT is being evaluated for the treatment of patients with traumatic brain injury. The study is being conducted at the Department of Neurosurgery at Rigshospitalet, University of Copenhagen, Denmark, with Jesper Kelsen as principal investigator.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study&rsquo;s first dosage group of 10 patients has now been treated with NeuroSTAT at the lower dose, and an interim analysis has been completed by an independent safety committee in order to evaluate the treatment&rsquo;s safety profile. The analysis includes an evaluation of blood concentrations of cyclosporin A (the active substance in NeuroSTAT) and changes in intracranial pressure and blood samples collected to analyse possible organ injury. According to the analysis, the low-dose treatment is judged to be safe and the study will now continue as planned with the higher dosage group including 10 additional patients.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We have now obtained important safety data on what we have designated to be the lower dose of NeuroSTAT for treating patients with traumatic brain injury. We can now move on to include patients that will be treated with a higher dose. This means that the study has reached an important milestone in the clinical trial programme of NeuroSTAT,&rdquo; commented NeuroVive&rsquo;s chief executive officer Mikael Br&ouml;nneg&aring;rd.</span></p></div>2015-04-22T16:00:00Z2015-04-22T16:00:00Zwebeditor@bibamedical.com stimulate body’s own stem cells to replace the brain cells lost in multiple sclerosis<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A pair of topical medicines already alleviating skin conditions each may prove to have another, even more compelling use: instructing stem cells in the brain to reverse damage caused by multiple sclerosis.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Led by researchers at Case Western Reserve, a multi-institutional team used a new discovery approach to identify drugs that could activate mouse and human brain stem cells in the laboratory. The two most potent drugs&mdash;one that currently treats athlete&rsquo;s foot, and the other, eczema&mdash;were capable of stimulating the regeneration of damaged brain cells and reversing paralysis when administered systemically to animal models of multiple sclerosis. The results are published&nbsp;online in the scientific journal&nbsp;<em>Nature</em>.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We know that there are stem cells throughout the adult nervous system that are capable of repairing the damage caused by multiple sclerosis, but until now, we had no way to direct them to act,&rdquo; says Paul Tesar, Dr Donald and Ruth Weber Goodman Professor of Innovative Therapeutics, and associate professor in the Department of Genetics &amp; Genome Sciences at the Case Western Reserve School of Medicine. &ldquo;Our approach was to find drugs that could catalyse the body&rsquo;s own stem cells to replace the cells lost in multiple sclerosis.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The findings mark the most promising developments to date in efforts to help the millions of people around the world who suffer from multiple sclerosis. The disease is the most common chronic neurological disorder among young adults, and results from aberrant immune cells destroying the protective coating, called myelin, around nerve cells in the brain and spinal cord.</span></p> <p><span style="font-size: 10pt;"><br />Without myelin, neural signals cannot be transmitted properly along nerves; over time, a patient&rsquo;s ability to walk, hold a cup or even see is inexorably eroded. Current multiple sclerosis therapies aim to slow further myelin destruction by the immune system, but the Case Western Reserve team used a new approach to create new myelin within the nervous system. Their work offers great promise of developing therapies that reverse disabilities caused by multiple sclerosis or similar neurological disorders.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;To replace damaged cells, much of the stem cell field has focused on direct transplantation of stem cell-derived tissues for regenerative medicine, and that approach is likely to provide enormous benefit down the road,&rdquo; says Tesar, also a New York Stem Cell Foundation Robertson Investigator and member of the National Center for Regenerative Medicine. &ldquo;But here we asked if we could find a faster and less invasive approach by using drugs to activate native stem cells already in the adult nervous system and direct them to form new myelin. Our ultimate goal was to enhance the body&rsquo;s ability to repair itself.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Tesar emphasised that much work remains before multiple sclerosis patients might benefit from the promising approach. Scientists still must find ways to transform the topical medications for internal use and determine their long-term efficacy and potential side effects. That said, using existing federally approved drugs enhances the likelihood that the compounds can be made safe for human use.</span></p> <p><span style="font-size: 10pt;"><br />Tesar and his colleagues could zero in on the two catalysing medications only because of a breakthrough that his laboratory achieved in 2011. Specifically, the researchers developed a unique process to create massive quantities of a special type of stem cell called an oligodendrocyte progenitor cell (OPC). These OPCs are normally found throughout the adult brain and spinal cord, and therefore inaccessible to study. But once Tesar and his team could produce billions of the OPCs with relative ease, they could begin to test different existing drug formulations to determine which, if any, induced the OPCs to form new myelinating cells.</span></p> <p><span style="font-size: 10pt;"><br />Using a state-of-the-art imaging microscope, the investigators quantified the effects of 727 previously known drugs, all of which have a history of use in patients, on OPCs in the laboratory. The most promising medications fell into two specific chemical classes. From there, the researchers found that miconazole and clobetasol performed best within the respective classes. Miconazole is found in an array of over-the-counter antifungal lotions and powders, including those to treat athlete&rsquo;s foot. Clobetasol, meanwhile, is typically available by prescription to treat scalp and other skin conditions such as dermatitis. Neither had been previously considered as a therapeutic for multiple sclerosis, but testing revealed each had an ability to stimulate OPCs to form new myelinating cells. When administered systemically to lab mice afflicted with a multiple sclerosis-like disease, both drugs prompted native OPCs to regenerate new myelin.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It was a striking reversal of disease severity in the mice,&rdquo; says Robert Miller, a member of the neurosciences faculty at Case Western Reserve who, with Tesar, is a co-senior author of the <em>Nature</em> paper. The two collaborated on this project while Miller also served as vice president for Research at Case Western Reserve; since June his primary appointments are at the George Washington University School of Medicine and Health Sciences, where he is Senior Associate Dean for Research and Vivian Gill Distinguished Research Chair. &ldquo;The drugs that we identified are able to enhance the regenerative capacity of stem cells in the adult nervous system. This truly represents a paradigm shift in how we think about restoring function to multiple sclerosis patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />While the drugs proved to have extraordinary effects on mice, their impact on human patients will not be known fully until actual clinical trials. Nevertheless, Tesar and his team already have added reason for optimism; in addition to the tests with animal cells, they also tested the drugs on human stem cells&mdash;and saw the medication prompt a similar response as seen in the mouse cells. Both medications worked well, with miconazole demonstrating the more potent effects.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have pioneered technologies that enable us to generate both mouse and human OPCs in our laboratory,&rdquo; says Fadi Najm, the first author of the study and Research Scientist in the Department of Genetics &amp; Genome Sciences at the Case Western Reserve School of Medicine. &ldquo;This uniquely positioned us to test if these drugs could also stimulate human OPCs to generate new myelinating cells.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Tesar, who recently received the 2015 International Society for Stem Cell Research Outstanding Young Investigator Award, said investigators next will work to deepen their understanding of the mechanism by which these drugs act. Once these details are clear, researchers will modify the drugs to increase their effectiveness in people.</span></p> <p><span style="font-size: 10pt;"><br />The team is enthusiastic that optimised versions of these two drugs can be advanced to clinical testing for multiple sclerosis in the future, but Tesar emphasised the danger of trying to use current versions for systemic human administration.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We appreciate that some patients or their families feel they cannot wait for the development of specific approved medications,&rdquo; Tesar says, &ldquo;but off-label use of the current forms of these drugs is more likely to increase other health concerns than alleviate multiple sclerosis symptoms. We are working tirelessly to ready a safe and effective drug for clinical use.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />While multiple sclerosis is the initial focus for translating this research into the clinic, a number of other disorders involve myelin loss or dysfunction including cerebral palsy, age-related dementia, optic neuritis and schizophrenia. Any drugs developed that enhance myelination in multiple sclerosis also hold promise for benefiting these other disorders.</span></p></div>2015-04-22T15:52:00Z2015-04-22T15:52:00Zwebeditor@bibamedical.com clears MRI-compatible MEMS cannula<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Alcyone Lifesciences has announced that the Alcyone MEMS cannula, a neuro-ventricular cannula, has received FDA clearance. The Alcyone MEMS cannula is a dual-lumen, MRI-compatible injection and aspiration cannula for use in the brain. The Alcyone MEMS cannula is not intended for implant, and it is intended for single patient use only.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The neuroscience community is pioneering new therapeutic agents including gene therapy, antibody and oncolytic biologic therapy that hold great promise in treating chronic CNS disorders, but unfortunately they have lacked a clinically effective technology for precise CNS delivery direct to a neurological target and for optimal bio-distribution,&rdquo; says PJ Anand, founder and chief executive officer of Alcyone Lifesciences. &ldquo;Given that the very potential of these new agents is dependent on optimal bio-distribution, it is our hope that the Alcyone MEMS cannula will offer a solution for this critical unmet clinical need and further open the gates to novel therapeutic options for patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Alcyone MEMS cannula was developed using our game-changing proprietary microelectromechanical system (MEMS) platform. Without burdening the neurosurgery community with unnecessary additional capital equipment, the Alcyone MEMS cannula can be utilised with any existing commercial imaging and stereotactic system. Neurosurgeons can select a target, navigate the Alcyone MEMS cannula precisely to the target, and observe in real-time the precision delivery of the therapeutic agent, all under intra-procedural MRI guidance,&rdquo; says Deep Singh, director of Product Development at Alcyone Lifesciences. &ldquo;In addition to the MEMS tip which has dual micro-channels, the Alcyone MEMS cannula features a unique patented distal end design that helps prevent reflux or back flow along the cannula shaft, which can be a significant drawback with current devices. The Alcyone MEMS cannula platform device is designed for optimal targeted bio-distribution and neurosurgeon&rsquo;s ease of use.&rdquo;</span></p></div>2015-04-22T14:26:00Z2015-04-22T14:26:00Zwebeditor@bibamedical.com announces European approval of the first and only full-body MR conditional deep brain stimulation systems<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>Medtronic plc has announced that systems within its Activa&nbsp;portfolio of deep brain stimulation (DBS) therapy neurostimulators have received European regulatory approval for MR conditional full-body magnetic resonance imaging (MRI).&nbsp;The expanded approval for full-body MRI scans applies to all patients receiving a new system and to an estimated 13,000 people in Europe already receiving Medtronic DBS Therapy.<sup>&nbsp;</sup>Medtronic DBS systems have previously been approved for MRI scans of the head only, under limited conditions. Medtronic DBS systems are not approved in the United States for full-body scans.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MRI scans have become a diagnostic standard of care, allowing physicians to detect a wide range of health conditions by viewing highly detailed images of tumours, internal organs, blood vessels, muscles, joints and other areas of the body by using strong magnetic fields and radio frequency pulses to create images of structures inside the body. Worldwide, it is estimated that approximately 60 million MRI procedures are performed each year.</span></p> <p><span style="font-size: 10pt;"><br />When programmed to appropriate settings, MR conditional Medtronic DBS systems allow patients to continue to receive therapy during MRI scans. Previously, patients receiving an MRI scan had their DBS systems turned off before the scan.</span></p> <p><span style="font-size: 10pt;">&ldquo;MRI is commonly the method of choice to image the body to diagnose disease or monitor existing conditions, but MRI use has often been limited in patients receiving DBS therapy,&rdquo; says John Thornton, medical physicist at the National Hospital for Neurology and Neurosurgery in London, UK. &ldquo;Patients receiving DBS therapy can now receive more advantages of MRI technology.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Most patients who we consider for a DBS implant have other conditions which may require MRI,&rdquo; says Ludvic Zrinzo, neurosurgeon at the National Hospital for Neurology and Neurosurgery in London. &ldquo;The MR conditional Activa systems mean patients can receive DBS care, and still may have the option of MRI when needed to manage other conditions.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />To receive approval for MR conditional DBS systems, Medtronic developed proprietary test and measurement systems, in conjunction with advanced electromagnetic modelling tools. Existing Activa DBS systems were rigorously tested and evaluated across millions of simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety. &nbsp;</span></p></div>2015-04-22T11:57:00Z2015-04-22T11:57:00Zwebeditor@bibamedical.com demonstrates a statistically significant effect in ALS patients<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>BrainStorm Cell Therapeutics presented results from its phase 2a study of NurOwn in amyotrophic lateral sclerosis (ALS) at a poster session at the American Academy of Neurology annual meeting, in Washington, DC, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Among the new results is a piecewise linear regression analysis of all subjects who received intrathecal (IT) administration in the phase 2a study and the prior phase 1/2 study. At six months post-treatment, there was a statistically significant improvement in the estimated rate of decline in Forced Vital Capacity (FVC), from -5.1% per month pre-treatment to -1.2% per month post-treatment (two-sided p=0.036) and a nearly significant improvement in the rate of ALS Functional Rating Score-Revised (ALSFRS-R) decline, from -1.2 points per month pre-treatment to -0.6 points per month post treatment (two-sided p=0.052).</span></p> <p><span style="font-size: 10pt;"><br />Also reported for the first time are local positive effects of intramuscular administration. 3D volumetric analysis using MRI revealed an improvement in the rate of decline in muscle mass in the right arm, the site of NurOwn administration, through one month post-treatment, as compared to the left arm. Electromyography demonstrated a trend of stabilisation of the compound motor axon potential in the right musculocutaneous nerve as compared to deterioration observed in the left.</span></p> <p><span style="font-size: 10pt;"><br />BrainStorm&rsquo;s chief executive officer, Tony Fiorino, comments, &ldquo;These results represent further validation for our NurOwn platform. In this study, we observed a large and clinically meaningful benefit after treatment with NurOwn. Moreover, our analysis of subjects who received IT administration in our two completed trials showed a statistically significant improvement in the rate of FVC decline, and a nearly significant improvement in the rate of ALSFRS-R decline, at six months post-treatment, a notable achievement given the small sample size. With our US phase 2 trial now more than half-enrolled and a multi-dose study being planned, BrainStorm is well-positioned to confirm and extend these findings over the coming year.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Professor Dimitrios Karussis of Hadassah University Medical Center, the principal investigator for the study, stated, &ldquo;We have observed in our two studies clear indications that a single intrathecal administration of NurOwn can induce clinically meaningful beneficial effects in ALS patients. In these studies, 88% of subjects with three months follow-up and 73% of those with six months follow-up responded to the cells, showing a post-treatment improvement in either ALSFRS-R or FVC, or both.&nbsp; We eagerly await the results of current and planned studies that will define the safety and efficacy profile of NurOwn, and we are particularly hopeful that the administration of repeated doses will increase the magnitude or duration of benefit, or both.&rdquo;</span></p></div>2015-04-21T15:19:00Z2015-04-21T15:19:00Zwebeditor@bibamedical.com different carotid artery stenting procedures show little difference in effectiveness<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Use of either proximal embolic protection devices (P-EPDs) or distal filter embolic protection devices (F-EPDs) during elective carotid artery stenting results in low rates of in-hospital stroke and death, according to a new study from researchers at the Perelman School of Medicine at the University of Pennsylvania, USA.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, published in&nbsp;<em><a href="">JACC: Cardiovascular Interventions</a></em>, found that although P-EPDs have been theorised to be more effective than F-EPDs at preventing stroke during carotid artery stenting, this first comparative effectiveness study revealed no statistically significant difference between the two devices.</span><br /><br /></p> <p><span style="font-size: 10pt;">Carotid artery stenting is commonly used to treat carotid artery disease, in which the carotid arteries develop a build-up of plaque that can lead to stroke. During carotid artery stenting, the placement of small mesh-like tubes via catheters to open the artery and stabilise the plaque, there is a risk of releasing small amounts of debris into the brain&rsquo;s circulation. To prevent this problem, two types of EPDs were developed: F-EPDs have a small filter to catch debris; while P-EPDs stop blood flow to the brain in the carotid artery being stented, then debris-containing blood is removed before normal blood flow resumes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These study results challenge the notion that proximal embolic protection devices are significantly superior to distal embolic protection devices, or that they can serve as a &lsquo;magic bullet&rsquo; for stroke prevention during carotid artery stenting,&rdquo; said first author Jay Giri, assistant professor of clinical medicine at the University of Pennsylvania. &ldquo;Even for patients who had recent symptoms of stroke or mini-stroke&mdash;who have been thought to get more benefit from proximal embolic protection devices&mdash;this study showed no statistical difference in device effectiveness.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The research team examined 10,246 consecutive elective carotid artery stenting procedures performed with embolic protection between January 2009 and March 2013 in the CARE (Carotid Artery Revascularization and Endarterectomy) Registry. P-EPDs were used in 590 (5.8%) of the cases, and the rest were F-EPDs. The differences in in-hospital stroke or death between P-EPDs (1.5%) and F-EPDs (2.4%) were not statistically significant, and the 30-day adverse events rates were similar for both P-EPDs (2.7%) and F-EPDs (4%).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;There is certainly no signal of harm with use of proximal embolic protection devices, and our study cannot rule out a small benefit of these devices. The choice of embolic protection device type in a given case really comes down to physician discretion,&rdquo; added Giri.</span><br /><br /></p> <p><span style="font-size: 10pt;">Given the overall results of this study, the research team has concluded that although a large controlled trial randomising patients to these two devices might be useful, its feasibility is unlikely due to the scope necessary.</span></p></div>2015-04-20T15:48:00Z2015-04-20T15:48:00Zwebeditor@bibamedical.com Jude Medical announces intent to acquire Spinal Modulation<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, Inc.&nbsp;has announced that it has exercised the company&rsquo;s exclusive option to acquire&nbsp;Spinal Modulation, Inc., developer of the Axium Neurostimulator System. Following the completion of this acquisition,&nbsp;St Jude Medical will become the only medical device manufacturer to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Once complete, the acquisition of&nbsp;Spinal Modulation will further support St Jude Medical&rsquo;s mission to help physicians tailor treatment to a patient&rsquo;s chronic pain condition to achieve superior outcomes. Stimulation of the dorsal root ganglion (DRG) with the&nbsp;Axium&nbsp;system has been shown to provide meaningful relief for patients battling chronic pain, and is especially useful for treating focal pain areas often challenging to treat using traditional spinal cord stimulation (SCS).</span></p> <p><span style="font-size: 10pt;"><br />The&nbsp;Axium&nbsp;system originally received CE mark approval in&nbsp;November 2011&nbsp;for the management of chronic, intractable pain. In&nbsp;December 2014, Spinal Modulation announced that enrolment in its ACCURATE US IDE trial had been completed. Spinal Modulation subsequently submitted its PMA application to the&nbsp;FDA&nbsp;in support of marketing approval in&nbsp;the United States. Results from the ACCURATE study will be presented at the 12<sup>th</sup>&nbsp;annual&nbsp;International Neuromodulation Society (INS) Congress, to be held in&nbsp;Montreal, Quebec, Canada,&nbsp;June 6-11, 2015.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Physicians need a range of options to effectively treat chronic pain, and our acquisition of Spinal Modulation is part of our ongoing commitment to providing physicians new and innovative therapy options,&rdquo; said&nbsp;Michael T Rousseau, chief operating officer of&nbsp;St Jude Medical. &ldquo;Dorsal root ganglion stimulation with the Axium&nbsp;system is highly complementary to our current chronic pain product portfolio, and acquiring this technology will further our ability to partner with physicians to reduce the burden of chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can dramatically affect quality of life, negatively impacting personal relationships, work productivity and daily routines. SCS and DRG stimulation have both been proven to offer patients relief from chronic pain while restoring lost quality of life.</span></p> <p><span style="font-size: 10pt;"><br />DRG stimulation works differently than traditional SCS, targeting nerves within the DRG, a structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain.&nbsp;Traditional SCS&nbsp;takes a different approach, targeting nerves along the spinal cord&rsquo;s dorsal column which often proves challenging to isolate the desired target painful area.</span></p> <p><span style="font-size: 10pt;"><br />By targeting the DRG, stimulation with the&nbsp;Axium&nbsp;system has been shown to be effective in treating conditions currently underserved by traditional SCS, such as chronic intractable pain in the leg, foot and groin. Research has also shown DRG stimulation can benefit patients suffering post-surgical pain and neuropathic pain. This underserved population is estimated to represent more than five times the current addressable market.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;St Jude Medical has a legacy of bringing new, innovative therapy options to patients suffering from chronic pain, and we believe adding DRG stimulation to their chronic pain portfolio will have a number of benefits to patients worldwide,&rdquo; said&nbsp;David Wood, president and chief executive officer of Spinal Modulation. &ldquo;We&rsquo;re proud of what the Spinal Modulation team has built over the past 10 years, and see great potential for&nbsp;St Jude Medical&nbsp;to continue expanding access to DRG stimulation therapy for patients who may benefit from additional therapeutic options.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Transaction Details</strong></span></p> <p><span style="font-size: 10pt;"><br />In&nbsp;June 2013,&nbsp;St Jude Medical&nbsp;entered into a series of agreements under which the company made a&nbsp;US$40 million&nbsp;equity investment in Spinal Modulation.&nbsp;In addition to providing&nbsp;St Jude Medical&nbsp;with an exclusive option to distribute the Axium Neurostimulator System in international markets where the technology is approved for sale, the agreements also provided&nbsp;St Jude Medical&nbsp;with an exclusive option to acquire the company. Having exercised its exclusive option,&nbsp;St Jude Medical expects to complete the acquisition of Spinal Modulation in the second quarter of 2015, subject to customary closing conditions.</span></p> <p><span style="font-size: 10pt;"><br />St Jude Medical&nbsp;will make a payment of approximately&nbsp;US$175 million&nbsp;upon closing with additional payments due upon&nbsp;FDA&nbsp;approval of the&nbsp;Axium&nbsp;system and achievement of certain revenue targets. </span><br /> <br /><span style="font-size: 10pt;"> According to a press release from St Jude Medical, &ldquo;Excluding acquisition-related expenses, we estimate that this acquisition will be approximately&nbsp;US$0.05&nbsp;dilutive to our adjusted consolidated earnings per share for the remainder of 2015, which we expect to partially offset with operating efficiencies.&nbsp;St Jude Medical will provide an update to its adjusted 2015 earnings per share guidance on its first quarter earnings call scheduled to be held on&nbsp;22 April, 2015.&rdquo;</span></p></div>2015-04-20T13:32:00Z2015-04-20T13:32:00Zwebeditor@bibamedical.com Medical closes US$5.6 million in Series B funding<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Contego Medical, the first and only provider of the Integrated Embolic Protection filter platform for angioplasty balloon and stent delivery catheters, announces the completion of a US$5.6 million Series B financing round led by Hatteras Venture Partners. The round also included Mountain Group Partners, Lookout Capital and Medical Mutual.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Contego Medical&rsquo;s portfolio of angioplasty balloons and stents embodying the Integrated Embolic Protection filter platform represents a breakthrough technology, which we believe will help endovascular interventionalists reduce the risk of stroke and other procedural complications,&rdquo; says Doug Reed, general partner of Hatteras Venture Partners. Doug Reed will be joining Contego Medical as a board member.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The company will use the funds to continue to grow its leadership, sales and engineering teams and to develop several new and innovative products with its next-generation Integrated Embolic Protection platform.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Paladin device and other devices under development address a multi-billion dollar market, and have the potential to become standards of care in their respective target treatment areas as the combination devices are designed to simplify procedures, improve outcomes and offer cost-effective solutions. We are excited to partner with Hatteras Venture Partners as we continue to expand and commercialise our portfolio of products,&rdquo; says Ravish Sachar, founder and chief executive officer of Contego Medical.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Contego Medical has expanded its executive team with the appointment of Paul Sanders as chief operating officer, Udayan Patel as chief technology officer, and Alan Bacharach as Contego Medical&rsquo;s European general manager. Elizabeth Saylors will continue as vice president of Quality and Clinical Affairs. The team&rsquo;s track record of success brings experienced management and leadership to Contego Medical&rsquo;s expanding commercialisation efforts throughout Europe and globally.</span></p></div>2015-04-20T09:04:00Z2015-04-20T09:04:00Zwebeditor@bibamedical.com US commercial procedure with the Enroute transcarotid neuroprotection 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 the first US commercial procedure using the Enroute transcarotid neuroprotection system was successfully performed at Mills-Peninsula Medical Center in Burlingame, USA by vascular surgeon John E Rosenman.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Transcarotid artery revascularisation, uses direct carotid artery access and robust, temporary flow reversal to protect the brain from particles that can dislodge during the carotid artery repair procedure. The Enroute transcarotid neuroprotection system recently received 510(k) clearance by the US Food &amp; Drug Administration (FDA).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The transcarotid artery revascularisation procedure using the Enroute transcarotid neuroprotection system allows me to perform a minimally invasive stent procedure expeditiously with less risk of nerve injury and less trauma to the patient than traditional open surgery,&rdquo; said Rosenman. &ldquo;We are excited to be one of the first hospitals in the nation to offer this procedure to our patients with carotid artery disease. We are confident in the effectiveness of flow reversal for stroke prevention during stent placement. The transcarotid approach is a less invasive, more patient friendly option compared to traditional open surgery.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The FDA cleared the Enroute transcarotid neuroprotection system based on the outcomes of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, a rate comparable to the gold standard of a surgical carotid endarterectomy (CEA) and the lowest to date for any prospective trial of carotid artery stenting. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age &gt;=75), women, and symptomatic patients.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The surgical treatment of carotid artery disease to reduce the long term risk of stroke is well established, but many patients have risk factors that can lead to complications as a consequence of the procedure itself, including stroke, death, and cranial nerve injuries,&rdquo; said Sumaira Macdonald, chief medical officer. &ldquo;Transcarotid artery revascularisation represents a procedural paradigm shift that brings together key principles of surgical and endovascular techniques to reduce these risks and is a welcome, clinically proven option for physicians and their patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Silk Road Medical will ramp up commercial operations throughout 2015 to broaden US distribution of the Enroute transcarotid neuroprotection system to vascular specialists. The Enroute transcarotid neuroprotection system has been available internationally since 2012 and more than 500 patients have been treated with the device in the US and Europe. The company also has a pending Premarket Approval (PMA) application for the Enroute transcarotid stent system&mdash;an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system.&nbsp;</span></p></div>2015-04-17T12:25:00Z2015-04-17T12:25:00Zwebeditor@bibamedical.com builds for endovascular treatment of acute ischaemic 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>With the publication of two more stroke trials, the evidence in favour of endovascular treatment in patients with acute ischaemic stroke has reached new heights. Data from SWIFT PRIME (Solitaire with the intention for thrombectomy as primary endovascular treatment) and REVASCAT (Randomized trial of revascularization with Solitaire FR device versus best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight hours of symptom onset), published online first in the <em>New England Journal of Medicine</em> (<em>NEJM</em>) and presented at the European Stroke Organisation conference (17&ndash;19 April, Glasgow, UK), add to that of three other trials&mdash;MR CLEAN, EXTEND-IA and ESCAPE&mdash;that have begun to change the face of ischaemic stroke treatment.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Both SWIFT PRIME and REVASCAT assessed if patients experiencing an acute ischaemic stroke and treated with a stent retriever (Solitaire, Covidien/Medtronic) in addition to current medical therapy, including IV t-PA when patients were eligible, had less stroke-related disability than patients treated with IV t-PA or medical therapy alone.</span></p> <p><span style="font-size: 10pt;"><br />SWIFT PRIME assessed 196 patients and found that the addition of the Solitaire device significantly decreased post-stroke disability and increased the number of patients who were independent within 90 days after a stroke. The trial found that the addition of the Solitaire device significantly increased patients&rsquo; rate of return to functional independence compared to IV t-PA alone (60.2% vs. 35.5%, p=0.0002).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;SWIFT PRIME showed that treatment with the Solitaire device is safe, technically successful and substantially reduces long-term disability levels,&rdquo; said Jeffrey L Saver, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles (UCLA) and director, UCLA Comprehensive Stroke Center, USA. &ldquo;This treatment marks the beginning of a new era in stroke care.&rdquo;</span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">He further told <em>NeuroNews</em>, &ldquo;This is a once in a generation advance in stroke care. The paradigm is changing. The best treatment for patients who have blockages in the large arteries in the brain is going to be to get t-PA and the clot retriever. Together they work much better than t-PA alone and that means that we have to change the medical system to ensure that patients are brought first to the sites where they can rapidly get t-PA started, but also to the specialised sites where they can do this procedure in the cath lab.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Similarly, REVASCAT (206 patients), conducted at four comprehensive stroke centres in Catalonia, Spain, showed that patients treated with the Solitaire device in addition to medical therapy (which included IV t-PA in eligible patients that comprised 70% of subjects enrolled) up to eight hours from onset of symptoms, experienced a statistically significant improvement in the rate of return to functional independence (43.7% vs. 28.2%) in favour of patients treated with the Solitaire device when compared to medical therapy alone.</span></p> <p><span style="font-size: 10pt;"><br />All five of the now-published trials have shown that the amount of time to treatment has a significant impact on outcomes. SWIFT PRIME demonstrated dramatic improvements in workflow (the complete cycle of care from diagnosis through treatment) compared to previous trials. The trial was conducted at 39 centres across seven countries, demonstrating broad applicability in different health systems and the achievability of fast, efficient stent thrombectomy care.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We now have five global trials that provide an overwhelming body of clinical evidence in support of [stent retriever] thrombectomy,&rdquo; said Antoni Davalos, director, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol. &ldquo;Based on these findings, it is time for the stroke community to come together to re-evaluate stroke treatment guidelines and to look for systems to facilitate the access of treatable patients to specialised centres.&rdquo;</span></p></div>2015-04-17T12:08:00Z2015-04-17T12:08:00Zwebeditor@bibamedical.com research study to demonstrate value of PET scans in Alzheimer’s disease diagnosis<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>A new four-year research study, with an estimated budget of US$100 million, has been announced by the Alzheimer&rsquo;s Association and the American College of Radiology (ACR). The Imaging dementia&mdash;Evidence for amyloid scanning (IDEAS) study will determine the clinical usefulness and value in diagnosing Alzheimer&rsquo;s and other dementias in certain situations of a brain positron emission tomography (PET) scan that detects a core feature of Alzheimer&rsquo;s disease.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The IDEAS study will assess the impact of brain amyloid PET imaging on a variety of patient outcomes. The study protocol received approval with requirements by the Centers for Medicare &amp; Medicaid Services (CMS). Participating providers will be reimbursed for the PET scans under the CMS Coverage with Evidence Development (CED) policy that requires research study participation as a condition of Medicare payment.</span></p> <p><span style="font-size: 10pt;">IDEAS is led by the Alzheimer&rsquo;s Association and managed by the ACR and American College of Radiology Imaging Network (ACRIN).</span></p> <p><span style="font-size: 10pt;"><br />Why the IDEAS study is needed</span></p> <p><span style="font-size: 10pt;"><br />Two abnormal structures called plaques and tangles are prime suspects in damaging and killing nerve cells in Alzheimer&rsquo;s. The plaques are deposits of a protein fragment called amyloid-beta that build up in the spaces between nerve cells. Amyloid PET imaging represents a potential major advance in the clinical assessment of people with cognitive impairment. The technology makes amyloid plaques light up on a brain PET scan, enabling for the first time accurate detection of plaques in living people.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The purpose of the IDEAS study is to examine how brain imaging, specifically an amyloid PET scan, helps guide doctors in diagnosing and treating Alzheimer&rsquo;s and other dementias in cases where the cause of cognitive impairment is difficult to diagnose,&rdquo; says Gil D Rabinovici, IDEAS study chair and Associate Professor of Neurology at the University of California, San Francisco, USA. &ldquo;We believe the study will show that, in diagnostically uncertain cases, knowledge of amyloid status will lead to significant changes in patient management&mdash;such as earlier counselling and prescription of more appropriate drugs&mdash;that will translate into improved long-term outcomes.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The IDEAS study was developed in response to the 2013 CMS National Coverage Decision (NCD) on amyloid PET imaging in dementia and neurodegenerative disease (CAG-00431N) not cover the scans because &ldquo;the evidence is insufficient to conclude that the use of positron emission tomography (PET) amyloid-beta (A) imaging is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of...Medicare beneficiaries with dementia or neurodegenerative disease.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />CMS questioned the ability of PET amyloid imaging to lead to improved health outcomes, such as: avoidance of futile treatment or tests, improving or slowing the decline of quality of life, and survival. However, CMS did find sufficient evidence that the use of PET A imaging is promising: (1) to exclude Alzheimer&rsquo;s in narrowly defined and clinically difficult diagnoses, and (2) to enrich clinical trials seeking better treatments or prevention strategies for Alzheimer&rsquo;s. Under the NCD, Medicare will provide coverage for one amyloid PET scan per patient enrolled in an approved clinical study.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&ldquo;I am confident that, at the end of this study, we will have amassed sufficient data to assess whether amyloid imaging has a positive impact on patient outcomes leading to expansion of beneficiary access to this important procedure beyond the IDEAS study,&rdquo; says Maria Carrillo, a co-chair of the IDEAS study and chief science officer at the Alzheimer&rsquo;s Association.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">The IDEAS study in more detail</span></p> <p><span style="font-size: 10pt;"><br />Amyloid PET imaging alone does not establish a diagnosis of Alzheimer&rsquo;s disease, but must be considered in the context of the person&rsquo;s medical history, physical examination, and cognitive testing. To guide clinicians on how best to apply amyloid PET in the clinical evaluation of people with cognitive decline, a working group convened by the Alzheimer&rsquo;s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) developed appropriate use criteria (AUC) for brain amyloid PET scans.</span></p> <p><span style="font-size: 10pt;"><br />The AUC indicate that amyloid PET should only be considered in patients with clear, measurable cognitive deficits when there is substantial diagnostic uncertainty after a comprehensive evaluation by a dementia specialist. According to AUC, amyloid PET may have greatest value in patients with either: (1) progressive, unexplained mild cognitive impairment (MCI); or (2) dementia of uncertain cause due to atypical or mixed symptoms, or unusually early age-of-onset.</span></p> <p><span style="font-size: 10pt;"><br />A total of 18,488 Medicare beneficiaries age 65 and older meeting AUC will be enrolled over 24 months at roughly 200 sites throughout the United States. Study participants will be recruited into one of two sub-groups: (1) progressive, unexplained MCI, and (2) dementia of uncertain cause.</span></p> <p><span style="font-size: 10pt;"><br />All referrals to the study and for amyloid PET will come from dementia specialists, defined by the Alzheimer&rsquo;s Association and SNMMI as &ldquo;physicians trained and board-certified in neurology, psychiatry, or geriatric medicine who devote a substantial proportion of patient contact time to the evaluation and care of adults with acquired cognitive impairment or dementia, including probable or suspected Alzheimer&rsquo;s disease.&rdquo; Dementia specialists will be recruited through societies such as the International Association of Gerontology and Geriatrics, American Academy of Neurology, American Society of Neuroradiology; plus clinician outreach through psychiatrists, members of the Alzheimer&rsquo;s Association, and news media outreach.</span></p></div>2015-04-17T11:39:00Z2015-04-17T11:39:00Zwebeditor@bibamedical.com ALS Association to collaborate with GlaxoSmithKline on new ALS clinical 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>The ALS Association, Harvard Stem Cell Institute, and Massachusetts General Hospital Neurological Clinical Research Institute have announced that they are collaborating with GlaxoSmithKline on a clinical trial to evaluate the potential of an anti-epileptic drug in ALS patients. In parallel testing, brain cells will be made from each patient&rsquo;s stem cells to see if they can predict which patients might respond to the medicine.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The trial will evaluate the potential of the drug, Retigabine, which has a unique mechanism of action and can calm the excitability of nerve cells that are thought to cause seizures. These &ldquo;hyperexcitable neurons&rdquo;are also thought to play a role in ALS. Alongside testing of the medicine, scientists will for the first time create stem cells from these patients to see if they can be used to determine in advance which patients could benefit from the medicine.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study is being led by Brian Wainger of the department of Neurology at Massachusetts General Hospital, in collaboration with Merit Cudkowicz, chief of Neurology at MGH. It will be performed at 12 academic sites within the Northeast ALS Consortium, an international, independent, non-profit group of researchers who collaboratively conduct clinical research in ALS and other motor neuron diseases. GSK will provide the drug, and funding support will come from HSCI, The ALS Association, the MGH NCRI and GSK.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This novel study will provide us with a better understanding of neuron hyperexcitability, a potentially important disease mechanism in ALS patients,&rdquo; says Lucie Bruijn, chief scientist for The ALS Association. &ldquo;This powerful collaboration of leaders in the fields of stem cells, clinical neurology, ALS research and GSK will be the first time that lab data from patient derived stem cells with disease-specific properties that respond to drugs have formed the basis for a clinical trial. It is our hope that this novel approach demonstrates promising results and leads to better clinical trials for ALS patients in the future.&rdquo;</span></p></div>2015-04-16T13:53:00Z2015-04-16T13:53:00Zwebeditor@bibamedical.com utility of real-time navigated laser therapy for lesion ablation within intraoperative MRI suites to be discussed at AANS <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 prominent neurosurgeons will review their clinical experience using real-time navigated laser therapy for brain lesion ablation within intraoperative MRI suites at the upcoming 83<sup>rd</sup> American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (2-6 May, Washington, DC, USA). IMRIS, MRI Interventions, and Monteris Medical jointly announced that the companies are sponsoring the Lunch and Learn seminar scheduled for on Monday, 4 May.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The panel will review workflow and results using Monteris&rsquo; NeuroBlate system, a minimally invasive robotic laser thermotherapy tool, coupled with MRI Interventions&rsquo; ClearPoint navigation system providing precise targeting for procedures conducted within an IMRIS VISIUS Surgical Theatre with intraoperative MRI (iMRI).</span></p> <p><span style="font-size: 10pt;"><br />Veronica LS Chiang of Yale-New Haven Hospital, New Haven, USA, will lead the discussion with panelists John Honeycutt of Cook Children&rsquo;s Hospital, Fort Worth; and Eric C Leuthardt of Barnes-Jewish Hospital, St. Louis.</span></p> <p><span style="font-size: 10pt;"><br />The NeuroBlate System employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue such as tumours and other neurological soft tissue lesions through a minimally invasive and image-guided approach.</span></p> <p><span style="font-size: 10pt;"><br />The ClearPoint system, the only neuro-navigation technology that enables minimally-invasive neurosurgery under continuous magnetic resonance (MR) guidance, provides surgeons with a high-resolution view of the patient&rsquo;s brain and real-time direction during intracranial procedures.</span></p> <p><span style="font-size: 10pt;"><br />The VISIUS Surgical Theatre allows use of the highest quality MR in the operating room&mdash;instead of a radiology or diagnostic room&mdash;and over the OR table by moving it to the patient with ceiling-mounted rails. The fully integrated suites allow the scanner to move between multiple rooms, providing on-demand access to high resolution MR images&mdash;before, during and after procedures, without moving the patient.</span></p> <p><span style="font-size: 10pt;"><br />The AANS Annual Scientific Meeting is one of the largest gatherings of neurological clinicians. More information about the luncheon and other AANS events is available on the society&rsquo;s website: <a href=""></a>.</span></p></div>2015-04-16T11:49:00Z2015-04-16T11:49:00Zwebeditor@bibamedical.com and men have different exclusion criteria for clot-busting stroke drug, say researchers<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>After analysing stroke treatment records, researchers at Rhode Island Hospital in collaboration with researchers from the&nbsp;University of Cincinnati, both USA,&nbsp;learned that women and men have different reasons for being excluded from receiving the common clot-dissolving drug, recombinant tissue plasminogen activator (rt-PA). Importantly, more women had very high blood pressures, which reduced their eligibility to be treated with the highly effective drug. The study was recently published in the American Heart Association&rsquo;s (AHA) journal, <em>Stroke.</em>&nbsp;&nbsp;</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Although men and women had similar overall eligibility rates for rt-PA, women were more likely to have severe hypertension&mdash;a potentially treatable condition, but a reason they can be excluded from receiving t-PA,&rdquo; said&nbsp;Tracy Madsen, an emergency department physician at Rhode Island Hospital. Madsen&rsquo;s main research focus is sex and gender differences in stroke, and she is the primary author of the AHA&nbsp;<em>Stroke</em>&nbsp;paper.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Interestingly, although the women were more likely to have severe hypertension, this treatable condition was often untreated,&rdquo; Madsen added.</span></p> <p><span style="font-size: 10pt;"><br />According to the&nbsp;US National Stroke Association, stroke is the third leading cause of death for women. In comparison, stroke is the fifth leading cause of death for men. Each year, 55,000 more women have a stroke than men. In general, women live longer than men and have more long-term negative consequences after stroke, so stroke will have a more negative impact on their lives.</span></p> <p><span style="font-size: 10pt;"><br />In addition to the hypertension exclusion, researchers found that women were more likely to be excluded from rt-PA treatment because of other factors, such as advanced age (80+) and very large strokes.</span></p> <p><span style="font-size: 10pt;"><br />As part of a large population-based stroke study, the researchers studied the records of all adult ischaemic stroke patients at 16 hospitals in southwest Ohio and northern Kentucky, USA, in 2005. Patient eligibility for rt-PA treatment and individual exclusion criteria was determined using the 2013 AHA and European Cooperative Acute Stroke Study (ECASS) III guidelines.</span></p> <p><span style="font-size: 10pt;"><br />The study was funded by a grant from the National Institutes of Neurological Disorders and Stroke. Madsen&rsquo;s principal affiliation is Rhode Island Hospital, and she also holds an academic appointment in the Department of Emergency Medicine (EM) at The Warren Alpert Medical School of Brown University. Within the Department of EM, Madsen is affiliated with both the Division of Sex and Gender in EM as well as the Division of Neurological Emergencies. Co-authors represent the University of Cincinnati College of Medicine, Cincinnati Children&rsquo;s Hospital Medical Center, and the Sanna Healthcare Network.</span></p></div>2015-04-14T12:42:00Z2015-04-14T12:42:00Zwebeditor@bibamedical.com Medical’s Nautilus BrainPulse detected cerebral vasospasm with clinically meaningful accuracy in UCSF study<div style="clear:both;"><p><strong><span style="font-size: 11pt;">Jan Medical has announced that a clinical study published in <em>Neurocritical Care</em>&nbsp;demonstrated that Nautilus BrainPulse is a highly sensitive skull accelerometry that can detect cerebral vasospasm &ldquo;with clinically meaningful accuracy&rdquo;, therefore suggesting, &ldquo;promise in the ICU environment to detect as well as reject cerebral vasospasm as the cause of neurological deficits in subarachnoid haemorrhage.&rdquo;</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Principal investigator for the Nautilus BrainPulse study was Wade S Smith, director, UCSF Neuroscience ICU, Professor of Neurology, University of California, San Francisco, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;What we need is a safe, noninvasive, user-independent method to detect cerebral vasospasm&nbsp;before&nbsp;it causes brain injury,&rdquo; says Smith. &ldquo;The technology needs to be simple, and portable, to be most effective in the Neuro Critical Care setting, by more immediately detecting vasospasm so we can aggressively prevent stroke with cerebral angioplasty and/or vasospressor therapy. Such a technology holds the promise to directly help patients and shorten the length of stay within the Neuro ICU.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our Nautilus BrainPulse&nbsp;system can rapidly provide critical information on a patient presenting with stroke symptoms, and it can also be used as a continuous monitor of changes to the cerebral vasculature. It is this latter ability, continuous monitoring, that provides a unique capability in detecting the onset of vasospasm,&rdquo; adds&nbsp;Paul Lovoi, chief executive officer of&nbsp;Jan Medical. &ldquo;This study has confirmed that our portable and continuous brain-sensing system can detect vasospasms quickly and noninvasively.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The Nautilus BrainPulse is designed to measure the normal brain pulse as well as disruptions of the brain pulse. By digitising the signal patterns from headset-mounted sensors measuring the skull&rsquo;s motion, and extracting features from them, algorithms have been developed to identify normal and a variety of abnormal brain pulse patterns in recording sessions that take approximately three minutes. The device is portable, entirely non-invasive and provides analysis immediately once the recording session is completed.</span></p></div>2015-04-14T11:13:00Z2015-04-14T11:13:00Zwebeditor@bibamedical.com DNA mutations may result in a better prognosis for 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>DNA mutations can cause cancer but in some cases, more mutations may mean a better prognosis for patients, according to a Yale-led comprehensive genomic analysis of more than 700 brain tumours. One such subtype of the most malignant brain tumour&mdash;glioblastoma&mdash;possesses thousands of tumour-specific DNA errors or mutations instead of dozens observed in most glioblastoma cases. It is also associated with longer survival.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The findings, reported in <em><a href="">Neuro-Oncology</a></em>, suggest it may be possible to develop personalised treatments for more aggressive forms of brain cancer, including immunotherapy for these hyper- or ultra-mutated tumours, said Murat G&uuml;nel, professor and chair of neurosurgery, who leads the Yale Program in Brain Tumor Research at Yale and Smilow Cancer Hospital at Yale-New Haven, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We have been able to translate various complementary cutting-edge genomic technologies, which were once solely research tools, to our clinical programmes to analyse individual cancers,&rdquo; said G&uuml;nel, who is also a professor of genetics and a researcher for the Yale Cancer Center. &ldquo;We can now gain comprehensive understanding of the molecular make-up of a cancer to pinpoint specific vulnerabilities and leverage these weak spots for precision treatments in our Recurrent Brain Tumor Treatment Program.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">While as many as 10,000 mutations were found in the newly described subset of glioblastomas, a more typical tumour contains less than 100. This counterintuitive pattern has also been observed in gynecological and colon cancers: an extraordinary number of mutations means a better chance of survival.</span><br /><br /></p> <p><span style="font-size: 10pt;">One theory holds that cells with greater number of mutations are able to trigger an aggressive immune system response against cancer cells, while cells with fewer mutations might escape detection, Gunel said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Although the number of glioblastomas in this newly identified group is small, the use of standard chemotherapy in some cases has been shown to inadvertently result in a hyper-mutated tumour. Indeed, the drug temozolomide, used as the first line of chemotherapy in glioblastoma, has been shown to sometimes increase mutations.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;But perhaps the na&iuml;ve immune system is not strong enough to eliminate the cancer cells in these brain tumours,&rdquo; Gunel noted.</span><br /><br /></p> <p><span style="font-size: 10pt;">However, if a new generation of immunotherapy drugs called checkpoint inhibitors were used in these hyper-mutated tumours, perhaps more cancer cells might be targeted for destruction, he said. Clinical trials currently underway might be improved by considering the molecular genetic make-up of the individual tumour, he concluded.</span><br /><br /></p> <p><span style="font-size: 10pt;">The work was funded by the Gregory Kiez and Mehmet Kutman Foundation and was co-authored by Zeynep Erson-Omay and Ahmet Okay &Ccedil;ağlayan from Yale.</span></p></div>2015-04-13T13:45:00Z2015-04-13T13:45:00Zwebeditor@bibamedical.com build brain–machine interface to control prosthetic hand<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 research team from the University of Houston has created an algorithm that allowed a man to grasp a bottle and other objects with a prosthetic hand, powered only by his thoughts.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The technique, demonstrated with a 56-year-old man whose right hand had been amputated, uses non-invasive brain monitoring, capturing brain activity to determine what parts of the brain are involved in grasping an object. With that information, researchers created a computer programme&mdash;or brain-machine interface&mdash;that harnessed the subject&rsquo;s intentions and allowed him to successfully grasp objects, including a water bottle and a credit card. The subject grasped the selected objects 80% of the time using a high-tech bionic hand fitted to the amputee&rsquo;s stump.<br /><br /></span></p> <p><span style="font-size: 10pt;">Previous studies involving either surgically implanted electrodes or myoelectric control, which relies upon electrical signals from muscles in the arm, have shown similar success rates, according to the researchers.</span><br /><br /></p> <p><span style="font-size: 10pt;">Jose Luis Contreras-Vidal, a neuroscientist and engineer at the University of Houston, said the non-invasive method offers several advantages: It avoids the risks of surgically implanting electrodes by measuring brain activity via scalp electroencephalogram (EEG), and myoelectric systems are not an option for all patients, as they require that neural activity from muscles relevant to hand grasping remain intact.<br /><br /></span></p> <p><span style="font-size: 10pt;">The results of the study were published in <em><a href="">Frontiers in Neuroscience</a></em>, in the Neuroprosthetics section.</span><br /><br /></p> <p><span style="font-size: 10pt;">Contreras-Vidal, Hugh Roy and Lillie Cranz Cullen Distinguished Professor of electrical and computer engineering at the University of Houston, was lead author of the paper, along with graduate students Harshavardhan Ashok Agashe, Andrew Young Paek and Yuhang Zhang.</span><br /><br /></p> <p><span style="font-size: 10pt;">The work, funded by the National Science Foundation, demonstrates for the first time EEG-based brain&ndash;machine interface control of a multi-fingered prosthetic hand for grasping by an amputee. It could also lead to the development of better prosthetics, Contreras-Vidal said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Beyond demonstrating that prosthetic control is possible using non-invasive EEG, researchers said the study offers a new understanding of the neuroscience of grasping and will be applicable to rehabilitation for other types of injuries, including stroke and spinal cord injury.&nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">The study subjects&mdash;five able-bodied, right-handed men and women, all in their 20s, as well as the amputee&mdash;were tested using a 64-channel active EEG, with electrodes attached to the scalp to capture brain activity. Contreras-Vidal said brain activity was recorded in multiple areas, including the motor cortex and areas known to be used in action observation and decision-making, and occurred between 50 milliseconds and 90 milliseconds before the hand began to grasp. That provided evidence that the brain predicted the movement, rather than reflecting it, he said.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;Current upper limb neuroprosthetics restore some degree of functional ability, but fail to approach the ease of use and dexterity of the natural hand, particularly for grasping movements,&rdquo; the researchers wrote, noting that work with invasive cortical electrodes has been shown to allow some hand control but not at the level necessary for all daily activities.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Further, the inherent risks associated with surgery required to implant electrodes, along with the long-term stability of recorded signals, is of concern&hellip;Here we show that it is feasible to extract detailed information on intended grasping movements to various objects in a natural, intuitive manner, from a plurality of scalp EEG signals.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Until now, this was thought to be possible only with brain signals acquired invasively inside or on the surface of the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers first recorded brain activity and hand movement in the able-bodied volunteers as they picked up five objects, each chosen to illustrate a different type of grasp: a soft drinks can, a compact disc, a credit card, a small coin and a screwdriver. The recorded data were used to create decoders of neural activity into motor signals, which successfully reconstructed the grasping movements.</span><br /><br /></p> <p><span style="font-size: 10pt;">They then fitted the amputee subject with a computer-controlled neuroprosthetic hand and told him to observe and imagine himself controlling the hand as it moved and grasped the objects.&nbsp;The subject&rsquo;s EEG data, along with information about prosthetic hand movements gleaned from the able-bodied volunteers, were used to build the algorithm.</span></p> <p><span style="font-size: 10pt;">Contreras-Vidal said additional practice, along with refining the algorithm, could increase the success rate to 100%.</span></p></div>2015-04-10T15:23:00Z2015-04-10T15:23:00Zwebeditor@bibamedical.com Technologies announces partnership with Epimed International<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 announced a partnership with&nbsp;Epimed International.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The partnership, in addition to co-product development, will support distribution of Stimwave&rsquo;s Wireless Pain Relief technology, expanding the Stimwave USA network to more than 100 sales representatives speaking directly to doctors, medical centres and hospitals across the country. Stimwave&rsquo;s wireless neuromodulation device became available in the USA in January 2015.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is an extremely significant partnership that will dramatically accelerate the introduction of Stimwave&rsquo;s Wireless Pain Relief technology not only to physicians across the country, but more importantly to the millions of chronic pain patients who will benefit from it,&rdquo; said Stimwave chairman Laura Tyler Perryman.</span><br /><br /></p> <p><span style="font-size: 10pt;">The partnership will include Stimwave utilisation of Epimed&rsquo;s manufacturing, packaging, fulfilment, distribution, reimbursement and physician services.</span></p></div>2015-04-10T14:57:00Z2015-04-10T14:57:00Zwebeditor@bibamedical.com restores brain function and memory in early Alzheimer’s disease<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 novel therapeutic approach for an existing drug reverses a condition in elderly patients who are at high risk for dementia due to Alzheimer&rsquo;s disease, researchers at Johns Hopkins University found.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The drug, commonly used to treat epilepsy, calms hyperactivity in the brain of patients with amnestic mild cognitive impairment (aMCI), a clinically recognised condition in which memory impairment is greater than expected for a person&rsquo;s age and which greatly increases risk for Alzheimer&rsquo;s dementia, according to the study published in&nbsp;<em><a href="">NeuroImage: Clinical</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">The findings validate the Johns Hopkins team&rsquo;s initial conclusions,&nbsp;<a href="">published three years ago</a>&nbsp;in the journal <em>Neuron</em>. They also closely match the results in animal studies performed by the team and scientists elsewhere. Next, neuroscientist Michela Gallagher, the lead investigator, hopes the therapy will be tested in a large-scale, longer-term clinical trial.</span><br /><br /></p> <p><span style="font-size: 10pt;">Hippocampal over-activity is well-documented in patients with aMCI and its occurrence predicts further cognitive decline and progression to Alzheimer&rsquo;s dementia, Gallagher said.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we have shown is that very low doses of the atypical antiepileptic levetiracetam reduces this over-activity,&rdquo; Gallagher said. &ldquo;At the same time, it improves memory performance on a task that depends on the hippocampus.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The team studied 84 subjects. Seventeen were healthy participants and the rest showed symptoms of pre-dementia memory loss defined as aMCI. Everyone was over 55 years old, with an average age of about 70.</span><br /><br /><span style="font-size: 10pt;"> The subjects were given varying doses of the drug and also a placebo in a double-blind randomised trial. Researchers found low doses both improved memory performance and normalised the over-activity detected by functional magnetic resonance imaging that measures brain activity during a memory task. The ideal dosing found in this clinical study matched earlier preclinical studies in animal models.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we want to discover now, is whether treatment over a longer time will prevent further cognitive decline and delay or stop progression to Alzheimer&rsquo;s dementia,&rdquo; Gallagher said.</span></p></div>2015-04-10T14:44:00Z2015-04-10T14:44:00Zwebeditor@bibamedical.com appoints Gabor Racz as chair of Medical Advisory Board<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 appointed Gabor Racz as the chair of the Stimwave medical advisory board. Honoured with numerous lifetime achievement awards throughout the industry, a company press release says that &ldquo;Racz is considered by many to be the father of interventional pain medicine.&rdquo;</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Gabor&nbsp;Racz is a renowned leader in the field of pain medicine, and we look forward to benefiting from his guidance and expertise,&rdquo; said Laura Tyler Perryman, chairman and chief executive officer of Stimwave.</span><br /><br /></p> <p><span style="font-size: 10pt;">Racz has been honoured with several lifetime achievement awards from societies throughout the world in recognition of contributions that span more than five decades. Racz is one of the founders and past presidents of the World Institute of Pain, as well as chairman emeritus and a lifetime member of the executive board.</span><br /><br /></p> <p><span style="font-size: 10pt;">Racz was also instrumental in the development of the American Society of Interventional Pain Physicians, a society of over 4,500 members specialising in pain medicine. In honour of Racz, the annual keynote speech of the society is called the Raj and Racz Award. He is currently chairman emeritus at the Department of Anesthesiology at Texas Tech University Health Science Center in Lubbock, USA, and an acknowledged Grover E Murray professor. Racz was the first to introduce the concept of using needle/catheter-based procedures to replace drug and other therapies for people suffering from chronic pain.</span></p></div>2015-04-03T14:45:00Z2015-04-03T14:45:00Zwebeditor@bibamedical.com outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis <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 a post-hoc analysis of the use of general anaesthesia in the MR CLEAN trial (Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands) investigators have found that the subgroup of patients treated without general anaesthesia benefited more from the endovascular treatment than the subgroup treated under general anaesthesia.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Olvert Berkhemer, Department of Radiology, Academic Medical Center, Amsterdam, the Netherlands, presented the results of the analysis at the International Stroke Conference (ISC, 11&ndash;13 February, Nashville, USA). MR CLEAN, a pragmatic, phase 3 clinical trial, compared intra-arterial treatment (intra-arterial thrombolysis, mechanical treatment, or both) plus usual care (which could include intravenous administration of alteplase) with usual care alone (control group) in patients with acute ischaemic stroke and a proximal intracranial arterial occlusion of the anterior circulation that was confirmed on vessel imaging. The results of the trial showed better outcomes in favour of intervention.</span></p> <p><span style="font-size: 10pt;"><br />Speaking of the post-hoc analysis, Berkhemer reported, &ldquo;We found that the treatment effect we saw in MR CLEAN in the subgroup of patients treated under general anaesthesia was less than the patients treated without general anaesthesia. We cannot definitely say that patients treated with general anaesthesia did not benefit, the benefit was certainly less.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Discussing the advantages and disadvantages of the use of general anaesthesia versus no general anaesthesia, Berkhemer compared the two, pointing out that general anaesthesia is generally associated with shorter procedural duration, delayed treatment time and higher risk of aspiration; while on the other hand, a non-general anaesthesia procedure is associated with faster treatment initiation, the ability for neurological assessment during intra-arterial treatment, patient movement with the risk of vessel perforation or dissection, and conversion to general anaesthesia with emergency intubation with higher likelihood of aspiration.</span></p> <p><span style="font-size: 10pt;"><br />The primary outcome was assessed using the score on the modified Rankin Scale at 90 days, while secondary outcomes included timing, safety parameters and procedural-related adverse events.</span></p> <p><span style="font-size: 10pt;">Of the 233 patients allocated to intra-arterial treatment, 79 were treated under general anaesthesia, and 137 without general anaesthesia (17 patients did not reach the angiosuite in MR CLEAN).</span></p> <p><span style="font-size: 10pt;"><br />Using the modified Rankin Scale score to assess patient outcome at 90 days, Berkhemer 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> <p><span style="font-size: 10pt;"><br />He concluded, noting, &ldquo;General anaesthesia is associated with delayed treatment initiation in the MR CLEAN trial. Procedural durations were equivalent in both groups, and there was no significant difference in time to revascularisation. There were no safety concerns in either group.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Further, Berkhemer underscored that &ldquo;there was significant interaction with treatment. The effect on outcome that we found in the MR CLEAN trial was not observed in the subgroup of patients treated with general anaesthesia.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />As for whether this analysis has the potential to influence change in current practice, Berkhemer explained that in the Netherlands there are already hospitals changing. &ldquo;They are leaving behind the &ldquo;always general&rdquo; approach, except in cases where it is absolutely necessary (for example, a patient who is moving around a lot), and avoiding general anaesthesia wherever is it possible,&rdquo; he said. &nbsp;</span></p> <p><span style="font-size: 10pt;"><br />He added that the findings of this post-hoc analysis will have to be confirmed by other trials, including the ongoing ANSTROKE (Sedation versus general anesthesia for endovascular therapy in acute stroke&mdash;impact on neurological outcome) and GOLIATH (General or local anaesthesia in intra-arterial therapy) trials.</span></p></div>2015-04-02T12:38:00Z2015-04-02T12:38:00Zwebeditor@bibamedical.coméal scientists get one step closer to finding how to repair damaged nerve 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>A team of researchers at the IRCM led by&nbsp;Fr&eacute;d&eacute;ric Charron, in collaboration with bioengineers at McGill University, uncovered a new kind of synergy in the development of the nervous system, which explains an important mechanism required for neural circuits to form properly. Their breakthrough, published in the scientific journal&nbsp;<em>PLoS Biology</em>, could eventually help develop tools to repair nerve cells following injuries to the nervous system (such as the brain and spinal cord).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Researchers in Charron&rsquo;s laboratory study neurons, the nerve cells that make up the central nervous system, as well as their long extensions known as axons. During development, axons must follow specific paths in the nervous system in order to properly form neural circuits and allow neurons to communicate with one another. IRCM researchers are studying a process called axon guidance to better understand how axons manage to follow the correct paths.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;To reach their target, growing axons rely on molecules known as guidance cues, which instruct them on which direction to take by repelling or attracting them to their destination,&rdquo; explains Charron, director of the Molecular Biology of Neural Development research unit at the IRCM.</span></p> <p><span style="font-size: 10pt;"><br />Over the past few decades, the scientific community has struggled to understand why more than one guidance cue would be necessary for axons to reach the proper target. In this paper, IRCM scientists uncovered how axons use information from multiple guidance cues to make their pathfinding decisions. To do so, they studied the relative change in concentration of guidance cues in the neuron&rsquo;s environment, which is referred to as the steepness of the gradient.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We found that the steepness of the gradient is a critical factor for axon guidance; the steeper the gradient, the better the axons respond to guidance cues,&rdquo; says&nbsp;Tyler FW Sloan, PhD student in Charron&rsquo;s laboratory and first author of the study. &ldquo;In addition, we showed that the gradient of one guidance cue may not be steep enough to orient axons. In those instances, we revealed that a combination of guidance cues can behave in synergy with one another to help the axon interpret the gradient&rsquo;s direction.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In collaboration with the Program in Neuroengineering at McGill University, Charron&rsquo;s team developed an innovative technique to recreate the concentration gradients of guidance cues&nbsp;<em>in vitro</em>, that is to say they can study the developing axons outside their biological context.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This new method provides us with several benefits when compared to previous techniques, and allows us to simulate more realistic conditions encountered in developing embryos, conduct longer-term experiments to observe the entire process of axon guidance, and obtain extremely useful quantitative data,&rdquo; adds Sloan. &ldquo;It combines knowledge from the field of microfluidics, which uses fluids at a microscopic scale to miniaturise biological experiments, with the cellular, biological and molecular studies we conduct in laboratories.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is true multidisciplinary work, and an excellent example of what the Program in Neuroengineering aims to accomplish in situations where neurobiologists like myself have a specific question they want to address, but the current tools are not adapted to answer their question,&rdquo; mentions Charron. &ldquo;Thus, thanks to this unique programme, we teamed up with McGill&rsquo;s bioengineers and microfluidic and mathematical modelling experts to create the device required for our study.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This scientific breakthrough could bring us closer to repairing damaged nerve cells following injuries to the central nervous system,&rdquo; states Charron. &ldquo;A better understanding of the mechanisms involved in axon guidance will offer new possibilities for developing techniques to treat lesions resulting from spinal cord injuries, and possibly even neurodegenerative diseases.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Injuries to the central nervous system affect thousands of Canadians every year and can lead to lifelong disabilities. Most often caused by an accident, stroke or disease, these injuries are currently very difficult to repair. Research is therefore required for the development of new tools to repair damage to the central nervous system.</span></p></div>2015-04-02T10:57:00Z2015-04-02T10:57:00Zwebeditor@bibamedical.com Sankyo Inc and Asubio Pharmaceuticals merge <div style="clear:both;"><p><strong><span style="font-size: 11pt;">Daiichi Sankyo Inc, the US subsidiary of Daiichi Sankyo Company, will merge with its US-based sister company, Asubio Pharmaceuticals.&nbsp; As a result, Asubio Pharmaceuticals projects will be integrated into the Daiichi Sankyo global development organisation, led by Mahmoud Ghazzi.</span></strong></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Asubio Pharmaceuticals&rsquo; parent company, Asubio Pharma Co, which is based in Japan, will continue to operate as a wholly owned subsidiary of Daiichi Sankyo Co, with a focus on discovery research.</span><br /><br /></p> <p><span style="font-size: 10pt;">Asubio Pharmaceuticals&rsquo;s ongoing clinical trial in patients with acute spinal cord injury (ASBI 603ASCENT study (SUN13837)) has already completed enrolment. An analysis and dissemination of the data will now be managed by Daiichi Sankyo.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;In line with the Daiichi Sankyo five-year business plan to optimise our business of delivering innovative treatments to patients, consolidating the current Asubio US projects under the company&rsquo;s overall research and development organisation helps us streamline our operations,&rdquo; said Glenn Gormley, senior executive officer and global head of research and development, Daiichi Sankyo Company, and executive chairman and president, Daiichi Sankyo, Inc.</span></p></div>2015-04-01T14:10:00Z2015-04-01T14:10:00Zwebeditor@bibamedical.com, CNS and Joint Cerebrovascular Section endorse interventional thrombectomy in treatment of acute ischaemic stroke<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>Until recently, thrombolytic therapy has been the only proven treatment for acute ischaemic stroke. A recent study in the Netherlands, however, found that interventional thrombectomy improved functional outcomes in patients with emergent cranial large-vessel occlusions, even among patients who had already received tissue plasminogen activator (tPA) for thrombolytic therapy.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The American Association of Neurological Surgeons, the Congress of Neurological Surgeons, and the Joint AANS/CNS Cerebrovascular Section strongly endorse interventional thrombectomy in the treatment of acute ischaemic stroke in their article, &ldquo;MR CLEAN: past the tipping point of clinical equipoise,&rdquo; by Henry H Woo <em>et al</em>, published online, ahead of print, in the&nbsp;<em><a href="">Journal of Neurosurgery</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">Five hundred patients with imaging-confirmed occlusion of proximal arteries in the anterior cerebral circulation were enrolled in MR CLEAN (the multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands) and treated within six hours of symptom onset. All patients were given the usual standard of care, which included prompt administration of tPA (alteplase) in 89% of patients. Approximately half of the patients also received interventional thrombectomy, which in 82% was accomplished using retrievable stents. The addition of interventional thrombectomy proved more favourable than usual care alone, with a 13.5% improvement in the absolute rate of functional independence between the two treatment groups. The results of MR CLEAN were reported in the&nbsp;<em><a href="">New England Journal of Medicine</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">Woo and colleagues describe differences between MR CLEAN and three previous studies that were unable to prove the advantages of interventional thrombectomy for acute ischaemic stroke. The earlier studies suffered from lack of imaging confirmation of large-vessel occlusion, use of antiquated interventional technologies, and insufficient statistical power. The authors applaud the achievements of MR CLEAN.</span><br /><br /></p> <p><span style="font-size: 10pt;">Speaking to the future, Woo and colleagues point out that work still needs to be done to improve patients&rsquo; lives following ischaemic stroke. The authors call on neurosurgeons and all health care professions to improve patient care by identifying and triaging patients with emergent large-vessel occlusion with greater accuracy and speed. They point out that these lesions may be more time sensitive than acute myocardial infarction, and first responders and the public should be trained to respond quickly and efficiently.</span></p></div>2015-04-01T10:00:00Z2015-04-01T10:00:00Zwebeditor@bibamedical.com reopens enrolment for subjects for anticipated completion of ongoing pilot 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>InVivo Therapeutics has announced the reopening of subject enrolment for the company&rsquo;s ongoing investigational device exemption pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrolment of each subject. To date, there have been no reported serious safety events related to the Neuro-Spinal Scaffold or the procedure to implant the Neuro-Spinal Scaffold with the study&rsquo;s first and second subjects, and InVivo has been approved by Food and Drug Administration and the Data Safety Monitoring Board to move forward with the study.</span><br /><br /></p> <p><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer and chairman, said, &ldquo;Despite a severe, multi-trauma injury that included a collapsed lung and resulted in a two day delay in spinal stabilisation and Neuro-Spinal Scaffold implantation, the second subject has not experienced any serious safety events to date related to our investigational product. Although we cannot predict when subjects will present, we anticipate enrolling subjects three through five this calendar year, which would complete enrolment for the pilot trial. We can now enrol the final patients concurrently, and we now have eight active clinical sites that can participate in this trial.&rdquo;</span></p></div>2015-03-27T14:47:00Z2015-03-27T14:47:00Zwebeditor@bibamedical.com Medical spotlights New Edge radiosurgery suite for non-invasive surgical procedures<div style="clear:both;"><p><span style="font-size: 11pt;"><strong>The Edge radiosurgery suite, a technology system for rapidly delivering precise, non-invasive surgical procedures in the treatment of cancer, is among the medical innovations that Varian Medical Systems is showcasing at the 27th International Medical Instruments &amp; Equipment Exhibition (26&ndash;28 March, Beijing, China).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Edge radiosurgery system offers clinicians a non-invasive alternative to traditional surgery. It accurately targets tumours and other abnormalities without an incision or the need for recovery in a hospital setting,&rdquo; said Dee Khuntia, Varian&rsquo;s vice president for medical affairs and chief medical officer. &ldquo;Cancer specialists can use the Edge system to accurately target tumours of the brain, spine, lung, and other areas that are typically difficult to treat surgically.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">As a non-invasive option, radiosurgery use in the USA has been growing steadily over the last decade for the treatment of cancer and other conditions that can be appropriately treated with focused radiation. Predictions are that it will continue to grow as research accrues about the benefits to patients. Radiosurgery involves the use of sophisticated software and hardware to ablate tumours or other abnormalities with high doses of radiation while minimising exposure of surrounding healthy tissue. Varian says that the Edge system can complete sophisticated radiosurgery treatments in just a few minutes&mdash;much faster than earlier generations of technology.</span><br /><br /></p> <p><span style="font-size: 10pt;">Edge was first unveiled in 2012 in the United States, and received clearance from the CFDA of China in 2014. As of March 2015, Edge systems had been installed and used at cancer centres in the USA, UK, Portugal, Italy, and Switzerland. Users have reported over 1,000 patients have now been treated using Edge technology, for lung, brain, gastrointestinal, genitourinary, and other types of cancer.</span><br /><br /></p> <p><span style="font-size: 10pt;">Clinicians at the Henry Ford Health System in Detroit, USA, were the first to use the Edge radiosurgery system in the USA. They have been presenting studies at the scientific meetings of the American Association of Physicists in Medicine (AAPM) and the American Society for Radiation Oncology (ASTRO).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Last year, we reported that the Edge radiosurgery system can deliver dose to a targeted tumour with sub-millimetre accuracy,&rdquo; said Salim Siddiqui, director of the stereotactic radiosurgery programme at Henry Ford. &ldquo;Compared with many other robot- or frame-based radiosurgery systems, the Edge is more convenient, more robust, more versatile, and substantially more efficient because it can be used to target multiple tumours at once and can treat anywhere in the body. Moreover, with the capability to deliver 2,400 monitor units per minute, some treatments can be completed up to four times faster than on other systems.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The Edge offers multiple advanced imaging modalities, including on-demand X-ray imaging and 4-D cone-beam computed tomography, for localisation and tracking of the patient&rsquo;s position throughout the treatment, which has greatly enhanced our confidence in the accuracy and efficiency of frameless stereotactic treatment,&rdquo; added Ning Wen, stereotactic radiosurgery physics lead. &ldquo;It has given us a variety of strategies to take aim at cancer.&rdquo;</span></p></div>2015-03-27T09:43:00Z2015-03-27T09:43:00Zwebeditor@bibamedical.com Canada greenlights IMRIS ceiling-mounted intraoperative CT solution <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>IMRIS Inc has announced that VISIUS iCT, the first and only ceiling-mounted intraoperative computed tomography scanner, has received Health Canada licensing allowing for sales and marketing in the country.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This completes our roll-out of VISIUS iCT for North America and another step in our overall global distribution,&rdquo; says IMRIS president and chief executive officer Jay D Miller. &ldquo;As procedures become more minimally invasive, the need for better visualisation with advanced imaging increases. VISIUS iCT places the highest quality CT imaging inside the operating room. This scanner delivers more flexibility for both bone and soft tissue scanning compared to other intraoperative CT scanners on the market.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />According to the company, VISIUS iCT provides personalised dose management together with diagnostic quality imaging during the surgical procedure to assist surgeons in critical decision making. Developed for the neurosurgery and spine surgery markets, VISIUS iCT has the 64-slice Siemens SOMATOM Definition AS scanner as its core technology&mdash;making it the highest quality computed tomography imagery in an operating room. Unlike other mobile intraoperative CT systems on the market, the VISIUS iCT can support complex brain tumour resection and neurovascular procedures.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Both neurosurgeons and spine surgeons will find this unique solution helpful in supporting the full spectrum of intracranial, spinal and neurovascular procedures,&rdquo; Miller adds.</span></p> <p><span style="font-size: 10pt;"><br />The scanner effortlessly moves into and out of the operating room during surgery using ceiling-mounted rails to ease workflow. This enables multiple room configurations to meet both clinical requirements and increase utilisation without compromising image quality or exam speed. Patient transport and the need for floor-mounted rails used in other systems is eliminated which opens up valuable operating room space and allows unimpeded movement of surgical equipment and simplified infection control.</span></p> <p><span style="font-size: 10pt;"><br />In addition, VISIUS iCT features a suite of software applications such as 3D volume rendering to aid in surgical planning and dose reduction which considers each patient&rsquo;s unique characteristics to maximise image quality and minimise dose. The system software allows healthcare practitioners to visualise dosage prior to scan and adjust settings based on the specific clinical need with detailed dosage reports produced after each scan.</span></p></div>2015-03-26T12:08:00Z2015-03-26T12:08:00Zwebeditor@bibamedical.com surpasses traditional spinal cord stimulation in first controlled trial comparing technologies<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 first-ever randomised, controlled trial to compare spinal cord stimulation technologies found that high-frequency stimulation using 10kHz (HF10) exceeded lower-frequency, traditional stimulation in response rate and pain relief. Further, this was achieved without the paraesthesia that may cause discomfort with traditional treatment, the researchers reported in a scientific poster at the 31st Annual Meeting of the American Academy of Pain Medicine (19&ndash;22 March, Washington, DC, USA).</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Traditional spinal cord low-frequency (~50 Hz) stimulation is an attempt to mask the sensation of pain with paraesthesia. Therefore, the therapeutic goal with traditional stimulation is to cover the areas of pain with paraesthesias, explained B Todd Sitzman, medical director of Advanced Pain Therapy, PLLC, in Hattiesburg, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">In contrast, &ldquo;high-frequency HF10 therapy utilises a stimulation frequency that is orders of magnitude higher than traditional spinal cord stimulation,&rdquo; Sitzman said. &ldquo;HF10 therapy does not produce paraesthesias and achieves superior back and leg pain relief.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">More importantly, HF10 therapy was shown to be superior to traditional stimulation in all of the study-related primary and secondary endpoints, including response rate and pain relief. The magnitude of back pain relief was consistent with previous European research of HF10 therapy.<br /><br /></span></p> <p><span style="font-size: 10pt;">The use of spinal cord stimulation, introduced in 1967, has expanded as a treatment for difficult pain syndromes, encompassing peripheral neuropathies, complex regional pain syndromes, peripheral vascular disease and other disorders in addition to failed back surgery syndrome.</span><br /><br /></p> <p><span style="font-size: 10pt;">Traditional low-frequency stimulation systems are widely used in clinical practice. However, the scientific literature indicates that achieving back pain coverage with traditional spinal cord stimulation is technically difficult and is often not sustained over time. According to one report, 71% of patients who received an implant with traditional stimulation experienced discomfort from the stimulation of paraesthesia. In the current study, 44% of patients receiving traditional spinal cord stimulation reported uncomfortable stimulation.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study was a prospective, randomised, multicentre, comparative trial of the investigational HF10 vs the standard stimulation therapy, designed in consultation with and monitored by the Food and Drug Administration (FDA). Institutional review board approval was obtained for each study site.</span><br /><br /></p> <p><span style="font-size: 10pt;">The 12-month follow-up data indicated that the responder rate with HF10 therapy was twice that with traditional stimulation for both back and leg pain. Also, the average degree of pain relief with HF10 therapy was more than 50% greater than with traditional stimulation. The level-1 evidence with 12-month follow-up meets the current rigorous standards for evidence-based healthcare and complies with regulatory agency and payer preference for comparative effectiveness, the investigators said.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These results provide important comparative effectiveness data for healthcare providers and clinically relevant information for pain physicians, patients and payers,&rdquo; Sitzman said.</span><br /><br /></p> <p><span style="font-size: 10pt;">At present, HF10 therapy is investigational in the USA. The manufacturer of the device, Nevro Corp, which funded this study, anticipates obtaining market approval from the FDA by mid-2015.</span></p></div>2015-03-26T11:33:00Z2015-03-26T11:33:00Zwebeditor@bibamedical.com who suffer migraine headaches may be at double the risk of 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>Numerous individual studies and meta-analyses have demonstrated that people who have migraines with aura are at a higher risk for ischaemic stroke. Citing these and other studies, Loyola University Medical Center neurologists Michael Star, and Jos&eacute; Biller, have described the association between stroke and migraine in their chapter in the new text <em>Headache and Migraine Biology and Management</em>.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">About 85% of strokes are ischaemic. Migraine with aura is a migraine headache that is preceded by an aura, which typically includes flashes of light, bright spots, blind spots and perhaps tingling in the hands or face. Recent studies also suggest there is a link between migraines and haemorrhagic strokes, caused by bleeding in the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The biology underlying the relationship between migraine and stroke is poorly defined,&rdquo; write Star and Biller. As such, researchers have proposed several possible explanations for the migraine-stroke association:</span></p> <ul> <li><span style="font-size: 10pt;">Migraine sufferers are more likely to have risk factors for cardiovascular disease, including low levels of HDL (also known as &ldquo;good cholesterol&rdquo;) and high levels of c-reactive protein.</span></li> <li><span style="font-size: 10pt;">Specific genes may predispose people to suffer both migraines and stroke.&nbsp;</span></li> <li><span style="font-size: 10pt;">Medications to treat migraines may increase the risk of stroke.&nbsp;</span></li> <li><span style="font-size: 10pt;">A phenomenon that occurs during migraine aura&mdash;cortical spreading depression&mdash;might trigger an ischaemic stroke. A cortical spreading depression is a slowly propagated wave of depolarisation, followed by depression of brain activity occurring during migraine aura. It includes changes in neural and vascular function.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;Taking all of these possible explanations into account, the research may point to stroke and migraine sharing a reciprocal causal relationship,&rdquo; Star and Biller write. &ldquo;There is a significant amount of research attempting to further elucidate this multifaceted relationship.&rdquo;</span></p></div>2015-03-26T11:06:00Z2015-03-26T11:06:00Zwebeditor@bibamedical.com tinnitus treatment study reduces total symptoms by almost 40% <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>Tinnitus affects around 10% of the population in the UK and in its severe form can cause sleep loss, anxiety, depression and a significant reduction in their quality of life.</strong></span></p></div><div style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Now, a year-long study by independent research organisation CERES, shows that Acoustic CR neuromodulation treatment is effective in reducing tonal tinnitus symptoms such as severity and loudness and annoyance by nearly 40%.</span></p> <p><span style="font-size: 10pt;"><br />Of the 200 patients treated in 23 ENT (Ear, Nose and Throat) centres across&nbsp;Germany, 67% reported that their tinnitus had improved, and 50% said that their tinnitus no longer had a negative influence on their quality of life.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Patients in this study had tinnitus for more than four years, and the majority had at least two other treatments before taking the Acoustic CR neuromodulation,&rdquo; says chief&nbsp;audiologist Mark Williams&nbsp;at the Tinnitus Clinic in Harley Street, London, which is acknowledged as UK&rsquo;s leading private treatment centre for tinnitus.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This peer-reviewed study shows without doubt, that in a clinical setting, Acoustic CR neuromodulation offers both progressive and sustainable therapeutic benefit to people affected by chronic tonal tinnitus.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Robert Stanley, a patient who has recently completed his Acoustic CR neuromodulation treatment at The Tinnitus Clinic, says,&nbsp;&ldquo;I would say my tinnitus is 80% better than it was&nbsp;and I believe that the Acoustic neuromodulation programme has significantly&nbsp;reduced&nbsp;my tinnitus both in frequency and volume. It has given me my quality of life back.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Acoustic CR neuromodulation therapy is designed to desynchronise nerves in the hearing part of the brain, by using the brains natural plasticity. This desynchronisation reduces the strength of the links between nerve clusters, shifting a nerve population from a synchronised (pathological) state to a stable desynchronised (healthy and normal) state, where the nerve clusters will remain after treatment.</span></p></div>2015-03-25T11:52:00Z2015-03-25T11:52:00Zwebeditor@bibamedical.com tumour cells decimated by mitochondrial “smart bomb”<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: 10pt;"><span style="font-size: 8pt;">Caption: The new drug MP-MUS (yellow) attacks cancer cell mitochondria by infiltrating both inner and outer membranes (green) after being converted from an inactive, non-toxic form to an active, toxic form by the enzyme MAO-B (purple). Once inside, the drug damages mitochondrial DNA, which cannot be repaired.</span><br /><br />As reported in April 2015 <em>ChemMedChem</em> (early online),&nbsp;Houston Methodist Kenneth R Peak Brain &amp; Pituitary Tumor Center director David S Baskin and Peak Center Head of Research Martyn Sharpe, designed a drug called MP-MUS that destroyed 90 to 95% of malignant glioma cells, yet in other experiments did not seem to adversely affect healthy human brain cells (<em>in vitro</em>). This compliments a soon to be published extensive study showing the same drug can treat human brain cancer grown in the brains of mice. Researchers hope to begin testing the drug in human clinical trials in 2016 or 2017.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are very optimistic that we will get there,&rdquo; says Baskin, also vice chair of the Department of Neurosurgery at Houston Methodist Hospital. &ldquo;Our past work has shown that MP-MUS has very low toxicity until it gets into tumour cells. Once it arrives, it is changed to its active form, doing a lot of damage where we want it to, leaving healthy brain cells alone&mdash;a bit like a &lsquo;smart bomb&rsquo;. To our knowledge, this is the first known example of selective mitochondrial chemotherapy, which we believe represents a powerful new approach to brain cancer.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Medical options for brain tumour patients are woeful, Baskin says. &ldquo;It is a horrible diagnosis. Because of where the tumours are located, and because of the way they can infiltrate healthy tissue, surgery is often not helpful long term. The most effective chemotherapy drug available right now, temozolomide, only extends life from nine to 15 months, and patients&rsquo; quality of life during that period is not very good.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />For that reason, Baskin says he and researchers around the world have been looking for new treatment approaches, such as vaccines intended to aid the body&rsquo;s immune system&rsquo;s recognition and removal of tumour cells, gene therapy and, in the present case, targeting tumour cell mitochondria.</span></p> <p><span style="font-size: 10pt;"><br />Gliomas develop from brain cells called astrocytes. Gliomas account for as much as 20 to 30% of all tumours of the brain and central nervous system.</span></p> <p><span style="font-size: 10pt;"><br />Mitochondria are often referred to as the &ldquo;powerhouses&rdquo; of cells&mdash;including misbehaving cancer cells&mdash;because they help cells create energy. In cancer cells this feature is partially switched off, causing cells to rely on other systems that generate energy. The numerous pill-shaped mitochondria in each cell perform a number of other crucial functions, however, and even cancer cells cannot grow and divide without healthy mitochondria.</span></p> <p><span style="font-size: 10pt;"><br />As luck would have it, an enzyme called MAO-B is over-expressed in brain tumour cells, which is the target of MP-MUS. This means that healthy cells are only exposed to low levels of MP-MUS and their mitochondria to very low levels of P+-MUS, Baskin says. On the other hand, in tumour cells the vast majority of the pro-drug is converted into P+-MUS, which essentially traps the drug inside their mitochondria where it attacks the mitochondrial DNA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We found that we could achieve profound effects with MP-MUS at very low concentrations, around 75 micromolar,&rdquo; says Baskin, professor of Neurological Surgery, Weill Cornell Medical College. &ldquo;By contrast, temozolomide must be used at concentrations two to three times that to be of any use to patients. Our approach is designed to capitalise on what is going inside the cells. Tumour cells have much more MAO-B, and when challenged, make even more MAO-B as a sort of defensive response. We hope that we are one step ahead of the cancer cells, as we are using that very fact to kill them.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The researchers reported MP-MUS&rsquo;s toxicity to healthy cells remained low at concentrations as high as 180 micromolar. This information will be useful to the researchers as they consider safety and efficacy trials in human patients.</span></p> <p><span style="font-size: 10pt;"><br />Houston Methodist and Baskin and Sharpe entered into an agreement with Virtici, LLC to develop MP-MUS and are currently preparing toxicology studies which are required prior to clinical trials.</span></p> <p><span style="font-size: 10pt;"><br />While human clinical trials have not yet begun for MP-MUS, Houston Methodist Neurological Institute doctors are overseeing participation in a number of clinical trials related to gliomas and glioblastomas.</span></p> </div>