Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2015-02-27T03:59:45Z Long sleepers may have an increased risk of stroke 2015-02-26T16:40:00Z 2015-02-26T16:40:00Z <div id="ImageMain1" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction1" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People who sleep more than eight hours a night may have an increased risk of stroke, according to a new study published in an online issue of&nbsp;<em><a href="">Neurology</a></em>, the medical journal of the American Academy of Neurology.</strong></span></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study found that people who slept more than eight hours a night were 46% more likely to have a stroke than people who slept six to eight hours a night, which was considered an average amount of sleep. People who shifted over time from sleeping less than six hours a night to sleeping more than eight hours a night were nearly four times as likely to have a stroke as people who consistently slept an average amount.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study involved 9,692 people with an average age of 62 who had never had a stroke. They were asked about their sleeping habits once and then again about four years later. The participants were followed for an average of 9.5 years. During that time, 346 people had a stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">Of the 986 people who slept more than eight hours a night, 52 had a stroke, compared to 211 of the 6,684 people who slept an average amount. The relationship between long sleep and stroke stayed the same after researchers accounted for factors such as high cholesterol, high blood pressure, body mass index and physical activity.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We do not know yet whether long sleep is a cause, consequence or early marker of ill health,&rdquo; said study author Yue Leng, of the University of Cambridge, UK. &ldquo;More research is needed to understand the relationship between long sleep and stroke.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Alberto Ramos, of the University of Miami Miller School of Medicine and a member of the American Academy of Neurology, who wrote a corresponding editorial, said, &ldquo;Since people whose sleep patterns changed from short to long were nearly four times as likely to have a stroke, it is possible that this could serve as an early warning sign, suggesting the need for additional tests or for people to take steps known to reduce stroke risk, such as lowering blood pressure and cholesterol.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Leng and her colleagues also conducted a meta-analysis, which is a review of previous studies on sleep duration and stroke. Those results also found an association between long sleep and stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study was supported by the Medical Research Council of the United Kingdom and Cancer Research UK.</span></p></div> Findings may help with the management of anticoagulant-related bleeding within the brain 2015-02-26T15:54:00Z 2015-02-26T15:54:00Z <div id="ImageMain2" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction2" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Among patients with oral anticoagulation-associated intracerebral haemorrhage, reversal of international normalised ratio (INR) below a certain level within four hours and systolic blood pressure less than 160mmHg at four hours were associated with lower rates of enlargement, and resumption of anticoagulant therapy was associated with a lower risk of ischaemic events without increased bleeding complications, according to a study in <em><a href="">JAMA</a>.</em></strong></span></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The prevalence of cardiovascular diseases requiring long-term oral anticoagulation is increasing. The most significant complication of this is intracerebral haemorrhage. Among all types of stroke, there is a substantial lack of data about how to manage this complication. Two of the most pressing unsettled questions are how to prevent haematoma enlargement and how to manage anticoagulation in the long-term. Consensus exists that elevated INR levels should be reversed to minimise haematoma enlargement, yet mode of reversal, timing, and extent of INR reversal are unclear. Valid data on safety and clinical benefit of oral anticoagulation resumption are missing and remain to be established, according to background information in the article.</span><br /><br /></p> <p><span style="font-size: 10pt;">Hagen B Huttner, of the University of Erlangen-Nuremberg, Erlangen, Germany, and colleagues conducted a study to assess the association of anticoagulation reversal and blood pressure with haematoma enlargement and the effects of oral anticoagulation resumption. The study, conducted at 19 German tertiary care centres (2006-2012), included 1,176 individuals for analysis of long-term functional outcome, 853 for analysis of hematoma enlargement, and 719 for analysis of oral anticoagulation resumption.</span><br /><br /></p> <p><span style="font-size: 10pt;">Haemorrhage enlargement occurred in 307 of 853 patients (36%). Reduced rates of haematoma enlargement were associated with reversal of INR levels &lt;1.3 within four hours after admission (43/217; 19.8%) vs INR of &ge;1.3 (264/636; 41.5%) and systolic blood pressure &lt;160mmHg at four hours (167/504; 33.1%) vs &ge;160mmHg (98/187; 52.4%).The combination of INR reversal &lt;1.3 within four hours and systolic blood pressure of &lt;160mmHg at four hours was associated with lower rates of haematoma enlargement (18.1% vs. 44.2% not achieving these values) and lower rates of in-hospital death (13.5% vs 20.7%).</span><br /><br /></p> <p><span style="font-size: 10pt;">Oral anticoagulation was resumed in 172 of 719 survivors (23.9%), while resumption showed fewer ischaemic complications (5.2% vs no oral anticoagulation 15%) and not significantly different haemorrhagic complications (8.1% vs no oral anticoagulation, 6.6%).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The study represents the largest cohort of patients with OAC&shy;ICH to date and reports two clinically valuable associations. First, rates of haematoma enlargement were decreased in patients with INR values reversed below 1.3 within four hours of admission and systolic blood pressures of less than 160mmHg at four hours. Second, rates of ischaemic events were decreased among patients who restarted oral anticoagulation without increased rates of bleeding complications,&rdquo; the authors write.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These retrospective findings require replication and assessment in prospective studies.&rdquo;</span></p></div> Next generation Medina coil system shows improvements in early human experience 2015-02-26T11:06:00Z 2015-02-26T11:06:00Z <div id="ImageMain3" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction3" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In early use of the Medina coil system, researchers have found the device to be a next generation coil that combines the familiar procedural safety and technique associated with conventional coils, with improved circumferential aneurysm filling, which, they say, it is thought will lead to improved long-term outcomes.</strong></span></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Aquilla S Turk <em>et al</em> discuss in the <em>Journal of Neurointerventional Surgery</em> their experience with the periprocedural safety and performance of the initial human experience with the Medina coil system, a layered three-dimensional coil made from a radiopaque, shade set core wire, and shape memory alloy outer coil filaments.</span></p> <p><span style="font-size: 10pt;"><br />The authors describe the use of the Medina coil stating: &ldquo;When deployed, the Medina coil begins a linear configuration and then deforms to fill space within the aneurysm. In its constrained state, the device retains a linear form with the petals unfolding into a wave form pattern. But, as the device is introduced into an aneurysm, it bends on itself and deforms to both cover the aneurysm ostium as well as to create a stable structure while still allowing contrast flow for visualisation. The three dimensional petals that constitute the coil surrounding filaments form broader &lsquo;loops&rsquo; rather than thinner wires, as with conventional coils, which allows for stable anchoring of the coil within the aneurysm sac. Mechanically, these broad petals broadly distribute the forces exerted on the aneurysm wall. The Medina coil line constitutes both framing and filler coils. The framing coils provide support and complex into an outer basket. The filler coils are softer, and are designed to fill the internal space within the framing coils.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />In this single centre, operator adjudicated study, the researchers treated nine aneurysms in five patients, ranging from 5 to 17mm in size in various locations. All aneurysms were wide necked with a neck to dome ratio &gt;2:1. All cases were performed without any technical or procedural complications. No periprocedural or postprocedure related clinical complications, such as stroke or aneurysm bleeding, were encountered.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div><div id="Text23" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors write: &ldquo;Wide necked medium and large sized aneurysms remain a common but challenging group in which to effect successful endovascular treatment. Adjunctive devices such as balloons and stents are often required to achieve acceptable endovascular results, but these techniques have been reported to carry a higher risk. Our early human experience with the Medina coil demonstrates the familiar coil ease of use methods and periprocedural safety. Additionally, we experienced relatively short procedure times while utilising few adjunctive technologies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In their experience, they found that the Medina coil, when deployed, takes advantage of its surrounding filament design to provide improved volumetric filling of the aneurysm, which will hopefully result in better long-term occlusion rates.</span></p> <p><span style="font-size: 10pt;">They add that at this early stage, the long-term implications of the device remain unclear, but the early use is &ldquo;extremely encouraging&rdquo;. Of the nine aneurysms treated in this experience, three have undergone follow-up angiography, demonstrating &gt;95% aneurysm occlusion.</span></p> <p><br /><span style="font-size: 10pt;">Turk <em>et al</em> conclude that &ldquo;as more delayed angiographic data become available, and larger numbers of aneurysms receive treatment with the Medina coil, it is possible that this technology will represent a major step forward in endovascular coil embolisation in cerebral aneurysms&rdquo;.</span></p></div> FDA clears Bioness StimRouter neuromodulation system 2015-02-25T10:38:00Z 2015-02-25T10:38:00Z <div id="Introduction4" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Bioness has announced that the US Food and Drug Administration (FDA) has cleared the StimRouter, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin.</strong></span></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The StimRouter is a disruptive technology that presents an opportunity to change the way healthcare professionals treat chronic peripheral pain by targeting and neuromodulating the affected nerve. Furthermore, the StimRouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">A minimally invasive implantable device designed to reduce pain by specifically targeting the affected peripheral nerve, Bioness believes that the StimRouter is a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.</span><br /><br /></p> <p><span style="font-size: 10pt;">According to Bioness founder Alfred Mann, &ldquo;The StimRouter is a disruptive technology that presents an opportunity to change the way healthcare professionals treat chronic peripheral pain by targeting and neuromodulating the affected nerve. Furthermore, the StimRouter represents a less invasive and more cost-effective treatment method when compared to commercially available pain management implanted devices.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Bioness president and chief executive officer Todd Cushman commented that, &ldquo;The StimRouter builds on the success of our external neuromodulation systems and allows us to expand into the pain management market as well as other future applications. The positive clinical results, ease of use and a specific indication for use that targets peripheral nerve pain, make the StimRouter a unique and compelling alternative to spinal cord stimulation and opiates.&rdquo;</span></p></div> Resistance to aspirin tied to more severe strokes 2015-02-24T15:04:00Z 2015-02-24T15:04:00Z <div id="ImageMain5" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People who exhibit a resistance to aspirin may be more likely to have more severe strokes than people who still respond to the drug, according to a study that will be presented at the American Academy of Neurology&rsquo;s 67<sup>th</sup> Annual Meeting (18&ndash;25 April 2015, Washington, DC, USA).</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study also found that in people with aspirin resistance the actual size of stroke appears larger.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Eventually we may be able to identify people who are likely to be resistant to aspirin and give them higher doses or different drugs to prevent blood clots,&rdquo; said study author Mi Sun Oh, of Hallym University College of Medicine, South Korea. &ldquo;However, we need better ways to identify people with aspirin resistance before any changes can be made. For now, people who are taking low-dose aspirin to prevent blood clotting and stroke should continue to do so.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The study involved 310 people who suffered an ischaemic stroke and had been taking aspirin for at least seven days before the first stroke symptoms.</span><br /><br /></p> <p><span style="font-size: 10pt;">A total of 86 people (27.7%) were resistant to aspirin in this study. In the aspirin-resistant group, the median stroke severity score was four, with scores ranging from three to 11, where scores from one to four indicate a minor stroke and scores from five to 15 indicate a moderate stroke. For those who responded to aspirin, the average stroke severity score was three, with scores ranging from one to six.</span><br /><br /></p> <p><span style="font-size: 10pt;">The people who were aspirin resistant also had larger areas of the brain affected by the stroke, as measured by MRI diffusion weighted imaging, with infarct size of 2.8cc compared to 1.6cc for those who responded to aspirin.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study was supported by a grant of the Korea Healthcare technology research and development project, Ministry of Health and Family Welfare and the Republic of Korea.</span></p></div> Medtronic acquires Advanced Uro-Solutions 2015-02-24T14:47:00Z 2015-02-24T14:47:00Z <div id="ImageMain6" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction6" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic has acquired Advanced Uro-Solutions, a privately-held developer of neurostimulation products for the treatment of bladder control issues based in Elizabethton, USA. Terms of the acquisition agreement, which closed in December 2014, were not disclosed.</strong></span></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Advanced Uro-Solutions develops and manufactures the NURO percutaneous tibial nerve stimulation system, which consists of a small external stimulator and a single, reusable lead to provide temporary stimulation to the tibial nerve. This therapy is 510(k) cleared by the US Food and Drug Administration (FDA) to treat patients with overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. Medtronic is preparing to launch the NURO system in the USA within the next 12 months.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The acquisition of Advanced Uro-Solutions expands Medtronic&rsquo;s portfolio of treatment options for those suffering from chronic symptoms of overactive bladder,&rdquo; said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. &ldquo;Medtronic continues to invest in fully-implantable bladder control and bowel control therapies, and the addition of the NURO system to our existing portfolio of products will introduce more people suffering from bladder control issues to the benefits of neuromodulation.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Since 2009, Advanced Uro-Solutions has been led by two founders, Brent Laing and John Green.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Studies show that roughly 80% of patients prescribed oral medications to treat their overactive bladder symptoms have stopped taking them at 12 months, and Medtronic shares our commitment to advancing neuromodulation and increasing patient access to advanced solutions intended to treat their symptoms,&rdquo; said John Green, former chairman and chief executive officer of Advanced Uro-Solutions. &ldquo;We are excited to take this step toward making this important therapy available to patients around the world.&rdquo;</span></p></div> SANTE study shows DBS therapy for treatment-resistant epilepsy demonstrates significant and sustained seizure reduction at five years 2015-02-20T14:54:00Z 2015-02-20T14:54:00Z <div id="ImageMain7" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction7" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic plc has announced five-year results from the pivotal <span style="color: #800000;"><a style="color: #800000;" href=";rank=2" target="_blank">SANTE</a></span>&nbsp;(Stimulation of the anterior nucleus of the thalamus in epilepsy) trial, the largest clinical study of deep brain stimulation (DBS) therapy for epilepsy in adults with treatment-resistant (refractory) epilepsy characterised by partial-onset seizures. The results, which were recently published online by <a href="" target="_blank">Neurology</a>&nbsp;and will be printed in their March 2015 issue, include safety, efficacy and quality of life outcomes associated with long-term Medtronic DBS Therapy.</strong></span></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">SANTE study results at five years include:</span></p> <ul> <li><span style="font-size: 10pt;">Medtronic DBS therapy for epilepsy was associated with a sustained and statistically significant reduction in seizure frequency from baseline that continued to improve over time: 69% median seizure reduction from baseline at five years and 41% at one year (p</span></li> <li><span style="font-size: 10pt;">The percentage of responders (patients with seizure reduction of 50% or greater) was 68% at five years and 43% at one year.</span></li> <li><span style="font-size: 10pt;">A seizure-free interval of at least six months during five years of therapy was reported by 16% of patients.</span></li> <li><span style="font-size: 10pt;">Statistically significant seizure severity and quality of life improvements were observed over baseline at five years and one year as measured by the Liverpool Seizure Severity Scale (LSSS) and Quality of Life measure (QOLIE-31) (p</span></li> <li><span style="font-size: 10pt;">The most common serious adverse event through five years was implant site infection, with a rate of 10%.</span></li> <li><span style="font-size: 10pt;">There were no device-related deaths and no unanticipated adverse device effects. Device-related implantation problems were reversible and as expected with this surgical procedure.</span></li> </ul> <p><span style="font-size: 10pt;"><br />Medtronic DBS therapy for epilepsy uses a surgically implanted medical device to deliver electrical stimulation to a target in the brain called the anterior nucleus of the thalamus, which has strong connections to other parts of the brain where seizures begin. Medtronic DBS therapy is approved in more than 30 countries, including Canada, Australia and countries in the European Union, as adjunctive treatment for partial-onset seizures in adults with medically-refractory epilepsy. This therapy is not approved by the US Food and Drug Administration (FDA) for commercialisation in the United States. Medtronic is working to obtain commercial approval of the therapy in the United States.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The latest SANTE study findings provide important insights into the long-term benefits of DBS therapy, which are encouraging for patients with severe partial epilepsy who are resistant to other treatments and are not candidates for resective epilepsy surgery,&rdquo; says Vicenta Salanova, professor of Neurology, Indiana University School of Medicine, USA and lead author of the publication. &ldquo;Long-term treatment efficacy is critical for people suffering from epilepsy, and it is particularly remarkable that DBS therapy is helping treatment-resistant patients to achieve sustained reduction in seizure frequency and severity over time while also leading to meaningful improvements in quality of life.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The SANTE trial continues to provide the medical community with valuable, real-world insight into the benefits of DBS therapy for people with refractory epilepsy,&rdquo; says Lothar Krinke, vice president and general manager of the Brain Modulation business at Medtronic. &ldquo;We are committed to providing physicians and researchers worldwide with robust clinical and pre-clinical data, including comprehensive registries, to help appropriate severe epilepsy patients who have not been successful with other treatments. We also continue to work with the FDA to make this therapy available to the right patients in the United States.&rdquo;</span></p></div> Development of personalised cellular therapy for brain cancer 2015-02-19T16:49:00Z 2015-02-19T16:49:00Z <div id="Introduction8" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Immune cells engineered to seek out and attack a type of deadly brain cancer were found to be both safe and effective at controlling tumour growth in mice that were treated with these modified cells, according to a study published in&nbsp;<em><a href="">Science Translational Medicine&nbsp;</a></em>by a team from the Perelman School of Medicine at the University of Pennsylvania and the Novartis Institutes for BioMedical Research, USA. The results paved the way for a newly opened clinical trial for glioblastoma patients at Penn.</strong></span></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;A series of Penn trials that began in 2010 have found that engineered T cells have an effect in treating some blood cancers, but expanding this approach into solid tumours has posed challenges,&rdquo; said the study&rsquo;s senior author, Marcela Maus, an assistant professor of haematology/oncology in Penn&rsquo;s Abramson Cancer Center. &ldquo;A challenging aspect of applying engineered T cell technology is finding the best targets that are found on tumours but not normal tissues. This is the key to making this kind of T cell therapy both effective and safe.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The new preclinical study, conducted in collaboration with Hideho Okada and his colleagues at the University of Pittsburgh, details the design and use of T cells engineered to express a chimeric antigen receptor that targets a mutation in the epidermal growth factor receptor protein called EGFRvIII, which is found on about 30% of glioblastoma patients&rsquo; tumour cells. Patients whose tumours express the EGFRvIII mutation tend to have more aggressive glioblastomas. Their tumours are less likely to respond favourably to standard therapies and more likely to recur following those treatments.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Patients with this type of brain cancer have a very poor prognosis. Many survive less than 18 months following their diagnosis,&rdquo; said M Sean Grady, the Charles Harrison Frazier professor and chair of the department of neurosurgery. &ldquo;We have brought together experts in an array of fields to develop an innovative personalised immunotherapy for certain brain cancers.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The new trial is led by Donald M O&rsquo;Rourke, an associate professor of neurosurgery, who oversees an interdisciplinary collaboration of neurosurgeons, neuro-oncologists, neuropathologists, immunologists, and transfusion medicine experts.</span><br /><br /></p> <p><span style="font-size: 10pt;">Maus describes the genesis of the new results as a &ldquo;tour de force,&rdquo; in terms of the range of experiments performed to characterise the EGFRvIII CAR T cell. First, the team developed and tested multiple antibodies, or what immunologists call single-chain variable fragments (scFv), which bind to cells expressing EGFRvIII on their surface. The scFvs recognising the mutated EGFRvIII protein must be rigorously tested to confirm that they do not also bind to normal, non-mutated EGFR proteins, which are widely expressed on cells in the human body.</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers then generated a panel of humanised scFvs and tested their specificity and function in chimeric antigen receptor modified T cells (humanised scFvs are molecularly changed from their origins in non-human species to increase their similarity to human antibodies). Out of the panel of humanised scFvs that were tested, the researchers selected one scFv to explore further based on its binding selectivity for EGFRvIII over normal non-mutated EGFR. They also evaluated the EGFRvIII chimeric antigen receptor T cells in an assay utilising normal EGFR-expressing skin cells in mice grafted with human skin. They found that the engineered EGFRvIII CAR T cells did not attack cells with normal EGFR in this model.</span><br /><br /></p> <p><span style="font-size: 10pt;">The lead scFv was then tested for its anti-cancer efficacy. Using human tumour cells, the scientific team determined that the EGFRvIII chimeric antigen receptor T cells could multiply and secrete cytokines in response to tumour cells bearing the EGFRvIII protein. Importantly, the researchers found that these cells controlled tumour growth in several mouse models of glioblastoma, as measured by magnetic resonance imaging (MRI) and luminescence of tumours in the mouse brains. In the mouse model, the EGFRvIII chimeric antigen receptor T cells caused tumour shrinkage when measured by MRI and were also effective in eliminating tumours when administered in combination with temozolomide chemotherapy that is used to treat patients with glioblastoma.</span><br /><br /></p> <p><span style="font-size: 10pt;">On the basis of these preclinical results, the investigators designed a phase 1 clinical study of chimeric antigen receptor T cells transduced with humanized scFv directed to EGFRvIII for both newly diagnosed and recurrent glioblastoma patients carrying the EGFRvIII mutation. &ldquo;There are unique aspects about the immune system that we are now able to utilise to study a completely new type of therapy,&rdquo; said O&rsquo;Rourke.</span><br /><br /></p> <p><span style="font-size: 10pt;">The investigational approach begins when some of each patient&rsquo;s T cells are removed via an apheresis process similar to dialysis, the cells are engineered using a viral vector that programmes them to find cancer cells that express EGFRvIII. Then, the patient&rsquo;s own engineered cells are infused back into their body, where a signalling domain built into the chimeric antigen receptor promotes proliferation of these &ldquo;hunter&rdquo; T-cells. In contrast to certain T cell therapies that also target some healthy cells, EGFRvIII is believed to be found only on tumour tissue, which the study&rsquo;s leaders hope will minimise side effects.</span><br /><br /></p> <p><span style="font-size: 10pt;">The new trial will enrol 12 adult patients whose tumours express EGFRvIII, in two groups: One arm of six patients whose cancers have returned after receiving other therapies, and one arm of six patients who are newly diagnosed with the disease and still have 1cm or more of tumour tissue remaining after undergoing surgery to remove it.</span><br /><br /></p> <p><span style="font-size: 10pt;">The clinical trial is sponsored by Novartis. In 2012, the University of Pennsylvania and Novartis announced an exclusive global research and licensing agreement to further study and commercialise novel cellular immunotherapies using chimeric antigen receptor technologies. The study is the first pre-clinical paper developed within the Penn-Novartis alliance, with Penn and Novartis scientists working collaboratively. </span><br /><br /><span style="font-size: 10pt;">Ongoing clinical trials evaluating a different type of Penn-developed The STM study therapy known as CTL019 have yielded promising results among some patients with certain blood cancers. In July 2014, the FDA granted CTL019 its Breakthrough Therapy designation for the treatment of relapsed and refractory acute lymphoblastic leukaemia in both children and adults.</span></p></div> Caputron Medical signs distribution agreement with Neurosoft 2015-02-16T15:49:00Z 2015-02-16T15:49:00Z <div id="ImageMain9" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction9" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Caputron Medical has entered into an agreement to distribute&nbsp;Neurosoft&nbsp;products for&nbsp;transcranial magnetic stimulation.</strong></span></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The distribution agreement gives Caputron Medical the rights to market the&nbsp;Neuro-MS/D Diagnostic, Therapeutic, and Advanced Therapeutic repetitive transcranial magnetic stimulation stimulators&nbsp;in the USA and Canada.</span></p> <p><span style="font-size: 10pt;">Neurosoft says that its transcranial magnetic stimulation systems combine features and performance not available in any other product, packaged in high-value systems for customers. These unique performance features include a high-performance cooling system capable of performing up to 10,000 pulses during one session, a peak magnetic field of up to 4 Tesla and20 Hz stimulation with 100% intensity. Neurosoft products are used internationally at leading medical research centres in the study of the non-invasive neuromodulation with applications areas in psychiatry, neurology, cognitive neuroscience, clinical neurophysiology and rehabilitation.</span><br /><br /></p> <p><span style="font-size: 10pt;">Robin Azzam, chief executive officer of&nbsp;Caputron Medical, commented: &ldquo;These products will complement our transcranial direct current stimulation (tDCS) and High Definition-tDCS systems provided through Soterix Medical and our broad range of neuromodulation accessories. Caputron Medical is a proud provider of&nbsp;ANT Neuro EEG and&nbsp;neuronavigation systems&nbsp;that pair seamlessly with Neurosoft products.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Michael Durdin, chief of development, said, &ldquo;Customers are becoming more educated and have higher expectations for transcranial magnetic stimulation products&mdash;they will no longer accept having to buy multiple systems, coils, or accessories for each application. Neurosoft systems are a &lsquo;one-stop&rsquo; solution mirroring the broader commitment of Caputron Medical to be a &lsquo;one-stop&rsquo; source in advanced brain research and modulation.&rdquo;</span></p></div> American Stroke Association and Medtronic collaborate to reduce recurrent strokes 2015-02-16T12:45:00Z 2015-02-16T12:45:00Z <div id="ImageMain10" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction10" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The American Heart Association/American Stroke Association (AHA/ASA) and Medtronic plc have agreed a collaboration to reduce the rate of recurrent strokes in the USA. The two organisations will work together over several years to educate, raise awareness and support effective management of patients who have strokes. The initiative, announced at the American Stroke Association&rsquo;s annual International Stroke Conference (10&ndash;12 February, Nashville, Tennessee) will focus on reducing strokes of unknown cause&mdash;cryptogenic stroke.</strong></span></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The most common (87%) type of stroke&mdash;ischaemic&mdash;occurs when blood vessels carrying oxygen and nutrients to the brain are blocked by a clot causing brain cells to die. Thirty per cent of ischaemic strokes have no known cause (deemed cryptogenic) even when diagnostic tests are performed during a stroke patient&rsquo;s hospitalisation.</span><br /><br /></p> <p><span style="font-size: 10pt;">Recent studies have shown that many stroke patients also suffer from atrial fibrillation. Patients with atrial fibrillation are five times more likely to have strokes,&nbsp;but their condition often goes undiagnosed because their atrial fibrillation episodes occur only sporadically and may not have any symptoms. Studies have shown that continuous, long-term cardiac monitoring of cryptogenic stroke patients helps physicians detect and diagnose atrial fibrillation and provide treatment to prevent a recurrent stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Recent evidence suggests that up to 20% of patients who do not have a cause for their stroke identified while in the hospital may demonstrate evidence of intermittent or paroxysmal atrial fibrillation during weeks to months of extended heart rhythm monitoring,&rdquo; said Lee Schwamm, American Stroke Association volunteer spokesperson, vice chairman, department of neurology, and director of stroke services at Massachusetts General Hospital. &ldquo;As the cost and convenience of outpatient cardiac rhythm recorders has improved, they will likely play an increasingly important role in identifying or excluding atrial fibrillation or other arrhythmias in patients with ischaemic stroke. Further research is needed to discern which types of patients benefit most from extended monitoring, and which types and what duration of atrial rhythm abnormalities increase the risk of future stroke.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This collaboration between AHA and Medtronic will help to address these critically important topics. As physicians, patients and families become more aware of atrial fibrillation as a potential cause of stroke, and as research confirms the risks associated with these more subtle disturbances, we believe that this could become a game changer in the stroke field in helping us to reduce recurrent strokes, ultimately reducing disability and saving lives,&rdquo; he said.</span><br /><br /></p> <p><span style="font-size: 10pt;">The new collaboration will support the AHA/ASA&rsquo;s goal to reduce death from stroke by 20% by 2020.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Our stroke prevention collaboration with the AHA was founded on a common goal of improving care for the hundreds of thousands of unexplained stroke patients across the country,&rdquo; said Nina Goodheart, vice president and general manager of the diagnostics and monitoring business at Medtronic. &ldquo;Insertable cardiac monitors have been proven to be highly effective for the detection of atrial fibrillation in these patients and when that occurs, clinicians are able to change patients&rsquo; treatment course, which can help reduce their risk of suffering a subsequent stroke. Together with AHA, we are committed to conducting more research and education to ensure that clinicians have the appropriate resources to better serve these patients.&rdquo;</span></p></div> Blood flow technology from VasSol Identifies risk of recurrent stroke 2015-02-16T11:38:00Z 2015-02-16T11:38:00Z <div id="ImageMain11" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction11" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A recently completed National Institutes of Health-funded trial confirms the efficacy of blood flow measurement technology from&nbsp;VasSol&nbsp;to predict the possibility of repeated stroke in at-risk individuals.</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">VasSol&rsquo;s&nbsp;NOVA&nbsp;(Non-invasive Optimal Vessel Analysis) software provided the quantitative data that underpinned the <a href=";;esheet=51039641&amp;newsitemid=20150212006556&amp;lan=en-US&amp;anchor=VERiTAS+%28Vertebrobasilar+Flow+Evaluation+and+Risk+of+Transient+Ischemic+Attack+and+Stroke%29+clinical+trial&amp;index=3&amp;md5=f90a36d25cba89c419323e9c2dec7b94">VERiTAS (Vertebrobasilar flow evaluation and risk of transient ischemic attack and stroke) clinical trial</a>, which found that low blood flow to the back of the brain increased patients&rsquo; risk of recurrent strokes. The&nbsp;results, presented at the International Stroke Conference (Nashville, USA, 11&ndash;13 February, 2015) are expected to substantially improve both the study and treatment of stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Identifying those at highest risk for a stroke makes studying the condition easier and leads to better, more precise therapies and more focused implementation of health care resources,&rdquo; said&nbsp;Fady Charbel, inventor of NOVA, which runs on magnetic resonance imaging (MRI) equipment found in most hospitals and imaging centres worldwide. Chairman of neurosurgery at the University of Illinois at Chicago Hospital, where much of the product&rsquo;s research took place, Charbel founded VasSol in 2001 to commercialise NOVA and continues as the company&rsquo;s chief scientific officer.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;More aggressive procedures such as angioplasty and stenting carry significant risks and are expensive. However, they may be necessary for high-risk patients. NOVA provides information that an MRI alone cannot provide. And because it helps patients receive the appropriate treatment, it improves patient safety and reduces health care costs,&rdquo; he said.</span><br /><br /></p> <p><span style="font-size: 10pt;">VasSol chief executive officer Chuck Doherty believes that qMRA (quantitative magnetic resonance angiography) tests, the procedure that NOVA software performs, will become a standard of care in evaluating posterior stroke patients, other stroke patients and those at risk for stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The rigorous protocols of the VERiTAS trial were impressive,&rdquo; he said. &ldquo;Before VERiTAS, physicians were in a quandary regarding treatment for posterior stroke. The average stroke rate in all posterior stroke patients was 8.5% in the first 12 months&mdash;too low to justify anything but medical management.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Decision-making is easier now that physicians can use our NOVA software to identify the low blood-flow patients who are most at risk for another stroke. Physicians can confidently prescribe more complex procedures to improve the quality of life and lifespan of these patients.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">To meet expected demand for NOVA software stemming from the VERiTAS results, VasSol is seeking a partner that can provide worldwide distribution, according to Doherty.</span></p></div> New device improves healing of some ruptured aneurysms 2015-02-16T09:53:00Z 2015-02-16T09:53:00Z <div id="ImageMain12" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction12" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Research presented at the American Stroke Association&rsquo;s International Stroke Conference (Nashville, USA, 11&ndash;13 February, 2015) suggests that a new device inserted into small ruptured brain aneurysms significantly improved healing of ruptured aneurysms compared to a standard device. The original clinical study (HydroCoil&nbsp;Endovascular aneurysm occlusion and Packing Study or HELPS) was funded by MicroVention.</strong></span></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Small&nbsp;aneurysms&nbsp;often cause no symptoms, but they can rupture and bleed into the area surrounding the brain or into the brain. When bleeding occurs, immediate treatment is critical. One treatment for medium-sized ruptured aneurysms (5-10mm) involves inserting a tiny platinum coil into the affected area to block blood flow and prevent the aneurysm from enlarging and rupturing.</span><br /><br /></p> <p><span style="font-size: 10pt;">In the study, researchers compared the effectiveness of the coils to HydroCoil (MicroVention), a new device that combines a gel-like substance with the standard platinum coil. When the substance comes into contact with blood, the gel expands to block blood flow to the aneurysm.</span></p> <p><span style="font-size: 10pt;">Researchers analysed data from 288 patients with medium-sized, ruptured aneurysms who were enrolled in a previous clinical study examining the effectiveness of HydroCoil compared to standard coils. Seventy per cent of patients were female and most were 55 years or younger.</span><br /><br /></p> <p><span style="font-size: 10pt;">Half the patients were randomly assigned to receive one of the two treatments, with researchers performing brain imaging studies 15-18 months later to determine whether the aneurysms had ruptured again or remained intact.</span><br /><br /></p> <p><span style="font-size: 10pt;">Among patients with ruptured, medium-sized aneurysms, the major recurrence rate was significantly lower&mdash;less than 20%&mdash;for those treated with HydroCoil&nbsp;compared to the rates of those treated with bare platinum coils&mdash;more than 30%. An aneurysm rupture recurrence occurs when the aneurysm is not completely healed after treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We think that one of the reasons that the HydroCoil had better outcomes than the bare platinum coil in the ruptured aneurysms is that a ruptured aneurysm can have a little bit more of a complex or irregular shape, the expansion of the hydrogel likely allows for filling of some of these irregular outpouchings and rupture sites,&rdquo; said Waleed Brinjikji, the study&rsquo;s lead author and a radiologist at the Mayo Clinic in Rochester, USA. &ldquo;The advantage of the HydroCoil is that it will expand to fill in that irregular shape.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Because the study included only a subgroup of patients, the results could be due to chance, researchers said. As such, further research is necessary before changing the recommended treatment for aneurysms.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We hope that these results help inform the development of future clinical trials,&rdquo; Brinjikji said. &ldquo;Since small aneurysms generally respond well to the bare platinum coils, and large aneurysms are difficult to treat with coils alone, clinicians should try to focus on enrolling patients with medium-sized, ruptured aneurysms in future trials. Only if these results can be replicated should they be used to change clinical management.&rdquo;</span></p></div> US stroke patients receiving better and more timely care 2015-02-13T12:42:00Z 2015-02-13T12:42:00Z <div id="ImageMain13" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction13" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>One in four acute ischaemic stroke patients treated with a time-dependent clot-busting drug were quickly transferred from an emergency department or smaller community hospital to a certified stroke centre, according to research presented at the American Stroke Association&rsquo;s International Stroke Conference 2015 (Nashville, USA, 11&ndash;13 February, 2015). This study will also be published simultaneously in the American Heart Association&rsquo;s journal&nbsp;<em><a href="">Stroke</a></em>.</strong></span></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Intravenous tissue-plasminogen activator, or&nbsp;(tPA), is a clot-busting drug that restores blood flow to the brain. If administered within three hours of the start of a stroke, tPA may significantly improve a patient&rsquo;s chances of recovery. Even though it is the only FDA-approved treatment for acute ischaemic stroke, rates of its administration are low, according to the presentation.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;One in four is a very good number, and while we do not know the best target, there may be room for improvement,&rdquo; said Kevin N Sheth, lead study author and chief of the Neurocritical Care and Emergency Neurology Division at Yale School of Medicine in New Haven, USA. &ldquo;We have to understand geographic and community variation in usage of inter-hospital transfer of tPA patients, and why some communities may use it more than other communities. Ultimately, the goal is to have any patient that presents to their initial hospital anywhere in the country be able to receive tPA.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">To look at these variations in stroke care, researchers analysed data on 44,667 ischaemic stroke patients (median age 72; 49% women) who received tPA in less than three hours at 1,440 hospitals between 2003 and 2010.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers compared patients who arrived at the hospital, received tPA and were later admitted there to those patients who received tPA at the arriving hospital and then were transferred to a certified stroke centre.</span><br /><br /></p> <p><span style="font-size: 10pt;">Among the 25% who were transferred to certified stroke centres they found:</span></p> <ul> <li><span style="font-size: 10pt;">Most were younger, more often male, and more often white.</span></li> <li><span style="font-size: 10pt;">Transferred patients were more likely to arrive during off-hours (7am&ndash;5pm, Monday&ndash;Friday).</span></li> <li><span style="font-size: 10pt;">Hospitals that accepted transferred patients were bigger with more beds, were more likely to be academic medical centres, have achieved certification as a designated stroke centre, and have maintained a higher volume of stroke cases per year.</span></li> <li><span style="font-size: 10pt;">Hospitals that accepted transferred stroke patients were more common in the Midwest.</span></li> </ul> <p><span style="font-size: 10pt;">Researchers said their study suggests that more patients are getting critical medication before being transferred to a certified stroke centre. When it comes to stroke, every hour counts in moving a stroke patient to a facility equipped with experts, proper diagnostic equipment and treatment. Not all facilities have this, particularly smaller community hospitals, and different hospitals vary on how quickly stroke patients receive tPA. There is also a wide variation in the type of patients who are transferred from smaller community hospitals to designated stroke centres.</span><br /><br /></p> <p><span style="font-size: 10pt;">Sheth said he was surprised that intracranial haemorrhage was higher among transferred stroke patients, a finding that warrants further study. &ldquo;We do not know the initial stroke severity for these patients and it is unclear why some patients were chosen to be transferred to a stroke centre and others were not, though it is possible the sicker patients were the ones who were transferred to another facility,&rdquo; he said. Why some geographic regions transfer stroke patients more than others and how can this transfer approach help facilitate increased use of tPA also needs further study, Sheth said.</span></p></div> Stem cell transplants may work better than existing drug for severe multiple sclerosis 2015-02-13T12:28:00Z 2015-02-13T12:28:00Z <div id="ImageMain14" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction14" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stem cell transplants may be more effective than the drug mitoxantrone for people with severe cases of multiple sclerosis, according to a new study published in <a href=""><em>Neurology</em>,</a> the medical journal of the <a href="">American Academy of Neurology.</a></strong></span></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, supported by the Italian Multiple Sclerosis Foundation, involved 21 people whose disability due to multiple sclerosis had increased during the previous year even though they were undergoing first-line treatments. The participants, who were an average age of 36, were at an average disability level where a cane or crutch was needed to walk.</span><br /><br /></p> <p><span style="font-size: 10pt;">In this phase II study, all of the participants received medications to suppress immune system activity. Then 12 of the participants received the drug mitoxantrone, which reduces immune system activity. For the other nine participants, stem cells were harvested from their bone marrow. After the immune system was suppressed, the stem cells were reintroduced through a vein. Over time, the cells migrate to the bone marrow and produce new cells that become immune cells. The participants were followed for up to four years.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This process appears to reset the immune system,&rdquo; said study author Giovanni Mancardi, of the University of Genoa in Italy. &ldquo;With these results, we can speculate that stem cell treatment may profoundly affect the course of the disease.&rdquo; Intense immunosuppression followed by stem cell treatment reduced disease activity significantly more than the mitoxantrone treatment. Those who received the stem cell transplants had 80% fewer new areas of brain damage&mdash;T2 lesions&mdash;than those who received mitoxantrone, with an average of 2.5 new T2 lesions for those receiving stem cells compared to eight new T2 lesions for those receiving mitoxantrone. For gadolinium-enhancing lesions, none of the patients who received the stem cell treatment had a new lesion during the study, while 56% of those taking mitoxantrone had at least one.</span><br /><br /></p> <p><span style="font-size: 10pt;">Mancardi noted that the serious side effects that occurred with the stem cell treatment were expected and resolved without permanent consequences. &ldquo;More research is needed with larger numbers of patients who are randomised to receive either the stem cell transplant or an approved therapy, but it is very exciting to see that this treatment may be so superior to a current treatment for people with severe multiple sclerosis that is not responding well to standard treatments,&rdquo; Mancardi said.</span></p></div> Mobile stroke units improve response times and outcomes for patients 2015-02-13T09:00:00Z 2015-02-13T09:00:00Z <div id="ImageMain15" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Mobile Stroke Treatment Units&mdash;specialised emergency rooms on wheels&mdash;are saving critical minutes in the diagnosis and treatment of stroke patients, according to two new studies presented at the American Stroke Association&rsquo;s International Stroke Conference 2015 (Nashville, USA, 11&ndash;13 February, 2015).</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Due to how critical time is in the treatment of stroke, using Mobile Stroke Treatment Units (MSTU) to provide pre-hospital evaluation and treatment of stroke should revolutionise the care of these patients,&rdquo; said Muhammad Shazam Hussain, lead researcher and head of the Cleveland Clinic Stroke Program.</span><br /><br /></p> <p><span style="font-size: 10pt;">MSTUs are specialised ambulances staffed with a nurse, paramedic, emergency personnel and a CT technologist. The unit also contains lab testing equipment and a CT scanner, which is required to diagnose the type of stroke. A stroke physician at the main hospital evaluated each patient via telemedicine and a neuroradiologist remotely assessed CT images. Two-way video conferencing allowed communication with the patient, family and stroke experts.</span><br /><br /></p> <p><span style="font-size: 10pt;">The CT image is an important diagnostic test distinguishing a&nbsp;haemorrhagic stroke from an ischemic&nbsp;stroke. The treatment for these types of strokes is different, and cannot be started until the CT scan is complete.</span><br /><br /></p> <p><span style="font-size: 10pt;">In this analysis, researchers report the evaluation and treatment in the first three weeks of implementation of the MSTU in Cleveland as compared to a control group of patients brought to the emergency department via traditional ambulance in the preceding three months. They measured the time from call dispatch from emergency medical service to the time a CT was completed and clot-busting treatment with tPA was started.</span><br /><br /></p> <p><span style="font-size: 10pt;">Twenty-three patients were treated in the MSTU and 34 in the emergency room. There were no significant differences in age or gender between the groups. Researchers found:</span></p> <ul> <li><span style="font-size: 10pt;">The median time for alarm to MSTU arrival at scene was 13 minutes.</span></li> <li><span style="font-size: 10pt;">There was a significant reduction of median alarm to CT scan completion times (41 minutes in MSTU vs. 62 minutes in emergency room patients).</span></li> <li><span style="font-size: 10pt;">There was a significant reduction in time to treatment (median alarm-to-thrombolysis times &ndash; 64 minutes in MSTU vs. 104 minutes in emergency room patients).</span></li> <li><span style="font-size: 10pt;">Six patients received clot-busting medication in the MSTU group and five in the emergency room group.</span></li> <li><span style="font-size: 10pt;">There were no early complications of clot-busting in the MSTU group.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;Estimates are that stroke victims lose two million neurons (brain cells) per minute, so this reduction in time with the MSTU could potentially result in much better outcomes,&rdquo; Hussain said.</span><br /><br /></p> <p><span style="font-size: 10pt;">In addition, researchers noted that the rate of clot-buster treatment was much higher in the MSTU than in the hospitals (26% vs. 14%). This also was much higher than the national average of 3&ndash;8%.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The main reason for patients not getting treated is that they do not arrive in time for this treatment&mdash;4.5 hours from symptom onset,&rdquo; Hussain said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Hussain noted that another advantage of the mobile unit is being able to triage patients to the most appropriate hospital for their condition. An ischaemic stroke patient with a large clot sitting in a major brain artery usually requires intravenous catheter-based treatment&mdash;available in larger facilities&mdash;in addition to an intravenous clot buster.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We eliminate the need to transfer them from a small hospital to a larger hospital by getting them there directly, saving critical time and making the difference between patients being able to receive advanced, lifesaving treatments,&rdquo; Hussain said.</span><br /><br /></p> <p><span style="font-size: 10pt;">In another study researchers at The University of Texas Health Science Center at Houston (UTHealth) reported how they created the first mobile stroke unit to operate in the USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">An ambulance company donated an ambulance and the Mobile Stroke Unit (MSU) build-out, begun with the purchase of a computed tomography (CT) scanner. A consortium was formed to set procedures and policies and obtain city and state licensing, undertake inspections and develop an accountability system. Staffed by a neurologist and a registered nurse with stroke expertise, CT technology and paramedic and telemedicine connectivity, the MSU responds to acute stroke dispatches within a five-mile radius from 8am&ndash;6pm daily.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Intravenous tPA remains the only level 1A treatment for&nbsp;ischaemic stroke. Pooled analyses confirm the relationship of treatment success with time from symptom onset to initiation of treatment. However, despite two decades of efforts to streamline systems of care, most patients are treated beyond the two hours when tPA is most effective,&rdquo; said Stephanie A Parker, lead author and project manager of the UTHealth Mobile Stroke Unit at the UTHealth Medical School in Houston, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">The UTHealth MSU treated its first patient in May 2014, and is carrying out acute stroke treatment within 10&ndash;18 minutes of arrival on location. During a nine-week run-in phase, approximately two patients per week were treated with tPA on the MSU, 40% of whom were treated within the first hour from symptom onset, Parker said.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Our ultimate goal is to show that patients treated on the mobile stroke unit will have better outcomes because of earlier treatment and, therefore, will have fewer long-term acute care needs and/or rehabilitation needs,&rdquo; Parker said.</span></p></div> Sorin announces enrolment of first patients in the Vanguard clinical study 2015-02-12T12:25:00Z 2015-02-12T12:25:00Z <div id="ImageMain16" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction16" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Sorin has announced the first successful implants of the Equilia system in the <a href="">Vanguard (Vagal nerve stimulation safeguarding heart failure patients) clinical study</a>. The system is intended to treat heart failure by stimulating the vagus nerve.</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Heart failure has been shown to be associated with an imbalance in the autonomic nervous system that controls cardiac activity. This imbalance, a reduction in parasympathetic activity and an increase in sympathetic activity, over-stresses the heart and contributes to the worsening of heart failure.</span><br /><br /></p> <p><span style="font-size: 10pt;">By stimulating the vagus nerve, the Equilia system is expected to normalise the autonomic imbalance. The Equilia system consists of a small device implanted under the skin in the patient&rsquo;s chest that delivers electrical pulses via the EquiCurl<sup>&nbsp;</sup>lead placed around the vagus nerve in the neck area.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Neurostimulation is expected to prolong heart failure patients&rsquo; survival, improve their quality of life and reduce the number of hospital readmissions. I believe the Equilia<sup>&nbsp;</sup>system has the potential to bring significant benefits to heart failure patients,&rdquo; says Albert Hag&egrave;ge, head of the cardiology department at the H&ocirc;pital Europ&eacute;en Georges Pompidou, Paris, France, and principal investigator in the Vanguard study.</span><br /><br /></p> <p><span style="font-size: 10pt;">The implant procedures were coordinated by Eloi Marijon, electrophysiologist at H&ocirc;pital Europ&eacute;en Georges Pompidou. Patients are also enrolled in the study at the Universit&eacute; Catholique de Louvain Hospital in Brussels, Belgium, by electrophysiologist Jean-Beno&icirc;t Le Polain de Waroux.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Our New Ventures organisation is actively working on several vagus nerve stimulation projects to treat heart failure disease. Equilia is New Ventures&rsquo; first innovation to enter clinical trials. Vagus nerve stimulation has the potential to expand the clinical indications for device-based therapies for heart failure and we look forward to bringing this exciting new therapy to the market&rdquo;, says Andr&eacute;-Michel Ballester, chief executive officer of Sorin.</span></p></div> Groundbreaking studies find that neurointerventional surgery reduces stroke mortality 2015-02-11T17:37:00Z 2015-02-11T17:37:00Z <div id="ImageMain17" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction17" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Two new clinical trials on the treatment of stroke (ESCAPE and EXTEND IA) demonstrate that neurointerventional surgery significantly increases the number of patients who are able to live independently without major neurological disabilities. The ESCAPE study, published 11 February in the <em>New England Journal of Medicine</em>, also shows that neurointerventional surgery reduces stroke mortality by 50%.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">ESCAPE (Endovascular treatment for small core and anterior circulation proximal occasion with emphasis on minimizing CT to recanalization times) and EXTEND IA (Extending the time for thrombolysis in emergency neurological deficits - intra-arterial) are two of three studies (together with SWIFT PRIME) that confirm the MR CLEAN study published in the <em>New England Journal of Medicine</em> late last year--which showed that the addition of inside-the-artery clot removal is more effective than IV-administered &ldquo;clot-busting&rdquo; tissue plasminogen activator (IV-tPA) treatment alone for the treatment of stroke.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;All three of these studies confirm what we are seeing in everyday practice. In many cases, instead of suffering major neurological disability, patients are able to go home to resume their lives,&rdquo; says Peter Rasmussen, director of the Cerebrovascular Center, Cleveland Clinic in Cleveland, Ohio, USA, and president of the Society of NeuroInterventional Surgery (SNIS). &ldquo;Within-the-artery procedures, which are performed by neurointerventional surgeons, are not the appropriate treatment for every patient suffering from stroke, but for those patients experiencing the most severe types of ischaemic strokes, they are life-saving, viable and effective therapies that offer many benefits over traditional treatments, including shorter recovery times and a better chance to return to normal activities.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />ESCAPE is the first study to show that the overall stroke mortality rate was reduced by 50% with neurointerventional surgery, from two in 10 patients for standard-of-care treatment to one in 10. ESCAPE and EXTEND IA showed better outcomes for those patients treated with neurointerventional surgery. In ESCAPE, nearly 30% of patients treated with IV-tPA treatment alone were able to live independently without major neurological disabilities. For patients receiving neurointerventional surgery, that number increased to 53%. EXTEND IA showed even better results, with 71% of patients who received neurointerventional surgery returning to independent living, compared with 40% in the standard treatment group.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Peter Mitchell, co-principal investigator of EXTEND IA and the director of neurointervention at the Royal Melbourne Hospital, Australia, two of the key differences in better outcomes for stroke patients were the use of more advanced brain imaging to select patients most likely to benefit and earlier treatment. The Royal Melbourne Hospital, where the EXTEND IA study was conducted, treats approximately 500 ischaemic stroke patients a year and is one of the few stroke centres in the world to treat patients within 20 minutes of arriving in the emergency department.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Donald Frei, a neurointerventional surgeon at Radiology Imaging Associates in Denver, USA, and president-elect of SNIS, treatment time is critical. While ESCAPE showed that neurointerventional surgery can be performed up to 12 hours from the onset of stroke, the success of the trial can be credited to fast treatment and the use of brain and blood vessel imaging. In ESCAPE, researchers were on average two hours faster in opening the blocked blood vessels than in previously reported trials.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These positive studies are important milestones in the transformation of care for stroke patients, but it&rsquo;s also important to understand that the comprehensive stroke centres that participated excel in providing this type care,&rdquo; says Frei. &ldquo;The results may not be replicable in every hospital. It&rsquo;s important that when stroke occurs, the disease is identified quickly and patients are transported to facilities that are equipped to provide the best evidence-based interventions for ischaemic and haemorrhagic stroke management.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />ESCAPE included 22 sites worldwide and patients in the USA, UK, Ireland and South Korea and evaluated the effect of endovascular treatment for patients with acute ischaemic stroke caused by a clot obstructing one of the major intracranial arteries. The study was ended early because it crossed the pre-specified boundary for efficacy. The study included 316 patients who fit the criteria for neurointerventional surgery and arrived for treatment within 12 hours of their stroke who were randomised to standard medical care (which included the IV-tPA where appropriate) or standard medical care plus neurointerventional surgery.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The EXTEND IA trial compared IV-tPA to IV-tPA and neurointerventional surgery in patients with acute ischaemic stroke receiving IV therapy within 4.5 hours of stroke onset. Patients were selected using CTA and CTP to identify those with large vessel occlusion and small core infarct with significant volume of &ldquo;threatened&rdquo; tissue. The trial was stopped early because of efficacy when 70 of the intended 100 patients had been randomised (35 to each arm) after the presentation of the MR CLEAN results prompted the DSMB to perform a pre-specified analysis.</span></p></div> Creatine does not slow rate of Parkinson’s disease progression 2015-02-10T16:00:00Z 2015-02-10T16:00:00Z <div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Treatment with creatine monohydrate for at least five years for patients with early and treated Parkinson&rsquo;s disease failed to slow clinical progression of the disease, compared with placebo, according to a study in <em><a href="">JAMA</a>.</em></strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Parkinson&rsquo;s disease is a progressive neurodegenerative disorder that affects approximately six million people worldwide. Incidence is expected to increase over the next decade, but neither a cure nor a treatment is available that has been proven to slow progression. Evidence indicates that creatine, an amino acid, plays an important role in cellular energy production, which may be impaired in Parkinson&rsquo;s disease. Oral creatine supplementation in mice has suggested a neuroprotective effect, according to information in the study.</span><br /><br /></p> <p><span style="font-size: 10pt;">Karl Kieburtz, of the University of Rochester, Rochester, USA, and colleagues, randomly assigned 1,741 men and women with early (within five years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson&rsquo;s disease to receive placebo or creatine monohydrate (10g/d) for a minimum of five years (maximum follow-up of eight years). Participants were recruited from 45 investigative sites in the USA and Canada, enrolled from March 2007 to May 2010, and followed up until September 2013.</span><br /><br /></p> <p><span style="font-size: 10pt;">The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least five years prior to the date of the analysis (n=955).The median follow-up time was four years. Using several measures of Parkinson&rsquo;s disease progression, the researchers found that treatment with creatine, compared with placebo, did not improve clinical outcomes.</span><br /><br /></p> <p><span style="font-size: 10pt;">There were no detectable differences in adverse and serious adverse events by body system.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These findings do not support the use of creatine monohydrate in patients with Parkinson disease,&rdquo; the authors conclude.</span></p></div> FDA clears Enroute transcarotid neuroprotection system 2015-02-10T14:37:00Z 2015-02-10T14:37:00Z <div id="ImageMain19" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction19" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Silk Road Medical has announced that it has received US Food &amp; Drug Administration (FDA) 510(k) clearance for its Enroute transcarotid neuroprotection system. According to the company, the Enroute transcarotid neuroprotection system 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 performing carotid angioplasty and stenting.</span></strong></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Enroute technology enables a true hybrid procedure offering the best of both worlds - the critical protection against peri-procedural stroke we have achieved with carotid endarterectomy with the ability to reduce surgical complications using minimally invasive endovascular techniques,&rdquo; says Manish Mehta, Professor of Surgery at Albany Medical College and an investigator in the <a href=";rank=1" target="_blank">ROADSTER</a>&nbsp;trial. &ldquo;It is also a quick, efficient procedure which can be performed under local anaesthesia with minimal scarring, which is highly beneficial for both the patient and the operator.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Richard Cambria, chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and the national co-principal investigator of the ROADSTER trial along with colleague Christopher Kwolek, comments: &ldquo;We continue to operate on high surgical risk patients because transfemoral carotid artery stenting has shown excess peri-procedural stroke risk. With the Enroute transcarotid neuroprotection system, we now have carotid endarterectomy-like neuroprotection and a simplified procedure that can fulfil the promise of carotid artery stenting.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The FDA cleared the Enroute transcarotid neuroprotection system based in part on the results of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, 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><br /><span style="font-size: 10pt;">Silk Road Medical has also submitted a Premarket Approval (PMA) application for the Enroute transcarotid stent system, which is an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system. &ldquo;With clearance of the Enroute transcarotid neuroprotection system in hand, we are on the eve of commercialisation in the United States.&nbsp; Severe carotid artery stenosis is one of the last frontiers in vascular disease that is still treated primarily by an open surgical approach. We look forward to bringing our less invasive, surgically-inspired Enroute systems to market for vascular specialists and their patients,&rdquo; says Erica Rogers, chief executive officer.</span></p></div> Human stem cells repair damage caused by radiation therapy for brain cancer in rats 2015-02-10T12:58:00Z 2015-02-10T12:58:00Z <div id="ImageMain20" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction20" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>For patients with brain cancer, radiation is a powerful and potentially life-saving treatment, but it can also cause considerable and even permanent injury to the brain. Now, through preclinical experiments conducted in rats, Memorial Sloan Kettering Cancer Center researchers have developed a method to turn human stem cells into cells that are instructed to repair damage in the brain. Rats treated with the human cells regained cognitive and motor functions that were lost after brain irradiation. The findings are reported in the journal&nbsp;<em><a href="">Cell Stem Cell</a></em>.</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">During radiation therapy for brain cancer, progenitor cells that later mature to produce the protective myelin coating around neurons are lost or significantly depleted, and there is no treatment available to restore them. These myelinating cells&mdash;called oligodendrocytes&mdash;are critical for shielding and repairing the brain&rsquo;s neurons throughout life.</span><br /><br /></p> <p><span style="font-size: 10pt;">A team led by neurosurgeon Viviane Tabar and research associate Jinghua Piao, of the Memorial Sloan Kettering Cancer Center in New York City, USA, explored whether stem cells could be coaxed to replace these lost oligodendrocyte progenitor cells. They found that this could be achieved by growing stem cells&mdash;either human embryonic stem cells or induced pluripotent stem cells derived from skin biopsies&mdash;in the presence of certain growth factors and other molecules.</span><br /><br /></p> <p><span style="font-size: 10pt;">Next, the investigators used the lab-grown oligodentrocyte progenitor cells to treat rats that had been exposed to brain irradiation. When the cells were injected into certain regions of the brain, brain repair was evident, and rats regained the cognitive and motor skills that they had lost due to radiation exposure. The treatment also appeared to be safe as none of the animals developed tumours or inappropriate cell types in the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Being able to repair radiation damage could imply two important things: improvement of the quality of life of survivors and potential expansion of the therapeutic window of radiation,&rdquo; said Tabar. &ldquo;This will have to be proven further, but if we can repair the brain effectively, we could be bolder with our radiation dosing, within limits.&rdquo; This could be especially important in children, for whom physicians deliberately deliver lower radiation doses.</span></p></div> Medtronic agrees US$2.8m False Claims Act settlement 2015-02-10T10:15:00Z 2015-02-10T10:15:00Z <div id="ImageMain21" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction21" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic has agreed to pay a US$2.8m fee to the US government in order to settle accusations that it encouraged off-label usage of one of its spinal cord stimulation devices.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Prosecutors alleged that the company made illegal payments to physicians in 20 US states from 2007&ndash;2011 in exchange for recommendations of procedures that were neither safe nor effective.</span><br /><br /></p> <p><span style="font-size: 10pt;">The procedure in question was the SubQ treatment, in which &nbsp;spinal cord stimulation devices were&nbsp;placed just beneath the skin near an area of pain, most often in the lower back. The devices&rsquo; electrical impulses created a tingling sensation to alleviate chronic pain. However, according to federal prosecutors, the safety and efficacy of SubQ stimulation had not been established by the Food and Drug Administration.</span><br /><br /></p> <p><span style="font-size: 10pt;">Having denied the allegations in a previous statement, Medtronic agreed to pay the $2.8m fee to settle the allegations with &ldquo;no admission of liability&rdquo;. A company press release stated: &ldquo;Medtronic is committed to following appropriate marketing and reimbursement practices at all times, and for many years has had in place a comprehensive and robust employee compliance programme.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Patients should be able to trust that their health care providers only use, and bill Medicare for, medical procedures that have been shown to be safe and effective,&rdquo; said Scott J Lampert of the Department of Health and Human Services&rsquo; Office of Inspector General.&nbsp; &ldquo;Our agency will continue to pursue medical device makers that ignore requirements designed to protect patient health and federal health care programmes.&rdquo;</span></p></div> Nevro receives expanded MR-conditional labelling for Senza system in Europe and Australia 2015-02-05T16:34:00Z 2015-02-05T16:34:00Z <div id="ImageMain22" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction22" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Nevro has received CE mark for expanded MR-conditional labelling. The labelling expansion now permits the Senza spinal cord stimulation system to be marketed in Europe and Australia for scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Spinal cord stimulation is an important tool in treating chronic pain, and the addition of 3 Tesla compatibility and extremities labelling is a significant advancement that provides HF10 therapy patients access to additional diagnostic tools,&rdquo; said Paul Verrills, president of the Australian and New Zealand Neuromodulation Society.</span><br /><br /></p> <p><span style="font-size: 10pt;">With the new MR-conditional labelling, Nevro is now the first company to offer MRI compatibility with 3 Tesla machines for an implantable spinal cord stimulation system. The new labelling includes all generations of the Senza system dating back to 2010 and applies to all geographies where Nevro currently sells the system commercially.</span></p></div> Transradial access valid for treatment of acute ischaemic stroke 2015-02-05T15:30:00Z 2015-02-05T15:30:00Z <div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>According to a recent retrospective review, the transradial approach to mechanical embolectomy is a valid approach for the endovascular treatment of acute ischaemic stroke.</strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Study authors Diogo Haussen <em>et al</em> say in the <em><a href="">Journal of NeuroInterventional Surgery</a></em> that, the transfemoral approach for the treatment of acute ischaemic stroke has been primarily used by neurointerventionalists due to the adequate size for large diameter catheterisation and relatively low puncture-related complications. But despite significant advances in hardware technology and procedural techniques, groin characteristics such as severe atherosclerotic disease in iliofemoral arteries and prominent groin fat deposits may lead to significant difficulties in safe and effective sheath placement. They therefore sought to demonstrate the validity and feasibility of the transradial approach as an alternative in the interventional management of acute ischaemic stroke.</span><br /><br /></p> <p><span style="font-size: 10pt;">The investigation was carried out via a retrospective review of the local institutional acute ischaemic stroke interventional databases of three tertiary academic centres (Grady Memorial Hospital/Emory University; Jackson Memorial Hospital/University of Miami; and Long Island College Hospital), from which the use of transradial access was identified.</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors found that altogether, transradial access was attempted in 15 (1.5%) of 1,001 patients. They report that, &ldquo;At Grady/Emory, transradial access was attempted in nine of 616 patients undergoing intra-arterial therapy for acute ischaemic stroke, allowing clot engagement in seven. At Jackson/University of Miami, transradial access was attempted in five of 110 patients undergoing intra-arterial therapy and was successful in four. Lastly, transradial access was attempted and was successful in one out of 275 patients undergoing intra-arterial treatment at Long Island College Hospital.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Haussen <em>et al</em> further report that transradial access was effective in allowing clot engagement in 13 of the 15 patients. In the other two cases, one patient had a hypoplastic radial artery that precluded sheath advancement and one had chronic innominate artery occlusion that could not be crossed. No radial puncture site complications were noted. At 90 days, two patients had a good clinical outcome and seven had died.</span><br /><br /></p> <p><span style="font-size: 10pt;">In conclusion, they write, &ldquo;The transradial approach to mechanical embolectomy is a valid approach for the endovascular treatment of acute ischaemic stroke. Failure of transfemoral access in the endovascular treatment of acute ischaemic stroke is uncommon but leads to unacceptable delays in reperfusion and poor outcomes. Standardisation of benchmarks for access switch could serve as a guide to neurointerventionalists.&rdquo;</span></p></div> FDA approves Pipeline Flex embolisation device 2015-02-05T14:58:00Z 2015-02-05T14:58:00Z <div id="ImageMain24" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction24" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic plc has announced that it has received US Food and Drug Administration (FDA) approval for its Pipeline Flex embolisation device.&nbsp;Available through a limited US launch in the coming weeks, Medtronic&rsquo;s latest-generation flow diversion device represents an unrivalled advancement in large and giant brain aneurysm treatment.</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Flow diversion has been a major breakthrough therapy for large or giant wide-necked brain aneurysms that are complex and have considerably higher risk of rupture and higher rates of complication with conventional treatment,&rdquo; says Ricardo Hanel, neurosurgeon, director of the Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, USA. &ldquo;With thousands of patients successfully treated with Pipeline embolisation device, the Pipeline Flex&rsquo;s innovative delivery system will result in further advancing endovascular treatment and care.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolisation device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The Pipeline Flex embolisation device is the next advancement in flow diversion, combining our clinically-proven braid design&nbsp;with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain,&rdquo; says Brett Wall, president, Neurovascular, Medtronic. &ldquo;We are excited to bring new value to our medical community and patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 and 5mm in diameter. An estimated 500,000 people throughout the world die each year caused due to ruptured brain aneurysms, and half the victims are younger than 50 years of age.</span></p> <p><br /><span style="font-size: 10pt;">The first-generation Pipeline embolisation device has been used to treat patients in the United States since it was approved by the FDA in 2011. This product is part of the Neurovascular portfolio in Medtronic&rsquo;s Restorative Therapies Group.</span></p></div> NeuroPace RNS system reduces seizures and improves quality of life for people with epilepsy 2015-02-04T15:57:00Z 2015-02-04T15:57:00Z <div id="ImageMain25" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction25" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroPace&nbsp;has announced that interim results from its ongoing long-term treatment study demonstrate the RNS system significantly reduces seizure frequency among adults who have a common form of epilepsy that is difficult to treat with medication.</strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Results of the ongoing study, which were recently published in&nbsp;<a href=";;esheet=51031339&amp;newsitemid=20150203005164&amp;lan=en-US&amp;anchor=Neurology&amp;index=2&amp;md5=0a6090f7979b7cbde27bb5735fccf4d9"><em>Neurology</em></a>, include data on 230 people with medically intractable partial onset epilepsy enrolled at 33 Comprehensive Epilepsy Centers in the USA. The median reduction in seizure frequency compared to patients&rsquo; pre-implant seizure frequency was 60% at the beginning of the third year post-implant and 66% at the beginning of the sixth year.</span><br /><br /></p> <p><span style="font-size: 10pt;">NeuroPace received premarket approval from the US Food and Drug Administration (FDA) for the RNS system in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The interim study results, which covered 1,293 patient stimulation years, confirm our belief that the therapeutic benefits of the RNS system are not only sustained, but actually increase over time for many people,&rdquo; said Martha Morrell, chief medical officer of NeuroPace and clinical professor of neurology at Stanford University. &ldquo;Beyond the sustained seizure frequency reduction, patients in this study gained significant improvements in quality of life in areas such as memory, language, attention, and overall health. This patient population has been unable to find relief with other treatments, and we are extremely hopeful that the RNS system can help hundreds of thousands of adults in the USA with refractory partial seizures in the future.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The study is an ongoing seven-year, multicentre prospective open-label study for participants who previously completed a feasibility or randomized controlled trial of the RNS system. Ninety-seven per cent of these patients elected to continue treatment and participate in the study. The median reduction in seizure frequency in the pivotal study was 44% at one year and 53% at two years, and ranged up to 66% over post-implant years three through six. Furthermore, 23% of patients experienced at least one six-month period free of seizures. For comparison, these patients had to average at least three seizures per month in order to enrol in the original trial. The study also demonstrated significant improvements in overall quality of life and indicates a more positive perception of cognitive function, relationships and social function, overall health, and vulnerability to seizures. There were no serious unanticipated device related adverse events in the trial and responsive neurostimulation was well-tolerated and safe over time.</span><br /><br /></p> <p><span style="font-size: 10pt;">As a closed-loop system, the RNS system monitors the brain&rsquo;s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain&rsquo;s response. The breakthrough aspect of the RNS system is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response.</span><br /><br /></p> <p><span style="font-size: 10pt;">The RNS system has been evaluated in three clinical trials, including a prospective, randomised, double-blinded, sham stimulation controlled pivotal study and the current study. Results of the clinical trials demonstrate that the substantial clinical improvements experienced by patients over the short- and long-term are meaningful and durable over many years of therapy. At this time, some patients have been treated with the RNS system for more than 11 years, and more than 1,500 patient years of experience with responsive neurostimulation have been accumulated to date.</span></p></div> New programme helps gauge blood flow during flow diverter treatment of aneurysms 2015-02-03T21:50:00Z 2015-02-03T21:50:00Z <div id="ImageMain26" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction26" style="clear:both;"> <p><strong><span style="font-size: 11pt;">A new computer programme allows interventionalists to assess blood flow in real-time while they are using flow-diverter devices to treat intracranial aneurysms, suggests a pilot study presented at the <a href="" target="_blank">27<sup>th</sup> annual International Symposium on Endovascular Therapy (ISET, 31 January&ndash;5 February, Hollywood, USA)</a></span></strong>.</p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 11pt;">The researchers set out to study the effect of flow diverter implantation on blood flow in the vicinity of treated aneurysms, and aimed to develop a computer programme for real-time, quantitative assessment of blood flow during flow diverter implantation procedures.</span><br /><br /><span style="font-size: 11pt;">Flow diverters are a class of endovascular devices for treating brain aneurysms by reconstructing the path of arterial flow and excluding an aneurysm from the circulation. &ldquo;Increasing experience with flow diverters worldwide has shown that adverse flow changes due to the treatment may lead to severe complications in patients. Flow diverters typically are used to treat large (2&ndash; 2.5cm) or giant (more than 2.5cm) aneurysms, or those with wide necks,&rdquo; the authors reported in the abstract. </span><br /><br /><span style="font-size: 11pt;">&ldquo;Until now, there was no safe way to measure the blood flow in real-time, during the procedure, including flow reduction to the aneurysm and flow to the rest of the brain,&rdquo; said Aichi Chien, assistant professor of interventional neuroradiology, University of California, Los Angeles, USA. &ldquo;Because the programme quantifies blood flow automatically, doctors do not need to stop the procedure to get this information, which helps them make the best decisions during the procedure.&rdquo;</span><br /><br /><span style="font-size: 11pt;">The Intracranial Stent Flow Mapping computer programme &ndash; <a href="" target="_blank">IS FlowMap</a>&nbsp;&ndash; takes advantage of the standard digital subtraction angiography (DSA) imaging being taken during the procedure. The program analyses the standard images, compares the difference in blood flow image to image and calculates the changes within seconds, providing that information to the interventionalist during treatment. If blood flow is not optimal, the doctor may choose to use a different treatment, such as placing coils in the aneurysm.</span><br /><br /><span style="font-size: 11pt;">In the study, 13 patients were treated, and the average reduction in blood flow entering the aneurysm was 48%. The flow diverter healed the aneurysm in 11 (85%) of the patients. </span><br /><br /><span style="font-size: 11pt;">&ldquo;This pilot study quantitatively comparing the flow before and after flow diverter treatment showed that treatment leads to a significant and immediate reduction in flow entering an aneurysm,&rdquo; the authors noted.&nbsp;</span></p> <p><br /><span style="font-size: 11pt;">&ldquo;There are many advances in devices to treat patients with aneurysms and other vascular disease, but the technology to see the effects of those devices is very limited,&rdquo; said Chien. &ldquo;The IS FlowMap provides a simple way to analyse the treatment without any additional procedures or risk. We will be able to use this information moving forward to compare treatments and determine what amount of blood flow change is optimal.&rdquo;</span></p></div> BrainStorm announces positive DSMB recommendation in ongoing NurOwn amyotrophic lateral sclerosis trial 2015-02-03T16:01:00Z 2015-02-03T16:01:00Z <div id="ImageMain27" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction27" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>BrainStorm has announced that the Data and Safety Monitoring Board (DSMB) met to conduct its first safety review of the randomised, double-blind, placebo-controlled <a href="">phase II clinical trial of NurOwn</a> in amyotrophic lateral sclerosis being conducted by BrainStorm at three academic medical centres in the USA.</strong></span></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The DSMB reviewed safety data collected through a cut-off date in January 2015, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern, and thus recommended that the study continue as planned.</span><br /><br /></p> <p><span style="font-size: 10pt;">BrainStorm&rsquo;s chief executive officer, Tony Fiorino, commented &ldquo;We are gratified that the DSMB has found no concerns after having reviewed the safety data accumulated for the study through January. This extends our prior safety observations made in the two prior amyotrophic lateral sclerosis studies of NurOwn conducted in Israel at Hadassah Medical Center. To date, the safety of NurOwn observed in our clinical trials has been quite good, and the ease of administration and tolerability of both intramuscular and the ease of administration and tolerability of both intramuscular and intravenous routes of administration are attractive aspects of NurOwn&rsquo;s emerging profile.&rdquo;</span></p></div> Heavy drinking in middle-age may increase stroke risk more than traditional factors 2015-01-30T15:39:00Z 2015-01-30T15:39:00Z <div id="ImageMain28" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction28" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Drinking more than two alcoholic beverages daily in middle-age may raise your&nbsp;stroke&nbsp;risk more than traditional factors such as high blood pressure and diabetes, according to new research in the American Heart Association journal&nbsp;<em><a href="">Stroke</a>.</em></strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In a study of 11,644 middle-aged Swedish twins who were followed &nbsp;for 43 years, researchers compared the effects of an average of more than two drinks daily (&ldquo;heavy drinking&rdquo;) to less than half a drink daily (&ldquo;light drinking&rdquo;).</span></p> <p><br /><span style="font-size: 10pt;">The study showed that:</span></p> <ul> <li><span style="font-size: 10pt;">Heavy drinkers had about a 34% higher risk of stroke compared to light drinkers.</span></li> <li><span style="font-size: 10pt;">Mid-life heavy drinkers (in their 50s and 60s) were likely to have a stroke five years earlier in life irrespective of genetic and early-life factors.</span></li> <li><span style="font-size: 10pt;">Heavy drinkers had increased stroke risk in their mid-life compared to well-known risk factors like&nbsp;high blood pressure&nbsp;and&nbsp;diabetes.</span></li> <li><span style="font-size: 10pt;">At around age 75, blood pressure and diabetes appeared to take over as one of the main influences on having a stroke.</span></li> </ul> <p><br /><span style="font-size: 10pt;">Past studies have shown that alcohol affects stroke risk, but this is the first study to pinpoint differences with age. The study was supported by the European Regional Development Fund.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We now have a clearer picture about these risk factors, how they change with age and how the influence of drinking alcohol shifts as we get older,&rdquo; said Pavla Kadlecov&aacute;, a statistician at St. Anne&rsquo;s University Hospital&rsquo;s International Clinical Research Center in the Czech Republic.</span></p> <p><br /><span style="font-size: 10pt;">Researchers analysed results from the Swedish Twin Registry of same-sex twins who answered questionnaires in 1967&ndash;70. All twins were under age 60 at the start. By 2010, the registry yielded 43 years of follow-up, including hospital discharge and cause of death data.</span></p> <p><br /><span style="font-size: 10pt;">Researchers then sorted the data based on stroke, high blood pressure, diabetes and other cardiovascular incidences. Almost 30% of participants had a stroke. They were categorised as light, moderate, heavy or non-drinkers based on the questionnaires. Researchers compared the risk from alcohol and health risks like high blood pressure, diabetes and&nbsp;smoking.</span></p> <p><br /><span style="font-size: 10pt;">Among identical twin pairs, siblings who had a stroke drank more than their siblings who had not, suggesting that mid-life drinking raises stroke risks regardless of genetics and early lifestyle. The study is consistent with the&nbsp;American Heart Association&rsquo;s recommended limit&nbsp;of two drinks a day for men and one for women (around 8 ounces of wine for a man and 4 ounces for a woman).</span></p> <p><br /><span style="font-size: 10pt;">Regular heavy drinking of any kind of alcohol can raise blood pressure and cause heart failure or irregular heartbeats over time with repeated drinking, in addition to stroke and other risks. &ldquo;For mid-aged adults, avoiding more than two drinks a day could be a way to prevent stroke in later productive age (around 60 years),&rdquo; Kadlecov&aacute; said.</span></p></div> Review confirms that electroCore’s non-invasive vagus nerve stimulation is safe and could be widely employed 2015-01-29T15:34:00Z 2015-01-29T15:34:00Z <div id="ImageMain29" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction29" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Non-invasive vagus nerve stimulation &ldquo;improves the safety and tolerability of vagus nerve stimulation making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted stimulation,&rdquo;&nbsp;according to a review in the <em><a href="">European Journal of Neurology</a></em>.<em>&nbsp;</em>The review then went on to look at the efficacy of both surgically implanted non-invasive vagus nerve stimulation, including electroCore&rsquo;s gammaCore device.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Stephen Silberstein of Thomas Jefferson University &ndash; one of the authors of the paper &ndash; commented, &ldquo;This review confirms that non-invasive vagus nerve stimulation is safe and effective. Because there is no surgery involved and because the costs are very competitive, we believe it could open up a whole variety of conditions which have responded to vagus nerve stimulation.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The Cyberonics vagus nerve stimulation implant, which has a licence in North America and Europe for refractory epilepsy and depression, has been implanted in more than 70,000 patients over the last twenty years and has been found to be helpful to patients with several other conditions including headache, anxiety, gastric obesity and other conditions. However, because of the high cost of treatment and the involvement of a surgical procedure, these conditions were never researched in-depth or brought to market.</span><br /><br /></p> <p><span style="font-size: 10pt;">JP Errico, chief executive officer and founder of electroCore, commented, &ldquo;[This paper] shows how our gammaCore device can eliminate the surgical side effects and still provide effective stimulation. Our extensive pre-clinical and clinical programme is already demonstrating how effective this treatment is across a variety of conditions.&rdquo;</span></p></div> Low-frequency deep brain stimulation improves difficult-to-treat Parkinson&apos;s symptoms 2015-01-29T15:27:00Z 2015-01-29T15:27:00Z <div id="ImageMain30" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction30" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Parkinson&rsquo;s disease patients treated with low-frequency deep brain stimulation show significant improvements in swallowing dysfunction and freezing of gait over typical high-frequency treatment. The study, published in&nbsp;<em><a href="">Neurology</a></em>, provides a new route for treating Parkinson&rsquo;s patients with these difficult-to-treat and sometimes life-threatening symptoms.</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is the first study to successfully treat swallowing dysfunction, and one of the first to treat difficulty with gait, using this unusual low-frequency 60Hz stimulation,&rdquo; said study author and principal investigator Tao Xie, assistant professor of neurology at the University of Chicago, USA. &ldquo;These conditions are usually difficult to manage by typical deep brain stimulation or medications. Our findings have a significant and direct clinical impact on improving quality of care and potentially reducing the morbidity and mortality in Parkinson&rsquo;s disease.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Deep brain stimulation is often the major treatment that alleviates symptoms of Parkinson&rsquo;s disease that cannot be adequately controlled by medications. The procedure, which involves the implantation of a &ldquo;brain pacemaker&rdquo;, sends electrical impulses to specific parts of the brain. Routine deep brain stimulation typically uses a high-frequency 130Hz impulse. However, this has been ineffective at improving swallowing issues and freezing of gait&mdash;symptoms which can lead to disability and mortality in Parkinson&rsquo;s.</span><br /><br /></p> <p><span style="font-size: 10pt;">Xie and his colleagues tested whether low-frequency stimulation at 60Hz would be more effective at treating these symptoms in a small trial involving seven Parkinson&rsquo;s patients who had swallowing issues and freezing of gait despite standard medication and 130Hz deep brain stimulation treatment. In two separate sessions separated by six weeks, patients received 60Hz, 130Hz, or no stimulation in a randomized, double-blind manner.</span></p> <p><br /><span style="font-size: 10pt;">The researchers recorded and analysed the oral, pharyngeal, laryngeal functions of patients after deep brain stimulation treatment, playing close attention to whether airway aspiration occurred during swallowing. Patients also filled out a swallowing questionnaire. Freezing of gait was assessed via a stand-walk-sit test and a questionnaire. Patients were also scored on a standard Parkinson&rsquo;s symptom scale, which measures gait, axial symptoms, tremor and other motor symptoms.</span></p> <p><br /><span style="font-size: 10pt;">The team found that 60Hz stimulation reduced airway aspiration issues by 57% and swallowing difficulty by 80%, as well as significantly reduced freezing of gait and axial symptoms, when compared to 130Hz stimulation. Patients continued on 60Hz treatment and benefits persisted when assessed six weeks later.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;For those with freezing of gait that cannot be treated with routine 130Hz stimulation, 60Hz stimulation should be used as it not only improves gait, but also swallowing and other Parkinsonian symptoms,&rdquo; Xie said. &ldquo;It is more effective than 130Hz in overall motor function, though it may not be good for those with medication refractory tremors.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Six out of the seven patients involved in the study have remained on 60Hz stimulation due to persistent benefit for about a year so far. Tao and his team are pursuing long-term follow up studies for these patients, as well as exploring the underlying brain circuitry that makes this treatment effective.</span></p> <p><br /><span style="font-size: 10pt;">The study, &ldquo;Low-frequency stimulation of STN-DBS reduces aspiration and freezing of gait in patients with PD,&rdquo; was funded by the Michael J Fox Foundation under the Rapid Response Innovation Award programme.</span></p></div> InspireMD receives CE mark for CGuard RX and announces six-month CARENET trial data at LINC 2015 2015-01-28T11:33:00Z 2015-01-28T11:33:00Z <div id="ImageMain31" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction31" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InspireMD has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet covered carotid stent technology.&nbsp; Concurrently, the company announced positive six-month follow up data from its CGuard CARENET (Carotid embolic protection study using MicroNet) trial at the LINC meeting in Leipzig, Germany.</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">InspireMD says that the RX delivery system, designed for use with the CGuard MicroNet, will enable clinicians to place the CGuard technology using an easy-to-use, and familiar, delivery system. The CGuard MicroNet mesh covered carotid stent remains unchanged.</span></p> <p><br /><span style="font-size: 10pt;">Piotr Musiałek, Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, and co-principal investigator for the CARENET study, presented the six-month data at a late breaking trial session at the LINC meeting. There was one major adverse cardiac and cerebrovascular event reported at six months which was not device-related. This six-month adverse event rate is substantially lower than rates reported in other conventional carotid stenting trials. The duplex ultrasound analysis performed at six months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing, consistent with historical data of conventional carotid artery stenting. Importantly, the external carotid artery showed unimpeded flow in 100% of cases demonstrating that the MicroNet allows excellent blood flow into bifurcated arteries. The reduction in both the incidence and the volume of new ischaemic lesions, as well as this six-month data showing minimal restenosis concern, and 100% patent internal and external carotid arteries, indicates that the therapeutic benefits of the CGuard MicroNet technology may extend well beyond the acute procedural period.</span></p> <p><br /><span style="font-size: 10pt;">Alan Milinazzo, chief executive officer of InspireMD, commented, &ldquo;Physicians continue to be impressed with the superior clinical data and our six-month results further validate that CGuard with MicroNet may represent a superior next generation of stenting technology. We plan to use the new clinical data and the RX approval to expand our commercial launch activities starting immediately.&rdquo;</span></p></div> Brain imaging may help predict future behaviour 2015-01-28T10:04:00Z 2015-01-28T10:04:00Z <div id="ImageMain32" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction32" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Non-invasive brain scans, such as functional magnetic resonance imaging, have led to basic science discoveries about the human brain, but have had only limited impacts on day-to-day lives. A review article published in the journal <em><a href="">Neuron</a></em>, however, highlights a number of recent studies showing that brain imaging can help predict an individual&rsquo;s future learning, criminality, health-related behaviours, and response to drug or behavioural treatments. The technology may offer opportunities to personalise educational and clinical practices.</strong></span></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">John Gabrieli of the Massachusetts Institute of Technology, Cambridge, USA, and his colleagues describe the predictive power of brain imaging across a variety of different future behaviours, including infants&rsquo; later performance in reading, students&rsquo; later performance in math, criminals&rsquo; likelihood of becoming repeat offenders, adolescents&rsquo; future drug and alcohol use, and addicts&rsquo; likelihood of relapse.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Presently, we often wait for failure, in school or in mental health, to prompt attempts to help, but by then a lot of harm has occurred,&rdquo; says Gabrieli. &ldquo;If we can use neuroimaging to identify individuals at high risk for future failure, we may be able to help those individuals avoid such failure altogether.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors also point to the clear ethical and societal issues that are raised by studies attempting to predict individuals&rsquo; behaviour. &ldquo;We will need to make sure that knowledge of future behaviour is used to personalise educational and medical practices, and not be used to limit support for individuals at higher risk of failure,&rdquo; says Gabrieli. &ldquo;For example, rather than simply identifying individuals to be more or less likely to succeed in a programme of education, such information could be used to promote differentiated education for those less likely to succeed with the standard education program.&rdquo;</span></p></div> InVivo update of first acute spinal cord injury subject implanted with neuro-spinal scaffold 2015-01-27T17:20:00Z 2015-01-27T17:20:00Z <div id="ImageMain33" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction33" style="clear:both;"> <p><strong><span style="font-size: 11pt;">InVivo Therapeutics has announced a three-month update for the first subject in the company&rsquo;s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in subjects with acute spinal cord injury. The Neuro-Spinal Scaffold was implanted in the subject in October 2014 at the Barrow Neurological Institute at St. Joseph&rsquo;s Hospital and Medical Center in Phoenix, USA by Nicholas Theodore, chief of spinal surgery.</span></strong></p> </div><div id="Text133" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In the time between implantation and the three-month post-injury assessment, there were no reported serious adverse events associated with the Neuro-Spinal Scaffold and the subject had progressed from a complete AIS A injury to an incomplete AIS C injury with motor, sensory, bowel, and bladder function improvements. Motor improvement from the pre-surgery assessment to the three-month visit involved the return of active movement of the hip flexors against gravity (allowing for leg to chest motions) and palpable contractions of the knee extensors. Sensory improvement from the pre-surgery assessment to the three-month visit involved the bilateral return of sensation to two dermatomes extending down the top of the subject&rsquo;s legs and the S4&ndash;S5 dermatome. In addition, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam, the Spinal Cord Independence Measure (SCIM III) exam, and additional assessments of bowel and bladder function demonstrated that between hospital discharge and the three-month visit, the subject has regained bowel function and improved bladder function.<br /><br /></span></p> <p><span style="font-size: 10pt;">Theodore said, &ldquo;I am very pleased with the first subject&rsquo;s progress since the scaffold was implanted. In my experience, this degree of sensory and motor improvement is unexpected. However, this is only one patient and we do not want to over-interpret the data.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer, said, &ldquo;We are impressed with the first subject&rsquo;s progress to date since comparable spontaneous recovery occurs infrequently in patients with similar injuries. We look forward to continuing to evaluate the Neuro-Spinal Scaffold in this first subject and the remaining subjects planned for this study.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The data from the first subject were obtained and calculated in accordance with the ISNCSCI, the standard examination used to determine motor and sensory impairment and severity of a spinal cord injury. This is the company&rsquo;s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption (HDE).</span></p></div> Siemens Healthcare and IMRIS bring hybrid ORs to Sahlgrenska University Hospital in Sweden 2015-01-27T11:08:00Z 2015-01-27T11:08:00Z <div id="ImageMain34" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction34" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that a VISIUS Surgical Theatre with intraoperative MRI (iMRI) will be integrated among four hybrid operating suites Siemens Healthcare recently sold to Sahlgrenska University Hospital, Sweden, in an example of growing cooperation between IMRIS and Siemens Healthcare.</strong></span></p> </div><div id="Text134" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This represents the close and progressing global collaboration IMRIS has with Siemens Healthcare to bring advanced imaging to the operating environment,&rdquo; said IMRIS president and chief executive officer Jay D Miller. &ldquo;Already many of the top neuroscience centres around the world are making intraoperative MR their standard of care.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Sahlgrenska University Hospital, one of the largest hospital systems in northern Europe, is associated with the Sahlgrenska Academy at the University of Gothenburg in Gothenburg, Sweden. This sale involves both radiology and MRI systems in four hybrid operating rooms for the hospital&rsquo;s new imaging centre with clinical opening planned in 2016.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The benefit for the patient is obvious with minimally invasive surgery, since he or she can leave the hospital much sooner,&rdquo; said Johan M&auml;lsj&ouml;, Head of Division of Imaging and Therapy at Siemens Healthcare in Sweden. &ldquo;This is also beneficial for the hospital which needs to manage its resources carefully. Siemens Healthcare sees a strong trend in this and expects an increasing demand for similar solutions.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The VISIUS iMRI will feature a two-room suite where a diagnostic quality MR travels to the patient using ceiling-mounted rails. The fully integrated suite allows the scanner to move between an operating room (OR) and a diagnostic room, providing neurosurgeons on-demand access to high resolution images before, during and after procedures without moving the patient from the OR table. Published studies have demonstrated that access to advanced imaging technology during procedures leads to improved precision and patient outcomes and reduced returns to surgery, particularly for neurosurgical conditions.</span></p></div> Medtronic completes acquisition of Covidien 2015-01-27T09:41:00Z 2015-01-27T09:41:00Z <div id="ImageMain35" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction35" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic has successfully completed the previously-announced acquisition of Covidien. Under the terms of the acquisition agreement, Medtronic Inc and Covidien plc are now combined under Medtronic plc.</strong></span></p> </div><div id="Text135" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The culmination of this acquisition marks a significant milestone in our industry, creating a company uniquely positioned to alleviate pain, restore health and extend life for more patients around the world. We can now bring together the extensive and innovative capabilities of both Medtronic and Covidien with an underlying objective to solve healthcare&rsquo;s biggest challenge &ndash; expanding access and improving clinical outcomes, while lowering costs,&rdquo; says Omar Ishrak, chairman and chief executive officer of Medtronic.</span></p> <p><br /><span style="font-size: 10pt;">Covidien and Medtronic Inc shares have now ceased trading on the New York Stock Exchange. The cash-and-stock transaction is valued at approximately US$49.9bn, based on Medtronic&rsquo;s closing stock price of US$75.59 per share on 26 January 2015. Under the terms of the transaction, each ordinary share of Covidien outstanding as of the closing has been converted into the right to receive US$35.19 in cash and 0.956 of an ordinary share of Medtronic plc. Each share of Medtronic Inc common stock outstanding as of the closing has been converted into the right to receive one ordinary share of Medtronic plc.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic plc has its principal executive offices in Ireland, where both companies have a longstanding presence. The company&rsquo;s operational headquarters will continue to be based in Minneapolis, USA.</span></p></div> Stem cell transplantation shows potential for reducing disability in multiple sclerosis patients 2015-01-27T09:25:00Z 2015-01-27T09:25:00Z <div id="Introduction36" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Results from a preliminary study indicate that among patients with relapsing-remitting multiple sclerosis, treatment with nonmyeloablative hematopoietic stem cell transplantation (low intensity stem cell transplantation) was associated with improvement in measures of disability and quality of life, according to a study in the <em><a href="">Journal of the American Medical Association</a>.</em></strong></span></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Fifty per cent of patients with multiple sclerosis are unable to continue employment after 10 years of&nbsp;diagnosis or are unable to walk after 25 years. Despite an annual cost of approximately US$47,000 per patient to treat multiple sclerosis, no therapy approved by the US Food and Drug Administration (FDA) has been shown to significantly reverse neurological disability or improve quality of life.</span><br /><br /></p> <p><span style="font-size: 10pt;">Multiple sclerosis is thought to be an immune&shy;mediated disorder of the central nervous system. Autologous haematopoietic stem cell transplantation (HSCT) is a form of immune suppression, which unlike standard immune-based drugs, is designed to reset rather than suppress the immune system. Richard K Burt of the Northwestern University Feinberg School of Medicine, Chicago, USA, and colleagues studied the association of nonmyeloablative HSCT with neurological disability and other clinical outcomes in patients with relapsing-remitting multiple sclerosis (defined as acute relapses followed by partial or complete recovery and stable clinical manifestations between relapses; n=123) or secondary-progressive multiple sclerosis (defined as a gradual progression of disability with or without superimposed relapses; n=28) treated between 2003 and 2014.</span><br /><br /></p> <p><span style="font-size: 10pt;">Outcome analysis was available for 145 patients with an average follow-up of 2.5 years. On the&nbsp;Expanded Disability Status Scale (EDSS) score, there was significant improvement in 41 patients (50% of patients tested at two years) and in 23 patients (64% of patients tested at four years). &ldquo;To our knowledge, this is the first report of significant and sustained improvement in the EDSS score following any treatment for multiple sclerosis,&rdquo; the authors write.</span><br /><br /></p> <p><span style="font-size: 10pt;">Receipt of HSCT was also associated with improvement in physical function, cognitive function and quality of life. There was also a reduction in the volume of brain lesions associated with multiple sclerosis seen on MRI images. Four-year relapse-free survival was 80% and progression-free survival was 87%.</span><br /><br /></p> <p><span style="font-size: 10pt;">Patient selection is important in determining outcome, the researchers write. &ldquo;In the post hoc analysis, the EDSS score did not improve in patients with secondary-progressive multiple sclerosis or in those with disease duration longer than 10 years.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors note the results are limited because this was an observational study without a control group. &ldquo;Definitive conclusions will require a randomised trial; however, this analysis provides the rationale, appropriate patient selection, and therapeutic approach for a randomised study.&rdquo;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Stephen L Hauser, University of California, San Francisco, USA, writes that the study by Burt <em>et al</em>, taken together with other available evidence, enables several conclusions to be made with reasonable confidence. &ldquo;First, autologous HSCT does not appear to be effective against established progressive forms of the condition and, absent new data, additional trials of these protocols are probably not indicated for patients with progressive multiple sclerosis. Second, immunosuppressive regimens that include HSCT appear to be effective against the relapsing-remitting form of multiple sclerosis, at least over several years of observation. However, it is by no means clear that the beneficial effects result from the infusion of stem cells rather than from the conditioning regimen. Given the availability of highly effective FDA-approved therapies against relapsing-remitting multiple sclerosis, it would seem reasonable to use these proven monotherapies in the clinical setting before considering complex HSCT regimens.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Hauser continues, &ldquo;Third, the mechanism of action of autologous HSCT in MS needs to be clarified. Fourth, it is important to remember that multiple sclerosis is a chronic disease, usually arising in young adults and lasting throughout the lifespan. Many important disability-related outcomes take many years or decades to develop. To understand the role of any therapy, and especially an intensive regimen with uncertain long-term risk, very long follow-up periods are required to meaningfully assess if the disease has indeed been rebooted over the long term, and also to increase confidence that these therapies have not caused undue harm.&rdquo;</span></p></div> Medtronic’s pending acquisition of Covidien approved by Irish High Court 2015-01-26T12:11:00Z 2015-01-26T12:11:00Z <div id="ImageMain37" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction37" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic and Covidien have announced that the Irish High Court has sanctioned the Covidien scheme of arrangement pursuant to which Medtronic will acquire Covidien under a new holding company incorporated in Ireland to be named Medtronic plc.&nbsp;</strong></span></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With the Court&rsquo;s approval of the scheme of arrangement, Medtronic and Covidien anticipate that the transaction, which will result in Medtronic and Covidien becoming wholly owned subsidiaries of Medtronic plc, will close.</span><br /><br /></p> <p><span style="font-size: 10pt;">The transaction is anticipated to close on 26 January 2015, with ordinary shares of Medtronic plc expected to begin trading on the New York Stock Exchange on January 27, 2015.</span></p></div> Interleukin 4 may assist in developing treatment for central nervous system injuries 2015-01-23T14:43:00Z 2015-01-23T14:43:00Z <div id="ImageMain38" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction38" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers have identified a beneficial immune response that occurs after injury to the central nervous system. By harnessing this response, researchers may be able to develop new and better treatments for brain and spinal cord injuries, and tools to predict how patients will respond to treatment, thus improving treatment of degenerative conditions.</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The newly-discovered immune response occurs independently of the process that typically spurs the immune system into action. In this process, the body identifies and attacks antigens such as bacteria and viruses. &ldquo;What we have shown is that the injured central nervous system talks to the immune system in a language that has not been previously recognised in this context,&rdquo; said Jonathan Kipnis, Department of Neuroscience at the UVA School of Medicine and director of the Center for Brain Immunology and Glia. &ldquo;It sends danger signals and activates the immune system very rapidly. These danger signals cause immune cells to produce a molecule called interleukin 4, which happens to be indispensable for immune mediated neuroprotection after central nervous system trauma.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Interleukin 4 helps protect the body&rsquo;s neurons and promote their regeneration, whereas uncontrolled inflammation can destroy them. As such, understanding how the body responds to damage to the central nervous system is critically important.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Once CNS neurons die, they are gone for life. They don&rsquo;t come back. So I think the central nervous system has evolved along with the immune system to respond in this protective fashion,&rdquo; explained UVA&rsquo;s James T Walsh, the lead author of the paper outlining the discovery. &ldquo;[The immune system in the central nervous system] has to be very metered with how it responds. It cannot attack everything like it does in a lot of other tissues, because it causes a lot of collateral damage. You really need the right kind of response. It can be a double-edged sword. The immune system can cause damage to the central nervous system, but it can also be beneficial, and we are showing here how it is beneficial.&rdquo;</span></p></div> Nevro receives FDA approvable letter for Senza spinal cord stimulation system 2015-01-23T09:49:00Z 2015-01-23T09:49:00Z <div id="ImageMain39" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction39" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Nevro has received a letter from the US Food and Drug Administration (FDA) informing the company of the approvability of its premarket approval application (PMA) for the Senza spinal cord stimulation system.</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA&rsquo;s Quality System Regulation, as well as finalisation of the product&rsquo;s labelling with the FDA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are working to satisfy the conditions of approval and anticipate initial commercial availability in the USA by mid-2015", said&nbsp;Michael DeMane, chairman and chief executive officer of Nevro.</span></p> <p><br /><span style="font-size: 10pt;">Leonardo Kapural, the lead investigator of the <a href="">SENZA-RCT study</a>, presented the study results at the Groundbreaking Clinical Trial Results plenary session of the recent North American Neuromodulation Society Meeting (11&ndash;14 December, 2014, Las Vegas, USA). The Senza system is commercially available in&nbsp;Europe&nbsp;and&nbsp;Australia&nbsp;where over 2,500 patients have been treated to date.</span></p></div> Link discovered between protective effects of cooling on the brain and prevention of neurodegeneration 2015-01-15T15:14:00Z 2015-01-15T15:14:00Z <div id="ImageMain40" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction40" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Medical Research Council (MRC) Toxicology Unit have identified a protective mechanism that activates when body temperature is lowered, initiating a process that prevents the loss of brain cells and the connections between them.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The MRC team discovered that this protective process may be defective in neurodegenerative diseases such as Alzheimer&rsquo;s, contributing to the death of brain cells in these disorders. By simulating the effects of cooling in mice, the scientists have revealed a possible new target for drugs that could protect against neurodegeneration.</span><br /><br /></p> <p><span style="font-size: 10pt;">It has long been known that during hibernation, where a mammal&rsquo;s core temperature cools to well below normal body temperature, synapses are depleted.&nbsp;This allows the animal to enter a state of torpor, allowing the animal to survive without nutrition for weeks or months.&nbsp;As the animal comes out of hibernation and warms up, connections between brain cells are reformed and the number of synapses once again rises, restoring normal brain activity.</span><br /><br /></p> <p><span style="font-size: 10pt;">In humans, hypothermia is known to protect the brain. For example, people have survived hours after a cardiac arrest with no brain damage after falling into icy water. Artificially cooling the brains of babies that have suffered a loss of oxygen at birth is also used to protect against brain damage.&nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">Cooling and hibernation lead to the production of a number of different proteins in the brain known as cold-shock proteins. One of these, RBM3, has been associated with preventing brain cell death, but it has been unclear how it affects synapse degeneration and regeneration.&nbsp;Knowing how these proteins activate synapse regeneration might help scientists find a way of preventing synapse loss, without the need for actual cooling.</span></p> <p><span style="font-size: 10pt;">In this study, researchers reduced the body temperature of healthy mice to 16-18 degrees Celsius &ndash; similar to the temperature of a hibernating small mammal &ndash; for 45 minutes. They found that the synapses in the brains of these mice, which do not naturally hibernate, also dismantled on cooling and regenerated on re-warming.</span><br /><br /></p> <p><span style="font-size: 10pt;">The team then repeated the cooling in mice bred to reproduce features of neurodegenerative diseases (Alzheimer&rsquo;s and prion disease) and found that the capacity for synapse regeneration disappeared as the disease progressed, accompanied by a disappearance of RBM3 levels.</span></p> <p><span style="font-size: 10pt;">When the scientists artificially boosted levels of the RBM3 protein they found that this alone was sufficient to protect the Alzheimer and prion mice, preventing synapse and brain cell depletion, reducing memory loss and extending lifespan.</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers were therefore able to conclude that RBM3 &ndash; and perhaps other cold-shock proteins &ndash; affects the ability of neurons to regenerate synapses in neurodegenerative diseases, which is essential to prevent synapse loss during disease progression. The pathway could be a useful target for drugs so that brain cells could be preserved without the need for cooling.</span><br /><br /></p> <p><span style="font-size: 10pt;">Giovanna Mallucci, who led the research team, said: &ldquo;We have known for some time that cooling can slow down or even prevent damage to brain cells, but reducing body temperature is rarely feasible in practice: it is unpleasant and involves risks such as pneumonia and blood clots. But, by identifying how cooling activates a process that prevents the loss of brain cells, we can now work towards finding a means to develop drugs that might mimic the protective effects of cold on the brain.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Hugh Perry, chairman of the MRC&rsquo;s Neurosciences and Mental Health Board, which funded the research, said: &ldquo;The neuroprotective pathway identified in this study could be an important step forward. We now need to find something to reproduce the effect of brain cooling. Just as anti-inflammatory drugs are preferable to cold baths in bringing down a high temperature, we need to find drugs which can induce the effects of hibernation and hypothermia.&rdquo;</span></p></div> Ischaemic micro-lesions associated with flow-diverting stents in treatment of intracranial aneurysms 2015-01-12T16:53:00Z 2015-01-12T16:53:00Z <div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The use of flow-diverting stents to treat intracranial aneurysms appears safe and highly successful. Recently, however, there have been reports of ischaemic complications occurring in brain territories supplied by the parent artery in which the stent is placed and in brain regions fed by small arterial branches whose ostia are covered by the stent.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">To determine the extent of these ischaemic complications and their implications on clinical outcomes in patients who receive flow-diverting stents, researchers from Dupuytren University Hospital in Limoges, France, conducted a prospective single-centre study in which 38 patients (seven male and 31 female) received flow-diverting stents to treat 49 intracranial aneurysms from 1 January 2012 &ndash; 1 July, 2013. Forty aneurysms (82%) were specifically treated using flow-diverting stents, rather than coils or clips, because the aneurysms were considered anatomically challenging.</span><br /><br /></p> <p><span style="font-size: 10pt;">Technical difficulties occurred during insertion of the flow-diverting stent in five patients, but nevertheless, treatment was deemed a technical success in all 49 aneurysms. Diffusion-weighted imaging was performed 24 hours before each procedure as well as 14&ndash;48 hours and three months after treatment. Clinical status and imaging findings before and after treatment were compared in patients who received flow-diverting stents, and these data were also compared with similar data in patients who underwent coil embolisation of aneurysms during the same time period. The authors, Christina Iosif and colleagues, report and discuss their findings in a new paper, &ldquo;Diffusion-weighted imaging&ndash;detected ischaemic lesions associated with flow-diverting stents in intracranial aneurysms: safety, potential mechanisms, clinical outcome, and concerns,&rdquo; 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;">In this study diffusion-weighted imaging (DWI) was used to identify ischaemic micro-lesions. Hyperintense areas&mdash;bright &lsquo;spots&rsquo;&mdash;on the patients&rsquo; DWI studies represented these lesions. These DWI spots were recorded with respect to their number, location, and size.</span><br /><br /></p> <p><span style="font-size: 10pt;">Within 48 hours after the flow-diversion procedure, 35 patients (92.1%) were found to harbour at least one ischaemic micro-lesion; one patient had as many as seven micro-lesions. In total 84 new lesions were identified on DWI during this period. In most cases the micro-lesions were clinically silent; however, in five cases they were clinically relevant, with permanent deficits occurring in three cases (7.8%)&ndash;&ndash;slight disability in one patient and moderate disability in two patients. Three late-occurring micro-lesions were identified by DWI during the follow-up period. All three were clinically silent.</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers compared the high incidence of clinically silent ischaemic micro-lesions in patients who underwent flow diversion (86.9% of patients) with the incidence of these lesions in a comparison group of similar patients who underwent aneurysm coiling (35% of patients). The difference between the two groups was statistically significant (p=0.04). The authors state this reveals &ldquo;an increased embolic tendency with this type of device [that is, the flow-diverting stent], probably due to its mechanical properties and to the technical manipulations during the procedures.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">In this study DWI spots that appeared early during the follow-up period were mostly located in tissue distal to the artery harbouring the treated aneurysm; the authors believe that these spots suggest ischaemic embolic micro-lesions that were a consequence of treatment. Other DWI spots appeared later in the follow-up period, but only in territories fed by arterial branches whose ostia were jailed (that is, covered) by flow-diverting stents; the authors state that these ischaemic events were primarily caused by haemodynamic factors, rather than embolic factors, and were due to a present, but inadequately developed, collateral arterial network competing for the perfusion of the brain territory of the jailed branches. As a new perfusion equilibrium is established, either by recruiting collateral arterial network or by arterial remodelling of the branch, symptoms usually regress.</span><br /><br /></p> <p><span style="font-size: 10pt;">An additional item investigated in this study was whether the location of an intracranial aneurysm treated with a flow-diverting stent has an effect on the number and clinical relevance of ischaemic events. They researchers found no statistical difference between the number of clinically relevant complications and associated outcomes in patients with aneurysms located above or below the circle of Willis.</span><br /><br /></p> <p><span style="font-size: 10pt;">In summary, the authors state that the number of clinically silent ischaemic lesions detected on DWI was much higher than they anticipated. Nevertheless, given the low permanent complication rate, they believe that the flow-diversion technique is safe and effective, and can be used both above and below the circle of Willis. The authors do caution, however, that in cases in which the flow-diverting stent may, of necessity, cover the entrance of an arterial branch, such as can occur in locations above the circle of Willis, the collateral blood supply should be examined carefully to predict whether late-occurring ischaemic micro-lesions may occur.</span><br /><br /></p> <p><span style="font-size: 10pt;">Iosif said: &ldquo;The early appearance of embolic DWI lesions after flow-diverting stents have been placed in intracranial locations in patients receiving appropriate anticoagulation therapy, although very frequent, seems to be free of clinical significance. When considering jailing a side arterial branch, special care should be taken to the competition of flow that may exist in the brain territory supplied by this branch. When an indirect collateral supply is present, due to the pial anastomotic network, the extent of the supply seems to determine whether late-occurring DWI lesions will appear during the jailed branch remodelling process. This study is the first step to understanding the complex haemodynamic mechanisms governing side branch behaviour after insertion of a flow-diverting stent. Further laboratory and clinical research is mandatory to fully elucidate these mechanisms in order to arrive at the point where most consequences of jailing a side branch can be predicted during therapeutic strategy decision-making.&rdquo;</span></p></div> InVivo Therapeutics announces reopening of enrolment for ongoing pilot trial 2015-01-12T16:39:00Z 2015-01-12T16:39:00Z <div id="ImageMain42" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction42" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InVivo Therapeutics has reopened subject enrolment for the company&rsquo;s <a href="">ongoing pilot trial</a> of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. To date, there have been no reported serious safety events with the study&rsquo;s first subject, and InVivo has been cleared by the Data Safety Monitoring Board (DSMB) to move forward with the study.</strong></span></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial.<br /><br /></span></p> <p><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer, said: &ldquo;Since enrolling the first subject, we have increased the number of clinical sites from three to six, putting us in a much better position to enrol the second subject. Although we cannot predict when subjects will present, we anticipate enrolling our second subject more quickly than our first.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Perrin continued: &ldquo;As we have already announced, once the second subject is enrolled, the Food and Drug Administration (FDA) will require only 30 days of safety data for that subject, rather than 90 days, before reopening enrolment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrolment of subjects three through five about two months after the second subject is enrolled. In parallel, we are taking full advantage of a previous FDA approval and are making significant progress to increase the number of participating clinical sites up to 20.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">This is the company&rsquo;s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a Humanitarian Device Exemption.</span></p></div> PulseRider safe and effective in early USA experience 2015-01-08T16:47:00Z 2015-01-08T16:47:00Z <div id="ImageMain43" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction43" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Initial experience with PulseRider (Pulsar Vascular) has shown the device to be safe and effective as an adjunct in the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus according to a report of the first three cases in the USA published in the <em><a href="" target="_blank">Journal of NeuroInterventional Surgery</a></em>.</span></strong></p> </div><div id="Text143" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In June of 2014, the US Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for the PulseRider, allowing Pulsar Vascular to begin a multicentre clinical trial in support of a humanitarian device exemption to evaluate the PulseRider for US approval for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus. PulseRider is currently only available in the USA in the context of the Adjunctive neurovascular support of wide-neck aneurysm embolization and reconstruction (ANSWER) clinical trial.</span></p> <p><span style="font-size: 10pt;"><br />The first three cases were done by physicians from the Medical University of South Carolina, Charleston, USA. Alejandro Spiotta <em>et al</em> explain that patients were pretreated the evening before the procedure with clopidogrel and aspirin and then maintained on daily doses thereafter. All cases were performed under general endotracheal anaesthesia. An appropriately sized PulseRider device was deployed across the neck of the aneurysm. A microcatheter was then navigated over a 0.014 inch microwire through the device into the aneurysm. In these first three cases, complete occlusion of the aneurysm was achieved without intraprocedural complications.</span></p> <p><span style="font-size: 10pt;"><br />The authors report: &ldquo;In our early experience we have found [PulseRider&rsquo;s] use to be simple and safe, being readily delivered in a standard method very similar to other available stents, making the procedure more familiar to an operator new to the device.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Confirming the safety and effectiveness of the device in their first experiences, they conclude that the PulseRider &ldquo;represents a useful addition to the armamentarium of the neuroendovascular specialist&rdquo;.</span></p></div> Non-invasive EEG reveals depolarisations 2015-01-08T12:09:00Z 2015-01-08T12:09:00Z <div id="ImageMain44" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction44" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New research at the University of Cincinnati Neuroscience Institute has shown that spreading depolarisations can be measured by the placement of electroencephalograph (EEG) electrodes on the scalp. Head of the research team, Jed Hartings (research associated professor, Department of Neurosurgery, University of Cincinnati Neuroscience Institute, USA) speaks to <em>NeuroNews</em> about the discovery and its potential to change current practice.</strong></span></p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>What were the findings of your research? How was it conducted?</strong></span></p> <p><span style="font-size: 10pt;"><br />We know how to identify spreading depolarisations from intracranial EEG recordings, that is, by placing electrodes directly on the brain. In this study, we wanted to know whether these waves could be observed with non-invasive EEG recordings from scalp electrodes. So what we did is combine the techniques &ndash; measure EEG both invasively and non-invasively &ndash; and then compare the non-invasive scalp data with confirmed spreading depolarisations identified invasively.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />What we found, in a series of 18 patients, is that the majority of spreading depolarisations had clear manifestations in the scalp EEG recordings. Typically, the spreading depolarisations were observed as reduced amplitudes of the scalp-recorded brain waves. These depressions developed over about 10 minutes and lasted about 30 minutes before recovery. When spreading depolarisations occurred continuously, repeating every 20-30 minutes, they maintained a continuous suppression of the scalp EEG that could last hours to more than a day.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />How will this discovery change current practice? </strong></span></p> <p><span style="font-size: 10pt;"><br />The clinical science of spreading depolarisation is in a relatively early stage of development, but progress in recent years has been solid, and it is accelerating. Evidence increasingly shows that spreading depolarisations, or certain patterns of them, are causally related to development of brain lesions and contribute to poor outcomes. This is a major breakthrough, since there has never been a method to look inside the black box of the injured brain and measure a mechanism of developing damage.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Still, significant advances are needed before this emerging field translates to clinical practice. We need to better understand the clinical significance of different patterns of spreading depolarisations, and we need to make information from monitoring more easily accessible at the bedside. Then there is the big question: what can we do to treat and prevent these events? What is the optimal treatment protocol once they are detected?&nbsp; These questions will take years to answer, and the answers will be refined over decades.&nbsp;&nbsp; &nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />How will the placement of EEG electrodes on the scalp work to measure depolarisations?</strong></span></p> <p><span style="font-size: 10pt;"><br />EEG techniques for measuring depolarisations would likely be very similar to current practice. In fact, the EEG recordings in our study were performed using clinically standard techniques. This is one reason it was so surprising to find evidence of spreading depolarisations in our data. The evidence has been there all along. The data just have to be viewed and analysed the right way to recognise these events.</span></p> <p><span style="font-size: 10pt;"><br />To optimise the technique, minor changes to current clinical practice might be necessary. We need to explore, for instance, whether a certain type of electrode picks up these signals better than other types, and modifications to EEG amplifier hardware could also enhance detection. Software for displaying the data would need to be modified to identify spreading depolarisations in real-time at the bedside. We need to be able to view trends in EEG activity over long time periods.&nbsp;</span></p></div><div id="Text244" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Why was this discovery not made sooner? How exactly was the discovery made?</strong></span></p> <p><span style="font-size: 10pt;"><br />It is incredible that spreading depolarisations were discovered in 1944 &ndash; 70 years ago - and only now are we learning how to see them in patients with methods that have been used clinically for decades. It is not because depolarisations are uncommon &ndash; they occur in about half of patients with severe brain trauma. Most likely, we did not see them sooner because we were not looking at the data with enough perspective. Customary practice is to analyse brain waves on the scale of seconds. But to see these events, the scale needs to be hours. As an analogy, you could describe a forest by walking through it and focusing on individual leaves, branches, and trees. But you would get a very different picture by describing the flow of terrain &ndash; hilltops, streams, and valleys &ndash; from, say, a satellite view. We are just now learning how to analyse this landscape view of brain activity.&nbsp; &nbsp;&nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong>What is the next step in the development of non-invasive EEG? Is there currently a device in use or, if not, are there any plans to develop one?</strong></span></p> <p><span style="font-size: 10pt;"><br />Moberg Research, in Ambler, Pennsylvania, USA, is a company that specialises in neurointensive care monitoring and has decades of experience in EEG recordings. They have taken an active interest in spreading depolarisations, and see this as a growth area in clinical neurophysiology. Currently they are developing a new EEG amplifier with advanced features designed to optimise detection of spreading depolarisations. It should be available next year, and we are quite excited about it.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Apart from the hardware, a lot of work still needs to be done in signal processing and data display to develop software that will make all of this information readily available to clinicians at the bedside. We are still at a point where EEG recordings are analysed by specialists off-line to identify these events.&nbsp; That is not very helpful for patients, but I am confident that bedside applications will be a reality in the future. It is a very solvable problem.&nbsp;&nbsp; &nbsp;&nbsp;</span></p></div> Publication demonstrates high accuracy for identification of acute stroke 2015-01-07T11:56:00Z 2015-01-07T11:56:00Z <div id="Introduction45" style="clear:both;"> <p><strong><span style="font-size: 11pt;">BrainScope Company has announced the publication of an independent study that demonstrated the potential clinical utility of its traumatic brain injury technology to identify acute stroke in the hospital Emergency Department setting. The results of this study, &ldquo;Identification of Acute Stroke Using Quantified Brain Electrical Activity&rdquo; were published in the peer-reviewed journal&nbsp;<em>Academic Emergency Medicine</em>&nbsp;authored by investigators from University Hospitals Case Medical Center, New York University School of Medicine, and The Johns Hopkins University School of Medicine, USA.</span></strong></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this publication, BrainScope&rsquo;s handheld, rapid, easy-to-use, non-invasive, and non-radiation emitting investigational device was used to evaluate potential acute stroke patients in hospital Emergency Departments. BrainScope&rsquo;s proprietary traumatic brain injury algorithms are based on advanced signal processing of brain electrical activity for classification of traumatic brain injury, developed on a large population of head injured patients with mild presentation to the Emergency Department. Using a BrainScope traumatic brain injury algorithm on an independent cohort of stroke patients, this study prospectively demonstrated high sensitivity (92%) for the identification of acute stroke (haemorrhagic and ischaemic).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Every year, 15 million people worldwide suffer a stroke. Nearly six million die and another five million are left permanently disabled. Stroke is the second leading cause of disability, after dementia. Complicating rapid triage are conditions presenting which clinically mimic stroke. The ability to detect the presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for stroke is currently practiced,&rdquo; states Edward Michelson, Associate Professor of Medicine and Emergency Medicine, Case Western Reserve University School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />The study included 48 acute stroke patients presenting to hospital Emergency Departments participating in the study and a control group of patients presenting with stroke-like symptoms (&ldquo;stroke mimics&rdquo;) but who did not experience a stroke. Study sites included: Bellevue Hospital Center, New York; University Hospitals Case Medical Center, Cleveland; William Beaumont Medical Center, Royal Oak; and Washington University, St. Louis, all USA. </span><br /> <br /><span style="font-size: 10pt;"> Sensitivity to stroke was 92%, specificity to stroke mimics was 50% and Negative Predictive Value (NPV) was 94%. Of particular interest was a group of ischaemic stroke patients who were initially negative for stroke on computerised tomography of the head (CT-) but later found to be positive on magnetic resonance imaging (MRI+). Eighty per cent of these CT-/MRI+ ischaemic strokes were correctly identified as positive using the BrainScope traumatic brain injury algorithm at the time the CT scan result was negative. The ability of a classification algorithm based on brain electrical activity to detect CT normal patients who are having ischaemic events may improve triage by increasing the number of treatment-eligible patients at a critical time in the care continuum. Considering that stroke-mimics routinely receive CT scans, the specificity of the traumatic brain injury algorithm suggests it may aid in better allocation of resources and a decrease in unnecessary radiation exposure.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Despite a small population and the use of a classification algorithm derived without the benefit of &lsquo;training&rsquo; it on a population of stroke and stroke mimic patients, this data suggests the potential clinical utility of this technology as an adjunct to acute assessment of stroke,&rdquo; states Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories and Professor of Psychiatry at the NYU School of Medicine, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While we as a company have fully focused our development efforts on traumatic brain injury and concussion, this peer-reviewed publication provides initial compelling evidence about the potential for our overall technology platform to assess the existence of stroke shortly after it occurs,&rdquo; says Michael Singer, president and chief executive officer of BrainScope. &ldquo;We are highly encouraged by the results of this study and will continue to look for opportunities to expand our capabilities in stroke, which is of course a substantial worldwide clinical need.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Results from independent clinical studies utilising BrainScope&rsquo;s technology have been published through 15 articles in leading peer-reviewed brain injury and emergency medicine journals such as&nbsp;<em>Journal of Neurotrauma</em>,&nbsp;<em>Brain Injury</em>,&nbsp;<em>Academic Emergency Medicine,</em>&nbsp;<em>The Journal of Head Trauma Rehabilitation</em>&nbsp;and&nbsp;<em>The American Journal of Emergency Medicine.</em></span></p></div> Update regarding coverage of VNS Therapy system in treatment-resistant depression 2015-01-06T11:38:00Z 2015-01-06T11:38:00Z <div id="Introduction46" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Cyberonics has announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services in the USA.</span></strong></p> </div><div id="Text146" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The decision concludes that the record regarding the VNS Therapy System for treatment-resistant depression is complete and adequate to support the 2007 National Coverage Determination (NCD).&nbsp; The Centers for Medicare &amp; Medicaid Services (CMS) concluded in the 2007 NCD that coverage for the treatment-resistant depression indication is not reasonable and necessary. The decision also clarifies that CMS and its contractors will allow coverage of maintenance services - including replacement of the implanted VNS Therapy device upon battery expiration - for beneficiaries who began receiving VNS Therapy prior to May 4, 2007.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While we acknowledge the importance of clarity for beneficiaries already benefiting from VNS Therapy, we are disappointed with this decision and disagree with the position taken by CMS. We believe that the total body of evidence presents a compelling rationale for access to the VNS Therapy System in a very ill subpopulation of Medicare beneficiaries,&rdquo; says Dan Moore, Cyberonics president and chief executive officer. &ldquo;The company is evaluating options for challenging the DAB decision.&rdquo;</span></p></div> Can exercise help people with Parkinson’s disease? 2015-01-02T11:30:00Z 2015-01-02T11:30:00Z <div id="Introduction47" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Exercise may help people with Parkinson&rsquo;s disease improve their balance, ability to move around and quality of life, even if it does not reduce their risk of falling, according to a new study published in the online issue of&nbsp;<a href="" target="_blank">Neurology</a>, the medical journal of the American Academy of Neurology.</span></strong></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">For the study, 231 people with Parkinson&rsquo;s disease either received their usual care or took part in an exercise programme of 40 to 60 minutes of balance and leg strengthening exercises three times a week for six months. This minimally-supervised exercise programme was prescribed and monitored by a physical therapist with participants performing most of the exercise at home. On average, 13% of the exercise sessions were supervised by a physical therapist.</span></p> <p><span style="font-size: 10pt;"><br />Falling is a common problem for people with Parkinson&rsquo;s, with 60% falling each year and two-thirds of those falling repeatedly. &ldquo;The resulting injuries, pain, limitations of activity and fear of falling again can really affect people&rsquo;s health and well-being,&rdquo; says study author Colleen G Canning of the University of Sydney in Australia.</span></p> <p><span style="font-size: 10pt;"><br />Compared to those in the control group, the number of falls by participants who exercised was reduced in those with less severe Parkinson&rsquo;s disease, but not in those with more severe disease. For those with less severe disease a 70% reduction in falls was reported in those who exercised compared to those who did not.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These results suggest that minimally supervised exercise programmes aimed at reducing falls in people with Parkinson&rsquo;s should be started early in the disease process,&rdquo; Canning says.</span></p> <p><span style="font-size: 10pt;"><br />Overall, those who took part in the exercise programme performed better on tests of ability to move around and balance, had a lower fear of falls and reported better overall mood and quality of life.</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by the Australian National Health and Medical Research Council and the Harry Secomb Foundation.</span></p></div> Stem cell transplants for Parkinson’s disease edging closer 2015-01-02T11:21:00Z 2015-01-02T11:21:00Z <div id="Introduction48" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A major breakthrough in the development of stem cell-derived brain cells has put researchers on a firm path towards the first ever stem cell transplantations in people with Parkinson&rsquo;s disease. A new study presents the next generation of transplantable dopamine neurons produced from stem cells. These cells carry the same properties as the dopamine neurons found in the human brain.</strong></span></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The experiments, performed in rat models of Parkinson&rsquo;s disease, reveal that the latest version of stem cell-derived dopamine cells fully mimic the characteristics and function of the dopamine neurons that are lost in Parkinson&rsquo;s disease. The potentially unlimited supply of transplantable cells, sourced from stem cell lines, opens the door to clinical application on a much broader scale. The results are published in the leading journal in the field,&nbsp;<a href="" target="_blank">Cell Stem Cell</a>.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study shows that we can now produce fully functioning dopamine neurons from stem cells. These cells have the same ability as the brain&rsquo;s normal dopamine cells to not only reach but also to connect to their target area over longer distances. This has been our goal for some time, and the next step is to produce the same cells under the necessary regulations for human use. Our hope is that they are ready for clinical studies in about three years,&rdquo; says Malin Parmar, who led the study conducted at Lund University and at MIRCen in Paris as part of the EU networks NeuroStemCell and NeuroStemcellRepair.</span></p> <p><span style="font-size: 10pt;"><br />Brain cell transplants with foetal dopamine cells obtained from human embryos have already been performed on a few occasions, with varying results. In the past decade, the EU network TRANSEURO has been working hard to get a new and improved trial underway. That moment is now here. In the coming months a small number of patients will be transplanted with foetal cells in Lund, Sweden and Cambridge, UK.</span></p> <p><span style="font-size: 10pt;"><br />The foetal dopamine cells that will be used within TRANSEURO, however, carry some restrictions. Firstly, there is the ethical concern of taking tissue from aborted foetuses. There is also the issue of availability of foetal cells, which is often scarce. The logistics surrounding the gathering of cells for any specific transplantation is partly down to luck and circumstance. These concerns will be resolved as the stem cell-derived dopamine cells become available in the clinic, making the treatment accessible for larger patient groups.</span></p> <p><span style="font-size: 10pt;"><br />The collaborative efforts within EU networks NeuroStemcellRepair and TRANSEURO have put cell therapy on a faster track towards reaching patients. Getting stem cells to become functioning dopamine neurons, the method of delivering them to a specific target, and learning how to get them to integrate in the brain, are all extremely complicated processes. The sharing of ideas and data has been integral to the success of these networks, explains Professor Elena Cattaneo, coordinator for NeuroStemcellRepair.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Collaborative research of this nature is so much more than the results it produces, especially if we consider its potential for expanding the boundaries of knowledge and dissolving cultural barriers. From this perspective, basic research and collaboration among nations stand out once more as something the scientific community should never distance itself from.&rdquo;</span></p></div> Stroke falls to No. 5 cause of death in USA 2014-12-31T11:11:00Z 2014-12-31T11:11:00Z <div id="Introduction49" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stroke&nbsp;has dropped from the USA&rsquo;s fourth-leading cause of death to No. 5, according to new federal statistics. It is the second time since 2011 that stroke has dropped a spot in the mortality rankings.</strong></span></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the&nbsp;Centers for Disease Control and Prevention report released recently, stroke swapped positions with unintentional injuries, which killed 1,579 more people than stroke in 2013.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The fact that the&nbsp;death rate&nbsp;is declining from this terrible and devastating disease is gratifying news,&rdquo; says American Heart Association president Elliott Antman. &ldquo;These statistics are a tribute to the many courageous survivors, healthcare professionals, researchers, volunteers and everyone else committed to fighting stroke.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Still, far too many people are still dying from stroke, and too many people are suffering greatly from this disease,&rdquo; says Antman, a professor of medicine and Associate Dean for Clinical/Translational Research at Harvard Medical School and a senior physician in the Cardiovascular Division of the Brigham and Women&rsquo;s Hospital in Boston, USA.</span></p> <p><span style="font-size: 10pt;"><br />The stroke death rate dropped slightly, from 36.9% in 2012 to 36.2% in 2013. While the death rate from heart disease dropped somewhat between 2012 and 2013, it remains the No. 1 cause of death in the nation. Cancer is the second-leading cause of death, followed by chronic lower respiratory diseases.</span></p> <p><span style="font-size: 10pt;"><br />The decline in stroke deaths may be due in part to improvements in&nbsp;treatment&nbsp;and&nbsp;prevention, says Ralph Sacco, past president of the American Heart Association and chairman of neurology at the University of Miami Miller School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There are more&nbsp;stroke centres&nbsp;now operating in the USA, and the acute care of stroke is improving,&rdquo; says Sacco, who in 2010 became the first neurologist to be named American Heart Association president. &ldquo;However, although mortality from stroke is dropping, we know that the number of people having strokes in the USA is rising each year due to the aging of our population and other signs that strokes have increased in younger groups.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Indeed, despite the lower death rate, 432 more people died from stroke in 2013 than in 2012, the report found.</span></p> <p><span style="font-size: 10pt;">Stroke also remains a leading cause of disability in the USA. In fact, the number of people having strokes &ndash; often with painful and debilitating after-effects &ndash; remains a major cause of concern. &ldquo;Stroke is more disabling than it is fatal,&rdquo; says Sacco.</span></p> <p><span style="font-size: 10pt;"><br />And that is why the American Heart Association remains committed to working with survivors, chief executive officer Nancy Brown says.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There is a great deal to be done on behalf of stroke survivors, who very often face highly debilitating consequences in the aftermath of this severe cardiovascular event,&rdquo; she says. &ldquo;We are committed to standing by their side as we continue striving for new breakthroughs in stroke prevention, treatment and rehabilitation.&rdquo;</span></p></div> NeuroMetrix to showcase Quell wearable pain relief technology 2014-12-30T12:31:00Z 2014-12-30T12:31:00Z <div id="ImageMain50" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction50" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroMetrix will unveil and demonstrate Quell, a novel wearable pain relief device at the 2015 International Consumer Electronics show (CES) 6-9 January in Las Vegas, USA. NeuroMetrix will also be one of an exclusive group that will participate in CES Unveiled, the official press event of CES.</strong></span></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Quell utilises NeuroMetrix&rsquo;s proprietary non-invasive neurostimulation technology to provide relief from chronic pain, such as due to diabetes, sciatica, fibromyalgia, and degenerative knee conditions. The advanced wearable device is lightweight and can be worn during the day while active, and at night while sleeping. It has been cleared by the FDA for treatment of chronic pain without a prescription. Users of the device will also have the option of using their smartphone to automatically track and personalize their pain therapy. The company expects Quell to be available for purchase by consumers in the second quarter of 2015.</span></p></div> Stem cell transplants may halt progression of multiple sclerosis 2014-12-30T11:02:00Z 2014-12-30T11:02:00Z <div id="ImageMain51" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction51" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Three-year outcomes from an ongoing clinical trial suggest that high-dose immunosuppressive therapy followed by transplantation of a person&rsquo;s own blood-forming stem cells may induce sustained remission in some people with relapsing-remitting multiple sclerosis (RRMS). The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded&nbsp;Immune Tolerance Network (ITN).</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Three years after the treatment, called high-dose immunosuppressive therapy and autologous hematopoietic cell transplant or HDIT/HCT, nearly 80% of trial participants had survived without experiencing an increase in disability, a relapse of MS symptoms or new brain lesions. Investigators observed few serious early complications or unexpected side effects, although many participants experienced expected side effects of high-dose immunosuppression, including infections and gastrointestinal problems. The three-year findings are published in the 29 December 2014, online issue of <em><a href="" target="_blank">JAMA Neurology</a></em>.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These promising results support the need for future studies to further evaluate the benefits and risks of HDIT/HCT and directly compare this treatment strategy to current MS therapies,&rdquo; says NIAID director Anthony S Fauci. &ldquo;If the findings from this study are confirmed, HDIT/HCT may become a potential therapeutic option for people with this often-debilitating disease, particularly those who have not been helped by standard treatments.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In the study, researchers tested the effectiveness of HDIT/HCT in 25 volunteers with RRMS who had relapsed and experienced worsened neurological disability while taking standard medications. Doctors collected blood-forming stem cells from participants and then gave them high-dose chemotherapy to destroy their immune systems. The doctors returned the stem cells to the participants to rebuild and reset their immune systems.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Notably, participants did not receive any MS drugs after transplant, yet most remained in remission after three years,&rdquo; says Daniel Rotrosen, director of NIAID&rsquo;s Division of Allergy, Immunology and Transplantation. &ldquo;In contrast, other studies have shown that the best alternative MS treatments induce much shorter remissions and require long-term use of immunosuppressive drugs that can cause serious side effects.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study researchers plan to follow participants for a total of five years, recording all side effects associated with the treatment. Final results from this and similar studies promise to help inform the design of larger trials to further evaluate HDIT/HCT in people with MS.</span></p> <p><br /><span style="font-size: 10pt;">The work was sponsored by NIAID, NIH, and conducted by the ITN (contract number N01 AI015416) and NIAID-funded statistical and clinical coordinating centres (contract numbers HHSN272200800029C and HHSN272200900057C). The identifier for the study High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT-MS) is&nbsp;<a href="">NCT00288626</a>.</span></p></div> Longer cooling, lower temperature no improvement for infant oxygen deprivation 2014-12-24T12:03:00Z 2014-12-24T12:03:00Z <div id="ImageMain52" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction52" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The standard treatment for newborns whose brains were deprived of oxygen appears to work better than proposed alternatives, according to a study from a National Institutes of Health research network. The standard treatment involves lowering an infant&rsquo;s body temperature by about six degrees Fahrenheit for 72 hours. Attempts to improve on this treatment by further lowering body temperature or increasing the duration of cooling were of no additional benefit, the researchers concluded.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Oxygen deprivation&nbsp;before, during, and just after birth may result from a number of causes, including compression of the umbilical cord, loss of blood from a tear in the placenta or a tear in the womb.&nbsp;A previous study&nbsp;found that lowering an infant&rsquo;s body temperature after oxygen deprivation could reduce the risk of death or disability.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Preliminary studies in animals suggested that lowering body temperature and increasing the duration of cooling might provide additional benefits,&rdquo; says study author Rosemary Higgins, programme scientist for the&nbsp;Eunice Kennedy Shriver National Institute of Child Health and Human Development&rsquo;s&nbsp;Neonatal Research Network, which conducted the study. &ldquo;Although the results are disappointing, they do show the need to test any modification of a treatment &mdash; no matter how promising it may appear &mdash; before putting it into practice.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Support for the study also was provided by NIH&rsquo;s National Center for Advancing Translational Sciences, and was published in the <em>Journal of the American Medical Association</em>.</span></p> <p><span style="font-size: 10pt;"><br />Oxygen deprivation in newborns, also known as neonatal hypoxic-ischaemic encephalopathy (HIE), is estimated to occur in 1 to 2 of every 1,000 live births in the developed world, according to the World Health Organisation. Survivors may develop long-term disabilities, such as&nbsp;intellectual impairment&nbsp;or&nbsp;cerebral palsy.</span></p> <p><span style="font-size: 10pt;"><br />Infants assessed as having HIE were randomly assigned to one of four treatments:</span></p> <ul> <li><span style="font-size: 10pt;">Lowering body temperature to 92.3 degrees for three days (the standard treatment)</span></li> <li><span style="font-size: 10pt;">92.3 degrees for five days</span></li> <li><span style="font-size: 10pt;">89.6 degrees for three days</span></li> <li><span style="font-size: 10pt;">89.6 degrees for five days</span></li> </ul> <p><span style="font-size: 10pt;">The current study was confined to the time period that the infants spent in the hospital.</span><br /><span style="font-size: 10pt;"> <br />The researchers are observing the children as they grow and will report disability rates in a subsequent publication.</span></p> <p><span style="font-size: 10pt;"><br />Although the differences in survival rates between the groups were not great enough to be statistically significant, infants receiving the standard treatment had a slightly higher survival rate than did the infants in the other groups. Only 7% of infants receiving the standard treatment died.</span></p> <p><span style="font-size: 10pt;"><br />The researchers noted that survival rates for infants in all the groups in the current study were higher than the survival rate for the cooled infants in the original study showing that cooling could benefit infants would HIE. That study, published in 2005, established newborn cooling as&nbsp;the standard treatment&nbsp;for HIE. In that study, 19% percent of the cooled infants died &mdash; an improvement in the survival rate compared to the then-standard treatment.</span></p> <p><span style="font-size: 10pt;"><br />The researchers are not sure why the death rate was so much lower in the current study than in the original study. It is possible that the increase in survival may be due to overall improvements in newborn care in the last decade, Shankaran says.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our study indicates that physicians won&rsquo;t get a better outcome by making infants a little bit cooler for a little bit longer,&rdquo; Higgins says.</span></p> <p><span style="font-size: 10pt;"><br />The researchers&rsquo; had planned to enrol 726 infants into the study. However, an independent committee that was monitoring the data undertook a statistical analysis indicating that there was less than a 2% chance of finding a benefit to longer or deeper cooling. Taking this analysis into consideration, along with the slightly higher survival rate of infants receiving the standard treatment, the researchers ended the study after only 364 infants had been enrolled.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It looked like it would not be worth continuing the study, because the likelihood of benefit appeared to be really very low,&rdquo; says the study&rsquo;s first author, Seetha Shankaran of the Children&rsquo;s Hospital of Michigan in Detroit, USA.</span></p></div> Alcyone Lifesciences appoints Michael Rogawski to Clinical and Scientific Advisory Board 2014-12-24T11:25:00Z 2014-12-24T11:25:00Z <div id="Introduction53" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Alcyone Lifesciences has announced the appointment of Michael Rogawski of the University of California, Davis, USA to its clinical and scientific advisory board.</strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Throughout his career, Rogawski has been in the forefront of bringing novel and effective treatment for hard to treat seizures and epilepsy,&rdquo; says PJ Anand, founder and chief executive officer, Alcyone Lifesciences. &ldquo;His research continues to drive significant advancement in the field and we look forward to his contribution to Alcyone.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Alcyone&rsquo;s technology platform is unique in that it has the potential to significantly improve certain seizure and epileptic conditions and offer new possibilities to help patients with this debilitating condition. I am looking forward to working with the talented Alcyone team,&rdquo; says Rogawski.</span></p> <p><span style="font-size: 10pt;"><br />Rogawski is an internationally recognised expert on treatments for seizures and epilepsy. He is currently professor of neurology and member of the Center for Neuroscience at the University of California, Davis. Until 2006, he was senior investigator and chief of the Epilepsy Research Section at the National Institute of Neurological Disorders and Stroke. Rogawski&rsquo;s research encompasses cellular neurophysiological studies of ion channels and animal seizure models. He was the first to investigate convection-enhanced delivery of anti-seizure agents in the treatment of epilepsy. In recognition of his research contributions, Rogawski received the NIH Director&rsquo;s Award and the Epilepsy Research Award from the American Society for Pharmacology and Experimental Therapeutics. He presented the William G Lennox Lecture of the American Epilepsy Society. <br /><br />Rogawski received his bachelor&rsquo;s degree in biophysics from Amherst College, and MD and PhD in pharmacology from Yale. After serving as a postdoctoral fellow in the Laboratory of Neurophysiology at NINDS, he completed residency training in neurology at Johns Hopkins.</span></p></div> Seventy-one teams to compete in NIH Neuro Startup Challenge 2014-12-24T11:17:00Z 2014-12-24T11:17:00Z <div id="ImageMain54" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction54" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>More than 70 teams composed of 568 students and entrepreneurs have been accepted to compete in the&nbsp;<a href="">Neuro Startup Challenge</a>,&nbsp;an open innovation competition designed to bring promising brain-related inventions to market. The challenge has teams competing&nbsp;to commercialise 16 National Institutes of Health-conceived and -developed inventions&nbsp;involving&nbsp;therapeutics, diagnostics, prognostics, and medical devices for a range of brain diseases.</strong></span></p> </div><div id="Text154" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are thrilled about the high quality teams from 96 universities that have entered the challenge,&rdquo; says Richard Merkin, founder and chief executive officer of the Heritage Provider Network (HPN). In addition to post-docs, PhDs, law and business students, team leaders have added venture capitalists, clinical research outsourcing organisations, law firms and serial entrepreneurs on their teams to increase their probability of success. Each team required a seasoned entrepreneur as well as two graduate students.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The challenge was launched in August 2014 by HPN&nbsp;in collaboration with&nbsp;NIH&nbsp;and the&nbsp;Center for Advancing Innovation.&nbsp;The teams selected to come into the challenge are from universities, research institutes, and hospitals from the United States and abroad. More than 20% of the teams are from outside the USA. In addition to deliverables due at the end of each of the three phases of the challenge, teams will participate in 40 rigorous, entrepreneurship and start-up training sessions.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The first phase of the challenge requires the teams to develop elevator speeches, a 350-word executive summary outlining potential commercial products and a company vision. These products will be posted on public voting website from 12-16 January, 2015, to be voted upon by the public.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Winners of the elevator speech phase will move on to compete in the second phase of the competition in which teams will develop a 10-page business plan and 20-minute &ldquo;live&rdquo; pitch presented to a panel of judges. Winners of the business plan phase will receive US$2,500 per team provided by the Heritage Provider Network, and will move on to phase three of the competition, the start-up phase. The start-up phase requires the remaining teams to launch their start-ups, including incorporating their business, applying for licenses, and raise seed funding.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is an excellent model for commercialising NIH technologies, while also providing real-world, hands-on experience in creating start-up businesses to all of the Challenge participants and creating the next generation of entrepreneurs,&rdquo; says Joseph M Conrad III, NCI Technology Transfer Specialist and NIH Coordinator for the Neuro Startup Challenge.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Center for Advancing Innovation (CAI) evaluated the teams who wanted to enter the challenge on more than 40 criteria.&nbsp;&ldquo;We wanted the teams that were accepted into the challenge to look like successful start-ups; therefore we rigorously evaluated the teams based on criteria that VCs, foundations and others would use to provide funding,&rdquo; says Rosemarie Truman, founder and chief executive officer of CAI. &ldquo;Based on the extraordinary effort the teams have devoted so far, I expect novel, creative and differentiating approaches to the elevator speech phase and invite people who have an interest neuroscience to vote and provide constructive feedback.&rdquo;&nbsp;</span></p></div> CHMP recommends approval of Xadago to treat Parkinson’s disease in the EU 2014-12-19T11:37:00Z 2014-12-19T11:37:00Z <div id="Introduction55" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Newron Pharmaceuticals and its partner Zambon has announced that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the use of Xadago (safinamide) as add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of patients with mid-late stage Parkinson&rsquo;s disease experiencing motor fluctuations despite being stabilised on &lsquo;Standard of Care&rsquo;.</strong></span></p> </div><div id="Text155" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">C Warren Olanow, Henry P and Georgette Goldschmidt, professor and chairman Emeritus of the Department of Neurology and Professor of Neuroscience at the Mount Sinai School of Medicine, states: &ldquo;Safinamide is the first NCE to be approved for the treatment of Parkinson&rsquo;s disease in the past 10 years. In a two year double blind study, the product demonstrated rapid onset of efficacy (within two weeks) and benefit with respect to improvements in &lsquo;ON and OFF Time&rsquo; without an increase in dyskinesia. This was maintained for the two year duration of the trial when used as an add-on treatment to Parkinson&rsquo;s disease patients with L-dopa-induced motor fluctuations, compared with Standard of Care. No other agent has demonstrated this duration of benefit in a double blind trial.</span></p> <p><span style="font-size: 10pt;"><br />Safinamide&rsquo;s effects are dependent upon pharmacological mechanisms that are not shared with other Parkinson&rsquo;s disease drugs. These effects include its dual mechanism of highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels that inhibit glutamate release, implicated in causing dyskinesia. Preclinical experiments and data from a large number of dyskinetic patients enrolled in a placebo controlled clinical study indicate that safinamide also has the potential to improve L-dopa induced dyskinesia in Parkinson&rsquo;s disease patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Fabrizio Stocchi, professor of Neurology, director of the Parkinson&rsquo;s Disease and Movement Disorders Research Centre, and Institute for Research and Medical Care IRCCS San Raffaele, Rome, who has been involved with safinamide trials from the beginning, says: &ldquo;The benefits of safinamide were demonstrated as adjunctive treatment for fluctuating patients on top of L-dopa alone or in combination with other Parkinson&rsquo;s disease medications. Safinamide demonstrated significantly improved motor fluctuations, Parkinsonism, Quality of Life and Activities of Daily Living without any increase in &lsquo;ON Time with troublesome dyskinesia&rsquo;.</span></p> <p><span style="font-size: 10pt;"><br />My experience in treating Parkinson&rsquo;s disease patients with safinamide in Rome over the last 10 years, as well as my review of all the data indicate that safinamide is extremely well tolerated even over long periods of time. Safinamide does not require any specific medical monitoring, dietary restrictions, or particular precautions because the risk of drug interactions is very low.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The CHMP&rsquo;s positive opinion on Xadagowill now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.</span></p> <p><span style="font-size: 10pt;"><br />The EU filing was based on results of a comprehensive development programme comprising over 300 preclinical studies and 37 clinical studies performed in over 30 countries worldwide, with over 3,000 subjects treated, and safinamide&rsquo;s safety being documented in &gt;1,100 patients for one year, &gt;500 patients for two years, &gt;220 patients for &gt;three years, and &gt;160 patients for four years.</span></p></div> MR CLEAN: Better outcomes with intervention in ischaemic stroke patients 2014-12-18T10:00:00Z 2014-12-18T10:00:00Z <div id="ImageMain56" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction56" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>For the first time, the Multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands (MR CLEAN) has shown better outcomes in favour of intervention in patients with acute ischaemic stroke.</strong></span></p> </div><div id="Text156" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The long-awaited study was released online by the <em>New England Journal of Medicine (NEJM)</em> yesterday. 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.</span><br /><br /></p> <p><span style="font-size: 10pt;">Study authors, Diederik Dippel <em>et al</em>, report that between December 2010 and March 2014, 500 patients with acute ischaemic stroke caused by an intracranial occlusion in the anterior circulation artery were randomised in 16 Dutch centres. Initiation of intra-arterial treatment had to be possible within six hours after stroke onset. Eligible patients had an occlusion of the distal intracranial carotid artery (M1 or M2), or anterior cerebral artery (A1 0r A2), established with computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital-subtraction angiography (DSA), and a score of 2 or higher on the National Institutes of Health Stroke Scale (NIHSS). All patients underwent clinical assessment at baseline, after 24 hours, and at five to seven days or at discharge if earlier.</span><br /><br /></p> <p><span style="font-size: 10pt;">According to the study, 233 patients (46.6%) were assigned to the intervention group and 267 patients (53.4%) were assigned to the control group. Actual intra-arterial therapy (with or without mechanical thrombectomy) was performed in 196 of the 233 patients in the intervention group. Mechanical treatment was performed in 195 of the 233 patients. Retrievable stents were used in 190 patients (81.5%), and other devices were used in five patients. Additional intra-arterial thrombolytic agents were given to 24 patients. Intra-arterial thrombolytic agents were used as monotherapy in one of the 233 patients. No intervention was given in 37 patients.</span><br /><br /></p> <p><span style="font-size: 10pt;">The authors report that the results show a shift in the distribution of the primary-outcome scores in favour of the intervention. &ldquo;The shift toward better outcomes in favour of the intervention was consistent for all categories of the modified Rankin scale, except death. The absolute between-group difference in the proportion of patients who were functionally independent (modified Rankin score, 0 to 2) was 13.5 percentage points (95% CI, 5.9 to 21.2) in favour of the intervention (32.6% vs. 19.1%), with an adjusted odds ratio of 2.16 (95% CI, 1.39 to 3.38).&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">In terms of secondary outcomes, the results show that intervention was also more favourable: &ldquo;The NIHSS score after five to seven days was, on average, 2.9 points lower in the intervention group than the control group.&rdquo; Additionally, an absence of residual occlusion at the target site was more common in the intervention group than in the control group.&rdquo;</span></p></div><div id="Text256" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Dippel <em>et al</em> conclude, &ldquo;Our results show that patients with acute ischaemic stroke caused by a proximal intracranial arterial occlusion of the anterior circulation have a benefit with respect to functional recovery when intra-arterial treatment is administered within six hours after stroke onset. This treatment leads to a clinically significant increase in functional independence in daily life by three months, without an increase in mortality. Our findings stand in clear distinction to those of recent randomised, controlled trials that failed to show a benefit of intra-arterial treatment.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Comparing this study to the Interventional management of stroke III trial (IMS III), the authors say that the cohort is similar to IMS III, in which intravenous alteplase alone was compared with intravenous altepase plus intra-arterial treatment. They say, &ldquo;Approximately 90% of patients in each treatment group of MR CLEAN received intravenous alteplase; however, in the IMS III trial, patients had to be enrolled and undergo randomisation within 40 minutes after the start of intravenous alteplase. This requirement may have led to the inclusion of more patients who had a favourable response to intravenous alteplase than in MR CLEAN, which had a median time from the start of intravenous alteplase to randomisation that was considerably longer than the maximum time in the IMS III trial. It is likely that intra-arterial treatment will not alter the natural history of acute ischaemic stroke in the absence of a proximal arterial occlusion&hellip;. Our study benefited from the widespread availability of retrievable stents, which were used in 82% of the patients in the intervention group. These devices were recently shown to be superior to the first-generation Merci device for both revascularisation and clinical outcomes.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Commenting on the results, Dippel told <em>NeuroNews</em> that going forward, &ldquo;the challenge for the future will be to identify all patients who are eligible for this treatment: those with an occlusion who can be treated within six hours, and transfer them quickly to an intervention centre.&rdquo;</span></p></div> Brainlab multiple metastases planning software available in the USA 2014-12-18T09:30:00Z 2014-12-18T09:30:00Z <div id="ImageMain57" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction57" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Brainlab has announced 510(k) clearance for two software modules for radiation oncologists and neurosurgeons. Adaptive Hybrid Surgery and Automatic Brain Metastases Planning software by Brainlab are now available in the USA after successful clinical use in several international markets.</strong></span></p> </div><div id="Text157" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Brainlab&rsquo;s Adaptive Hybrid Surgery helps physicians to balance surgical risk with radiosurgical toxicity for multi-disciplinary treatment of skull-base tumours. A complete set of automated tools enables analysis of adjuvant radiosurgery at any time, while planning and performing a surgical resection. Elements Intraoperative Structure Update captures residual tumour volumes based on points acquired inside the resection cavity. An intuitive traffic light display provides comprehensive information about tumour coverage and critical dose constraints for calculated treatment plans.</span><br /><br /></p> <p><span style="font-size: 10pt;">The Automatic Brain Metastasis Planning software introduces the market to technology that consistently and rapidly generates radiosurgery plans for the efficient treatment of multiple metastases. This breakthrough technology allows clinicians to plan and treat multiple brain metastases with time and dose efficiencies while helping to minimise exposure to healthy surrounding tissue. Treatment delivery and planning time can be reduced drastically, even for as many as 10 metastatic tumours in the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We expect [our new software&rsquo;s] capabilities, efficiency and usability to help change the way certain life-threatening diseases are treated,&rdquo; comments Stefan Vilsmeier, president and chief executive officer of Brainlab.</span></p></div> American Academy of Neurology calls for more research on medical marijuana for brain diseases 2014-12-18T09:00:00Z 2014-12-18T09:00:00Z <div id="ImageMain58" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction58" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The American Academy of Neurology (AAN) is calling for more research on the use of medical marijuana for brain, spine and nervous system disorders.</strong></span></p> </div><div id="Text158" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The current medical marijuana legislation being passed by policymakers across the country, which promotes marijuana-based products as treatment options for various brain and nervous system disorders, is not supported by high-level medical research,&rdquo; says position statement author Anup Patel, with Nationwide Children&rsquo;s Hospital in Columbus, Ohio, and a member of the AAN. &ldquo;There may be some safety concerns for marijuana-based products, especially for long-term use in patients with these diseases, as to date it has not been well-studied.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The AAN supports the reclassification of marijuana-based products by the federal government from their current status as a Schedule I drug to improve access for study of marijuana or cannabinoids under approved research protocols.</span><br /><br /></p> <p><span style="font-size: 10pt;">The AAN does not advocate for the legalisation of marijuana-based products for use in brain and nervous system disorders at this time, Patel states, as further research is needed to determine the benefits and safety of such products. This is especially important in the cases of people with underlying brain disorders and in children whose developing brains may be more vulnerable to the toxic effects of marijuana, according to the position statement.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We recognise that there may be potential use for these agents in the treatment of some brain and nervous system disorders, but there is not sufficient evidence to make any definitive conclusions regarding the effectiveness of marijuana-based products for many neurologic conditions at this time,&rdquo; Patel says.</span><br /><br /></p> <p><span style="font-size: 10pt;">In March 2014, the AAN published a guideline on complementary alternative therapies, such as medical marijuana, to treat multiple sclerosis.&nbsp;In April 2014, the AAN published a systematic review on the efficacy and safety of medical marijuana in selected brain and nervous system disorders, such as epilepsy, Parkinson&rsquo;s disease, multiple sclerosis and Tourette syndrome.</span></p> <p><span style="font-size: 10pt;">The position statement also notes that many cannabis preparations used in studies are not available in the USA. &ldquo;It is not appropriate to extrapolate the results of trials of standardised preparations to other, non-standardised, non-regulated cannabis products that may be commercially available in states with laws supporting the use of medical marijuana,&rdquo; Patel comments.</span></p></div> Cyberonics reports positive results from AspireSR generator vagus nerve stimulation studies 2014-12-17T15:36:00Z 2014-12-17T15:36:00Z <div id="Introduction59" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cyberonics announced new results from two multi-site clinical studies of the AspireSR generator, <a href=";rank=1">E-36</a> and <a href=";rank=1">E-37</a>, at the American Epilepsy Society Annual Meeting (AES; 5&ndash;9 December, Seattle, USA).&nbsp;</strong></span></p> </div><div id="Text159" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Investigators presented results from the European E-36 study and the US E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life. Assessments of seizure severity and quality of life were made using validated scales scored by patients, and physicians.</span><br /><br /></p> <p><span style="font-size: 10pt;">The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies. Seizure activity was recorded using concurrent video-electroencephalography (EEG) and electrocardiogram (ECG) monitoring. Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.</span><br /><br /></p> <p><span style="font-size: 10pt;">During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These clinical results show that the AspireSR vagus nerve stimulation (VNS) therapy system is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy,&rdquo; says Paul A J M Boon, professor and chairman of the Department of Neurology and director, Institute for Neuroscience, Ghent University Hospital. &ldquo;The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS therapy systems, but with added convenience to both the patient and caregiver.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;More than 60% of patients receiving VNS therapy report benefits from manual magnet activation, yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura,&rdquo; adds Robert Fisher, director of the Stanford Epilepsy Center, Palo Alto, USA. &ldquo;The AspireSR generator delivers programmed VNS therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures. This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy.&rdquo;<br /><br />The AspireSR generator is investigational in the USA and not approved for commercial use. The device has attained the CE mark and is&nbsp;available in an increasing number of European countries.<br /></span></p></div> Stroke treatment in England varies widely by location 2014-12-17T11:08:00Z 2014-12-17T11:08:00Z <div id="ImageMain60" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction60" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New figures released by the Health and Social Care Information Centre (HSCIC) show that the treatment of stroke patients in England varies widely depending on where patients live.</strong></span></p> </div><div id="Text160" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Of the 68,800 patients admitted to hospital with stroke during 2013-14, 41,200 (60%) were admitted to an acute stroke unit within four hours of arrival at hospital. This figure varied by clinical commissioning group (CCG), from 22% of patients in NHS Wyre Forest CCG to 85% of patients in NHS Hillingdon CCG.</span></p> <p><br /><span style="font-size: 10pt;">In 71 of the 2,114 CCGs across the country, less than 55% of patients were admitted to a stroke unit within four hours of admission to hospital and in 13 CCGs, this figure was less than 40%. No CCGs were able to ensure that 90% or more of their patients were admitted to a stroke unit within four hours of admission to hospital.</span></p> <p><br /><span style="font-size: 10pt;">The report, &ldquo;<a href="">CCG Outcomes Indicator Set, December 2014</a>&rdquo;, shows two further indicators which examine stroke at CCG level &ndash; people who have had an acute stroke who receive thrombolysis and people who have had an acute stroke who spend 90% or more of their hospital stay on a stroke unit.</span></p> <p><br /><span style="font-size: 10pt;">The report also shows that in 2013-14:</span></p> <ul> <li><span style="font-size: 10pt;">Nationally, 84% of people spent 90% or more of their stay on a stroke unit and this was exceeded in more than half of CCGs (53%)</span></li> <li><span style="font-size: 10pt;">In three CCGs, less than 70% of patients spent 90% or more of their stay on a stroke unit</span></li> <li><span style="font-size: 10pt;">NHS Corby CCG had the lowest rate of stroke patients spending 90% or more of their stay on a stroke unit (66%), whereas NHS Ealing CCG had the highest rate (95%).</span></li> </ul> <p><span style="font-size: 10pt;">HSCIC chair, Kingsley Manning, says: &ldquo;It is important that patients suffering a stroke receive appropriate care as soon as possible. I am sure health professionals and those responsible for delivering care for stroke patients will use this report to identify how improvements in treatment can be made, such as how quickly patients are admitted to a stroke unit.&rdquo;</span></p></div> First trial of oral anticoagulant to prevent recurrent stroke due to a blood clot of undetermined source 2014-12-15T11:36:00Z 2014-12-15T11:36:00Z <div id="ImageMain61" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The first patient has been enrolled in the <a href="">RE-SPECT ESUS</a> phase III study to investigate the efficacy and safety of dabigatran etexilate (Boehringer Ingelheim) for the prevention of recurrent embolic stroke of undetermined source (ESUS). <a href="">RE-SPECT ESUS</a>&nbsp;aims to include 6,000 patients in 35 countries.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Patients who experience an ESUS are at increased risk of another stroke.&nbsp;These recurrent strokes can lead to potentially devastating consequences and are associated with high rates of morbidity and mortality.&nbsp;The currently available treatment options to prevent recurrent stroke following ESUS offer only limited efficacy.&nbsp;There is also limited knowledge and data available to guide treatment decisions in these patients, resulting in a considerable unmet need.</span><br /><br /></p> <p><span style="font-size: 10pt;">Professor Hans-Christoph Diener, professor of neurology and chairman of the Department of Neurology, University of Essen, Germany, says: &ldquo;This trial investigates the safety and efficacy profile of dabigatran etexilate versus acetylsalicylic acid in patients with embolic strokes of undetermined source. These patients are at high risk of a recurrent embolic stroke. Embolic strokes of undetermined sources make up a quarter of all strokes and are caused by blood clots, which travel into the brain via large blood vessels.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Boehringer Ingelheim hopes that the <a href="">RE-SPECT ESUS</a> (Randomised&nbsp;evaluation in&nbsp;secondary stroke&nbsp;prevention&nbsp;comparing the thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid in&nbsp;embolic&nbsp;stroke of undetermined&nbsp;source) study aims to include 6,000 patients from study sites in Asia, Europe, North and South America. It is part of Boehringer Ingelheim&rsquo;s clinical trial programme, RE-VOLUTION. Also including the recently announced <a href="">RE-CIRCUIT</a> and <a href="">RE-DUAL PCI</a> studies, the entire programme will involve over 60,000 patients globally.</span></p></div> Acorda initiates phase 3 trial of CVT-301 in Parkinson’s disease 2014-12-12T11:20:00Z 2014-12-12T11:20:00Z <div id="Introduction62" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Acorda Therapeutics has enrolled its first patient in a phase 3 study of CVT-301 for the treatment of &ldquo;off&rdquo; episodes in Parkinson&rsquo;s disease. &ldquo;Off&rdquo; episodes are characterised by a re-emergence of Parkinson&rsquo;s disease symptoms such as tremor, muscle stiffness and impaired ability to move.</strong></span></p> </div><div id="Text162" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">CVT-301 is a novel, self-administered inhaled therapy designed to provide rapid, reliable delivery of a precise dose of levodopa (L-dopa) through the lungs to return people with Parkinson&rsquo;s disease to an &ldquo;on&rdquo; state, when a patient&rsquo;s symptoms are adequately controlled.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;About 350,000 people with Parkinson&rsquo;s disease in the USA experience &ldquo;off&rdquo; episodes, which can be exceptionally disruptive, impacting their lives on a daily basis, even multiple times per day. We believe CVT-301 has the potential to be an important treatment for people experiencing &ldquo;off&rdquo; episodes,&rdquo; says&nbsp;Enrique Carrazana, Acorda Therapeutics&rsquo; chief medical officer.</span></p> <p><br /><span style="font-size: 10pt;">The multicentre, double blind, randomised trial is expected to enrol approximately 345 participants across three arms: 50mg, 35mg, or placebo. These are the same doses used in the phase 2b study. The primary outcome measure is improvement on the Unified Parkinson&rsquo;s Disease Rating Scale (UPDRS) Part III after administration of CVT-301.</span></p> <p><br /><span style="font-size: 10pt;">Positive results from the CVT-301 phase 2b study were presented at the 2014 American Academy of Neurology Annual Meeting. In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction in average UPDRS Part III motor score versus placebo across time points beginning at 10 and up to 60 minutes post-administration (p &lt; 0.001). Both doses of CVT-301 were well tolerated, with no increase relative to placebo in troublesome or non-troublesome dyskinesias during &ldquo;on&rdquo; periods. There were no serious adverse events in the trial, and the incidence of drug-related adverse events was similar between treatment groups. The CVT-301 inhaler was shown to be easily self-administered in the &ldquo;off&rdquo; state.</span></p></div> Memory lapses among highly educated may signal higher stroke risk 2014-12-12T11:02:00Z 2014-12-12T11:02:00Z <div id="ImageMain63" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction63" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People with a high level of education who complain about memory lapses have a higher risk for stroke, according to new research in the American Heart Association journal <a href=""><em>Stroke</em></a>.</strong></span></p> </div><div id="Text163" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Studies have shown how stroke causes memory complaints,&rdquo; says Arfan Ikram, associate professor of neuroepidemiology at Erasmus University Rotterdam in the Netherlands. &ldquo;Given the shared underlying vascular pathology, we posed the reverse question: &lsquo;Do memory complaints indicate an increased risk of strokes?&rsquo;&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">As part of the Rotterdam Study (1990-93 and 2000-01), 9,152 participants 55 or older completed a subjective memory complaints questionnaire and took the Mini-Mental State Examination (MMSE).&nbsp;By 2012, 1,134 strokes occurred: 663 were ischemic, 99 haemorrhagic and 372 unspecified.</span></p> <p><span style="font-size: 10pt;">Subjective memory complaints were independently associated with a higher risk of stroke, but a higher MMSE score was not. Furthermore, those with memory complaints had a 39% higher risk of stroke if they also had a higher level of education. The finding is comparable to the association between subjective memory complaints and Alzheimer&rsquo;s disease among highly educated people.</span></p> <p><span style="font-size: 10pt;">&ldquo;Given the role of education in revealing subjective memory complaints, we investigated the same association but in three separate groups: low education, medium education and high education,&rdquo; Ikram says. &ldquo;We found that the association of memory complaints with stroke was strongest among people with the highest education. If in future research we can confirm this, then I would like to assess whether people who complain about changes in their memory should be considered primary targets for further risk assessment and prevention of stroke.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers categorised level of education into three groups: low education &ndash; primary education only; intermediate education &ndash; primary education plus some higher education, lower vocational education, intermediate vocational education, or general secondary education; and high education &ndash; higher vocational education or university training.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study results apply evenly to men and women. With more than 95% of study participants being Caucasians living in Rotterdam, future studies could include more racially diverse groups.</span></p></div> First US patients receive Genzyme’s Lemtrada following FDA approval 2014-12-05T14:37:00Z 2014-12-05T14:37:00Z <div id="ImageMain64" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction64" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Genzyme has announced that the first US patients have initiated treatment with Lemtrada&nbsp;(alemtuzumab) in the commercial setting following its FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS).&nbsp;</strong></span></p> </div><div id="Text164" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Christopher LaGanke, founder of North Central Neurology Associates in Cullman, USA, wasthe first physician to initiate patient treatment in the US.</span></p> <p><span style="font-size: 10pt;"><br />Lemtrada has a dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.</span></p> <p><span style="font-size: 10pt;"><br />The FDA approval of Lemtrada was based on two pivotal randomised phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif&nbsp;(high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (<a href="">CARE-MS I</a>) or who had relapsed while on prior therapy (<a href=";rank=2">CARE-MS II</a>).</span></p> <p><span style="font-size: 10pt;"><br />In <a href="">CARE-MS I</a>, 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 <a href=";rank=2">CARE-MS II</a>, 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 compared to those given interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.</span></p> <p><span style="font-size: 10pt;"><br />Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.</span></p></div> Images of brain after mild stroke predict future risk 2014-12-05T09:19:00Z 2014-12-05T09:19:00Z <div id="ImageMain65" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction65" style="clear:both;"> <p><strong><span style="font-size: 11pt;">A&nbsp;CT scan&nbsp;of the brain within 24 hours of a mild, non-disabling stroke&nbsp;can predict when patients will be at the highest risk of another stroke or when symptoms may worsen, according to new research published in the American Heart Association journal <a href=""><em>Stroke</em></a>.</span></strong></p> </div><div id="Text165" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;All patients should get a CT scan of their brain after a transient ischaemic attack&nbsp;(TIA) or non-disabling stroke,&rdquo; says Jeffrey J Perry, co-senior author of the study and associate professor of emergency medicine at the University of Ottawa in Canada. &ldquo;Images can help healthcare professionals identify patterns of damage associated with different levels of risk for a subsequent stroke or help predict when symptoms may get worse.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Of 2,028 patients who received CT scans within 24 hours of a TIA or non-disabling stroke, 814 (40.1%) had brain damage due to ischaemia. Compared to patients without ischaemia, the probability of another stroke occurring within 90 days of the initial episode was:</span></p> <ul> <li><span style="font-size: 10pt;">2.6 times greater if the CT image revealed newly damaged tissue due to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">5.35 times greater if tissue was previously damaged (chronic ischaemia) in addition to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">4.9 times greater if any type of small vessel damage occurred in the brain, such as narrowing of the microangiopathy, in addition to acute ischaemia;</span></li> <li><span style="font-size: 10pt;">8.04 times greater if acute and chronic ischaemia occurred in addition to microangiopathy.</span></li> </ul> <p><span style="font-size: 10pt;">While 3.4% of the patients in the study group had a subsequent stroke within 90 days, 25% of patients with CT scans showing all three types of damage to their brain had strokes.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;During the 90-day period, and also within the first two days after the initial attack, patients did much worse in terms of experiencing a subsequent stroke if they had additional areas of damage along with acute ischemia,&rdquo; says Perry, who is also a senior scientist at the Ottawa Hospital Research Institute.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These findings should prompt physicians to be more aggressive in managing patients with TIA or non-disabling stroke who are diagnosed with acute ischaemia, especially if there is additional chronic ischaemia and/or microangiopathy.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Measures to avert a new stroke might include cardiac monitoring or medications to lower blood pressure, treat high cholesterol or prevent blood clots. The researchers are assessing how to incorporate the study&rsquo;s findings into stroke risk scores that rely on symptoms along with patient factors such as age and the presence of high blood pressure or diabetes.</span></p></div> Spinal Modulation completes enrolment of Axium neurostimulator US pivotal trial 2014-12-03T11:42:00Z 2014-12-03T11:42:00Z <div id="ImageMain66" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction66" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Spinal Modulation has completed enrolment of the <a href="">ACCURATE study</a>, a randomised, controlled pivotal clinical trial designed to evaluate the safety and efficacy of the company&rsquo;s Axium neurostimulator system.</strong></span></p> </div><div id="Text166" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Axium system is a targeted form of spinal cord stimulation, which uses an implantable medical device to deliver mild electrical pulses that mask or interrupt pain signals as they travel from the periphery to the brain. Unlike traditional spinal cord stimulation devices, Axium uniquely targets the dorsal root ganglion, a neural structure within the spine that has been shown to play a critical role in the development and maintenance of chronic pain.</span></p> <p><br /><span style="font-size: 10pt;">The <a href="">ACCURATE</a> study enrolled 152 patients at 22 centres throughout the USA. This represents the largest neuromodulation study to be conducted in patients suffering from nerve injuries or complex regional pain syndrome to date.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Approximately 10-50% of patients who undergo common procedures like hernia repair, knee surgery, and other lower limb surgeries will suffer from chronic pain resulting from nerve injury. These conditions have historically been difficult to treat with currently available technology,&rdquo; says Timothy Deer, co-study lead and chief executive officer and president of the Center for Pain Relief in Charleston, West Virginia. &ldquo;Results from prior European studies have been promising, and we are hopeful that the <a href="">ACCURATE</a> trial will continue to substantiate the effectiveness of this therapy for our patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Investigators will present the <a href="">ACCURATE</a> trial design at the 18<sup>th</sup>&nbsp;Annual North American Neuromodulation Society (NANS) meeting in Las Vegas, Nevada, December 11 &ndash; 14, 2014. Clinical outcomes from Europe and Australia, where the Axium system is commercially available, will also be presented.</span></p></div> Eli Lilly and Company and AstraZeneca initiate early Alzheimer’s disease pivotal clinical trial 2014-12-01T14:27:00Z 2014-12-01T14:27:00Z <div id="Introduction67" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Eli Lilly and Company and AstraZeneca have announced enrolment of the first patient into AMARANTH, a phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer&rsquo;s disease.&nbsp;</strong></span></p> </div><div id="Text167" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">AZD3293, also known as LY3314814, has been shown in phase I studies to reduce levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer&rsquo;s patients and healthy volunteers. The progression of Alzheimer&rsquo;s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. The study will investigate the safety and efficacy of AZD3293/ LY3314814 compared with placebo in the treatment of early Alzheimer&rsquo;s disease.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our AstraZeneca partners share our determination to find answers for this condition that shatters lives. We are pleased that the first patient enrolment in AMARANTH comes fewer than three months since we announced our alliance,&rdquo; says Phyllis Ferrell, global brand development leader for Alzheimer&rsquo;s disease at Lilly.</span></p> <p><br /><span style="font-size: 10pt;">Samantha Budd, vice president and head of translational science in AstraZeneca&rsquo;s Neuroscience Innovative Medicines Unit says: &ldquo;We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease. Together with Lilly, we have unique expertise that will allow us to evaluate the potential of AZD3293 as a treatment for Alzheimer&rsquo;s patients.&rdquo;</span><br /><br /><span style="font-size: 10pt;">AstraZeneca and Lilly announced an alliance earlier in 2014 for the development and commercialisation of AZD3293/ LY3314814. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca&rsquo;s Neuroscience Innovative Medicines Unit, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch. &nbsp;</span></p></div> IMRIS completes SYMBIS surgical system human factors study 2014-12-01T12:50:00Z 2014-12-01T12:50:00Z <div id="ImageMain68" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction68" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has successfully completed the human factors study for the SYMBIS surgical system &ndash; the validation used to support the product&rsquo;s 510(k) submission to the US Food and Drug Administration (FDA).&nbsp;</strong></span></p> </div><div id="Text168" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This is a significant step leading to our goals of merging intraoperative imaging with robotics,&rdquo; saysIMRIS president and chief executive officer Jay D Miller. &ldquo;By finding ways to enhance the vision and precision of surgery through technology, we are working towards improving the outcomes for patients with neurological disorders at lower costs for the healthcare system.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Over the past eight years, the FDA has been actively working with companies to apply the science of human factors &ndash; understanding how humans interact physically and psychologically with a device &ndash; to medical device development.</span></p> <p><br /><span style="font-size: 10pt;">The human factors study provided a neurosurgeon&rsquo;s perspective on how well use-related risks were mitigated by the IMRIS design team, when the SYMBIS surgical system is used by neurosurgeons. The study physicians were asked to perform a planned simulated procedure without any outside intervention. Throughout the study, the subject&rsquo;s interaction with the system was observed for any use-related errors.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The human factors study was not only an opportunity for IMRIS to validate the performance of the SYMBIS system with real users,&rdquo; Miller explains, &ldquo;we also captured the voice of the customer on how surgeons perceive the current system, as well as the future clinical applications where robotics in neurosurgery can provide both clinical and economic value.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The SYMBIS human factors study involved a diverse group of 18 neurosurgeons of varying demographics and range of neurosurgical experience. Subjects were recruited from nine leading neurosurgical centres in the USA &ndash; including three centres that do not currently have a VISIUS surgical theatre with intraoperative MRI (iMRI).</span></p> <p><br /><span style="font-size: 10pt;">One of the study subjects, neurosurgeon William Broaddus of Richmond, VA, comments:&nbsp;&ldquo;After working with the SYMBIS System as a human factors study subject, I see this technology as an exciting platform for major advances in neurosurgical practice.&rdquo;</span></p></div> Philips launches DoseWise Portal radiation dose management software 2014-12-01T12:20:00Z 2014-12-01T12:20:00Z <div id="ImageMain69" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction69" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Royal Philips&nbsp;has introduced the DoseWise Portal, a comprehensive radiation dose management software solution aimed at managing radiation exposure risk to patients and their caregivers.&nbsp;</strong></span></p> </div><div id="Text169" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Announced at the 100<sup>th</sup><span class="apple-converted-space">&nbsp;</span>annual meeting of the Radiological Society of<span class="apple-converted-space">&nbsp;</span><span class="xn-location">North America (RSNA; 30 November</span>&ndash;5 December, Chicago, USA), the Philips DoseWise Portal enables health care providers to proactively record, analyse and monitor imaging radiation dose for patients and clinicians across multiple diagnostic settings.</span></p> <p><br /><span style="font-size: 10pt;">While the risk of radiation exposure through imaging scans is thought to be low, and the diagnostic rewards generally outweigh those risks, the industry has committed to reducing radiation exposure through improvements in technology and user training. Computer tomography (CT) scans are of most concern, with a higher average diagnostic radiation dose per scan and nearly 68 million performed annually in the USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Dose management is a critical issue, and the reality is that sometimes the higher radiation dose of a CT is necessary for a particular patient to in order reach a definitive diagnosis, in the shortest time, and at the lowest cost,&rdquo; says<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Gene Saragnese</span>, executive vice president and chief executive officer of Philips Imaging Systems. &ldquo;Philips DoseWise Solutions return a measure of control to patient care, arming clinicians and informing patients with the tools, training and insights they need in order to ask the right questions regarding&nbsp;radiation dose.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The company says that Philips DoseWise Solutions include a comprehensive portfolio of products and services including<span class="apple-converted-space">&nbsp;</span>ClarityIQ,<span class="apple-converted-space">&nbsp;</span>IMR<span class="apple-converted-space">&nbsp;</span>and<span class="apple-converted-space">&nbsp;</span>DoseAware that empower health care providers with both the data and support they need to implement a broad and comprehensive dose management strategy.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Philips DoseWise is the first integrated, holistic solution that integrates staff and patient dose protecting both patients and clinicians and helping us to comply with critical new dose management standards and regulations,&rdquo; comments<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Christoph Wald</span>, executive vice chair, Department of Radiology at Lahey Hospital and Medical Center in<span class="apple-converted-space">&nbsp;</span><span class="xn-location">Burlington</span>, USA.&nbsp;</span></p></div> Same regions in brain are vulnerable to both Alzheimer’s and schizophrenia 2014-11-27T12:40:00Z 2014-11-27T12:40:00Z <div id="ImageMain70" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction70" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In the largest study of its kind, researchers have found a specific network of brain regions that is not only more vulnerable to unhealthy ageing, for example, Alzheimer&rsquo;s disease, but also to disorders that emerge in young people, such as schizophrenia.</strong></span></p> </div><div id="Text170" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The international team, led by Medical Research Council funded researcher Gwena&euml;lle Douaud, at the Oxford University Functional MRI of the Brain Centre, also discovered that, in healthy people, these parts of the brain are the last to develop and the first to show signs of neurodegeneration. The research has been published in the journal <em><a href="">Proceedings of the National Academy of Sciences</a></em>.</span></p> <p><br /><span style="font-size: 10pt;">The network of nerve cells in the brain, consisting of mainly higher-order regions that coordinate information coming from different senses, develops in late adolescence or early adulthood and is associated with both intellectual ability and long-term memory. These mental abilities become significantly impaired in, respectively, people with schizophrenia or those with Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">The University of Oxford team used MRI scans to look at changes in the brain structure of 484 healthy people, ranging in age from 8 to 85 years. Uniquely, the researchers used a data-driven approach to study these age-related changes, in which instead of looking for a particular pattern of brain change over the lifespan in a specific location of the brain, they analysed all the imaging data to see what patterns were revealed.</span></p> <p><br /><span style="font-size: 10pt;">The imaging data showed a specific network within the grey matter linking mostly higher order regions of the brain. This network was found to develop later than the rest of the brain, and was the first to degenerate in older age.</span></p> <p><br /><span style="font-size: 10pt;">The findings fit with a retrogenesis theory of brain change across the lifespan which dates back to the 1880s. It proposes that brain capacity declines in reverse order to the way in which it develops, both in human developmental terms and in evolutionary terms. This study is the first to demonstrate this theory in the grey matter on a large scale using complex, data-driven image analysis techniques.</span></p> <p><br /><span style="font-size: 10pt;">Although it has been known for some time that grey matter declines with age, this study revealed one specific network that was more vulnerable to age-related neurodegeneration. The researchers compared this network, identified from MRI data of healthy subjects&rsquo; brains, with the pattern of grey matter damage observed in the scans of people suffering from Alzheimer&rsquo;s and from schizophrenia. As the researchers found striking similarities between the three, and could relate the network to key symptoms of both diseases, they suggest that these areas of the brain likely play a crucial role in the emergence of these two very different disorders.</span></p> <p><br /><span style="font-size: 10pt;">Research has shown previously that these higher-order regions are not as developed in the brains of chimpanzees and other primates. In addition, because these animals appear not to suffer from schizophrenia or Alzheimer&rsquo;s, some scientists have suggested that these diseases might be a result of humans&rsquo; highly-evolved brains and extended lifespan.</span></p> <p><br /><span style="font-size: 10pt;">The study was the result of an international collaboration between the University of Oxford neuroscience imaging team, neuroscience researchers from the University of Oslo and research clinicians from the University Hospital Basel, Imperial College London and the University of Oxford&rsquo;s Department of Psychiatry.&nbsp;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Douaud explains: &ldquo;Our results show that the same specific parts of the brain not only develop more slowly, but also degenerate faster than other parts. These complex regions, which combine information coming from various senses, seem to be more vulnerable than the rest of the brain to both schizophrenia and Alzheimer&rsquo;s. These results, which might seem surprising at first, are really exciting as they actually reconcile two historical hypotheses &ndash; until now presented completely separately in the scientific literature &ndash; that the brain damage observed in Alzheimer&rsquo;s and schizophrenia is related to these higher order regions of the brain.&rdquo;</span></p> <p><span style="font-size: 10pt;">Hugh Perry, chairman of the MRC&rsquo;s Neurosciences and Mental Health Board, which funded the work, says: &ldquo;Early doctors called schizophrenia &lsquo;premature dementia&rsquo; but until now we had no clear evidence that the same parts of the brain might be associated with two such different diseases. This large-scale and detailed study provides an important, and previously missing, link between development, ageing and disease processes in the brain.&rdquo;&nbsp;</span></p></div> Medtronic acquisition of Covidien receives US Federal Trade Commission and European Commission clearance 2014-11-27T09:50:00Z 2014-11-27T09:50:00Z <div id="ImageMain71" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction71" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The US Federal Trade Commission (FTC) and the European Commission have given clearance of Medtronic&rsquo;s proposed acquisition of Covidien.&nbsp;</strong></span></p> </div><div id="Text171" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The FTC&rsquo;s and European Commission&rsquo;s clearances follow Medtronic&rsquo;s and Covidien&rsquo;s agreement to a proposed consent order, which includes a commitment to divest certain assets related to Covidien&rsquo;s drug-coated balloon catheter product. A subsidiary of Covidien entered into an agreement to divest these assets to Spectranetics and the divestiture is expected to close shortly following completion of Medtronic&rsquo;s acquisition of Covidien.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic and Covidien also entered into a parallel consent agreement regarding the divestiture of assets related to Covidien&rsquo;s drug-coated balloon catheter product with the Canadian Competition Bureau, which announced its clearance of the deal&nbsp;at the same time as the FTA.</span></p> <p><br /><span style="font-size: 10pt;">Medtronic&rsquo;s acquisition of Covidien is expected to close in early 2015 after receipt of certain additional regulatory clearances and approvals by both companies&rsquo; shareholders and sanction by the High Court of Ireland.&nbsp;</span></p> </div> Silk Road Medical unveils data from the ROADSTER trial 2014-11-26T11:10:00Z 2014-11-26T11:10:00Z <div id="ImageMain72" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction72" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Silk Road Medical&rsquo;s 30-day outcomes from the ROADSTER IDE study were presented at the Late Breaking Clinical Trials Session at the 2014 Vascular InterVentional Advances (VIVA) Meeting in&nbsp;Las Vegas, with additional data presented at the VEITHsymposium in&nbsp;New York. &nbsp;</strong></span></p> </div><div id="Text172" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The trial studied the Enroute transcarotid neuroprotection system (NPS), which is designed to provide direct access to the carotid artery and reduce the risk of stroke during carotid angioplasty and stenting (CAS) by diverting dangerous debris away from the brain with a surgically-inspired mechanism to temporarily reverse blood flow. The 1.4% 30-day stroke rate was the lowest seen to date of any contemporary prospective trial of CAS.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Celebrating its 60<sup>th</sup>&nbsp;anniversary in 2013, carotid endarterectomy (CEA) has been the gold standard in carotid artery revascularisation because of the low stroke and death rates in multiple prospective trials. Yet CEA is not free of the potential for certain local and systemic complications such as cranial nerve injury and myocardial infarction.</span></p> <p><br /><span style="font-size: 10pt;">Fifteen years ago transfemoral CAS was introduced with much initial excitement due to the minimally invasive, endovascular advantage, but fell out of favour for physicians and payers due to the excess risk of periprocedural stroke compared to CEA. In a standard surgical risk population, the CREST trial demonstrated that periprocedural strokes occur twice as often in transfemoral CAS patients.</span></p> <p><span style="font-size: 10pt;">ROADSTER was a prospective, multicentre, IDE study designed to evaluate the safety and effectiveness of the Enroute transcarotid NPS in a hybrid procedure combining the best elements of CEA and CAS. Richard Cambria and&nbsp;Christopher Kwolek, of Massachusetts General Hospital, served as the trial national co-principal investigators. Patients were enrolled at 15 vascular surgery sites, one neurosurgery site, and two multi-specialty sites. The primary endpoint was a composite of any stroke (S), death (D), or myocardial infarction (MI) through 30 days.</span></p> <p><br /><span style="font-size: 10pt;">Two-hundred and eight&nbsp;(67 lead-in, 141 pivotal) symptomatic and asymptomatic patients who were at high risk for complications from CEA were enrolled.&nbsp;Food and Drug Administration (FDA)-approved carotid stent systems were delivered through the direct carotid access point under high rate flow reversal afforded by the Enroute transcarotid NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age greater than or equal to 75.&nbsp;</span></p> <table> <tbody> <tr> <td> <p><span style="font-size: 10pt;">ROADSTER trial</span></p> <p><span style="font-size: 10pt;">results at 30 days</span></p> </td> <td> <p><span style="font-size: 10pt;">ITT population</span></p> <p><span style="font-size: 10pt;">n=141</span></p> </td> <td> <p><span style="font-size: 10pt;">Per protocol population</span></p> <p><span style="font-size: 10pt;">n=136</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">Stroke/death/MI</span></p> </td> <td> <p><span style="font-size: 10pt;">3.5%</span></p> </td> <td> <p><span style="font-size: 10pt;">2.9%</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">Stroke/death</span></p> </td> <td> <p><span style="font-size: 10pt;">2.8%</span></p> </td> <td> <p><span style="font-size: 10pt;">2.2%</span></p> </td> </tr> <tr> <td> <p><span style="font-size: 10pt;">All stroke</span></p> </td> <td> <p><span style="font-size: 10pt;">1.4%</span></p> </td> <td> <p><span style="font-size: 10pt;">0.7%</span></p> </td> </tr> </tbody> </table> <p><span style="font-size: 10pt;">There were no strokes in patient&rsquo;s age greater than or equal to 75 or in symptomatic patients. There was one (0.7%) CNI presenting as hoarseness which fully resolved.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These stroke rates in a high surgical risk population are the lowest to date for CAS and comparable to the periprocedural rates in the standard surgical risk CEA arm of CREST (2.3%). The Silk Road procedure is less of an operation for the patient than a traditional CEA and can be performed in under an hour with local anaesthesia,&rdquo; Cambria explains.</span><br /><br /></p> <p><span style="font-size: 10pt;">Erica Rogers, chief executive officer of Silk Road Medical, says: &ldquo;The ROADSTER data support our hypotheses that led to this device design and procedure.&nbsp;It is all about stroke.&nbsp;Doctors perform these procedures to reduce the risk of stroke, not to cause a stroke. The ENROUTE transcarotid platform finally delivers a less invasive alternative with the neuroprotection you would expect from a CEA procedure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Enroute NPS and Stent Systems are limited by&nbsp;United States&nbsp;law to investigational use; the Enroute transcarotid NPS has been submitted for 510(k) review and the ROADSTER trial also supports the pending Premarket Approval PMA for the Enroute transcarotid Stent System. The Enroute transcarotid NPS and the Enroute transcarotid Stent System have been granted CE mark.</span></p></div> New Alzheimer’s programme to focus on prevention, intervention, research and support 2014-11-25T17:00:00Z 2014-11-25T17:00:00Z <div id="ImageMain73" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction73" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cedars-Sinai&nbsp;has launched the Alzheimer&rsquo;s Prevention Program to help identify patients at risk of developing the neurological disorder and to reduce the impact on those diagnosed with the condition.</strong></span></p> </div><div id="Text173" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The programme represents a concerted effort by clinicians, researchers, patients, families, caregivers and community agencies to address an approaching &ldquo;tsunami&rdquo; of Alzheimer&rsquo;s care. Medical authorities expect the number of cases nationally to triple by 2050, costing more than US$1tn.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We know that we can have a major impact on this disease if we take bold action,&rdquo; says&nbsp;Dean Sherzai, director of the programme. &ldquo;If Alzheimer&rsquo;s is detected early enough, we can take steps to slow or even prevent its progression.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Sherzai said the first goal of the Alzheimer&rsquo;s Prevention Program will be to identify patients in the early stages of the disease when interventions and treatments can have the biggest impact. The second goal will be to provide patients and families with comprehensive, long-term care and education in a well-established centre that combines research and clinical services with a network of support in the community.</span><br /><br /></p> <p><span style="font-size: 10pt;">Cedars-Sinai&rsquo;s comprehensive approach eventually may serve as a model that can be implemented elsewhere, with interventions, treatments and care plans built around each patient&rsquo;s background and interests.</span><br /><br /><span style="font-size: 10pt;">&ldquo;If we tell patients they have Alzheimer&rsquo;s, prescribe the drugs that exist right now and send them out without providing any other resources, all we have done is create chaos in their lives,&rdquo; comments Sherzai, a faculty member in the department of neurology&nbsp;and the&nbsp;department of neurosurgery. &ldquo;We have to give them counselling and direction. We can help make the journey much less painful, becoming one in which families bceome&nbsp;closer rather than being torn apart by tensions and financial burdens.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The Alzheimer&rsquo;s Prevention Program will serve as the hub for a clinical trial site for experimental Alzheimer&rsquo;s drugs, including several studied at Cedars-Sinai. Over 50 drugs have worked in animal models of dementia and Alzheimer&rsquo;s disease but failed when applied to humans. Researchers believe the drugs did not work in patients because their disease was too advanced. Indeed, existing drugs treat symptoms without slowing the onset of the disease.</span><br /><br /></p> <p><span style="font-size: 10pt;">Although genetic and environmental factors influence the development of the disease, lifestyle changes, especially if made early, can alter its course. If applied early enough, nutrition, exercise and certain kinds of mental activity not only affect quality of life but its length as well. &ldquo;This is remarkable, because none of the drugs we have can do that,&rdquo; Sherzai notes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The studies going on at Cedars-Sinai are very exciting, and we&rsquo;re looking forward to helping patients participate in clinical trials,&rdquo; he said.&nbsp;</span></p></div> Repetitive transcranial magnetic stimulation studied for stroke rehabilitation 2014-11-25T16:39:00Z 2014-11-25T16:39:00Z <div id="ImageMain74" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction74" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Ohio State University Wexner Medical Center are attempting to improve arm movement in stroke patients by using a transcranial magnetic stimulator (TMS) device. By using TMS to reduce brain activity on the uninjured side of the brain, researchers hope that the injured side may have a better chance of recovering.</strong></span></p> </div><div id="Text174" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">When one side of the brain is damaged by a stroke, the healthy side tends to increase its activity to compensate. However, that may actually prevent the injured side from recovering, according to&nbsp;principal investigator Marcia Bockbrader, assistant professor of physical medicine and rehabilitation at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">Ohio State is one of 12 rehabilitation sites nationwide participating in the multicentre clinical trial that will enrol up to 200 patients during the next two years. Nexstim has launched the double-blinded, randomised, and sham-controlled trial to determine the therapeutic effects of navigated repetitive transcranial magnetic stimulation (rTMS) for stroke rehabilitation. This stroke therapy combines occupational therapy with navigated repetitive transcranial magnetic stimulation (n-rTMS).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Nexstim is a way to specifically stimulate a brain area of interest,&rdquo; says Bockbrader. &ldquo;In our study, we are stimulating the motor areas that are sometimes injured in a stroke. This device targets the overactive side, quieting it down enough, so that through therapies, the injured side can learn to express itself again.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">To qualify for the study, participants must have had a stroke 3-12 months before, and continue to experience&nbsp;weakness in the arm and hand on one side. All participants also receive six weeks of hand and arm therapy free of charge. An occupational therapist focuses on improving movement, flexibility, strength and use of the weak arm and hand. The study lasts for up to eight months and will involve up to 29 visits.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;In this particular study, we are looking at people who are 3-12 months after stroke who have not recovered all the way and are trying to use this technology to boost their recovery process to restore the brain balance,&rdquo; Bockbrader explains.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers are using stereotactic MRI-guided rTMS to non-invasively modulate precise areas of the motor cortex. The system&rsquo;s targeting tool allows the therapist to accurately locate the patient&rsquo;s exact stimulation target using technology similar to mapping the globe with a GPS. The n-rTMS is used to stimulate the patient&acute;s non-injured brain hemisphere at a low frequency, said co-investigator Stephen Page, associate professor of health and rehabilitation sciences at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">This results in down-regulation of the excitability of the healthy side and restoration of the balance between the lesioned and healthy sides, allowing the lesioned side to regain function. Adding navigation to TMS is the key to finding the exact location and orientation of the motor area that should be inhibited by stimulation. The stimulation is then accurately repeated in every session, assuring the dose is applied to the correct place, said co-investigator Lise Worthen-Chaudhari, assistant professor of physical medicine and rehabilitation at Ohio State.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we are doing is allowing the brain to be ready and more receptive for therapies,&rdquo; comments Bockbrader. &ldquo;It is not a technology limited to just motor recovery after stroke, it seems to be something that has a potential to affect many of the brain circuits that are injured in stroke.&rdquo; Other sites in the clinical trial are Mayo Clinic in Arizona; Ranchos Los Amigos National Rehabilitation Institute in California; Shepherd Center in Georgia; Rehabilitation Institute of Chicago; Indiana University; Spaulding Rehabilitation Hospital in Massachusetts; Columbia University; Burke Rehabilitation Center in New York; Duke University, University of Cincinnati; and TIRR Memorial Hermann Hospital in Texas.</span></p></div> InVivo Therapeutics announces OHSU as fifth clinical trial site for Neuro-Spinal Scaffold 2014-11-25T16:22:00Z 2014-11-25T16:22:00Z <div id="Introduction75" style="clear:both;"> <p><strong><span style="font-size: 11pt;">InVivo Therapeuticshas announced that the Oregon Health &amp; Science University (OHSU) in Portland, Oregon, USA, is the fifth clinical site in the company&rsquo;s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Ahmed Raslan, an assistant professor of neurological surgery at OHSU, will be the study&rsquo;s principal investigator at that site.</span></strong></p> </div><div id="Text175" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;It is very exciting to be a part of this first-in-human trial for the Neuro-Spinal Scaffold,&rdquo; Raslan comments. &ldquo;This important contribution to science demonstrated promising results in pre-clinical studies and provides, for the first time, a categorically distinct form of potential repair after SCI.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In October, InVivo announced enrolment of its first patient at Barrow Neurological Institute in Phoenix, Arizona, USA. Mark Perrin, InVivo chief executive officer, says: &ldquo;We are delighted to have Ahmed Raslan and OHSU join us. OHSU and the other centres will be able to enrol the next subject following the three-month observation period for first patient.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">This is the company&rsquo;s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the US Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialisation under a humanitarian device exemption.</span></p></div> Portable electric device found to slow and reverse growth of glioblastoma 2014-11-21T10:35:00Z 2014-11-21T10:35:00Z <div id="ImageMain76" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction76" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A non-invasive, portable electrical device tested at the Hermelin Brain Tumor Center at Henry Ford Hospital along with other major medical centres around the USA, has been found to lengthen the lives of some patients suffering from glioblastoma, the most common and deadliest form of brain cancer.</strong></span></p> </div><div id="Text176" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The device proved to be so successful in early testing that an independent monitoring committee recommended cutting short the latest phase of its clinical trials and allowing all test patients to be treated with it.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is not a cure,&rdquo; says Tobias Walbert, a neuro-oncologist and researcher in the department of neurosurgery at Henry Ford Hospital. &ldquo;But these early results have been so impressive that we might be looking at a game-changer in the treatment of glioblastoma.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The electrical device, designed to be worn at least 20 hours a day to be effective, weighs about six pounds (2.72kg), is powered by rechargeable batteries and is carried by the patient in a small backpack. It received US Food and Drug Administration (FDA) approval in 2011 only to treat patients with recurring glioblastoma, not first-time cases.</span><br /><br /></p> <p><span style="font-size: 10pt;">The manufacturer, Novocure, is currently seeking FDA approval to use the device on all glioblastoma patients. Marketed under the brand name Optune, the equipment creates low-intensity alternating electric fields, referred to as tumour treating fields, and delivers them through wires attached to the patient&rsquo;s shaved scalp by four adhesive transducer pads that target the brain tumour. Individual placement of the transducers is determined by MRI scan. The clinical trials showed that the tumour treating fields reversed the tumour&rsquo;s growth and killed cancer cells by disrupting mitosis, the process by which cells divide and replicate.</span><br /><br /></p> <p><span style="font-size: 10pt;">Research results were presented by the study&rsquo;s leader Roger Stupp, chairman of the oncology department at Switzerland&rsquo;s University of Zurich, at the annual meeting of the Society for Neuro-Oncology in Miami, USA. Data collected from the first 315 of around 700 patients included in the international clinical trials showed:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Patients treated with both tumour treating fields and temozolomide chemotherapy showed a &ldquo;significant increase&rdquo; in progression-free survival compared to those treated with chemotherapy alone - a median of 7.1 months compared to 4 months;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Those treated with both tumour treating fields and temozolomide also showed a &ldquo;significant increase&rdquo; in overall survival compared to temozolomide alone - a median 19.6 months compared the 16.6 months.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 43% of patients treated with both tumour treating fields and temozolomide chemotherapy were still alive after 2 years compared to 29% treated with the chemotherapy alone.</span><br /><br /></li> </ul> <p><span style="font-size: 10pt;">The only side effect reported by the researchers was irritation of the scalp where the transducers were attached. &ldquo;These results are spectacular, a lot better and much more convincing than we ever would have dreamt of,&rdquo; says Stupp.</span></p></div> Barrow neurosurgeons implant the world’s first scaffold into a patient’s spinal cord 2014-11-21T10:19:00Z 2014-11-21T10:19:00Z <div id="Introduction77" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurosurgeons at Barrow Neurological Institute have implanted the world&rsquo;s first scaffolding device into the spinal cord of a patient.&nbsp;Performed last month, the surgery involves inserting a bioresorbable scaffolding implant to act as a bridge across the gap of the injured section of the cord in an attempt to help the spinal cord heal.</strong></span></p> </div><div id="Text177" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This first case is part of a pilot study to measure the clinical safety of the implanted device developed by InVivo Therapeutics. &ldquo;This could be the first step in identifying a new treatment option to improve the overall recovery of individuals with acute spinal cord injury,&rdquo; says Nicholas Theodore, chief of spinal surgery at Barrow and principal investigator of the study.</span></p> <p><span style="font-size: 10pt;">Twenty-five-year-old Jordan Fallis, the first patient to have the scaffold implanted, will be closely monitored throughout his recovery to see if there are any changes or improvements to his spinal cord and mobility. A section of Fallis&rsquo; spinal cord was injured in a dirt biking accident and he was airlifted to Barrow which is located at Dignity Health St Joseph&rsquo;s Hospital and Medical Center, where he underwent emergency surgery that evening. Fallis spent a week in the ICU before being transferred to the hospital&rsquo;s Neuro Rehabilitation Center where he is currently undergoing intensive physical and occupational therapy.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;I&rsquo;m excited to be the first patient in this research study that may one day become the standard of spinal cord injury treatment,&rdquo; says Fallis.</span><br /><br /></p> <p><span style="font-size: 10pt;">To measure the safety of the device, the US Federal Drug Authority has approved five individuals in the USA&nbsp;to undergo the procedure. Fallis will be monitored for three months before InVivo reopens enrolment. In addition to Barrow, the University of North Carolina, the University of Arizona and the Washington University Medical Center are participants in the study.</span></p></div> FDA clears Ahead 100 device for adjunctive assessment of traumatic brain injury 2014-11-20T15:30:00Z 2014-11-20T15:30:00Z <div id="ImageMain78" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction78" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>BrainScope&nbsp;has announced that the United States Food and Drug Administration (FDA) has cleared the company&rsquo;s Ahead&nbsp;100 device through the&nbsp;<em>de novo</em>&nbsp;classification process. The Ahead&nbsp;100 uses a patient&rsquo;s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient&rsquo;s brain after head injury.</strong></span></p> </div><div id="Text178" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head computerised tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;Each year there are approximately two million patients in the United States alone who sustain head injuries and go to Emergency Departments for evaluation,&rdquo; states J Stephen Huff, associate professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the clinical principal investigator of the B-AHEAD II trial. &ldquo;Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain. An objective, accurate capability that can rapidly help identify and categorise patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system. The performance and clinical utility of the Ahead&nbsp;100 is superior to that of standard of practice tools. Also, the possibility of reduction of use of neuroimaging in patients with head injury is consistent with the&nbsp;<em>Choosing Wisely</em>&nbsp;campaign sponsored by several professional organisations.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;This is a landmark event in the assessment of head injury,&rdquo; adds Daniel Hanley, the Jeffrey &amp; Harriet Legum professor of Acute Care Neurology at Johns Hopkins University, director of the Johns Hopkins Brain Injury Outcomes Services division, and Medical Advisory Board member to BrainScope. &ldquo;I am greatly impressed by the performance of the Ahead&nbsp;100 for discriminating clinically important mild traumatic brain injury and believe this device is a practical, safe and transformative adjunct to acute CT scan.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> The BrainScope Ahead&nbsp;100 has been developed over six years of technology development and clinical studies at hospital Emergency Rooms across the USA, creating an extensive database of head injured patients. &ldquo;Using sophisticated classification algorithm methods we sought neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,&rdquo; explains Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU School of Medicine and consultant to BrainScope. &ldquo;One of the most important findings was the extremely high performance of the Ahead&nbsp;100 to identify the absence of structural brain injury after a patient has sustained a head injury. This provides important information to the clinician, contributing to a rule-out for one of the most prevalent concerns clinicians have with mildly presenting patients.&rdquo;</span></p></div> Specialised ambulance increases thrombolysis for stroke patients in ‘golden hour’ 2014-11-19T09:40:00Z 2014-11-19T09:40:00Z <div id="ImageMain79" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction79" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A specialised ambulance staffed with a neurologist and equipped with a computed tomographic scanner helped increase the percentage of patients with stroke who received thrombolysis to break down blood clots within the so-called &lsquo;golden hour,&rsquo; the 60 minutes from time of symptom onset to treatment when treatment may be most effective, according to a study published online by <a href="" target="_blank"><em>JAMA Neurology</em></a>.</strong></span></p> </div><div id="Text179" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The time to treatment with tissue plasminogen activator (tPA) to break down blood clots is crucial to how patients fare after acute ischaemic stroke. But when pre-hospital times are added to hospital delays the onset to treatment (OTT) within 60 minutes seems out of reach for most patients. An approach to shorten the OTT is pre-hospital thrombolysis in a specialised ambulance, according to background information in the study.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Martin Ebinger of the Charit&eacute;-Universit&auml;tsmedizin Berlin, Germany, and co-authors examined the achievable rate of golden hour thrombolysis in pre-hospital care and the effect it had on how patients fared. The authors used data from a study conducted in Berlin where weeks were randomised according to the availability of a stroke emergency mobile unit (STEMO) from May 2011 through January 2013.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Study results indicate there were 3,213 emergency calls for suspected stroke during weeks when STEMO was available and 2,969 calls during control weeks when STEMO was not available. Overall, 200 of 614 patients with stroke (32.6%) received thrombolysis when the STEMO was deployed and 330 of 1,497 patients (22%) received thrombolysis in conventional care. Median OTT was 24.5 minutes shorter after STEMO deployment compared with conventional care. In all ischaemic strokes, the rate of golden hour thrombolysis increased from 16 of 1,497 patients (1.1%) during conventional care to 62 of 614 (10.1%) after STEMO deployment. The median OTT was 50 minutes in golden hour thrombolysis vs. 105 minutes in all other thrombolysis. Patients with golden hour thrombolysis had no higher risks for seven- or 90-day mortality compared with patients with longer OTT and were more likely to be discharged home.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The use of STEMO increases the percentage of patients receiving thrombolysis within the golden hour. Golden hour thrombolysis entails no risk to the patients&rsquo; safety and is associated with better short-term outcomes,&rdquo; the study notes.</span></p> <p><span style="font-size: 10pt;"><strong>&nbsp;</strong></span></p> <p><span style="font-size: 10pt;"><br />In a related editorial, Steven Warach of the University of Texas Southwestern Medical Center, Austin, USA, writes: &ldquo;There is no doubt that, in Berlin, STEMO significantly shortened the time to thrombolytic treatment, which may translate to clinical benefits. Let there also be no doubt that the mobile stroke unit is here to stay and is starting to disseminate into pre-hospital stroke care. Many questions need to be answered in order to determine the appropriate niche where the benefit justifies the intensive use of resources that this approach requires. It is the duty of the early adopters to resist the temptation to uncritically embrace this approach as a certain good and to address these issues through rigorous clinical investigations.&rdquo;</span></p></div> MR CLEAN: expert opinion 2014-11-18T11:31:00Z 2014-11-18T11:31:00Z <div id="ImageMain80" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction80" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Since the first presentation of data at the World Stroke Congress, the MR CLEAN trial has sent a ripple across the entire neurointerventional arena, raising questions about the future of stroke treatment and the fate of similar trials, some of which have already been halted.</strong></span></p> </div><div id="Text180" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">At the Society of Vascular and Interventional Neurology meeting (SVIN) the as yet unpublished MR CLEAN (Multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands) results were discussed by an expert panel. The panel, including Jeffrey Saver, Tudor Jovin, Osama Zaidat, Italo Linfante, Raul Nogueira, and Dileep Yavagal, focused on the effect of the trial results on other trials and where that leaves clinical practice going forward.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;"> MR CLEAN is a pragmatic phase III multicentre randomised clinical trial with blinded outcome assessment. Endovascular treatment (intra-arterial thrombolysis, mechanical treatment or both) was compared with no treatment, against a background of optimal medical management, with or without intravenous alteplase. With the enrolment of 500 patients complete, the results presented at World Stroke Congress were in favour of interventional treatment.</span></p> <p><br /><span style="font-size: 10pt;"> Jeffrey Saver, who was present at the World Stroke Congress, gave a brief summary of MR CLEAN: &ldquo;MR CLEAN had a very broad design. They could enrol patients who were getting t-PA or not getting t-PA as the background therapy up to six hours after onset. They had broad clinical criteria&mdash;NIHSS score of two or higher. Patients had to have an occlusion in the terminal ICA, in the M1 M2 or in the A1 A2. Even though they were broadly inclusive and started in the pre-stent retriever era, most of the patients (97%) were treated with retrievable stents, so MR CLEAN is basically a stent retriever trial. The average time from onset to t-PA was under 90 minutes, but the average time from onset to randomisation was 200 minutes. Because there was 110 minutes between t-PA start and randomisation, they ended up with t-PA failure patients. Onset to groin puncture was 60 minutes faster than some of the prior studies. Serious adverse events were not greatly different between the two groups. In terms of results, in the onset to randomisation, whether patients were randomised early or late, within the first two hours or beyond the first two hours, they benefited, so two hours is not a key cut point.&rdquo;</span></p> <p><strong><br /> <br /> </strong></p></div><div id="Text280" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong>Way forward</strong></span></p> <p><br /><span style="font-size: 10pt;"> The question was then raised: with MR CLEAN and similar trials such as ESCAPE and EXTEND IA declared positive, what is the next step? &ldquo;Are we done with our trials; can we just go into clinical practice and not have to worry about anything yet?&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Saver responded that just looking at the results of MR CLEAN, the answer is no. He pointed to the fully able to return to work/non-disabled outcome which reportedly showed that 88% of patients in the intervention arm are still unable to return to work and 97% of patients still have symptoms from their stroke. &ldquo;So there is still a huge need for additional therapies. We have had a major step forward but we need to keep doing better, and so we need to move on to the next generation of trials.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> As for the process of making decisions for other trials based on data that are yet to be published, the expert panel maintained that care must be taken.</span></p> <p><br /><span style="font-size: 10pt;"> Tudor Jovin cautioned, &ldquo;We must remember that these results are in non-published form; we do not know how these results are going to look in their definitive form. The same applies to ESCAPE. Before ESCAPE we could have said that this could be an outlier, but to me, the fact that ESCAPE was stopped due to crossing pre-defined efficacy boundaries tells me that this probably is the kind of treatment effect that we are looking at. So I suspect the data are real and because of that I have no reason to believe that other ongoing trials are not going to go the same direction. The question to me is less &lsquo;should the trials be stopped&rsquo;, and more, &lsquo;should consenting be changed&rsquo;, because for all of these reasons you can make a good argument that trials should not be stopped. The question is &lsquo;how do we incorporate this kind of information into the consenting process&rsquo;.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Following on from Jovin, Raul Nogueira stated, &ldquo;Equipoise is not what we [personally] think, it is about what the whole medical community thinks, and we do not know if things are going to change, and stopping before things change would be a mistake. We have duties to the patient in front of us and to the whole community of patients we will see for the rest of our lives. It is a complicated ethical dilemma, I think we need to measure the degree of equipoise in the whole community, and I think the trials should probably be put on hold as opposed to stopped.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;"> Up to time of publication, the ESCAPE trial has been permanently halted, the SWIFT-PRIME trial has been temporarily halted, and the REVASCAT trial continues to enrol, with a scheduled pre-planned analysis due in the near future.</span></p></div> Majority of UK neurosurgical units following published recommendations, but room for improvement remains 2014-11-18T11:00:00Z 2014-11-18T11:00:00Z <div id="ImageMain81" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction81" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>It has been discovered via a national survey of current practice that six months post-publication of the National Confidential Enquiry into Patient Outcome and Death report, the majority of neurosurgical units across the United Kingdom and Ireland have been following most of the key recommendations for the management of aneurysmal subarachnoid haemorrhage.</strong></span></p> </div><div id="Text181" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Study authors Othman Al-Helli <em>et al</em> report in the <a href="" target="_blank"><em>Journal of Neurointerventional Surgery</em></a> however, that in the remainder of neurosurgical units they found variability in clinical practice.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the authors, the management of aneurysmal subarachnoid haemorrhage has undergone extensive change in recent years with the publication of recommendations and guidelines by specialty bodies. The National Confidential Enquiry into Patient Outcome and Death report and recommendations were published in November 2013 as a follow-up to the 2012 recommendations for the management of aneurysmal subarachnoid haemorrhage published by the Royal College of Physicians and the American Heart Association/American Stroke Association. The aim of Al-Helli <em>et al&rsquo;s</em> study was to assess how many of these recommendations were being followed six months after the latest publication, and to compare current practice with the National Confidential Enquiry into Patient Outcome and Death data collected in 2011.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To carry out their investigation, study authors formulated a survey composed of 19 questions regarding the management of aneurysmal subarachnoid haemorrhage, and conducted a telephone interview with the neurosurgical registrars on call. The 19 questions covered six areas: hospital policies and facilities for treatment of aneurysmal subarachnoid haemorrhage; medical measures to prevent rebleeding; surgical and endovascular methods of treatment; management of cerebral vasospasm and delayed cerebral ischaemia; management of hydrocephalus; and management of medical complications. Thirty neurosurgical units participated in the survey. The results were then compared against currently available published recommendations.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the results, &ldquo;22 out of the 30 centres aimed to treat ruptured aneurysms by coiling or clipping within 48 hours of ictus, yet only 15 units offered regular weekend interventional neuroradiological treatment. In nine units, all aneurysmal subarachnoid haemorrhages were routinely discussed in a multidisciplinary meeting.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors note: &ldquo;In the vast majority of neurosurgical centres, the main recommendations from the Royal College of Physicians, the American Heart Association/American Stroke Association, and the National Confidential Enquiry into Patient Outcome and Death report were being followed. Given data from previous studies over the past 15 years suggesting a longer interval to securing a ruptured intracranial aneurysm compared with other developed countries such as the USA, this survey suggests that there has been improvement in the service in the UK.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />They conclude noting that while there appears to be recent considerable improvement in the management of aneurysmal subarachnoid haemorrhage in the UK, more work is required before care delivery is optimised. They further state their intention to repeat the survey in the future to assess the progress made.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Al-Helli told <em>NeuroNews</em>: &ldquo;The most concerning finding of the study is the fact that only half of the neuroscience centres provide weekend neurointerventional service despite the guidelines recommend very clearly that early treatment not later than 48 hours post-ictus is a key factor for better outcome. I believe that our findings imply that patients who their bleed on a Friday night will have worse outcome that those who have it on any other weekday.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Commenting on what might be done to improve outcomes, he added, &ldquo;Providing a six day service might help. I personally wish that neither myself or any friend or family or indeed anybody get their bleed on a Friday night. Otherwise they might have to wait more than 48 hours to secure aneurysm preventing the potentially disastrous complication of rebleeding!&rdquo;</span></p></div> CE mark for new Asahi Intecc neurovascular guide wires 2014-11-17T14:36:00Z 2014-11-17T14:36:00Z <div id="ImageMain82" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction82" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Asahi Intecc has received CE certification of neurovascular guide wires: Asahi Chikai 008, Asahi Chikai black, and Asahi Chikai black 18 and is initiating sales in Europe.</strong> </span></p> </div><div id="Text182" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the company, the above wires join the currently marketed Asahi Chikai and Asahi Chikai 10 in incorporating Asahi Intecc&rsquo;s unique Actone technology, which provides improved torque performance, shape retention and support. One of the new wires, Asahi Chikai 008 is designed to deliver the flow directed microcatheters that are used for the arterial venous malformation treatment. Asahi Chikai black 18 is designed to deliver microcatheters for stent assist procedures, flow diverters, stroke devices and other devices that require large inner lumen diameter catheters. The third wire, Asahi Chikai black is a 0.014 inch workhorse wire for neuro endovascular procedures. Unlike the Asahi Chikai, the Chikai black has a polymer jacket over the spring coils to facilitate enhanced lubricity. </span><br /><span style="font-size: 10pt;"> <br />Masahiko Miyata, president and chief executive officer of Asahi Intecc comments, &ldquo;Developing and manufacturing various sizes and designs of the neurovascular wires in response to the neuro interventionalists&rsquo; needs will contribute to the expansion of neuro endovascular therapy and ultimately benefit patients.&rdquo;</span><br /><span style="font-size: 10pt;"> <br />Asahi Intecc started selling neurovascular guide wires in Japan from 2010 and has more than 60% market share in Japan today. In addition to the Asahi Chikai series Asahi Intecc will continue to improve guide wire and product design allowing for increased business expansion overseas.</span></p></div> Lazarus Effect Cover device receives CE mark 2014-11-06T16:17:00Z 2014-11-06T16:17:00Z <div id="Introduction83" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Lazarus Effect has announced that the Lazarus Cover accessory device has received CE mark. The Lazarus Cover is a nitinol-mesh cover that surrounds a retriever device and captures material during removal from a blood vessel.</strong></span></p> </div><div id="Text183" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Lazarus Cover provides a unique solution to what has been a major limitation of current retrieval systems, and it does so without requiring physicians to switch from their favourite stent or other retriever device,&rdquo; says Martin Dieck, chairman and chief executive of Lazarus Effect. &ldquo;It is among a series of disruptive devices Lazarus Effect is developing to overcome longstanding challenges associated with current vascular interventional procedures.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Stent-based thrombectomy devices have demonstrated success in &lsquo;capturing&rsquo; clots within an affected blood vessel, but often lose thrombus as the device is extracted. Recent results from a 500-patient, multicentre, randomised European ischaemic stroke trial (<a href="">MR CLEAN</a>), presented at the 9th World Stroke Congress in Istanbul, Turkey, revealed that direct vascular intervention (97% used retrievable stents) generated better outcomes than standard stroke therapy alone. The study also demonstrated that, despite generating better outcomes for patients, there is still room for improvement in vascular intervention. Clot particles were lost during interventional procedures, resulting in an ischaemic stroke to a new region of the brain 5.6% of the time, vs. 0.4% of the time in the control (ie., standard therapy) group.</span></p> <p><br /><span style="font-size: 10pt;">Lazarus Effect plans to launch the Lazarus Cover, which can be used with a variety of available retriever devices, in Europe during Q1 2015.</span></p> <p><br /><span style="font-size: 10pt;">The US Patent and Trademark Office recently issued a new patent covering core technology behind the Lazarus Cover, as well as the Lazarus ReCover device. The Lazarus Cover is a generalised device and can be used with a number of retriever types, whereas the ReCover is designed specifically for the retrieval of thrombus during an ischaemic stroke.</span></p></div> American Shared Hospital Services announces 2015 CMS gamma knife and proton reimbursement rates 2014-11-04T16:46:00Z 2014-11-04T16:46:00Z <div id="Introduction84" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>American Shared Hospital Services has announced that the Centers for Medicare and Medicaid Services (CMS) has posted its final Medicare hospital outpatient prospective payment rates for calendar year 2015. The rates for gamma knife and proton therapy remained as proposed earlier this year.</strong></span></p> </div><div id="Text184" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Effective as of 1 January, 2015, the Centers for Medicare and Medicaid Services has established a comprehensive ambulatory payment classification for both gamma knife and LINAC one session cranial radiosurgery. The reimbursement rate of approximately US$9,768 will be inclusive of the delivery and ancillary codes but exclusive of co-insurance payments or other adjustments. The average current Centers for Medicare and Medicaid Services reimbursement rate for delivery and ancillary codes (exclusive of co-insurance and other adjustments) is approximately US$5,600. This represents an estimated increase of US$4,168 per Medicare gamma knife treatment (exclusive of co-insurance and other adjustments) effective as of 1 January, 2015.<br /><br /></span></p> <p><span style="font-size: 10pt;">Medicaid Services&rsquo; final 2015 proton therapy delivery code rates per daily session are US$515 (US$872 in 2014) for a simple treatment without compensation, US$1,056 (US$872 in 2014) for a simple treatment with compensation, and US$1,056 (US$1,205 in 2014) for an intermediate or complex treatment.</span></p></div> ALS Association triples research spending following ice bucket donations 2014-11-04T15:56:00Z 2014-11-04T15:56:00Z <div id="ImageMain85" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction85" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The ALS (amyotrophic lateral sclerosis) Association Board of Trustees has developed a long-term strategy for leveraging the Ice Bucket Challenge donations it has received to advance its integrated mission of leading the fight to treat and cure ALS through global research, care services and public policy. This will result in the Association tripling the amount of money it spends on ALS research to ensure the most promising research continues to be funded. It will also result in greater support to the Association&rsquo;s Certified Treatment Centers of Excellence, which provide evidence-based, multi-disciplinary ALS care and services in a supportive atmosphere with an emphasis on hope and quality of life.</strong></span></p> </div><div id="Text185" style="clear:both; text-align:left"><p>&ldquo;We are thrilled with the additional funding for research and care services that the Ice Bucket Challenge has provided, even more important is the chance the entire ALS community now has to leverage our good fortune to work together toward our common goal of defeating this horrific disease,&rdquo; says Bill Thoet, chairman of the Board of Trustees of the ALS Association. &ldquo;Together, we now have the unique opportunity to fundamentally change the nature of this fight.&rdquo;<br /><br /></p> <p>&ldquo;We now have tremendous momentum in the search for a cure. Our integrated mission, combined with increased collaboration, is accelerating our ability to move potential treatments through the drug development process and improve the support for people living with ALS at our care centres,&rdquo; says Barbara Newhouse, president and chief executive officer of the ALS Association. The Certified Treatment Centers of Excellence both extend and improve the quality of life for those living with ALS, and actively participate in ALS-related research.</p> <p>Earlier this month, the ALS Association announced it was supporting six different programmes and initiatives designed to expedite the search for treatments and a cure for ALS. Four of these projects involve global research cooperative alliances that would not have moved forward without the funding from the ALS Association and the matching donations it received.<br /><br /></p> <p>In addition, the Association launched a new collaborative initiative that will bring the ALS community together to establish an ALS drug development guidance document. No such document currently exists, which creates uncertainty and risk for what already is a difficult, lengthy and costly process. The Association hopes that this initiative will incentivise ALS drug development, reduce obstacles and provide new opportunities to accelerate research and bring new treatments forward.</p></div> NeuroSigma receives notice of allowance for subcutaneous trigeminal nerve stimulation patent 2014-11-04T15:51:00Z 2014-11-04T15:51:00Z <div id="ImageMain86" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction86" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced that the Mexican Institute of Industrial Property has issued a Notice of Allowance for Mexican Patent Application No. MX/a/2012/004051. The patent application is co-owned by NeuroSigma and the Regents of the University of California as a result of research conducted by physicians and scientists at NeuroSigma and the University of California, Los Angeles (UCLA). NeuroSigma is the exclusive licensee of the Regents&rsquo; rights to the patent application.</strong></span></p> </div><div id="Text186" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The patent application is related to the use of trigeminal nerve stimulation with minimally invasive, subcutaneously implanted electrodes and pulse generator for the treatment of a wide variety of medical disorders including neurological and neuropsychiatric disorders such as epilepsy, depression, post-traumatic stress disorder, attention deficient hyperactivity disorder, and traumatic brain injury.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;NeuroSigma has previously received several US patents related to our external and subcutaneous trigeminal nerve stimulation systems. We are very pleased to be receiving our first non-US patent related to our minimally invasive, fully implantable subcutaneous trigeminal nerve stimulation system, which is currently under development. It is an important step in obtaining patent coverage in markets outside of the USA in support of our global commercialisation strategy,&rdquo; says David Hayes, chief administrative officer and general counsel of NeuroSigma.</span></p></div> Studies support the use of the CyberKnife system as a safe and effective treatment option 2014-11-04T15:03:00Z 2014-11-04T15:03:00Z <div id="ImageMain87" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction87" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Accuray Incorporated has announced that studies presented at the 15<sup>th</sup> European Congress of Neurosurgical Societies (EANS) in Prague, October 12 &ndash; 17, 2014 reinforce the benefits of the CyberKnife robotic radiosurgery system for the treatment of neurological diseases such as meningiomas, acoustic neuromas, trigeminal neuralgia, and spinal tumours.</strong></span></p> </div><div id="Text187" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Alfredo Conti, neurosurgeon at the University Hospital of Messina in Italy is using the CyberKnife system to treat perioptic meningiomas. The flexibility of the CyberKnife system enabled by its unique architecture allows tumour control while preserving vision. The results Conti presented in a plenary session included a series of 64 patients with perioptic meningiomas treated in 2-5 fractions with CyberKnife schemes from July 2007&ndash;May 2010.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study included two cohorts of patients with different tumour volumes. In one cohort, 25 patients with a small tumour volume (less than 5cc) were followed for an average of 60 months (+12 months). In the second cohort, 39 patients with a larger tumour volume (7.5cc) were followed for an average of 17 months (+10 months). No visual deterioration was observed and tumour control was achieved in all cases.</span><br /><br /></p> <p><span style="font-size: 10pt;">These results support the clinical benefits of CyberKnife treatment for perioptic meningiomas, and were achieved thanks to the ability to fractionate depending on the tumour volume and its proximity to the optic nerve.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The CyberKnife robotic radiosurgery system is able to treat safely and efficiently tumours with large volumes, in particular meningiomas, as well as acoustic neuromas,&rdquo; says Alfredo Conti. &ldquo;This is a real breakthrough because treating large tumours with radiosurgery in a single fraction is very challenging, and often not possible. Furthermore, treating tumours close to the optic nerves or other critical brain structures is sometimes very challenging for neurosurgeons and the CyberKnife system represents a safer and effective treatment option.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">A second study done by Pantaleo Romanelli, CyberKnife Center, Centro Diagnostico Italiano, Milan, Italy, evaluated the clinical benefits of the CyberKnife system as a treatment for patients with trigeminal neuralgia. A cohort of 103 patients was treated with a 60 Gy dose delivered in a single fraction by the CyberKnife system.</span><br /><br /></p> <p><span style="font-size: 10pt;">Results indicate that use of the CyberKnife system provides a safe and effective treatment option for people with trigeminal neuralgia. After six months, more than 90% of patients showed significant improvement in their symptoms. The system also provided an opportunity to successfully retreat 24 patients who had relapsed within two years from their first treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">Finally, at the Accuray symposium held in Prague at the 15th EANS congress, Alexander Muacevic, director of the Europ&auml;isches CyberKnife Zentrum in Munich, Germany, presented the extension of indications, such as spinal tumours, treated with the CyberKnife system. &ldquo;The CyberKnife robotic radiosurgery system is safe and effective in the treatment of spinal lesions. It treats with a sub-millimetre accuracy, which is crucial for tumour treatments all along the spine,&rdquo; Muacevic comments.</span></p></div> Boston Scientific announces schedule for presentations at NANS meeting 2014-11-03T16:38:00Z 2014-11-03T16:38:00Z <div id="ImageMain88" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction88" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Boston Scientific will present data on key clinical programs at the 18th <a href="">North American Neuromodulation Society (NANS) Meeting</a>, being held in <span class="xn-location">Las Vegas</span>, from the 11-14 December 2014.&nbsp;</strong></span><span style="font-size: 11pt;"><strong>The company&rsquo;s data will focus on long-term back pain relief using the Boston Scientific Precision Spectra spinal cord stimulator system and highlight research on stimulation waveforms.</strong></span></p> </div><div id="Text188" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are excited about the continuing success of our next-generation Precision Spectra spinal cord stimulator system in providing sustained and highly significant low back pain relief, and we look forward to releasing our &rsquo;real-world&rsquo; experience with 12-month clinical data,&rdquo; says Maulik Nanavaty, president, neuromodulation, Boston Scientific. &ldquo;In addition, we are committed to further advancing the science and understanding of pain relief with our comprehensive research program exploring both high rate therapy and novel waveforms.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Boston Scientific data will be presented during oral sessions or as posters. All programmes will be held at the Mandalay Bay and Four Seasons Hotels in Las Vegas. The programmes are as follows:<br /><br /></span></p> <p><span style="font-size: 10pt;">Precision Spectra spinal cord stimulation system:</span></p> <ul> <li><span style="font-size: 10pt;">PRO study (low back pain) - One-year, multicentre consecutive case-series of patients with chronic low back pain treated with the Precision Spectra spinal cord stimulation system using a 32-contact multiple independent current control system.</span></li> </ul> <p><span style="font-size: 10pt;">Advanced Research Programs:</span></p> <ul> <li><span style="font-size: 10pt;">ACCELERATE &ndash;Prospective multicentre trial evaluating high-rate (10 kHz) spinal cord stimulation in management of chronic, intractable pain.</span></li> <li><span style="font-size: 10pt;">WHISPER &ndash; Prospective multicentre trial evaluating the use of sub-perception multiple independent current control spinal cord stimulation</span></li> <li><span style="font-size: 10pt;">Preclinical Research &ndash; Pre-clinical model for investigating the mechanism of spinal cord stimulation.</span></li> </ul> <p><span style="font-size: 10pt;">Additionally, results will be released from the investigator-sponsored exploratory research of the sub-perception multiple independent current control spinal cord stimulation.</span></p></div> Over US$30m in funding allocated to rare brain disease research 2014-10-31T11:43:00Z 2014-10-31T11:43:00Z <div id="ImageMain89" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction89" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers studying frontotemporal degeneration disease, a leading cause of early onset dementia, will receive more than US$30m over the next five years in grants from the National Institutes of Health (NIH). The funding will be used to further scientific collaboration and investigate new treatments in the quest to find a cure for frontotemporal degeneration.</strong></span></p> </div><div id="Text189" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Frontotemporal degeneration received a total of four grants, each independently peer reviewed, that will allow for building reliable clinical networks to diagnose and treat frontotemporal degeneration and related variants; recruiting frontotemporal degeneration -causing gene mutation carriers for study; and study of a specific genetic mutation that is the most common cause of both inherited frontotemporal degeneration and inherited amyotrophic lateral sclerosis.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The frontotemporal degeneration community is extremely gratified to be the recipient of this unprecedented level of funding that we believe is the result of the tremendous momentum underway in frontotemporal degeneration science,&rdquo; says Susan Dickinson, executive director of The Association for Frontotemporal Degeneration. &ldquo;What started with frontotemporal degeneration&rsquo;s recent inclusion in national research priorities to cure Alzheimer&rsquo;s disease and other dementias by 2025, has now catapulted into what promises to be significant progress in learning about this debilitating neurodegenerative disease.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Three of the grants, totalling US$5.9 million per year, are being funded by the NIH&rsquo;s National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA) and the National Center for Advancing Translational Sciences (NCATS). The three projects will enable scientists to collaborate on research approaches for frontotemporal degeneration, with the goal of diagnosing and treating patients more effectively.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The projects aim to advance our understanding of frontotemporal degeneration by improving diagnosis, identifying preventive strategies and providing new insights into the genetics underlying this complex disorder,&rdquo; says Margaret Sutherland, program director at NINDS.</span><br /><br /></p> <p><span style="font-size: 10pt;">A fourth grant is part of US$29m earmarked for the Rare Diseases Clinical Research Network, a network of 22 consortia dedicated to furthering translational research and investigating new treatments for patients with rare diseases. The major focus of this grant is to study amyotrophic lateral sclerosis, including the disease variant of amyotrophic lateral sclerosis with frontotemporal degeneration.</span></p></div> Researchers join Biogen Idec to advance drug discovery for neurodegenerative diseases 2014-10-31T11:26:00Z 2014-10-31T11:26:00Z <div id="Introduction90" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Two leading neuroscientists have joined Biogen Idec to advance its research in neurodegenerative diseases. Christopher Henderson joins as vice president, neurology. Richard Ransohoff joins as senior research fellow, neuroimmunology. The addition of these top researchers bolsters Biogen Idec&rsquo;s discovery engine.</strong></span></p> </div><div id="Text190" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Henderson joins Biogen Idec from Columbia University, where he was the Gurewitsch and Vidda Foundation professor of rehabilitation and regenerative medicine with joint appointments in the departments of Pathology and Cell Biology, Neurology and Neuroscience. Ransohoff joins Biogen Idec from the Cleveland Clinic, where he served as director of the Neuroinflammation Research Center in the Department of Neurosciences of the Lerner Research Institute; professor of Molecular Medicine at the Lerner College of Medicine at Case Western Reserve University; and staff neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research.</span><br /><br /></p> <p><span style="font-size: 10pt;">Biogen Idec has extensive discovery efforts focused on neurodegenerative and neuroimmune diseases, including Alzheimer&rsquo;s disease, Parkinson&rsquo;s disease, amyotrophic lateral sclerosis and multiple sclerosis. Henderson and Ransohoff will work collaboratively within Biogen Idec&rsquo;s research and development organisation to identify and accelerate the development of new product candidates. Both will report directly to Spyros Artavanis-Tsakonas, senior vice president and chief scientific officer of Biogen Idec.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Transformative medicines result from transformative science,&rdquo; says Artavanis-Tsakonas. &ldquo;We are bringing together some of the brightest minds in research to create new ways of looking at devastating neurological diseases where there are few, if any, effective therapies. Chris and Richard will help accelerate our efforts to bring innovative new medicines to patients who desperately need them.&rdquo;</span></p></div> New test to help brain injury victims recover 2014-10-30T16:31:00Z 2014-10-30T16:31:00Z <div id="ImageMain91" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction91" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A dynamic new assessment for helping victims of trauma to the brain, including those suffering from progressive conditions such as dementia, has been developed by a clinical neuropsychologist at the University of Leicester, UK.</strong></span></p> </div><div id="Text191" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Short Parallel Assessments of Neuropsychological Status (SPANS) is the brainchild of Gerald Burgess from the University of Leicester&rsquo;s School of Psychology and has been designed to engage with patients suffering from a variety of brain injuries in order to aid in their recovery. </span><br /> <br /><span style="font-size: 10pt;"> SPANS is unique in that it measures the cognitive skills of individuals with acquired brain injury and progressive neurological conditions in a user-friendly and concise way, taking patients an estimated 35 minutes to complete. </span><br /> <br /><span style="font-size: 10pt;"> The assessment is capable of measuring seven key cognitive skills: orientation, attention and concentration, language, memory and learning, visuo-motor performance, efficiency and conceptual flexibility.</span><br /> <br /><span style="font-size: 10pt;"> An alternate version is available, SPANS B, which complements SPANS A for reliable retesting of patients. </span><br /> <br /><span style="font-size: 10pt;"> Both versions were developed based upon real neurological syndromes, such as aphasia, and common referral questions informed by Burgess&rsquo;s experience as a clinical psychologist in brain injury wards. </span><br /> <br /><span style="font-size: 10pt;"> Burgess says: &ldquo;With SPANS clinicians now have a broader and more reliable assessment that is even more useful than most tests for tracking changes in cognitive skills over time. Patients are now more thoroughly assessed by&nbsp;a test&nbsp;that is less taxing on them than some other tests, so that their difficulties may be better understood.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The test is suitable to be administered by a range of healthcare professionals, including clinical or research psychologists, occupational therapists, speech and language therapists, psychiatrists and neurologists. </span><br /> <br /><span style="font-size: 10pt;"> During the development of SPANS Burgess worked with Hogrefe, the publisher, who helped in collecting data and developing SPANS to a professional standard through production and marketing efforts.</span></p></div> Diets high in fruit, vegetables, whole grains and nuts lower first-time stroke risk 2014-10-30T09:49:00Z 2014-10-30T09:49:00Z <div id="ImageMain92" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction92" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Eating Mediterranean or DASH (Dietary Approaches to Stop Hypertension)-style diets, regularly engaging in physical activity and keeping blood pressure under control can lower a person&rsquo;s risk of a first-time stroke, according to updated American Heart&nbsp;</span><span style="font-size: 15px;">Association</span><span style="font-size: 11pt;">/American&nbsp;Stroke Association guidelines published in the </span><a style="font-size: 11pt;" href="">American Heart Association&rsquo;s</a><span style="font-size: 11pt;"> journal </span><em style="font-size: 11pt;"><a href="">Stroke</a></em><span style="font-size: 11pt;">.</span></strong></p> </div><div id="Text192" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We have a huge opportunity to improve how we prevent new strokes, because risk factors that can be changed or controlled &mdash; especially high blood pressure &mdash; account for 90% of strokes,&rdquo; says James Meschia, lead author of the study and professor and chairman of neurology at the Mayo Clinic in Jacksonville, Florida, USA.<br /><br /></span></p> <p><span style="font-size: 10pt;">The updated guidelines recommend the following tips to lower risk:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Eat a Mediterranean or DASH-style diet, supplemented with nuts;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Monitor high blood pressure at home with a cuff device;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Keep pre-hypertension from becoming high blood pressure by making lifestyle changes such as getting more physical activity, eating a healthy diet and managing your weight;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Reduce the amount of sodium in your diet;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Visit your healthcare provider annually for blood pressure evaluation;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; If your medication to lower blood pressure does not work or has bad side effects, talk to your healthcare provider about finding a combination of drugs that work for you;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Do not smoke. Smoking and taking oral birth control pills can significantly increase your stroke risk. If you are a woman who experiences migraines with aura, smoking raises your risk of stroke even more than in the general population.</span></li> </ul> <p><span style="font-size: 10pt;">Mediterranean-style and DASH-style diets are similar in their emphasis on fruits, vegetables, whole grains, legumes, nuts, seeds, poultry and fish. Both are limited in red meat and foods containing saturated fats, which are mostly found in animal-based products such as meat, butter, cheese and full-fat dairy.<br /><br /></span></p> <p><span style="font-size: 10pt;">Mediterranean-style diets are generally low in dairy products and DASH-style diets emphasise low-fat dairy products. Avoiding second hand smoke also lowers stroke and heart attack risks, according to the guidelines.<br /><br /></span></p> <p><span style="font-size: 10pt;">The writing committee reviewed existing guidelines, randomised clinical trials and some observational studies. &ldquo;Talking about stroke prevention is worthwhile,&rdquo; Meschia says. &ldquo;In many instances, stroke is not fatal, but it leads to years of physical, emotional and mental impairment that could be avoided.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Co-authors are Cheryl Bushnell, Bernadette Boden-Albala, Lynne Braun, Dawn Bravata, Seemant Chaturvedi, Mark Creager, Robert Eckel, Mitchell Elkind, Myriam Fornage, Larry Goldstein, Steven Greenberg, Susanna Horvath, Costantino Iadecola, Edward Jauch, Wesley Moore, and John Wilson.</span></p></div> Traumatic brain injury associated with increased dementia risk in older adults 2014-10-29T09:55:00Z 2014-10-29T09:55:00Z <div id="Introduction93" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>According to a study published online by <em><a href="">JAMA Neurology</a>,</em>&nbsp;traumatic brain injury appears to be associated with an increased risk of dementia in adults 55 years and older.</strong></span></p> </div><div id="Text193" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Controversy exists about whether there is a link between a single traumatic brain injury and the risk of developing dementia because of conflicting study results. The Centers for Disease Control and Prevention says that Americans 55 years and older account for more than 60% of all hospitalisations for traumatic brain injury, with the highest rates of traumatic brain injury-related emergency department visits, inpatient stays and deaths happening among those patients 75 years and older. Therefore, understanding the effects of a recent traumatic brain injury and the subsequent development of dementia among middle or older adults has important public health implications.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers Raquel C Gardner, of the University of California, San Francisco, and colleagues examined the risk of dementia among adults 55 years and older with recent traumatic brain injury compared with adults with non- traumatic brain injury body trauma, which was defined as fractures but not of the head or neck. The study included 164,661 patients identified in a state-wide California administrative health database of emergency department and inpatient visits.</span><br /><br /></p> <p><span style="font-size: 10pt;">In the study, a total of 51,799 patients with trauma (31%) had traumatic brain injury. Of those, 4,361 patients (8.4%) developed dementia compared with 6,610 patients (5.9%) with non-traumatic brain injury body trauma. The average time from trauma to dementia diagnosis was 3.2 years and it was shorter in the traumatic brain injury group compared with the non- traumatic brain injury group (3.1 vs 3.3 years). Moderate to severe traumatic brain injury was associated with increased risk of dementia at 55 years or older, while mild traumatic brain injury at 65 years or older increased the dementia risk.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Whether a person with traumatic brain injury recovers cognitively or develops dementia, however, is likely dependent on multiple additional risk and protective factors, ranging from genetics and medical comorbidities to environmental exposures and specific characteristics of the traumatic brain injury itself,&rdquo; the authors note.</span><br /><br /></p> <p><span style="font-size: 10pt;">Steven T DeKosky, of the University of Pittsburgh School of Medicine, writes: &ldquo;Unfortunately, there was not a non-trauma control group included, which may have answered the question of whether non-traumatic brain injury body trauma raised the risk of dementia significantly above age-equivalent controls without non-brain trauma (perhaps from inflammation or other complications).&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Judicious use of data by skilled researchers who are familiar with the entire range of dementia research from pathobiology to healthcare needs will enable us to ask important questions, evolve new or more informed queries, and both lead and complement the translational questions that are before us. Dementia is both a global problem and a pathological conundrum; thus, the complementary use of big data and basic neuroscience analyses offers the most promise,&rdquo; DeKosky concludes.</span></p></div> Thymosin beta-4 crosses blood-brain barrier in animal stroke model 2014-10-29T09:32:00Z 2014-10-29T09:32:00Z <div id="Introduction94" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>At the <a href="">Fourth International Symposium on Thymosins in Health and Disease</a> in Rome, Italy, researchers from RegeneRx Biopharmaceuticals reported on study findings in which thymosin beta-4 crossed the blood-brain barrier in an animal stroke model.</strong></span></p> </div><div id="Text194" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;When thymosin beta 4 (TB4) linked with rhodamine was injected into the peritoneal cavity in a rodent model of stroke, it was visualised outside of blood vessels and throughout the brain parenchyma. The leakage of TB4 in this rat model of embolic stroke confirmed our hypothesis that TB4 crossed the blood brain barrier since previous experiments using MRI and gadolinium showed compromise of the blood brain barrier in this model of embolic stroke,&rdquo; reports Daniel Morris, senior staff physician, Department of Emergency Medicine, Henry Ford Health System, Detroit, MI, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">These experiments show the ability of TB4 to cross the blood-brain barrier, which is impermeable to most drugs. Thus, health care providers would potentially have a novel means to treat patients of neurological injury in which the blood brain barrier is compromised, such as stroke, by systemically administering TB4 to accelerate repair and regenerate damaged brain tissue.&nbsp;</span></p></div> The Roskamp Institute discovers new target for drugs to treat Alzheimer&apos;s disease 2014-10-27T17:12:00Z 2014-10-27T17:12:00Z <div id="ImageMain95" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction95" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Published in the online edition of the <em><a href="">Journal of Biological Chemistry</a></em>, the results of the extensive studies offer a new target for drug development in the quest for a cure for Alzheimer&rsquo;s, the most prevalent form of dementia in the elderly.&nbsp;</strong></span></p> </div><div id="Text195" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Roskamp researchers have identified a single enzyme which propagates the three key hallmarks of Alzheimer&rsquo;s disease &ndash; inflammation, accumulation of amyloid protein, and modulation of the &rsquo;tau&rsquo; protein, all of which are responsible for damage to the nerve cells of the brain.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;These studies suggest there is a single drug target to inhibit all the three key pathologies of Alzheimer&rsquo;s disease,&rdquo; says neurobiologist Daniel Paris, lead researcher for the study.<br /><br /></span></p> <p><span style="font-size: 10pt;">Michael Mullan, senior author of the published study, adds, &ldquo;Our studies have revealed that the spleen tyrosine kinase (SYK) enzyme is at a crossroad from which all three of the brain abnormalities known to be associated with Alzheimer&rsquo;s disease diverge. Hopefully, academic or industry researchers can now develop new drugs to inhibit SYK which are suitable for clinical trials in Alzheimer&rsquo;s disease.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In working out how an anti-hypertensive drug called Nilvadipine works to reduce amyloid protein accumulations, Roskamp researchers realized the drug also had positive effects on neuroinflammation and thetau protein. The scientists retraced the molecular steps leading to these three factors and discovered they all led back to the SYK protein.<br /><br /></span></p> <p><span style="font-size: 10pt;">Paris then went on to show that drugs blocking SYK activity in the brain could represent a new strategy for treating Alzheimer&rsquo;s. "The potential for developing a single "multi-modal" drug treatment that will control all three of these Alzheimer&rsquo;s characteristics has us very excited,&rdquo; Paris says. &ldquo;All of these pathologies are interrelated. In theory, by interrupting these three molecular pathways, we can develop more effective drugs to stop the disease. To date, all the drugs that have been tested only attack one Alzheimer&rsquo;s characteristic, at a time. What is needed is one drug to address all three.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Having discovered and demonstrated the molecular pathway linking SYK with these traits, Roskamp scientists are looking forward to testing their hypothesis, either by developing new drugs themselves or partnering with academic and commercial groups.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;We didn&rsquo;t know until now that SYK was a possible therapeutic target for Alzheimer&rsquo;s disease,&rdquo; says Fiona Crawford, chief executive officer of the Roskamp Institute. &ldquo;We&rsquo;d be delighted for anyone to come up with an &lsquo;anti-SYK&rsquo; treatment to stop Alzheimer&rsquo;s.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;These findings are really significant,&rdquo; states David H Cribbs, research professor at University of California Irvine, associate director of the Institute for Memory Impairment and Neurological Disorders, and co-leader of the University of California Irvine Alzheimer&rsquo;s Disease Research Center neuropathology core.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;With all of the failures of the clinical trials of drugs for this dementia up to this point the finding of new therapeutics is wonderful. And Nilvadipine has a good safety profile,&rdquo; he adds. A phase III clinical trial of Nilvadipine for Alzheimer&rsquo;s disease is currently underway in Europe.<br /><br /></span></p> <p><span style="font-size: 10pt;">Five hundred Alzheimer&rsquo;s patients in 26 clinics across nine countries are participating in the double-blind, placebo-controlled study that began in 2013. Each participant will be followed for 18 months to see if the drug is effective at slowing or stopping the course of the disease.</span></p></div> Encouraging trial results for electroCore’s non-invasive vagus nerve stimulation treatment for headaches 2014-10-27T15:50:00Z 2014-10-27T15:50:00Z <div id="ImageMain96" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction96" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Preliminary results of an open-label trial carried in the <em><a href="">Journal of Headache and Pain</a></em> reported that a single treatment with electroCore&rsquo;s handheld non-invasive vagus nerve stimulation device gammaCore, completely resolved 44.8% of migraines within 30 minutes, with an additional 11.4% experiencing moderate benefits (incomplete resolution of their headaches) by two hours.&nbsp;</strong></span><br /> <!--[endif]--></p> </div><div id="Text196" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This result follows two presentations at the International Headache Meeting in Copenhagen in September showing that patients using gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care. It also found that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.<br /><br /></span></p> <p><span style="font-size: 10pt;">This open-label migraine study was carried out at the Headache Centre in the Neurological Institute in Milan. The study involved thirty patients, 18 &ndash; 65, who had migraine without aura and suffered from five to nine attacks per month. Patients treated between three and six migraine episodes with gammaCore. Ninety six migraine attacks were treated by a single dose. Forty three attacks were resolved completely within 30 minutes (44.8%); for 42 (43.7%) attacks the application did not show any benefit in the first two hours so patients recurred to rescue medication; in 11 (11.4%) attacks the result was uncertain: no resolution of attack, only a moderate relief of pain. No adverse events were recorded.<br /><br /></span></p> <p><span style="font-size: 10pt;">Licia Grazzi, lead author, comments: &ldquo;The results look very promising and patients found the therapy easy to apply and it was well tolerated.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore had previously reported, at the <em><a href="">American Headache Society</a></em> that a US prevention of chronic migraine study, with a sham control arm, met its primary endpoint of safety, and demonstrated a reduction in the number of headache days per month for patients using the active device. The study suggests that patients who remain on therapy for longer periods of time, enjoy progressively larger decreases in headache days.<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore, which is running the broadest headache trial programs in the world, will report shortly on two further sham-controlled clinical studies; a US trial on the acute treatment of episodic and chronic cluster, and a European trial on the acute treatment of episodic and chronic cluster headache.<br /><br /></span></p> <p><span style="font-size: 10pt;">electroCore chief executive officer and founder JP Errico says: &ldquo;As the results of our studies continue to demonstrate positive results, we are increasingly optimistic that the extensive investment we have made in both pre-clinical trials and clinical trials was a wise use of our capital and human resources. We believe that this therapy is unique in both its safety and efficacy profiles. With few adverse events reported, non-invasive vagus nerve stimulation appears to be the first therapeutic option that offers both acute and prophylactic benefits for patients who suffer frequent and severe headaches. As such, we believe that gammaCore will ultimately move to a first line treatment for these patients, and will continue to conduct the clinical research necessary to support that conclusion.&rdquo;</span></p></div> A new window of opportunity to prevent cardiovascular and cerebrovascular diseases 2014-10-24T16:46:00Z 2014-10-24T16:46:00Z <div id="Introduction97" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Future prevention and treatment strategies for vascular diseases may lie in the evaluation of early brain imaging tests long before heart attacks or strokes occur, according to a systematic review conducted by a team of cardiologists, neuroscientists, and psychiatrists from Icahn School of Medicine at Mount Sinai and published in <em><a href="">JACC Cardiovascular Imaging</a></em>.</strong></span></p> </div><div id="Text197" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Mount Sinai researchers examined all relevant brain imaging studies conducted over the last 33 years. They looked at studies that used every available brain imaging modality in patients with vascular disease risk factors but no symptoms that would lead to a diagnosis of diseased blood vessels in the heart or brain, or periphery.</span><br /><br /></p> <p><span style="font-size: 10pt;">The review demonstrates that patients with high blood pressure, diabetes, obesity, high cholesterol, smoking, or metabolic syndrome, but no symptoms, still had visible signs on their neuroimaging scans of structural and functional brain changes long before the development of any events related to vascular diseases of the heart or brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is the first time we have been able to disentangle the brain effects of vascular disease risk factors from the brain effects of cardiovascular and cerebrovascular disease and/or events after they develop,&rdquo; says the article&rsquo;s lead author, Joseph I Friedman, associate professor in the Departments of Psychiatry and Neuroscience at Icahn School of Medicine at Mount Sinai. &ldquo;Moreover, subtle cognitive impairment is an important clinical manifestation of these vascular disease risk factor-related brain imaging changes in these otherwise healthy persons.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Friedman adds that, because diminished cognitive capacity adversely impacts a person&rsquo;s ability to benefit from treatment for these medical conditions, early identification of these brain changes may &ldquo;present a new window of opportunity&rdquo; for doctors to intervene early and improve prevention of advancement from vascular disease risk factors to established cardiovascular and cerebrovascular diseases. His team is currently testing these hypotheses in ongoing studies at Mount Sinai.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Patients need to start today to control their vascular risk factors, otherwise their brains may forever harbour physical changes leading to devastating heart and vascular conditions impacting their future overall health and even cognitive decline causing diseases like dementia or when it exists it can accelerate Alzheimer&rsquo;s,&rdquo; says study author, Valentin Fuster, director of Mount Sinai Heart, physician-in-chief of The Mount Sinai Hospital, and chief of the Division of Cardiology at Icahn School of Medicine at Mount Sinai. &ldquo;Our publication raises the possibility that these early brain changes are major warning signs of what the future may hold for these asymptomatic patients. These high risk patients, along with their doctors, hold the power to modify their daily vascular risk factors to help halt the future course of the manifestation of their potentially looming cardiovascular diseases.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We hope our publication serves as a primer for cardiologists and other doctors interpreting the early neuroimaging data of their patients who may be high risk for vascular disease,&rdquo; says senior article author Jagat Narula, director of cardiovascular imaging, professor of medicine and Philip J and Harriet L. Goodhart chair in cardiology at Icahn School of Medicine at Mount Sinai. &ldquo;These subtle brain changes are clues to us physicians that our patients need to start to lower their vascular risk factors always and way before symptoms or a cardiac or brain event happens. This simple step to lower vascular risk factors can have huge impacts on global prevention efforts of cardiovascular diseases.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers identified the following impact of key vascular risk factors on the structural and functional brain health of asymptomatic patients:</span></p> <ul> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Hypertension is associated with globally appreciable brain volume reductions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Connecting brain fibre abnormalities, reduced brain blood flow and alterations in the normal pattern of synchronised brain activity between different regions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Diabetes is associated with connecting brain fibre abnormalities, reduced brain blood flow, and alterations in the normal pattern of synchronised brain activity between different regions;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Obesity is associated with brain volume reductions, reduced brain blood flow and metabolism;</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High total cholesterol and low-density lipoprotein cholesterol are associated with brain volume reductions, and connecting brain fibre abnormalities. In addition, high triglycerides are associated with reduced brain blood flow, and high total cholesterol is associated with reduced brain metabolism.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Smoking is associated with brain volume reductions, and alterations of the normal pattern of blood flow. In addition, it causes reduced Monoamine Oxidase B which metabolizes dopamine, the neurotransmitter chemical that controls the brain&rsquo;s reward and pleasure zones.</span></li> <li><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Metabolic Syndrome is associated with a greater burden of silent brain infarcts, visible only on MRI, which represents subclinical cerebrovascular disease. In addition, it is associated with connecting brain fibre abnormalities, and alterations in the normal pattern of synchronised brain.</span></li> </ul></div> ALS Association and NEALS issue request for proposals for phase II clinical development of ALS treatments 2014-10-24T15:26:00Z 2014-10-24T15:26:00Z <div id="Introduction98" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>ALS Accelerated Therapeutics (ALS ACT), the ALS Association, and the Translational Research Advancing Therapy ALS (TREAT ALS) Northeast ALS Consortium (NEALS) clinical trials have announced a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis (ALS).</strong></span></p> </div><div id="Text198" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The call for clinical study proposals is directed toward academic-industry partnerships, including pharmaceutical, biotherapeutic/biotechnology companies, academic members of the NEALS Consortium, and ALS scientists throughout the world. Up to US$1,500,000 in direct costs in ALS ACT clinical research support is available.<br /><br /> </span></p> <p><span style="font-size: 10pt;">In the United States, ALS affects one in approximately 30,000 people, with 5,000 new diagnoses each year. There is currently one FDA-approved treatment for ALS &ndash; Riluzole (Rilutek). The goal of this request for proposals is to expedite the process of bringing new treatments forward for testing in people with ALS and to measure if that therapeutic agent is reaching its target.<br /><br /></span></p> <p><span style="font-size: 10pt;">For this request for proposals, potential phase II clinical trials should include therapeutic interventions that have the following attributes: A pharmacodynamics marker that can measure whether pathway of interest has been affected and a plan to collect samples for biomarker studies.<br /><br /></span></p> <p><span style="font-size: 10pt;">The ALS ACT steering committee will review the applications, which will be judged on scientific rationale, merit, novelty, and the value of the project and the availability of appropriate facilities and the technical ability to carry out the clinical study.<br /><br /> </span></p> <p><span style="font-size: 10pt;">Funds will be awarded in the form of infrastructure support provided by NEALS and funds for per subject fee, sample collection, pharmacodynamic marker testing and other trial-related costs as needed. Applicants may apply for a combination of any of the following clinical research support services available through NEALS: project management, grants and contracts management, data management, study monitoring, outcome measure development and training, biostatistical support, site selection, start-up, regulatory document review, and ongoing site management and site trainings, which encompass good clinical practice, regulatory compliance and site management.</span></p></div> New NICE guidance to tackle inequalities in multiple sclerosis care 2014-10-24T15:18:00Z 2014-10-24T15:18:00Z <div id="Introduction99" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>People with multiple sclerosis should be offered a rapid and accurate diagnosis of their condition and access to specialist advice and proven therapies, says the National Institute for Healthcare and Excellence (NICE).</strong></span></p> </div><div id="Text199" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Multiple sclerosis is the most common neurological condition in young adults in the UK, affecting around 100,000 people. Currently, many people with multiple sclerosis are diagnosed in an ad-hoc way and are often misdiagnosed. People with multiple sclerosis can be left for more than a year without having their condition and medication monitored.<br /><br /></span></p> <p><span style="font-size: 10pt;">An audit carried out by the Royal College of Physicians and the Multiple Sclerosis Trust in 2011 found that although some multiple sclerosis patients received excellent care from the NHS, this was not universal and there were variations in both the quality and the quantity of care provided in England and Wales.<br /><br /></span></p> <p><span style="font-size: 10pt;">In an update to the original 2003 guideline, NICE has set out how people with multiple sclerosis can receive better care. Paul Cooper, consultant neurologist at the Greater Manchester Neuroscience Centre, who chaired the NICE guideline group, says: &ldquo;The care someone receives should not depend on where they live. One of the central areas that we have tried to address in the guidance is identifying and recognising inequalities in services and in care throughout the NHS.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Cooper continues: "In the past some people got access to prompt and appropriate treatment but many did not. Many people with multiple sclerosis were diagnosed perhaps in a rather ad-hoc way without access to specialist advice, or information and support at the time of diagnosis. Many were potentially being misdiagnosed. The other area that we have tried to address is improving access to therapies of proven benefit for this disabling and distressing condition.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">Mark Baker, director of clinical practice at NICE, comments: &ldquo;It&rsquo;s a paradigm-shifting guideline which reshapes much of our advice on multiple sclerosis and its management. It&rsquo;s a full update and it lays out a new framework for the diagnosis and management of people suspected of having multiple sclerosis.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">In the update, NICE recommends that people with suspected multiple sclerosis should be referred to a consultant neurologist. Multiple sclerosis should not be diagnosed on the basis of MRI findings alone and only a consultant neurologist should make the diagnosis of multiple sclerosis.<br /><br /></span></p> <p><span style="font-size: 10pt;">Every person with multiple sclerosis should have a comprehensive review of all aspects of their care at least once a year and that multidisciplinary teams - made up of multiple sclerosis nurses, GPs, psychologists, and therapists - should oversee the care they receive.<br /><br /></span></p> <p><span style="font-size: 10pt;">The guidance does not recommend the use of the cannabinoid drug Sativex or fampridine as they provide only a modest benefit at a significant cost to the NHS. Sativex costs &pound;50,000 per quality-adjusted life year (QALY), while fampridine costs in the region of &pound;160,000 per QALY. Both are well above NICE&rsquo;s threshold of &pound;30,000 per QALY.<br /><br /></span></p> <p><span style="font-size: 10pt;">Other key recommendations include offering people with multiple sclerosis an appropriate single point of contact to speak about their care, concerns and different treatment options, and encouraging people with multiple sclerosis to exercise. Supervised exercise programmes should be available for those who struggle with mobility and fatigue.</span></p></div> Costs to treat bleeding strokes increases 10 years later 2014-10-24T14:59:00Z 2014-10-24T14:59:00Z <div id="ImageMain100" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction100" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Costs to treat strokes caused by bleeding in the brain may increase significantly 10 years later, according to a study in the <em><a href="">American Heart Association</a></em> journal <em><a href="">Stroke</a>. </em>The Australian study is the first to include 10 years of follow-up data on stroke cost estimates</strong>.</span></p> </div><div id="Text1100" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Generally, expenses associated with a stroke peak within the first year and decline over time. Previous estimates of lifetime costs in Australia were based on a five-year average and may have underestimated costs, specifically for haemorrhagic strokes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Prevention of stroke should be a focus, since the costs of providing care to people who suffer stroke are unlikely to diminish,&rdquo; says Dominique Cadilhac, study senior author and an associate professor and head of the Translational Public Health: Stroke and Ageing Research Centre at Monash University in Victoria, Australia. &ldquo;Much could be gained if we could work to prevent the majority of strokes that are due to modifiable risk factors, such as high blood pressure or diabetes.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers interviewed 243 ischemic stroke patients and 43 intracerebral haemorrhage patients who had survived for 10 years or more. The patients had participated in an earlier Australian regional study that estimated five-year costs.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers found that:</span></p> <ul> <li><span style="font-size: 10pt;">Average annual direct costs for ischaemic stroke remained stable between five to 10 years at about US$5,207.</span></li> <li><span style="font-size: 10pt;">Average annual direct costs for intracerebral haemorrhage stroke increased 31%, from US$5,807 at five years to US$7,607 at 10 years and the overall average lifetime costs per case for intracerebral haemorrhage stroke increased 25%, from US$43,786 to US$54,956.</span></li> <li><span style="font-size: 10pt;">Medication, aged-care facilities and informal care expenses explained the majority of costs at 10 years. Rehabilitation expenses decreased for ischemic stroke.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;We did not know that the cost differentials would be so great between ischaemic stroke and interecerebral haemorrhage and that short-term estimates (six-12 months after a first stroke) used to approximate lifetime annual resource use after the first year would not be a good predictor of future costs,&rdquo; says Cadilhac, who is also the head of public health and epidemiology within the Stroke Division of the Florey Institute of Neuroscience and Mental Health and Data Custodian for the Australian Stroke Clinical Registry.</span><br /><br /></p> <p><span style="font-size: 10pt;">The Australian healthcare system is funded through public and private health insurance. However, the way health care is delivered and priced may influence cost differences between the two health systems. For example, if patients in America stay in the hospital longer or are offered different rehabilitation choices to what is available in Australia, estimates may be too low or high.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We hope that our findings can be used to influence the need for more primary prevention and to also support assessment of the cost effectiveness of interventions to reduce disability from stroke,&rdquo; Cadilhac comments. &ldquo;In addition, ensuring that the best evidenced-based guideline treatment is provided in hospitals will assist in reducing disability associated with stroke and may, in turn, avoid unnecessary aged-care placements or an undue burden to caregivers.&rdquo;</span></p></div>