Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2015-05-05T22:18:56Z St Jude Medical completes acquisition of Spinal Modulation 2015-05-04T14:21:00Z 2015-05-04T14:21:00Z <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>St Jude Medical has announced that it has completed the acquisition of Spinal Modulation, developer of the Axium neurostimulator system. The acquisition was completed on 1&nbsp;May, 2015.</strong></span></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With the closing of the acquisition,&nbsp;St Jude Medical&nbsp;has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.</span></p> <p><span style="font-size: 10pt;"><br />Commenting on the acquisition, St Jude Medical&rsquo;s chief operating officer&nbsp;Michael T Rousseau&nbsp;said: &ldquo;Completing the acquisition of&nbsp;Spinal Modulation, Inc.&nbsp;is another important step forward in building momentum and accelerating sales growth across our neuromodulation product portfolio. We are confident the&nbsp;Axium&nbsp;system will further support our goal of providing physicians multiple options to tailor treatment for patients with chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The&nbsp;Axium&nbsp;system has CE mark in the&nbsp;European Union&nbsp;for the management of chronic intractable pain and TGA approval in&nbsp;Australia&nbsp;for the management of chronic, intractable pain of the trunk and/or limbs. In&nbsp;December 2014, Spinal Modulation announced that enrolment in its ACCURATE US IDE trial had been completed and subsequently submitted its PMA application to the&nbsp;FDA&nbsp;in support of marketing approval in&nbsp;the United States. The full results from the ACCURATE Study will be presented at the 12<sup>th</sup>&nbsp;annual&nbsp;International Neuromodulation Society (INS) Congress, to be held in&nbsp;Montreal, Quebec, Canada&nbsp;from&nbsp;6&ndash;11 June, 2015.</span></p></div> FDA approves world’s smallest upgradeable MR-conditional SCS system 2015-04-30T15:05:00Z 2015-04-30T15:05:00Z <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>St Jude Medical has announced FDA approval of the company&rsquo;s Prot&eacute;g&eacute; MRI spinal cord stimulation system. In addition to the approval of the new Prot&eacute;g&eacute; MRI system, St Jude Medical has also secured FDA approval for MRI compatibility of the company&rsquo;s 60cm Octrode percutaneous leads, which has received MR-conditional labelling for use with the Prot&eacute;g&eacute; MRI system.</strong></span></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Prot&eacute;g&eacute; MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the United States, and the only upgradeable IPG on the market to allow patients to safely undergo head and extremity MRI scans. Upgradeable technology allows patients to access future SCS technology from St Jude Medical, once approved, through software updates rather than surgical device replacement. Historically, most patients would need additional surgery to receive new product features and benefits.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The launch of the Prot&eacute;g&eacute; MRI system provides physicians with a solution that offers the benefits of future therapy upgrades as they are approved without the need for a future surgery,&rdquo; said Robert Levy, director of the Marcus Neuroscience Institute in Boca Raton, Florida, USA. &ldquo;The Prot&eacute;g&eacute; MRI system is an innovative technology advancement that optimises chronic pain care without compromising a patient&rsquo;s potential need for future head and extremity MRI scans.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. In total, the condition costs the American population 515 million workdays annually and generates upwards of 40 million visits to physicians each year.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />SCS therapy can offer proven, meaningful chronic pain relief for many patients while improving quality of life and reducing or even eliminating a patient&rsquo;s use of pain medication. Yet for some patients battling chronic pain, the possible need for future MRI scans has acted as a barrier to SCS therapy.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With the approval of the Prot&eacute;g&eacute; MRI system, St Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology,&rdquo; said Eric S Fain, group president of St Jude Medical. &ldquo;Going forward, patients implanted with a Prot&eacute;g&eacute; MRI system will not only have the ability to access future upgrades, but will also have the ability to undergo head and extremity MRI scans.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In addition to the approval of the Prot&eacute;g&eacute; MRI system, St Jude Medical also plans to seek updated labeling in key markets around the world for several existing products, including their flagship Penta paddle lead, in order to allow more patients the ability to safely undergo MRI scans. St Jude Medical also plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.</span></p></div> Long-term exposure to air pollution may pose risk to brain structure, cognitive functions 2015-04-24T17:07:00Z 2015-04-24T17:07:00Z <div id="Introduction3" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Air pollution, even at moderate levels, has long been recognised as a factor in raising the risk of stroke. A new study led by scientists from Beth Israel Deaconess Medical Center and Boston University School of Medicine, USA, suggests that long-term exposure can cause damage to brain structures and impair cognitive function in middle-aged and older adults.</strong></span></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Writing in the May 2015 issue of&nbsp;<em>Stroke</em>, researchers who studied more than 900 participants of the Framingham Heart Study found evidence of smaller brain structure and of covert brain infarcts, a type of &ldquo;silent&rdquo; ischaemic stroke resulting from a blockage in the blood vessels supplying the brain.</span></p> <p><span style="font-size: 10pt;"><br />The study evaluated how far participants lived from major roadways and used satellite imagery to assess prolonged exposure to ambient fine particulate matter, particles with a diameter of 2.5 millionth of a meter, referred to as PM2.5.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> These particles come from a variety of sources, including power plants, factories, trucks and automobiles and the burning of wood. They can travel deeply into the lungs and have been associated in other studies with increased numbers of hospital admissions for cardiovascular events such as heart attacks and strokes.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is one of the first studies to look at the relationship between ambient air pollution and brain structure,&rdquo; says Elissa Wilker, a researcher in the Cardiovascular Epidemiology Research Unit at Beth Israel Deaconess Medical Center. &ldquo;Our findings suggest that air pollution is associated with insidious effects on structural brain aging, even in dementia- and stroke-free individuals.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Study participants were at least 60 years old and were free of dementia and stroke. The evaluation included total cerebral brain volume, a marker of age-associated brain atrophy; hippocampal volume, which reflect changes in the area of the brain that controls memory; white matter hyperintensity volume, which can be used as a measure of pathology and aging; and covert brain infarcts.</span></p> <p><span style="font-size: 10pt;"><br />The study found that an increase of only 2&micro;g per cubic meter in PM2.5, a range commonly observed across metropolitan regions in New England and New York, was associated with being more likely to have covert brain infarcts and smaller cerebral brain volume, equivalent to approximately one year of brain aging.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These results are an important step in helping us learn what is going on in the brain,&rdquo; Wilker says. &ldquo;The mechanisms through which air pollution may affect brain aging remain unclear, but systemic inflammation resulting from the deposit of fine particles in the lungs is likely important.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study shows that for a 2 microgram per cubic meter of air (&mu;g/m3) increase in PM2.5, a range commonly observed across major US cities, on average participants who lived in more polluted areas had the brain volume of someone a year older than participants who lived in less polluted areas. They also had a 46% higher risk of silent strokes on MRI,&rdquo; said Sudha Seshadri, a professor of Neurology at Boston University School of Medicine and Senior Investigator, the Framingham Study.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This is concerning since we know that silent strokes increase the risk of overt strokes and of developing dementia, walking problems and depression. We now plan to look at more the impact of air pollution over a longer period, its effect on more sensitive MRI measures, on brain shrinkage over time, and other risks including of stroke and dementia.&rdquo;</span></p></div> Brainlab Introduces new generation of volumetric arc therapy at ESTRO 2015-04-24T12:45:00Z 2015-04-24T12:45:00Z <div id="Introduction4" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A Brainlab press release says that the &ldquo;Elements&rdquo; strategy&mdash;indication-specific focused software applications aimed at enhancing the workflow for difficult to treat indications in the brain and spine introduced in 2013&mdash;has now come full circle with the introduction of automated stereotactic radiosurgery planning tools at ESTRO 2015 (24&ndash;28 April, Barcelona, Spain), which enable improvised generation of consistent treatment plans for volumetric arc therapy delivery.</strong></span></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Elements are a new generation of products that are indication-specific, user-friendly, fast, automatic and flexible,&rdquo; said Stefan Vilsmeier, president and chief executive officer of Brainlab. &ldquo;Instead of competing with existing treatment planning systems, Elements complement them by providing additional treatment possibilities for difficult to treat indications.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Previously-introduced Elements for cranial radiosurgery have focused on enhancing image fusion, distortion correction of various magnetic imaging resonance sequences, interactive segmentation of tumours and vascular structures, fibretracking, dose review, and automatic segmentation of critical structures. Adaptive Hybrid Surgery tools have helped to simulate and evaluate the feasibility of radiosurgery treatments at different resection levels during surgery. Radiosurgery treatment planning for cranial indications, however, remains a manual iterative process that is highly user-dependent.</span><br /><br /></p> <p><span style="font-size: 10pt;">One of the new Elements tools Brainlab will introduce automatically generates highly conformal treatment plans for a variety of indications, locations, sizes, shapes and fractionation schemes, all with the click of a button. Instead of choosing between different delivery techniques, the Element algorithm produces an monitor unit-optimised plan for delivery as volumetric, intensity modulated arc. For treatment of spherical targets, such as singular metastases, or small functional targets, such as trigeminal neuralgia, another new Element has been designed around the challenges of these specific treatments.</span><br /><br /></p> <p><span style="font-size: 10pt;">Spinal radiosurgery represents another challenging treatment with multiple complex and manual steps. In addition to streamlining the fusion and segmentation steps, another volumetric arc therapy -based automatic planning Element for spinal stereotactic radiosurgery can generate complex yet highly conformal plans. This tool is specifically designed to address the visualisation and optimisation requirements for stereotactic treatments for spine indications.</span></p></div> Clinical phase II study with NeuroSTAT for traumatic brain injury passes safety evaluation 2015-04-22T17:00:00Z 2015-04-22T17:00:00Z <div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The independent safety committee has endorsed moving on to the next dose level without any safety issues, following the treatment of 10 of 20 patients in the ongoing clinical phase IIa study for traumatic brain injury with NeuroVive&rsquo;s drug candidate NeuroSTAT. Consequently, the study will continue as planned and move on to the next dosage group.</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The ongoing CHIC study (Copenhagen Head Injury Ciclosporin Study) is an open-label, non-comparative clinical phase IIa study enrolling a total of 20 patients divided into two different dosage groups, where NeuroVive&rsquo;s drug candidate NeuroSTAT is being evaluated for the treatment of patients with traumatic brain injury. The study is being conducted at the Department of Neurosurgery at Rigshospitalet, University of Copenhagen, Denmark, with Jesper Kelsen as principal investigator.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study&rsquo;s first dosage group of 10 patients has now been treated with NeuroSTAT at the lower dose, and an interim analysis has been completed by an independent safety committee in order to evaluate the treatment&rsquo;s safety profile. The analysis includes an evaluation of blood concentrations of cyclosporin A (the active substance in NeuroSTAT) and changes in intracranial pressure and blood samples collected to analyse possible organ injury. According to the analysis, the low-dose treatment is judged to be safe and the study will now continue as planned with the higher dosage group including 10 additional patients.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We have now obtained important safety data on what we have designated to be the lower dose of NeuroSTAT for treating patients with traumatic brain injury. We can now move on to include patients that will be treated with a higher dose. This means that the study has reached an important milestone in the clinical trial programme of NeuroSTAT,&rdquo; commented NeuroVive&rsquo;s chief executive officer Mikael Br&ouml;nneg&aring;rd.</span></p></div> Drugs stimulate body’s own stem cells to replace the brain cells lost in multiple sclerosis 2015-04-22T16:52:00Z 2015-04-22T16:52:00Z <div id="Introduction6" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A pair of topical medicines already alleviating skin conditions each may prove to have another, even more compelling use: instructing stem cells in the brain to reverse damage caused by multiple sclerosis.</strong></span></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Led by researchers at Case Western Reserve, a multi-institutional team used a new discovery approach to identify drugs that could activate mouse and human brain stem cells in the laboratory. The two most potent drugs&mdash;one that currently treats athlete&rsquo;s foot, and the other, eczema&mdash;were capable of stimulating the regeneration of damaged brain cells and reversing paralysis when administered systemically to animal models of multiple sclerosis. The results are published&nbsp;online in the scientific journal&nbsp;<em>Nature</em>.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We know that there are stem cells throughout the adult nervous system that are capable of repairing the damage caused by multiple sclerosis, but until now, we had no way to direct them to act,&rdquo; says Paul Tesar, Dr Donald and Ruth Weber Goodman Professor of Innovative Therapeutics, and associate professor in the Department of Genetics &amp; Genome Sciences at the Case Western Reserve School of Medicine. &ldquo;Our approach was to find drugs that could catalyse the body&rsquo;s own stem cells to replace the cells lost in multiple sclerosis.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The findings mark the most promising developments to date in efforts to help the millions of people around the world who suffer from multiple sclerosis. The disease is the most common chronic neurological disorder among young adults, and results from aberrant immune cells destroying the protective coating, called myelin, around nerve cells in the brain and spinal cord.</span></p> <p><span style="font-size: 10pt;"><br />Without myelin, neural signals cannot be transmitted properly along nerves; over time, a patient&rsquo;s ability to walk, hold a cup or even see is inexorably eroded. Current multiple sclerosis therapies aim to slow further myelin destruction by the immune system, but the Case Western Reserve team used a new approach to create new myelin within the nervous system. Their work offers great promise of developing therapies that reverse disabilities caused by multiple sclerosis or similar neurological disorders.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;To replace damaged cells, much of the stem cell field has focused on direct transplantation of stem cell-derived tissues for regenerative medicine, and that approach is likely to provide enormous benefit down the road,&rdquo; says Tesar, also a New York Stem Cell Foundation Robertson Investigator and member of the National Center for Regenerative Medicine. &ldquo;But here we asked if we could find a faster and less invasive approach by using drugs to activate native stem cells already in the adult nervous system and direct them to form new myelin. Our ultimate goal was to enhance the body&rsquo;s ability to repair itself.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Tesar emphasised that much work remains before multiple sclerosis patients might benefit from the promising approach. Scientists still must find ways to transform the topical medications for internal use and determine their long-term efficacy and potential side effects. That said, using existing federally approved drugs enhances the likelihood that the compounds can be made safe for human use.</span></p> <p><span style="font-size: 10pt;"><br />Tesar and his colleagues could zero in on the two catalysing medications only because of a breakthrough that his laboratory achieved in 2011. Specifically, the researchers developed a unique process to create massive quantities of a special type of stem cell called an oligodendrocyte progenitor cell (OPC). These OPCs are normally found throughout the adult brain and spinal cord, and therefore inaccessible to study. But once Tesar and his team could produce billions of the OPCs with relative ease, they could begin to test different existing drug formulations to determine which, if any, induced the OPCs to form new myelinating cells.</span></p> <p><span style="font-size: 10pt;"><br />Using a state-of-the-art imaging microscope, the investigators quantified the effects of 727 previously known drugs, all of which have a history of use in patients, on OPCs in the laboratory. The most promising medications fell into two specific chemical classes. From there, the researchers found that miconazole and clobetasol performed best within the respective classes. Miconazole is found in an array of over-the-counter antifungal lotions and powders, including those to treat athlete&rsquo;s foot. Clobetasol, meanwhile, is typically available by prescription to treat scalp and other skin conditions such as dermatitis. Neither had been previously considered as a therapeutic for multiple sclerosis, but testing revealed each had an ability to stimulate OPCs to form new myelinating cells. When administered systemically to lab mice afflicted with a multiple sclerosis-like disease, both drugs prompted native OPCs to regenerate new myelin.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It was a striking reversal of disease severity in the mice,&rdquo; says Robert Miller, a member of the neurosciences faculty at Case Western Reserve who, with Tesar, is a co-senior author of the <em>Nature</em> paper. The two collaborated on this project while Miller also served as vice president for Research at Case Western Reserve; since June his primary appointments are at the George Washington University School of Medicine and Health Sciences, where he is Senior Associate Dean for Research and Vivian Gill Distinguished Research Chair. &ldquo;The drugs that we identified are able to enhance the regenerative capacity of stem cells in the adult nervous system. This truly represents a paradigm shift in how we think about restoring function to multiple sclerosis patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />While the drugs proved to have extraordinary effects on mice, their impact on human patients will not be known fully until actual clinical trials. Nevertheless, Tesar and his team already have added reason for optimism; in addition to the tests with animal cells, they also tested the drugs on human stem cells&mdash;and saw the medication prompt a similar response as seen in the mouse cells. Both medications worked well, with miconazole demonstrating the more potent effects.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have pioneered technologies that enable us to generate both mouse and human OPCs in our laboratory,&rdquo; says Fadi Najm, the first author of the study and Research Scientist in the Department of Genetics &amp; Genome Sciences at the Case Western Reserve School of Medicine. &ldquo;This uniquely positioned us to test if these drugs could also stimulate human OPCs to generate new myelinating cells.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Tesar, who recently received the 2015 International Society for Stem Cell Research Outstanding Young Investigator Award, said investigators next will work to deepen their understanding of the mechanism by which these drugs act. Once these details are clear, researchers will modify the drugs to increase their effectiveness in people.</span></p> <p><span style="font-size: 10pt;"><br />The team is enthusiastic that optimised versions of these two drugs can be advanced to clinical testing for multiple sclerosis in the future, but Tesar emphasised the danger of trying to use current versions for systemic human administration.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We appreciate that some patients or their families feel they cannot wait for the development of specific approved medications,&rdquo; Tesar says, &ldquo;but off-label use of the current forms of these drugs is more likely to increase other health concerns than alleviate multiple sclerosis symptoms. We are working tirelessly to ready a safe and effective drug for clinical use.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />While multiple sclerosis is the initial focus for translating this research into the clinic, a number of other disorders involve myelin loss or dysfunction including cerebral palsy, age-related dementia, optic neuritis and schizophrenia. Any drugs developed that enhance myelination in multiple sclerosis also hold promise for benefiting these other disorders.</span></p></div> FDA clears MRI-compatible MEMS cannula 2015-04-22T15:26:00Z 2015-04-22T15:26:00Z <div id="Introduction7" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Alcyone Lifesciences has announced that the Alcyone MEMS cannula, a neuro-ventricular cannula, has received FDA clearance. The Alcyone MEMS cannula is a dual-lumen, MRI-compatible injection and aspiration cannula for use in the brain. The Alcyone MEMS cannula is not intended for implant, and it is intended for single patient use only.</strong></span></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The neuroscience community is pioneering new therapeutic agents including gene therapy, antibody and oncolytic biologic therapy that hold great promise in treating chronic CNS disorders, but unfortunately they have lacked a clinically effective technology for precise CNS delivery direct to a neurological target and for optimal bio-distribution,&rdquo; says PJ Anand, founder and chief executive officer of Alcyone Lifesciences. &ldquo;Given that the very potential of these new agents is dependent on optimal bio-distribution, it is our hope that the Alcyone MEMS cannula will offer a solution for this critical unmet clinical need and further open the gates to novel therapeutic options for patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Alcyone MEMS cannula was developed using our game-changing proprietary microelectromechanical system (MEMS) platform. Without burdening the neurosurgery community with unnecessary additional capital equipment, the Alcyone MEMS cannula can be utilised with any existing commercial imaging and stereotactic system. Neurosurgeons can select a target, navigate the Alcyone MEMS cannula precisely to the target, and observe in real-time the precision delivery of the therapeutic agent, all under intra-procedural MRI guidance,&rdquo; says Deep Singh, director of Product Development at Alcyone Lifesciences. &ldquo;In addition to the MEMS tip which has dual micro-channels, the Alcyone MEMS cannula features a unique patented distal end design that helps prevent reflux or back flow along the cannula shaft, which can be a significant drawback with current devices. The Alcyone MEMS cannula platform device is designed for optimal targeted bio-distribution and neurosurgeon&rsquo;s ease of use.&rdquo;</span></p></div> Medtronic announces European approval of the first and only full-body MR conditional deep brain stimulation systems 2015-04-22T12:57:00Z 2015-04-22T12:57:00Z <div id="ImageMain8" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction8" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic plc has announced that systems within its Activa&nbsp;portfolio of deep brain stimulation (DBS) therapy neurostimulators have received European regulatory approval for MR conditional full-body magnetic resonance imaging (MRI).&nbsp;The expanded approval for full-body MRI scans applies to all patients receiving a new system and to an estimated 13,000 people in Europe already receiving Medtronic DBS Therapy.<sup>&nbsp;</sup>Medtronic DBS systems have previously been approved for MRI scans of the head only, under limited conditions. Medtronic DBS systems are not approved in the United States for full-body scans.</strong></span></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MRI scans have become a diagnostic standard of care, allowing physicians to detect a wide range of health conditions by viewing highly detailed images of tumours, internal organs, blood vessels, muscles, joints and other areas of the body by using strong magnetic fields and radio frequency pulses to create images of structures inside the body. Worldwide, it is estimated that approximately 60 million MRI procedures are performed each year.</span></p> <p><span style="font-size: 10pt;"><br />When programmed to appropriate settings, MR conditional Medtronic DBS systems allow patients to continue to receive therapy during MRI scans. Previously, patients receiving an MRI scan had their DBS systems turned off before the scan.</span></p> <p><span style="font-size: 10pt;">&ldquo;MRI is commonly the method of choice to image the body to diagnose disease or monitor existing conditions, but MRI use has often been limited in patients receiving DBS therapy,&rdquo; says John Thornton, medical physicist at the National Hospital for Neurology and Neurosurgery in London, UK. &ldquo;Patients receiving DBS therapy can now receive more advantages of MRI technology.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Most patients who we consider for a DBS implant have other conditions which may require MRI,&rdquo; says Ludvic Zrinzo, neurosurgeon at the National Hospital for Neurology and Neurosurgery in London. &ldquo;The MR conditional Activa systems mean patients can receive DBS care, and still may have the option of MRI when needed to manage other conditions.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />To receive approval for MR conditional DBS systems, Medtronic developed proprietary test and measurement systems, in conjunction with advanced electromagnetic modelling tools. Existing Activa DBS systems were rigorously tested and evaluated across millions of simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety. &nbsp;</span></p></div> NurOwn demonstrates a statistically significant effect in ALS patients 2015-04-21T16:19:00Z 2015-04-21T16:19:00Z <div id="Introduction9" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>BrainStorm Cell Therapeutics presented results from its phase 2a study of NurOwn in amyotrophic lateral sclerosis (ALS) at a poster session at the American Academy of Neurology annual meeting, in Washington, DC, USA.</strong></span></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Among the new results is a piecewise linear regression analysis of all subjects who received intrathecal (IT) administration in the phase 2a study and the prior phase 1/2 study. At six months post-treatment, there was a statistically significant improvement in the estimated rate of decline in Forced Vital Capacity (FVC), from -5.1% per month pre-treatment to -1.2% per month post-treatment (two-sided p=0.036) and a nearly significant improvement in the rate of ALS Functional Rating Score-Revised (ALSFRS-R) decline, from -1.2 points per month pre-treatment to -0.6 points per month post treatment (two-sided p=0.052).</span></p> <p><span style="font-size: 10pt;"><br />Also reported for the first time are local positive effects of intramuscular administration. 3D volumetric analysis using MRI revealed an improvement in the rate of decline in muscle mass in the right arm, the site of NurOwn administration, through one month post-treatment, as compared to the left arm. Electromyography demonstrated a trend of stabilisation of the compound motor axon potential in the right musculocutaneous nerve as compared to deterioration observed in the left.</span></p> <p><span style="font-size: 10pt;"><br />BrainStorm&rsquo;s chief executive officer, Tony Fiorino, comments, &ldquo;These results represent further validation for our NurOwn platform. In this study, we observed a large and clinically meaningful benefit after treatment with NurOwn. Moreover, our analysis of subjects who received IT administration in our two completed trials showed a statistically significant improvement in the rate of FVC decline, and a nearly significant improvement in the rate of ALSFRS-R decline, at six months post-treatment, a notable achievement given the small sample size. With our US phase 2 trial now more than half-enrolled and a multi-dose study being planned, BrainStorm is well-positioned to confirm and extend these findings over the coming year.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Professor Dimitrios Karussis of Hadassah University Medical Center, the principal investigator for the study, stated, &ldquo;We have observed in our two studies clear indications that a single intrathecal administration of NurOwn can induce clinically meaningful beneficial effects in ALS patients. In these studies, 88% of subjects with three months follow-up and 73% of those with six months follow-up responded to the cells, showing a post-treatment improvement in either ALSFRS-R or FVC, or both.&nbsp; We eagerly await the results of current and planned studies that will define the safety and efficacy profile of NurOwn, and we are particularly hopeful that the administration of repeated doses will increase the magnitude or duration of benefit, or both.&rdquo;</span></p></div> Two different carotid artery stenting procedures show little difference in effectiveness 2015-04-20T16:48:00Z 2015-04-20T16:48:00Z <div id="Introduction10" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Use of either proximal embolic protection devices (P-EPDs) or distal filter embolic protection devices (F-EPDs) during elective carotid artery stenting results in low rates of in-hospital stroke and death, according to a new study from researchers at the Perelman School of Medicine at the University of Pennsylvania, USA.</strong></span></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, published in&nbsp;<em><a href="">JACC: Cardiovascular Interventions</a></em>, found that although P-EPDs have been theorised to be more effective than F-EPDs at preventing stroke during carotid artery stenting, this first comparative effectiveness study revealed no statistically significant difference between the two devices.</span><br /><br /></p> <p><span style="font-size: 10pt;">Carotid artery stenting is commonly used to treat carotid artery disease, in which the carotid arteries develop a build-up of plaque that can lead to stroke. During carotid artery stenting, the placement of small mesh-like tubes via catheters to open the artery and stabilise the plaque, there is a risk of releasing small amounts of debris into the brain&rsquo;s circulation. To prevent this problem, two types of EPDs were developed: F-EPDs have a small filter to catch debris; while P-EPDs stop blood flow to the brain in the carotid artery being stented, then debris-containing blood is removed before normal blood flow resumes.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These study results challenge the notion that proximal embolic protection devices are significantly superior to distal embolic protection devices, or that they can serve as a &lsquo;magic bullet&rsquo; for stroke prevention during carotid artery stenting,&rdquo; said first author Jay Giri, assistant professor of clinical medicine at the University of Pennsylvania. &ldquo;Even for patients who had recent symptoms of stroke or mini-stroke&mdash;who have been thought to get more benefit from proximal embolic protection devices&mdash;this study showed no statistical difference in device effectiveness.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The research team examined 10,246 consecutive elective carotid artery stenting procedures performed with embolic protection between January 2009 and March 2013 in the CARE (Carotid Artery Revascularization and Endarterectomy) Registry. P-EPDs were used in 590 (5.8%) of the cases, and the rest were F-EPDs. The differences in in-hospital stroke or death between P-EPDs (1.5%) and F-EPDs (2.4%) were not statistically significant, and the 30-day adverse events rates were similar for both P-EPDs (2.7%) and F-EPDs (4%).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;There is certainly no signal of harm with use of proximal embolic protection devices, and our study cannot rule out a small benefit of these devices. The choice of embolic protection device type in a given case really comes down to physician discretion,&rdquo; added Giri.</span><br /><br /></p> <p><span style="font-size: 10pt;">Given the overall results of this study, the research team has concluded that although a large controlled trial randomising patients to these two devices might be useful, its feasibility is unlikely due to the scope necessary.</span></p></div> St Jude Medical announces intent to acquire Spinal Modulation 2015-04-20T14:32:00Z 2015-04-20T14:32:00Z <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>St Jude Medical, Inc.&nbsp;has announced that it has exercised the company&rsquo;s exclusive option to acquire&nbsp;Spinal Modulation, Inc., developer of the Axium Neurostimulator System. Following the completion of this acquisition,&nbsp;St Jude Medical will become the only medical device manufacturer to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Once complete, the acquisition of&nbsp;Spinal Modulation will further support St Jude Medical&rsquo;s mission to help physicians tailor treatment to a patient&rsquo;s chronic pain condition to achieve superior outcomes. Stimulation of the dorsal root ganglion (DRG) with the&nbsp;Axium&nbsp;system has been shown to provide meaningful relief for patients battling chronic pain, and is especially useful for treating focal pain areas often challenging to treat using traditional spinal cord stimulation (SCS).</span></p> <p><span style="font-size: 10pt;"><br />The&nbsp;Axium&nbsp;system originally received CE mark approval in&nbsp;November 2011&nbsp;for the management of chronic, intractable pain. In&nbsp;December 2014, Spinal Modulation announced that enrolment in its ACCURATE US IDE trial had been completed. Spinal Modulation subsequently submitted its PMA application to the&nbsp;FDA&nbsp;in support of marketing approval in&nbsp;the United States. Results from the ACCURATE study will be presented at the 12<sup>th</sup>&nbsp;annual&nbsp;International Neuromodulation Society (INS) Congress, to be held in&nbsp;Montreal, Quebec, Canada,&nbsp;June 6-11, 2015.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Physicians need a range of options to effectively treat chronic pain, and our acquisition of Spinal Modulation is part of our ongoing commitment to providing physicians new and innovative therapy options,&rdquo; said&nbsp;Michael T Rousseau, chief operating officer of&nbsp;St Jude Medical. &ldquo;Dorsal root ganglion stimulation with the Axium&nbsp;system is highly complementary to our current chronic pain product portfolio, and acquiring this technology will further our ability to partner with physicians to reduce the burden of chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can dramatically affect quality of life, negatively impacting personal relationships, work productivity and daily routines. SCS and DRG stimulation have both been proven to offer patients relief from chronic pain while restoring lost quality of life.</span></p> <p><span style="font-size: 10pt;"><br />DRG stimulation works differently than traditional SCS, targeting nerves within the DRG, a structure packed with sensory nerves that transmit information to the spinal cord, which then conducts those signals to the brain.&nbsp;Traditional SCS&nbsp;takes a different approach, targeting nerves along the spinal cord&rsquo;s dorsal column which often proves challenging to isolate the desired target painful area.</span></p> <p><span style="font-size: 10pt;"><br />By targeting the DRG, stimulation with the&nbsp;Axium&nbsp;system has been shown to be effective in treating conditions currently underserved by traditional SCS, such as chronic intractable pain in the leg, foot and groin. Research has also shown DRG stimulation can benefit patients suffering post-surgical pain and neuropathic pain. This underserved population is estimated to represent more than five times the current addressable market.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;St Jude Medical has a legacy of bringing new, innovative therapy options to patients suffering from chronic pain, and we believe adding DRG stimulation to their chronic pain portfolio will have a number of benefits to patients worldwide,&rdquo; said&nbsp;David Wood, president and chief executive officer of Spinal Modulation. &ldquo;We&rsquo;re proud of what the Spinal Modulation team has built over the past 10 years, and see great potential for&nbsp;St Jude Medical&nbsp;to continue expanding access to DRG stimulation therapy for patients who may benefit from additional therapeutic options.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Transaction Details</strong></span></p> <p><span style="font-size: 10pt;"><br />In&nbsp;June 2013,&nbsp;St Jude Medical&nbsp;entered into a series of agreements under which the company made a&nbsp;US$40 million&nbsp;equity investment in Spinal Modulation.&nbsp;In addition to providing&nbsp;St Jude Medical&nbsp;with an exclusive option to distribute the Axium Neurostimulator System in international markets where the technology is approved for sale, the agreements also provided&nbsp;St Jude Medical&nbsp;with an exclusive option to acquire the company. Having exercised its exclusive option,&nbsp;St Jude Medical expects to complete the acquisition of Spinal Modulation in the second quarter of 2015, subject to customary closing conditions.</span></p> <p><span style="font-size: 10pt;"><br />St Jude Medical&nbsp;will make a payment of approximately&nbsp;US$175 million&nbsp;upon closing with additional payments due upon&nbsp;FDA&nbsp;approval of the&nbsp;Axium&nbsp;system and achievement of certain revenue targets. </span><br /> <br /><span style="font-size: 10pt;"> According to a press release from St Jude Medical, &ldquo;Excluding acquisition-related expenses, we estimate that this acquisition will be approximately&nbsp;US$0.05&nbsp;dilutive to our adjusted consolidated earnings per share for the remainder of 2015, which we expect to partially offset with operating efficiencies.&nbsp;St Jude Medical will provide an update to its adjusted 2015 earnings per share guidance on its first quarter earnings call scheduled to be held on&nbsp;22 April, 2015.&rdquo;</span></p></div> Contego Medical closes US$5.6 million in Series B funding 2015-04-20T10:04:00Z 2015-04-20T10:04:00Z <div id="Introduction12" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Contego Medical, the first and only provider of the Integrated Embolic Protection filter platform for angioplasty balloon and stent delivery catheters, announces the completion of a US$5.6 million Series B financing round led by Hatteras Venture Partners. The round also included Mountain Group Partners, Lookout Capital and Medical Mutual.</strong></span></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Contego Medical&rsquo;s portfolio of angioplasty balloons and stents embodying the Integrated Embolic Protection filter platform represents a breakthrough technology, which we believe will help endovascular interventionalists reduce the risk of stroke and other procedural complications,&rdquo; says Doug Reed, general partner of Hatteras Venture Partners. Doug Reed will be joining Contego Medical as a board member.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The company will use the funds to continue to grow its leadership, sales and engineering teams and to develop several new and innovative products with its next-generation Integrated Embolic Protection platform.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Paladin device and other devices under development address a multi-billion dollar market, and have the potential to become standards of care in their respective target treatment areas as the combination devices are designed to simplify procedures, improve outcomes and offer cost-effective solutions. We are excited to partner with Hatteras Venture Partners as we continue to expand and commercialise our portfolio of products,&rdquo; says Ravish Sachar, founder and chief executive officer of Contego Medical.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Contego Medical has expanded its executive team with the appointment of Paul Sanders as chief operating officer, Udayan Patel as chief technology officer, and Alan Bacharach as Contego Medical&rsquo;s European general manager. Elizabeth Saylors will continue as vice president of Quality and Clinical Affairs. The team&rsquo;s track record of success brings experienced management and leadership to Contego Medical&rsquo;s expanding commercialisation efforts throughout Europe and globally.</span></p></div> First US commercial procedure with the Enroute transcarotid neuroprotection system 2015-04-17T13:25:00Z 2015-04-17T13:25:00Z <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>Silk Road Medical has announced the first US commercial procedure using the Enroute transcarotid neuroprotection system was successfully performed at Mills-Peninsula Medical Center in Burlingame, USA by vascular surgeon John E Rosenman.</strong></span></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Transcarotid artery revascularisation, uses direct carotid artery access and robust, temporary flow reversal to protect the brain from particles that can dislodge during the carotid artery repair procedure. The Enroute transcarotid neuroprotection system recently received 510(k) clearance by the US Food &amp; Drug Administration (FDA).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The transcarotid artery revascularisation procedure using the Enroute transcarotid neuroprotection system allows me to perform a minimally invasive stent procedure expeditiously with less risk of nerve injury and less trauma to the patient than traditional open surgery,&rdquo; said Rosenman. &ldquo;We are excited to be one of the first hospitals in the nation to offer this procedure to our patients with carotid artery disease. We are confident in the effectiveness of flow reversal for stroke prevention during stent placement. The transcarotid approach is a less invasive, more patient friendly option compared to traditional open surgery.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The FDA cleared the Enroute transcarotid neuroprotection system based on the outcomes of the ROADSTER trial, which achieved a 30 day stroke rate of 1.4% in the pivotal cohort, a rate comparable to the gold standard of a surgical carotid endarterectomy (CEA) and the lowest to date for any prospective trial of carotid artery stenting. There were no major strokes and there were no strokes in important high risk subgroups, including the elderly (age &gt;=75), women, and symptomatic patients.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The surgical treatment of carotid artery disease to reduce the long term risk of stroke is well established, but many patients have risk factors that can lead to complications as a consequence of the procedure itself, including stroke, death, and cranial nerve injuries,&rdquo; said Sumaira Macdonald, chief medical officer. &ldquo;Transcarotid artery revascularisation represents a procedural paradigm shift that brings together key principles of surgical and endovascular techniques to reduce these risks and is a welcome, clinically proven option for physicians and their patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Silk Road Medical will ramp up commercial operations throughout 2015 to broaden US distribution of the Enroute transcarotid neuroprotection system to vascular specialists. The Enroute transcarotid neuroprotection system has been available internationally since 2012 and more than 500 patients have been treated with the device in the US and Europe. The company also has a pending Premarket Approval (PMA) application for the Enroute transcarotid stent system&mdash;an optimised stent delivery system designed for use with the Enroute transcarotid neuroprotection system.&nbsp;</span></p></div> Evidence builds for endovascular treatment of acute ischaemic stroke 2015-04-17T13:08:00Z 2015-04-17T13:08:00Z <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>With the publication of two more stroke trials, the evidence in favour of endovascular treatment in patients with acute ischaemic stroke has reached new heights. Data from SWIFT PRIME (Solitaire with the intention for thrombectomy as primary endovascular treatment) and REVASCAT (Randomized trial of revascularization with Solitaire FR device versus best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight hours of symptom onset), published online first in the <em>New England Journal of Medicine</em> (<em>NEJM</em>) and presented at the European Stroke Organisation conference (17&ndash;19 April, Glasgow, UK), add to that of three other trials&mdash;MR CLEAN, EXTEND-IA and ESCAPE&mdash;that have begun to change the face of ischaemic stroke treatment.</strong></span></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Both SWIFT PRIME and REVASCAT assessed if patients experiencing an acute ischaemic stroke and treated with a stent retriever (Solitaire, Covidien/Medtronic) in addition to current medical therapy, including IV t-PA when patients were eligible, had less stroke-related disability than patients treated with IV t-PA or medical therapy alone.</span></p> <p><span style="font-size: 10pt;"><br />SWIFT PRIME assessed 196 patients and found that the addition of the Solitaire device significantly decreased post-stroke disability and increased the number of patients who were independent within 90 days after a stroke. The trial found that the addition of the Solitaire device significantly increased patients&rsquo; rate of return to functional independence compared to IV t-PA alone (60.2% vs. 35.5%, p=0.0002).</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;SWIFT PRIME showed that treatment with the Solitaire device is safe, technically successful and substantially reduces long-term disability levels,&rdquo; said Jeffrey L Saver, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles (UCLA) and director, UCLA Comprehensive Stroke Center, USA. &ldquo;This treatment marks the beginning of a new era in stroke care.&rdquo;</span></p></div><div id="Text214" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">He further told <em>NeuroNews</em>, &ldquo;This is a once in a generation advance in stroke care. The paradigm is changing. The best treatment for patients who have blockages in the large arteries in the brain is going to be to get t-PA and the clot retriever. Together they work much better than t-PA alone and that means that we have to change the medical system to ensure that patients are brought first to the sites where they can rapidly get t-PA started, but also to the specialised sites where they can do this procedure in the cath lab.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Similarly, REVASCAT (206 patients), conducted at four comprehensive stroke centres in Catalonia, Spain, showed that patients treated with the Solitaire device in addition to medical therapy (which included IV t-PA in eligible patients that comprised 70% of subjects enrolled) up to eight hours from onset of symptoms, experienced a statistically significant improvement in the rate of return to functional independence (43.7% vs. 28.2%) in favour of patients treated with the Solitaire device when compared to medical therapy alone.</span></p> <p><span style="font-size: 10pt;"><br />All five of the now-published trials have shown that the amount of time to treatment has a significant impact on outcomes. SWIFT PRIME demonstrated dramatic improvements in workflow (the complete cycle of care from diagnosis through treatment) compared to previous trials. The trial was conducted at 39 centres across seven countries, demonstrating broad applicability in different health systems and the achievability of fast, efficient stent thrombectomy care.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We now have five global trials that provide an overwhelming body of clinical evidence in support of [stent retriever] thrombectomy,&rdquo; said Antoni Davalos, director, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol. &ldquo;Based on these findings, it is time for the stroke community to come together to re-evaluate stroke treatment guidelines and to look for systems to facilitate the access of treatable patients to specialised centres.&rdquo;</span></p></div> New research study to demonstrate value of PET scans in Alzheimer’s disease diagnosis 2015-04-17T12:39:00Z 2015-04-17T12:39:00Z <div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A new four-year research study, with an estimated budget of US$100 million, has been announced by the Alzheimer&rsquo;s Association and the American College of Radiology (ACR). The Imaging dementia&mdash;Evidence for amyloid scanning (IDEAS) study will determine the clinical usefulness and value in diagnosing Alzheimer&rsquo;s and other dementias in certain situations of a brain positron emission tomography (PET) scan that detects a core feature of Alzheimer&rsquo;s disease.</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The IDEAS study will assess the impact of brain amyloid PET imaging on a variety of patient outcomes. The study protocol received approval with requirements by the Centers for Medicare &amp; Medicaid Services (CMS). Participating providers will be reimbursed for the PET scans under the CMS Coverage with Evidence Development (CED) policy that requires research study participation as a condition of Medicare payment.</span></p> <p><span style="font-size: 10pt;">IDEAS is led by the Alzheimer&rsquo;s Association and managed by the ACR and American College of Radiology Imaging Network (ACRIN).</span></p> <p><span style="font-size: 10pt;"><br />Why the IDEAS study is needed</span></p> <p><span style="font-size: 10pt;"><br />Two abnormal structures called plaques and tangles are prime suspects in damaging and killing nerve cells in Alzheimer&rsquo;s. The plaques are deposits of a protein fragment called amyloid-beta that build up in the spaces between nerve cells. Amyloid PET imaging represents a potential major advance in the clinical assessment of people with cognitive impairment. The technology makes amyloid plaques light up on a brain PET scan, enabling for the first time accurate detection of plaques in living people.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The purpose of the IDEAS study is to examine how brain imaging, specifically an amyloid PET scan, helps guide doctors in diagnosing and treating Alzheimer&rsquo;s and other dementias in cases where the cause of cognitive impairment is difficult to diagnose,&rdquo; says Gil D Rabinovici, IDEAS study chair and Associate Professor of Neurology at the University of California, San Francisco, USA. &ldquo;We believe the study will show that, in diagnostically uncertain cases, knowledge of amyloid status will lead to significant changes in patient management&mdash;such as earlier counselling and prescription of more appropriate drugs&mdash;that will translate into improved long-term outcomes.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The IDEAS study was developed in response to the 2013 CMS National Coverage Decision (NCD) on amyloid PET imaging in dementia and neurodegenerative disease (CAG-00431N) not cover the scans because &ldquo;the evidence is insufficient to conclude that the use of positron emission tomography (PET) amyloid-beta (A) imaging is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of...Medicare beneficiaries with dementia or neurodegenerative disease.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />CMS questioned the ability of PET amyloid imaging to lead to improved health outcomes, such as: avoidance of futile treatment or tests, improving or slowing the decline of quality of life, and survival. However, CMS did find sufficient evidence that the use of PET A imaging is promising: (1) to exclude Alzheimer&rsquo;s in narrowly defined and clinically difficult diagnoses, and (2) to enrich clinical trials seeking better treatments or prevention strategies for Alzheimer&rsquo;s. Under the NCD, Medicare will provide coverage for one amyloid PET scan per patient enrolled in an approved clinical study.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&ldquo;I am confident that, at the end of this study, we will have amassed sufficient data to assess whether amyloid imaging has a positive impact on patient outcomes leading to expansion of beneficiary access to this important procedure beyond the IDEAS study,&rdquo; says Maria Carrillo, a co-chair of the IDEAS study and chief science officer at the Alzheimer&rsquo;s Association.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">The IDEAS study in more detail</span></p> <p><span style="font-size: 10pt;"><br />Amyloid PET imaging alone does not establish a diagnosis of Alzheimer&rsquo;s disease, but must be considered in the context of the person&rsquo;s medical history, physical examination, and cognitive testing. To guide clinicians on how best to apply amyloid PET in the clinical evaluation of people with cognitive decline, a working group convened by the Alzheimer&rsquo;s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) developed appropriate use criteria (AUC) for brain amyloid PET scans.</span></p> <p><span style="font-size: 10pt;"><br />The AUC indicate that amyloid PET should only be considered in patients with clear, measurable cognitive deficits when there is substantial diagnostic uncertainty after a comprehensive evaluation by a dementia specialist. According to AUC, amyloid PET may have greatest value in patients with either: (1) progressive, unexplained mild cognitive impairment (MCI); or (2) dementia of uncertain cause due to atypical or mixed symptoms, or unusually early age-of-onset.</span></p> <p><span style="font-size: 10pt;"><br />A total of 18,488 Medicare beneficiaries age 65 and older meeting AUC will be enrolled over 24 months at roughly 200 sites throughout the United States. Study participants will be recruited into one of two sub-groups: (1) progressive, unexplained MCI, and (2) dementia of uncertain cause.</span></p> <p><span style="font-size: 10pt;"><br />All referrals to the study and for amyloid PET will come from dementia specialists, defined by the Alzheimer&rsquo;s Association and SNMMI as &ldquo;physicians trained and board-certified in neurology, psychiatry, or geriatric medicine who devote a substantial proportion of patient contact time to the evaluation and care of adults with acquired cognitive impairment or dementia, including probable or suspected Alzheimer&rsquo;s disease.&rdquo; Dementia specialists will be recruited through societies such as the International Association of Gerontology and Geriatrics, American Academy of Neurology, American Society of Neuroradiology; plus clinician outreach through psychiatrists, members of the Alzheimer&rsquo;s Association, and news media outreach.</span></p></div> The ALS Association to collaborate with GlaxoSmithKline on new ALS clinical trial 2015-04-16T14:53:00Z 2015-04-16T14:53:00Z <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>The ALS Association, Harvard Stem Cell Institute, and Massachusetts General Hospital Neurological Clinical Research Institute have announced that they are collaborating with GlaxoSmithKline on a clinical trial to evaluate the potential of an anti-epileptic drug in ALS patients. In parallel testing, brain cells will be made from each patient&rsquo;s stem cells to see if they can predict which patients might respond to the medicine.</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The trial will evaluate the potential of the drug, Retigabine, which has a unique mechanism of action and can calm the excitability of nerve cells that are thought to cause seizures. These &ldquo;hyperexcitable neurons&rdquo;are also thought to play a role in ALS. Alongside testing of the medicine, scientists will for the first time create stem cells from these patients to see if they can be used to determine in advance which patients could benefit from the medicine.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study is being led by Brian Wainger of the department of Neurology at Massachusetts General Hospital, in collaboration with Merit Cudkowicz, chief of Neurology at MGH. It will be performed at 12 academic sites within the Northeast ALS Consortium, an international, independent, non-profit group of researchers who collaboratively conduct clinical research in ALS and other motor neuron diseases. GSK will provide the drug, and funding support will come from HSCI, The ALS Association, the MGH NCRI and GSK.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This novel study will provide us with a better understanding of neuron hyperexcitability, a potentially important disease mechanism in ALS patients,&rdquo; says Lucie Bruijn, chief scientist for The ALS Association. &ldquo;This powerful collaboration of leaders in the fields of stem cells, clinical neurology, ALS research and GSK will be the first time that lab data from patient derived stem cells with disease-specific properties that respond to drugs have formed the basis for a clinical trial. It is our hope that this novel approach demonstrates promising results and leads to better clinical trials for ALS patients in the future.&rdquo;</span></p></div> Clinical utility of real-time navigated laser therapy for lesion ablation within intraoperative MRI suites to be discussed at AANS 2015-04-16T12:49:00Z 2015-04-16T12:49:00Z <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>Three prominent neurosurgeons will review their clinical experience using real-time navigated laser therapy for brain lesion ablation within intraoperative MRI suites at the upcoming 83<sup>rd</sup> American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (2-6 May, Washington, DC, USA). IMRIS, MRI Interventions, and Monteris Medical jointly announced that the companies are sponsoring the Lunch and Learn seminar scheduled for on Monday, 4 May.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The panel will review workflow and results using Monteris&rsquo; NeuroBlate system, a minimally invasive robotic laser thermotherapy tool, coupled with MRI Interventions&rsquo; ClearPoint navigation system providing precise targeting for procedures conducted within an IMRIS VISIUS Surgical Theatre with intraoperative MRI (iMRI).</span></p> <p><span style="font-size: 10pt;"><br />Veronica LS Chiang of Yale-New Haven Hospital, New Haven, USA, will lead the discussion with panelists John Honeycutt of Cook Children&rsquo;s Hospital, Fort Worth; and Eric C Leuthardt of Barnes-Jewish Hospital, St. Louis.</span></p> <p><span style="font-size: 10pt;"><br />The NeuroBlate System employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue such as tumours and other neurological soft tissue lesions through a minimally invasive and image-guided approach.</span></p> <p><span style="font-size: 10pt;"><br />The ClearPoint system, the only neuro-navigation technology that enables minimally-invasive neurosurgery under continuous magnetic resonance (MR) guidance, provides surgeons with a high-resolution view of the patient&rsquo;s brain and real-time direction during intracranial procedures.</span></p> <p><span style="font-size: 10pt;"><br />The VISIUS Surgical Theatre allows use of the highest quality MR in the operating room&mdash;instead of a radiology or diagnostic room&mdash;and over the OR table by moving it to the patient with ceiling-mounted rails. The fully integrated suites allow the scanner to move between multiple rooms, providing on-demand access to high resolution MR images&mdash;before, during and after procedures, without moving the patient.</span></p> <p><span style="font-size: 10pt;"><br />The AANS Annual Scientific Meeting is one of the largest gatherings of neurological clinicians. More information about the luncheon and other AANS events is available on the society&rsquo;s website: <a href=""></a>.</span></p></div> Women and men have different exclusion criteria for clot-busting stroke drug, say researchers 2015-04-14T13:42:00Z 2015-04-14T13:42:00Z <div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>After analysing stroke treatment records, researchers at Rhode Island Hospital in collaboration with researchers from the&nbsp;University of Cincinnati, both USA,&nbsp;learned that women and men have different reasons for being excluded from receiving the common clot-dissolving drug, recombinant tissue plasminogen activator (rt-PA). Importantly, more women had very high blood pressures, which reduced their eligibility to be treated with the highly effective drug. The study was recently published in the American Heart Association&rsquo;s (AHA) journal, <em>Stroke.</em>&nbsp;&nbsp;</strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Although men and women had similar overall eligibility rates for rt-PA, women were more likely to have severe hypertension&mdash;a potentially treatable condition, but a reason they can be excluded from receiving t-PA,&rdquo; said&nbsp;Tracy Madsen, an emergency department physician at Rhode Island Hospital. Madsen&rsquo;s main research focus is sex and gender differences in stroke, and she is the primary author of the AHA&nbsp;<em>Stroke</em>&nbsp;paper.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Interestingly, although the women were more likely to have severe hypertension, this treatable condition was often untreated,&rdquo; Madsen added.</span></p> <p><span style="font-size: 10pt;"><br />According to the&nbsp;US National Stroke Association, stroke is the third leading cause of death for women. In comparison, stroke is the fifth leading cause of death for men. Each year, 55,000 more women have a stroke than men. In general, women live longer than men and have more long-term negative consequences after stroke, so stroke will have a more negative impact on their lives.</span></p> <p><span style="font-size: 10pt;"><br />In addition to the hypertension exclusion, researchers found that women were more likely to be excluded from rt-PA treatment because of other factors, such as advanced age (80+) and very large strokes.</span></p> <p><span style="font-size: 10pt;"><br />As part of a large population-based stroke study, the researchers studied the records of all adult ischaemic stroke patients at 16 hospitals in southwest Ohio and northern Kentucky, USA, in 2005. Patient eligibility for rt-PA treatment and individual exclusion criteria was determined using the 2013 AHA and European Cooperative Acute Stroke Study (ECASS) III guidelines.</span></p> <p><span style="font-size: 10pt;"><br />The study was funded by a grant from the National Institutes of Neurological Disorders and Stroke. Madsen&rsquo;s principal affiliation is Rhode Island Hospital, and she also holds an academic appointment in the Department of Emergency Medicine (EM) at The Warren Alpert Medical School of Brown University. Within the Department of EM, Madsen is affiliated with both the Division of Sex and Gender in EM as well as the Division of Neurological Emergencies. Co-authors represent the University of Cincinnati College of Medicine, Cincinnati Children&rsquo;s Hospital Medical Center, and the Sanna Healthcare Network.</span></p></div> Jan Medical’s Nautilus BrainPulse detected cerebral vasospasm with clinically meaningful accuracy in UCSF study 2015-04-14T12:13:00Z 2015-04-14T12:13:00Z <div id="Introduction19" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Jan Medical has announced that a clinical study published in <em>Neurocritical Care</em>&nbsp;demonstrated that Nautilus BrainPulse is a highly sensitive skull accelerometry that can detect cerebral vasospasm &ldquo;with clinically meaningful accuracy&rdquo;, therefore suggesting, &ldquo;promise in the ICU environment to detect as well as reject cerebral vasospasm as the cause of neurological deficits in subarachnoid haemorrhage.&rdquo;</span></strong></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Principal investigator for the Nautilus BrainPulse study was Wade S Smith, director, UCSF Neuroscience ICU, Professor of Neurology, University of California, San Francisco, USA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;What we need is a safe, noninvasive, user-independent method to detect cerebral vasospasm&nbsp;before&nbsp;it causes brain injury,&rdquo; says Smith. &ldquo;The technology needs to be simple, and portable, to be most effective in the Neuro Critical Care setting, by more immediately detecting vasospasm so we can aggressively prevent stroke with cerebral angioplasty and/or vasospressor therapy. Such a technology holds the promise to directly help patients and shorten the length of stay within the Neuro ICU.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our Nautilus BrainPulse&nbsp;system can rapidly provide critical information on a patient presenting with stroke symptoms, and it can also be used as a continuous monitor of changes to the cerebral vasculature. It is this latter ability, continuous monitoring, that provides a unique capability in detecting the onset of vasospasm,&rdquo; adds&nbsp;Paul Lovoi, chief executive officer of&nbsp;Jan Medical. &ldquo;This study has confirmed that our portable and continuous brain-sensing system can detect vasospasms quickly and noninvasively.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The Nautilus BrainPulse is designed to measure the normal brain pulse as well as disruptions of the brain pulse. By digitising the signal patterns from headset-mounted sensors measuring the skull&rsquo;s motion, and extracting features from them, algorithms have been developed to identify normal and a variety of abnormal brain pulse patterns in recording sessions that take approximately three minutes. The device is portable, entirely non-invasive and provides analysis immediately once the recording session is completed.</span></p></div> More DNA mutations may result in a better prognosis for brain tumours 2015-04-13T14:45:00Z 2015-04-13T14:45:00Z <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>DNA mutations can cause cancer but in some cases, more mutations may mean a better prognosis for patients, according to a Yale-led comprehensive genomic analysis of more than 700 brain tumours. One such subtype of the most malignant brain tumour&mdash;glioblastoma&mdash;possesses thousands of tumour-specific DNA errors or mutations instead of dozens observed in most glioblastoma cases. It is also associated with longer survival.</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The findings, reported in <em><a href="">Neuro-Oncology</a></em>, suggest it may be possible to develop personalised treatments for more aggressive forms of brain cancer, including immunotherapy for these hyper- or ultra-mutated tumours, said Murat G&uuml;nel, professor and chair of neurosurgery, who leads the Yale Program in Brain Tumor Research at Yale and Smilow Cancer Hospital at Yale-New Haven, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We have been able to translate various complementary cutting-edge genomic technologies, which were once solely research tools, to our clinical programmes to analyse individual cancers,&rdquo; said G&uuml;nel, who is also a professor of genetics and a researcher for the Yale Cancer Center. &ldquo;We can now gain comprehensive understanding of the molecular make-up of a cancer to pinpoint specific vulnerabilities and leverage these weak spots for precision treatments in our Recurrent Brain Tumor Treatment Program.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">While as many as 10,000 mutations were found in the newly described subset of glioblastomas, a more typical tumour contains less than 100. This counterintuitive pattern has also been observed in gynecological and colon cancers: an extraordinary number of mutations means a better chance of survival.</span><br /><br /></p> <p><span style="font-size: 10pt;">One theory holds that cells with greater number of mutations are able to trigger an aggressive immune system response against cancer cells, while cells with fewer mutations might escape detection, Gunel said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Although the number of glioblastomas in this newly identified group is small, the use of standard chemotherapy in some cases has been shown to inadvertently result in a hyper-mutated tumour. Indeed, the drug temozolomide, used as the first line of chemotherapy in glioblastoma, has been shown to sometimes increase mutations.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;But perhaps the na&iuml;ve immune system is not strong enough to eliminate the cancer cells in these brain tumours,&rdquo; Gunel noted.</span><br /><br /></p> <p><span style="font-size: 10pt;">However, if a new generation of immunotherapy drugs called checkpoint inhibitors were used in these hyper-mutated tumours, perhaps more cancer cells might be targeted for destruction, he said. Clinical trials currently underway might be improved by considering the molecular genetic make-up of the individual tumour, he concluded.</span><br /><br /></p> <p><span style="font-size: 10pt;">The work was funded by the Gregory Kiez and Mehmet Kutman Foundation and was co-authored by Zeynep Erson-Omay and Ahmet Okay &Ccedil;ağlayan from Yale.</span></p></div> Researchers build brain–machine interface to control prosthetic hand 2015-04-10T16:23:00Z 2015-04-10T16:23:00Z <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>A research team from the University of Houston has created an algorithm that allowed a man to grasp a bottle and other objects with a prosthetic hand, powered only by his thoughts.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The technique, demonstrated with a 56-year-old man whose right hand had been amputated, uses non-invasive brain monitoring, capturing brain activity to determine what parts of the brain are involved in grasping an object. With that information, researchers created a computer programme&mdash;or brain-machine interface&mdash;that harnessed the subject&rsquo;s intentions and allowed him to successfully grasp objects, including a water bottle and a credit card. The subject grasped the selected objects 80% of the time using a high-tech bionic hand fitted to the amputee&rsquo;s stump.<br /><br /></span></p> <p><span style="font-size: 10pt;">Previous studies involving either surgically implanted electrodes or myoelectric control, which relies upon electrical signals from muscles in the arm, have shown similar success rates, according to the researchers.</span><br /><br /></p> <p><span style="font-size: 10pt;">Jose Luis Contreras-Vidal, a neuroscientist and engineer at the University of Houston, said the non-invasive method offers several advantages: It avoids the risks of surgically implanting electrodes by measuring brain activity via scalp electroencephalogram (EEG), and myoelectric systems are not an option for all patients, as they require that neural activity from muscles relevant to hand grasping remain intact.<br /><br /></span></p> <p><span style="font-size: 10pt;">The results of the study were published in <em><a href="">Frontiers in Neuroscience</a></em>, in the Neuroprosthetics section.</span><br /><br /></p> <p><span style="font-size: 10pt;">Contreras-Vidal, Hugh Roy and Lillie Cranz Cullen Distinguished Professor of electrical and computer engineering at the University of Houston, was lead author of the paper, along with graduate students Harshavardhan Ashok Agashe, Andrew Young Paek and Yuhang Zhang.</span><br /><br /></p> <p><span style="font-size: 10pt;">The work, funded by the National Science Foundation, demonstrates for the first time EEG-based brain&ndash;machine interface control of a multi-fingered prosthetic hand for grasping by an amputee. It could also lead to the development of better prosthetics, Contreras-Vidal said.</span><br /><br /></p> <p><span style="font-size: 10pt;">Beyond demonstrating that prosthetic control is possible using non-invasive EEG, researchers said the study offers a new understanding of the neuroscience of grasping and will be applicable to rehabilitation for other types of injuries, including stroke and spinal cord injury.&nbsp;</span><br /><br /></p> <p><span style="font-size: 10pt;">The study subjects&mdash;five able-bodied, right-handed men and women, all in their 20s, as well as the amputee&mdash;were tested using a 64-channel active EEG, with electrodes attached to the scalp to capture brain activity. Contreras-Vidal said brain activity was recorded in multiple areas, including the motor cortex and areas known to be used in action observation and decision-making, and occurred between 50 milliseconds and 90 milliseconds before the hand began to grasp. That provided evidence that the brain predicted the movement, rather than reflecting it, he said.<br /><br /></span></p> <p><span style="font-size: 10pt;">&ldquo;Current upper limb neuroprosthetics restore some degree of functional ability, but fail to approach the ease of use and dexterity of the natural hand, particularly for grasping movements,&rdquo; the researchers wrote, noting that work with invasive cortical electrodes has been shown to allow some hand control but not at the level necessary for all daily activities.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Further, the inherent risks associated with surgery required to implant electrodes, along with the long-term stability of recorded signals, is of concern&hellip;Here we show that it is feasible to extract detailed information on intended grasping movements to various objects in a natural, intuitive manner, from a plurality of scalp EEG signals.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Until now, this was thought to be possible only with brain signals acquired invasively inside or on the surface of the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">Researchers first recorded brain activity and hand movement in the able-bodied volunteers as they picked up five objects, each chosen to illustrate a different type of grasp: a soft drinks can, a compact disc, a credit card, a small coin and a screwdriver. The recorded data were used to create decoders of neural activity into motor signals, which successfully reconstructed the grasping movements.</span><br /><br /></p> <p><span style="font-size: 10pt;">They then fitted the amputee subject with a computer-controlled neuroprosthetic hand and told him to observe and imagine himself controlling the hand as it moved and grasped the objects.&nbsp;The subject&rsquo;s EEG data, along with information about prosthetic hand movements gleaned from the able-bodied volunteers, were used to build the algorithm.</span></p> <p><span style="font-size: 10pt;">Contreras-Vidal said additional practice, along with refining the algorithm, could increase the success rate to 100%.</span></p></div> Stimwave Technologies announces partnership with Epimed International 2015-04-10T15:57:00Z 2015-04-10T15:57:00Z <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>Stimwave Technologies has announced a partnership with&nbsp;Epimed International.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The partnership, in addition to co-product development, will support distribution of Stimwave&rsquo;s Wireless Pain Relief technology, expanding the Stimwave USA network to more than 100 sales representatives speaking directly to doctors, medical centres and hospitals across the country. Stimwave&rsquo;s wireless neuromodulation device became available in the USA in January 2015.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;This is an extremely significant partnership that will dramatically accelerate the introduction of Stimwave&rsquo;s Wireless Pain Relief technology not only to physicians across the country, but more importantly to the millions of chronic pain patients who will benefit from it,&rdquo; said Stimwave chairman Laura Tyler Perryman.</span><br /><br /></p> <p><span style="font-size: 10pt;">The partnership will include Stimwave utilisation of Epimed&rsquo;s manufacturing, packaging, fulfilment, distribution, reimbursement and physician services.</span></p></div> Drug restores brain function and memory in early Alzheimer’s disease 2015-04-10T15:44:00Z 2015-04-10T15:44:00Z <div id="ImageMain23" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A novel therapeutic approach for an existing drug reverses a condition in elderly patients who are at high risk for dementia due to Alzheimer&rsquo;s disease, researchers at Johns Hopkins University found.</strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The drug, commonly used to treat epilepsy, calms hyperactivity in the brain of patients with amnestic mild cognitive impairment (aMCI), a clinically recognised condition in which memory impairment is greater than expected for a person&rsquo;s age and which greatly increases risk for Alzheimer&rsquo;s dementia, according to the study published in&nbsp;<em><a href="">NeuroImage: Clinical</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">The findings validate the Johns Hopkins team&rsquo;s initial conclusions,&nbsp;<a href="">published three years ago</a>&nbsp;in the journal <em>Neuron</em>. They also closely match the results in animal studies performed by the team and scientists elsewhere. Next, neuroscientist Michela Gallagher, the lead investigator, hopes the therapy will be tested in a large-scale, longer-term clinical trial.</span><br /><br /></p> <p><span style="font-size: 10pt;">Hippocampal over-activity is well-documented in patients with aMCI and its occurrence predicts further cognitive decline and progression to Alzheimer&rsquo;s dementia, Gallagher said.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we have shown is that very low doses of the atypical antiepileptic levetiracetam reduces this over-activity,&rdquo; Gallagher said. &ldquo;At the same time, it improves memory performance on a task that depends on the hippocampus.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The team studied 84 subjects. Seventeen were healthy participants and the rest showed symptoms of pre-dementia memory loss defined as aMCI. Everyone was over 55 years old, with an average age of about 70.</span><br /><br /><span style="font-size: 10pt;"> The subjects were given varying doses of the drug and also a placebo in a double-blind randomised trial. Researchers found low doses both improved memory performance and normalised the over-activity detected by functional magnetic resonance imaging that measures brain activity during a memory task. The ideal dosing found in this clinical study matched earlier preclinical studies in animal models.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;What we want to discover now, is whether treatment over a longer time will prevent further cognitive decline and delay or stop progression to Alzheimer&rsquo;s dementia,&rdquo; Gallagher said.</span></p></div> Stimwave appoints Gabor Racz as chair of Medical Advisory Board 2015-04-03T15:45:00Z 2015-04-03T15:45:00Z <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>Stimwave Technologies has appointed Gabor Racz as the chair of the Stimwave medical advisory board. Honoured with numerous lifetime achievement awards throughout the industry, a company press release says that &ldquo;Racz is considered by many to be the father of interventional pain medicine.&rdquo;</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Gabor&nbsp;Racz is a renowned leader in the field of pain medicine, and we look forward to benefiting from his guidance and expertise,&rdquo; said Laura Tyler Perryman, chairman and chief executive officer of Stimwave.</span><br /><br /></p> <p><span style="font-size: 10pt;">Racz has been honoured with several lifetime achievement awards from societies throughout the world in recognition of contributions that span more than five decades. Racz is one of the founders and past presidents of the World Institute of Pain, as well as chairman emeritus and a lifetime member of the executive board.</span><br /><br /></p> <p><span style="font-size: 10pt;">Racz was also instrumental in the development of the American Society of Interventional Pain Physicians, a society of over 4,500 members specialising in pain medicine. In honour of Racz, the annual keynote speech of the society is called the Raj and Racz Award. He is currently chairman emeritus at the Department of Anesthesiology at Texas Tech University Health Science Center in Lubbock, USA, and an acknowledged Grover E Murray professor. Racz was the first to introduce the concept of using needle/catheter-based procedures to replace drug and other therapies for people suffering from chronic pain.</span></p></div> Better outcomes observed in MR CLEAN non-general anaesthesia subgroup in post-hoc analysis 2015-04-02T13:38:00Z 2015-04-02T13:38:00Z <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>In a post-hoc analysis of the use of general anaesthesia in the MR CLEAN trial (Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands) investigators have found that the subgroup of patients treated without general anaesthesia benefited more from the endovascular treatment than the subgroup treated under general anaesthesia.</strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Olvert Berkhemer, Department of Radiology, Academic Medical Center, Amsterdam, the Netherlands, presented the results of the analysis at the International Stroke Conference (ISC, 11&ndash;13 February, Nashville, USA). MR CLEAN, a pragmatic, phase 3 clinical trial, compared intra-arterial treatment (intra-arterial thrombolysis, mechanical treatment, or both) plus usual care (which could include intravenous administration of alteplase) with usual care alone (control group) in patients with acute ischaemic stroke and a proximal intracranial arterial occlusion of the anterior circulation that was confirmed on vessel imaging. The results of the trial showed better outcomes in favour of intervention.</span></p> <p><span style="font-size: 10pt;"><br />Speaking of the post-hoc analysis, Berkhemer reported, &ldquo;We found that the treatment effect we saw in MR CLEAN in the subgroup of patients treated under general anaesthesia was less than the patients treated without general anaesthesia. We cannot definitely say that patients treated with general anaesthesia did not benefit, the benefit was certainly less.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Discussing the advantages and disadvantages of the use of general anaesthesia versus no general anaesthesia, Berkhemer compared the two, pointing out that general anaesthesia is generally associated with shorter procedural duration, delayed treatment time and higher risk of aspiration; while on the other hand, a non-general anaesthesia procedure is associated with faster treatment initiation, the ability for neurological assessment during intra-arterial treatment, patient movement with the risk of vessel perforation or dissection, and conversion to general anaesthesia with emergency intubation with higher likelihood of aspiration.</span></p> <p><span style="font-size: 10pt;"><br />The primary outcome was assessed using the score on the modified Rankin Scale at 90 days, while secondary outcomes included timing, safety parameters and procedural-related adverse events.</span></p> <p><span style="font-size: 10pt;">Of the 233 patients allocated to intra-arterial treatment, 79 were treated under general anaesthesia, and 137 without general anaesthesia (17 patients did not reach the angiosuite in MR CLEAN).</span></p> <p><span style="font-size: 10pt;"><br />Using the modified Rankin Scale score to assess patient outcome at 90 days, Berkhemer said, &ldquo;We noticed that patients treated without general anaesthesia have a higher chance of a functional independent lifestyle. They did better after 90 days.&rdquo; Intra-arterial treatment without general anaesthesia resulted in 38% good outcome, compared to 23% in the under general anaesthesia group.</span></p> <p><span style="font-size: 10pt;"><br />He concluded, noting, &ldquo;General anaesthesia is associated with delayed treatment initiation in the MR CLEAN trial. Procedural durations were equivalent in both groups, and there was no significant difference in time to revascularisation. There were no safety concerns in either group.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Further, Berkhemer underscored that &ldquo;there was significant interaction with treatment. The effect on outcome that we found in the MR CLEAN trial was not observed in the subgroup of patients treated with general anaesthesia.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />As for whether this analysis has the potential to influence change in current practice, Berkhemer explained that in the Netherlands there are already hospitals changing. &ldquo;They are leaving behind the &ldquo;always general&rdquo; approach, except in cases where it is absolutely necessary (for example, a patient who is moving around a lot), and avoiding general anaesthesia wherever is it possible,&rdquo; he said. &nbsp;</span></p> <p><span style="font-size: 10pt;"><br />He added that the findings of this post-hoc analysis will have to be confirmed by other trials, including the ongoing ANSTROKE (Sedation versus general anesthesia for endovascular therapy in acute stroke&mdash;impact on neurological outcome) and GOLIATH (General or local anaesthesia in intra-arterial therapy) trials.</span></p></div> Montr&#xe9;al scientists get one step closer to finding how to repair damaged nerve cells 2015-04-02T11:57:00Z 2015-04-02T11:57:00Z <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><span style="font-size: 11pt;"><strong>A team of researchers at the IRCM led by&nbsp;Fr&eacute;d&eacute;ric Charron, in collaboration with bioengineers at McGill University, uncovered a new kind of synergy in the development of the nervous system, which explains an important mechanism required for neural circuits to form properly. Their breakthrough, published in the scientific journal&nbsp;<em>PLoS Biology</em>, could eventually help develop tools to repair nerve cells following injuries to the nervous system (such as the brain and spinal cord).</strong></span></p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Researchers in Charron&rsquo;s laboratory study neurons, the nerve cells that make up the central nervous system, as well as their long extensions known as axons. During development, axons must follow specific paths in the nervous system in order to properly form neural circuits and allow neurons to communicate with one another. IRCM researchers are studying a process called axon guidance to better understand how axons manage to follow the correct paths.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;To reach their target, growing axons rely on molecules known as guidance cues, which instruct them on which direction to take by repelling or attracting them to their destination,&rdquo; explains Charron, director of the Molecular Biology of Neural Development research unit at the IRCM.</span></p> <p><span style="font-size: 10pt;"><br />Over the past few decades, the scientific community has struggled to understand why more than one guidance cue would be necessary for axons to reach the proper target. In this paper, IRCM scientists uncovered how axons use information from multiple guidance cues to make their pathfinding decisions. To do so, they studied the relative change in concentration of guidance cues in the neuron&rsquo;s environment, which is referred to as the steepness of the gradient.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We found that the steepness of the gradient is a critical factor for axon guidance; the steeper the gradient, the better the axons respond to guidance cues,&rdquo; says&nbsp;Tyler FW Sloan, PhD student in Charron&rsquo;s laboratory and first author of the study. &ldquo;In addition, we showed that the gradient of one guidance cue may not be steep enough to orient axons. In those instances, we revealed that a combination of guidance cues can behave in synergy with one another to help the axon interpret the gradient&rsquo;s direction.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In collaboration with the Program in Neuroengineering at McGill University, Charron&rsquo;s team developed an innovative technique to recreate the concentration gradients of guidance cues&nbsp;<em>in vitro</em>, that is to say they can study the developing axons outside their biological context.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This new method provides us with several benefits when compared to previous techniques, and allows us to simulate more realistic conditions encountered in developing embryos, conduct longer-term experiments to observe the entire process of axon guidance, and obtain extremely useful quantitative data,&rdquo; adds Sloan. &ldquo;It combines knowledge from the field of microfluidics, which uses fluids at a microscopic scale to miniaturise biological experiments, with the cellular, biological and molecular studies we conduct in laboratories.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is true multidisciplinary work, and an excellent example of what the Program in Neuroengineering aims to accomplish in situations where neurobiologists like myself have a specific question they want to address, but the current tools are not adapted to answer their question,&rdquo; mentions Charron. &ldquo;Thus, thanks to this unique programme, we teamed up with McGill&rsquo;s bioengineers and microfluidic and mathematical modelling experts to create the device required for our study.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This scientific breakthrough could bring us closer to repairing damaged nerve cells following injuries to the central nervous system,&rdquo; states Charron. &ldquo;A better understanding of the mechanisms involved in axon guidance will offer new possibilities for developing techniques to treat lesions resulting from spinal cord injuries, and possibly even neurodegenerative diseases.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Injuries to the central nervous system affect thousands of Canadians every year and can lead to lifelong disabilities. Most often caused by an accident, stroke or disease, these injuries are currently very difficult to repair. Research is therefore required for the development of new tools to repair damage to the central nervous system.</span></p></div> Daiichi Sankyo Inc and Asubio Pharmaceuticals merge 2015-04-01T15:10:00Z 2015-04-01T15:10:00Z <div id="Introduction27" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Daiichi Sankyo Inc, the US subsidiary of Daiichi Sankyo Company, will merge with its US-based sister company, Asubio Pharmaceuticals.&nbsp; As a result, Asubio Pharmaceuticals projects will be integrated into the Daiichi Sankyo global development organisation, led by Mahmoud Ghazzi.</span></strong></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Asubio Pharmaceuticals&rsquo; parent company, Asubio Pharma Co, which is based in Japan, will continue to operate as a wholly owned subsidiary of Daiichi Sankyo Co, with a focus on discovery research.</span><br /><br /></p> <p><span style="font-size: 10pt;">Asubio Pharmaceuticals&rsquo;s ongoing clinical trial in patients with acute spinal cord injury (ASBI 603ASCENT study (SUN13837)) has already completed enrolment. An analysis and dissemination of the data will now be managed by Daiichi Sankyo.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;In line with the Daiichi Sankyo five-year business plan to optimise our business of delivering innovative treatments to patients, consolidating the current Asubio US projects under the company&rsquo;s overall research and development organisation helps us streamline our operations,&rdquo; said Glenn Gormley, senior executive officer and global head of research and development, Daiichi Sankyo Company, and executive chairman and president, Daiichi Sankyo, Inc.</span></p></div> AANS, CNS and Joint Cerebrovascular Section endorse interventional thrombectomy in treatment of acute ischaemic stroke 2015-04-01T11:00:00Z 2015-04-01T11:00:00Z <div id="Introduction28" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Until recently, thrombolytic therapy has been the only proven treatment for acute ischaemic stroke. A recent study in the Netherlands, however, found that interventional thrombectomy improved functional outcomes in patients with emergent cranial large-vessel occlusions, even among patients who had already received tissue plasminogen activator (tPA) for thrombolytic therapy.</strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The American Association of Neurological Surgeons, the Congress of Neurological Surgeons, and the Joint AANS/CNS Cerebrovascular Section strongly endorse interventional thrombectomy in the treatment of acute ischaemic stroke in their article, &ldquo;MR CLEAN: past the tipping point of clinical equipoise,&rdquo; by Henry H Woo <em>et al</em>, published online, ahead of print, in the&nbsp;<em><a href="">Journal of Neurosurgery</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">Five hundred patients with imaging-confirmed occlusion of proximal arteries in the anterior cerebral circulation were enrolled in MR CLEAN (the multicentre randomised clinical trial of endovascular treatment for acute ischaemic stroke in the Netherlands) and treated within six hours of symptom onset. All patients were given the usual standard of care, which included prompt administration of tPA (alteplase) in 89% of patients. Approximately half of the patients also received interventional thrombectomy, which in 82% was accomplished using retrievable stents. The addition of interventional thrombectomy proved more favourable than usual care alone, with a 13.5% improvement in the absolute rate of functional independence between the two treatment groups. The results of MR CLEAN were reported in the&nbsp;<em><a href="">New England Journal of Medicine</a></em>.</span><br /><br /></p> <p><span style="font-size: 10pt;">Woo and colleagues describe differences between MR CLEAN and three previous studies that were unable to prove the advantages of interventional thrombectomy for acute ischaemic stroke. The earlier studies suffered from lack of imaging confirmation of large-vessel occlusion, use of antiquated interventional technologies, and insufficient statistical power. The authors applaud the achievements of MR CLEAN.</span><br /><br /></p> <p><span style="font-size: 10pt;">Speaking to the future, Woo and colleagues point out that work still needs to be done to improve patients&rsquo; lives following ischaemic stroke. The authors call on neurosurgeons and all health care professions to improve patient care by identifying and triaging patients with emergent large-vessel occlusion with greater accuracy and speed. They point out that these lesions may be more time sensitive than acute myocardial infarction, and first responders and the public should be trained to respond quickly and efficiently.</span></p></div> InVivo reopens enrolment for subjects for anticipated completion of ongoing pilot trial 2015-03-27T14:47:00Z 2015-03-27T14:47:00Z <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>InVivo Therapeutics has announced the reopening of subject enrolment for the company&rsquo;s ongoing investigational device exemption pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrolment of each subject. To date, there have been no reported serious safety events related to the Neuro-Spinal Scaffold or the procedure to implant the Neuro-Spinal Scaffold with the study&rsquo;s first and second subjects, and InVivo has been approved by Food and Drug Administration and the Data Safety Monitoring Board to move forward with the study.</span><br /><br /></p> <p><span style="font-size: 10pt;">Mark Perrin, InVivo&rsquo;s chief executive officer and chairman, said, &ldquo;Despite a severe, multi-trauma injury that included a collapsed lung and resulted in a two day delay in spinal stabilisation and Neuro-Spinal Scaffold implantation, the second subject has not experienced any serious safety events to date related to our investigational product. Although we cannot predict when subjects will present, we anticipate enrolling subjects three through five this calendar year, which would complete enrolment for the pilot trial. We can now enrol the final patients concurrently, and we now have eight active clinical sites that can participate in this trial.&rdquo;</span></p></div> Varian Medical spotlights New Edge radiosurgery suite for non-invasive surgical procedures 2015-03-27T09:43:00Z 2015-03-27T09:43:00Z <div id="Introduction30" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Edge radiosurgery suite, a technology system for rapidly delivering precise, non-invasive surgical procedures in the treatment of cancer, is among the medical innovations that Varian Medical Systems is showcasing at the 27th International Medical Instruments &amp; Equipment Exhibition (26&ndash;28 March, Beijing, China).</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Edge radiosurgery system offers clinicians a non-invasive alternative to traditional surgery. It accurately targets tumours and other abnormalities without an incision or the need for recovery in a hospital setting,&rdquo; said Dee Khuntia, Varian&rsquo;s vice president for medical affairs and chief medical officer. &ldquo;Cancer specialists can use the Edge system to accurately target tumours of the brain, spine, lung, and other areas that are typically difficult to treat surgically.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">As a non-invasive option, radiosurgery use in the USA has been growing steadily over the last decade for the treatment of cancer and other conditions that can be appropriately treated with focused radiation. Predictions are that it will continue to grow as research accrues about the benefits to patients. Radiosurgery involves the use of sophisticated software and hardware to ablate tumours or other abnormalities with high doses of radiation while minimising exposure of surrounding healthy tissue. Varian says that the Edge system can complete sophisticated radiosurgery treatments in just a few minutes&mdash;much faster than earlier generations of technology.</span><br /><br /></p> <p><span style="font-size: 10pt;">Edge was first unveiled in 2012 in the United States, and received clearance from the CFDA of China in 2014. As of March 2015, Edge systems had been installed and used at cancer centres in the USA, UK, Portugal, Italy, and Switzerland. Users have reported over 1,000 patients have now been treated using Edge technology, for lung, brain, gastrointestinal, genitourinary, and other types of cancer.</span><br /><br /></p> <p><span style="font-size: 10pt;">Clinicians at the Henry Ford Health System in Detroit, USA, were the first to use the Edge radiosurgery system in the USA. They have been presenting studies at the scientific meetings of the American Association of Physicists in Medicine (AAPM) and the American Society for Radiation Oncology (ASTRO).</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Last year, we reported that the Edge radiosurgery system can deliver dose to a targeted tumour with sub-millimetre accuracy,&rdquo; said Salim Siddiqui, director of the stereotactic radiosurgery programme at Henry Ford. &ldquo;Compared with many other robot- or frame-based radiosurgery systems, the Edge is more convenient, more robust, more versatile, and substantially more efficient because it can be used to target multiple tumours at once and can treat anywhere in the body. Moreover, with the capability to deliver 2,400 monitor units per minute, some treatments can be completed up to four times faster than on other systems.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The Edge offers multiple advanced imaging modalities, including on-demand X-ray imaging and 4-D cone-beam computed tomography, for localisation and tracking of the patient&rsquo;s position throughout the treatment, which has greatly enhanced our confidence in the accuracy and efficiency of frameless stereotactic treatment,&rdquo; added Ning Wen, stereotactic radiosurgery physics lead. &ldquo;It has given us a variety of strategies to take aim at cancer.&rdquo;</span></p></div> Health Canada greenlights IMRIS ceiling-mounted intraoperative CT solution 2015-03-26T12:08:00Z 2015-03-26T12:08:00Z <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>IMRIS Inc has announced that VISIUS iCT, the first and only ceiling-mounted intraoperative computed tomography scanner, has received Health Canada licensing allowing for sales and marketing in the country.</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This completes our roll-out of VISIUS iCT for North America and another step in our overall global distribution,&rdquo; says IMRIS president and chief executive officer Jay D Miller. &ldquo;As procedures become more minimally invasive, the need for better visualisation with advanced imaging increases. VISIUS iCT places the highest quality CT imaging inside the operating room. This scanner delivers more flexibility for both bone and soft tissue scanning compared to other intraoperative CT scanners on the market.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />According to the company, VISIUS iCT provides personalised dose management together with diagnostic quality imaging during the surgical procedure to assist surgeons in critical decision making. Developed for the neurosurgery and spine surgery markets, VISIUS iCT has the 64-slice Siemens SOMATOM Definition AS scanner as its core technology&mdash;making it the highest quality computed tomography imagery in an operating room. Unlike other mobile intraoperative CT systems on the market, the VISIUS iCT can support complex brain tumour resection and neurovascular procedures.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Both neurosurgeons and spine surgeons will find this unique solution helpful in supporting the full spectrum of intracranial, spinal and neurovascular procedures,&rdquo; Miller adds.</span></p> <p><span style="font-size: 10pt;"><br />The scanner effortlessly moves into and out of the operating room during surgery using ceiling-mounted rails to ease workflow. This enables multiple room configurations to meet both clinical requirements and increase utilisation without compromising image quality or exam speed. Patient transport and the need for floor-mounted rails used in other systems is eliminated which opens up valuable operating room space and allows unimpeded movement of surgical equipment and simplified infection control.</span></p> <p><span style="font-size: 10pt;"><br />In addition, VISIUS iCT features a suite of software applications such as 3D volume rendering to aid in surgical planning and dose reduction which considers each patient&rsquo;s unique characteristics to maximise image quality and minimise dose. The system software allows healthcare practitioners to visualise dosage prior to scan and adjust settings based on the specific clinical need with detailed dosage reports produced after each scan.</span></p></div> High-frequency surpasses traditional spinal cord stimulation in first controlled trial comparing technologies 2015-03-26T11:33:00Z 2015-03-26T11:33:00Z <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>The first-ever randomised, controlled trial to compare spinal cord stimulation technologies found that high-frequency stimulation using 10kHz (HF10) exceeded lower-frequency, traditional stimulation in response rate and pain relief. Further, this was achieved without the paraesthesia that may cause discomfort with traditional treatment, the researchers reported in a scientific poster at the 31st Annual Meeting of the American Academy of Pain Medicine (19&ndash;22 March, Washington, DC, USA).</strong></span></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Traditional spinal cord low-frequency (~50 Hz) stimulation is an attempt to mask the sensation of pain with paraesthesia. Therefore, the therapeutic goal with traditional stimulation is to cover the areas of pain with paraesthesias, explained B Todd Sitzman, medical director of Advanced Pain Therapy, PLLC, in Hattiesburg, USA.</span><br /><br /></p> <p><span style="font-size: 10pt;">In contrast, &ldquo;high-frequency HF10 therapy utilises a stimulation frequency that is orders of magnitude higher than traditional spinal cord stimulation,&rdquo; Sitzman said. &ldquo;HF10 therapy does not produce paraesthesias and achieves superior back and leg pain relief.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">More importantly, HF10 therapy was shown to be superior to traditional stimulation in all of the study-related primary and secondary endpoints, including response rate and pain relief. The magnitude of back pain relief was consistent with previous European research of HF10 therapy.<br /><br /></span></p> <p><span style="font-size: 10pt;">The use of spinal cord stimulation, introduced in 1967, has expanded as a treatment for difficult pain syndromes, encompassing peripheral neuropathies, complex regional pain syndromes, peripheral vascular disease and other disorders in addition to failed back surgery syndrome.</span><br /><br /></p> <p><span style="font-size: 10pt;">Traditional low-frequency stimulation systems are widely used in clinical practice. However, the scientific literature indicates that achieving back pain coverage with traditional spinal cord stimulation is technically difficult and is often not sustained over time. According to one report, 71% of patients who received an implant with traditional stimulation experienced discomfort from the stimulation of paraesthesia. In the current study, 44% of patients receiving traditional spinal cord stimulation reported uncomfortable stimulation.</span><br /><br /></p> <p><span style="font-size: 10pt;">The study was a prospective, randomised, multicentre, comparative trial of the investigational HF10 vs the standard stimulation therapy, designed in consultation with and monitored by the Food and Drug Administration (FDA). Institutional review board approval was obtained for each study site.</span><br /><br /></p> <p><span style="font-size: 10pt;">The 12-month follow-up data indicated that the responder rate with HF10 therapy was twice that with traditional stimulation for both back and leg pain. Also, the average degree of pain relief with HF10 therapy was more than 50% greater than with traditional stimulation. The level-1 evidence with 12-month follow-up meets the current rigorous standards for evidence-based healthcare and complies with regulatory agency and payer preference for comparative effectiveness, the investigators said.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;These results provide important comparative effectiveness data for healthcare providers and clinically relevant information for pain physicians, patients and payers,&rdquo; Sitzman said.</span><br /><br /></p> <p><span style="font-size: 10pt;">At present, HF10 therapy is investigational in the USA. The manufacturer of the device, Nevro Corp, which funded this study, anticipates obtaining market approval from the FDA by mid-2015.</span></p></div> People who suffer migraine headaches may be at double the risk of stroke 2015-03-26T11:06:00Z 2015-03-26T11:06:00Z <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><span style="font-size: 11pt;"><strong>Numerous individual studies and meta-analyses have demonstrated that people who have migraines with aura are at a higher risk for ischaemic stroke. Citing these and other studies, Loyola University Medical Center neurologists Michael Star, and Jos&eacute; Biller, have described the association between stroke and migraine in their chapter in the new text <em>Headache and Migraine Biology and Management</em>.</strong></span></p> </div><div id="Text133" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">About 85% of strokes are ischaemic. Migraine with aura is a migraine headache that is preceded by an aura, which typically includes flashes of light, bright spots, blind spots and perhaps tingling in the hands or face. Recent studies also suggest there is a link between migraines and haemorrhagic strokes, caused by bleeding in the brain.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The biology underlying the relationship between migraine and stroke is poorly defined,&rdquo; write Star and Biller. As such, researchers have proposed several possible explanations for the migraine-stroke association:</span></p> <ul> <li><span style="font-size: 10pt;">Migraine sufferers are more likely to have risk factors for cardiovascular disease, including low levels of HDL (also known as &ldquo;good cholesterol&rdquo;) and high levels of c-reactive protein.</span></li> <li><span style="font-size: 10pt;">Specific genes may predispose people to suffer both migraines and stroke.&nbsp;</span></li> <li><span style="font-size: 10pt;">Medications to treat migraines may increase the risk of stroke.&nbsp;</span></li> <li><span style="font-size: 10pt;">A phenomenon that occurs during migraine aura&mdash;cortical spreading depression&mdash;might trigger an ischaemic stroke. A cortical spreading depression is a slowly propagated wave of depolarisation, followed by depression of brain activity occurring during migraine aura. It includes changes in neural and vascular function.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;Taking all of these possible explanations into account, the research may point to stroke and migraine sharing a reciprocal causal relationship,&rdquo; Star and Biller write. &ldquo;There is a significant amount of research attempting to further elucidate this multifaceted relationship.&rdquo;</span></p></div> New tinnitus treatment study reduces total symptoms by almost 40% 2015-03-25T11:52:00Z 2015-03-25T11:52:00Z <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>Tinnitus affects around 10% of the population in the UK and in its severe form can cause sleep loss, anxiety, depression and a significant reduction in their quality of life.</strong></span></p> </div><div id="Text134" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Now, a year-long study by independent research organisation CERES, shows that Acoustic CR neuromodulation treatment is effective in reducing tonal tinnitus symptoms such as severity and loudness and annoyance by nearly 40%.</span></p> <p><span style="font-size: 10pt;"><br />Of the 200 patients treated in 23 ENT (Ear, Nose and Throat) centres across&nbsp;Germany, 67% reported that their tinnitus had improved, and 50% said that their tinnitus no longer had a negative influence on their quality of life.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Patients in this study had tinnitus for more than four years, and the majority had at least two other treatments before taking the Acoustic CR neuromodulation,&rdquo; says chief&nbsp;audiologist Mark Williams&nbsp;at the Tinnitus Clinic in Harley Street, London, which is acknowledged as UK&rsquo;s leading private treatment centre for tinnitus.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This peer-reviewed study shows without doubt, that in a clinical setting, Acoustic CR neuromodulation offers both progressive and sustainable therapeutic benefit to people affected by chronic tonal tinnitus.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Robert Stanley, a patient who has recently completed his Acoustic CR neuromodulation treatment at The Tinnitus Clinic, says,&nbsp;&ldquo;I would say my tinnitus is 80% better than it was&nbsp;and I believe that the Acoustic neuromodulation programme has significantly&nbsp;reduced&nbsp;my tinnitus both in frequency and volume. It has given me my quality of life back.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Acoustic CR neuromodulation therapy is designed to desynchronise nerves in the hearing part of the brain, by using the brains natural plasticity. This desynchronisation reduces the strength of the links between nerve clusters, shifting a nerve population from a synchronised (pathological) state to a stable desynchronised (healthy and normal) state, where the nerve clusters will remain after treatment.</span></p></div> Brain tumour cells decimated by mitochondrial “smart bomb” 2015-03-25T11:21:00Z 2015-03-25T11:21:00Z <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: 10pt;"><span style="font-size: 8pt;">Caption: The new drug MP-MUS (yellow) attacks cancer cell mitochondria by infiltrating both inner and outer membranes (green) after being converted from an inactive, non-toxic form to an active, toxic form by the enzyme MAO-B (purple). Once inside, the drug damages mitochondrial DNA, which cannot be repaired.</span><br /><br />As reported in April 2015 <em>ChemMedChem</em> (early online),&nbsp;Houston Methodist Kenneth R Peak Brain &amp; Pituitary Tumor Center director David S Baskin and Peak Center Head of Research Martyn Sharpe, designed a drug called MP-MUS that destroyed 90 to 95% of malignant glioma cells, yet in other experiments did not seem to adversely affect healthy human brain cells (<em>in vitro</em>). This compliments a soon to be published extensive study showing the same drug can treat human brain cancer grown in the brains of mice. Researchers hope to begin testing the drug in human clinical trials in 2016 or 2017.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are very optimistic that we will get there,&rdquo; says Baskin, also vice chair of the Department of Neurosurgery at Houston Methodist Hospital. &ldquo;Our past work has shown that MP-MUS has very low toxicity until it gets into tumour cells. Once it arrives, it is changed to its active form, doing a lot of damage where we want it to, leaving healthy brain cells alone&mdash;a bit like a &lsquo;smart bomb&rsquo;. To our knowledge, this is the first known example of selective mitochondrial chemotherapy, which we believe represents a powerful new approach to brain cancer.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Medical options for brain tumour patients are woeful, Baskin says. &ldquo;It is a horrible diagnosis. Because of where the tumours are located, and because of the way they can infiltrate healthy tissue, surgery is often not helpful long term. The most effective chemotherapy drug available right now, temozolomide, only extends life from nine to 15 months, and patients&rsquo; quality of life during that period is not very good.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />For that reason, Baskin says he and researchers around the world have been looking for new treatment approaches, such as vaccines intended to aid the body&rsquo;s immune system&rsquo;s recognition and removal of tumour cells, gene therapy and, in the present case, targeting tumour cell mitochondria.</span></p> <p><span style="font-size: 10pt;"><br />Gliomas develop from brain cells called astrocytes. Gliomas account for as much as 20 to 30% of all tumours of the brain and central nervous system.</span></p> <p><span style="font-size: 10pt;"><br />Mitochondria are often referred to as the &ldquo;powerhouses&rdquo; of cells&mdash;including misbehaving cancer cells&mdash;because they help cells create energy. In cancer cells this feature is partially switched off, causing cells to rely on other systems that generate energy. The numerous pill-shaped mitochondria in each cell perform a number of other crucial functions, however, and even cancer cells cannot grow and divide without healthy mitochondria.</span></p> <p><span style="font-size: 10pt;"><br />As luck would have it, an enzyme called MAO-B is over-expressed in brain tumour cells, which is the target of MP-MUS. This means that healthy cells are only exposed to low levels of MP-MUS and their mitochondria to very low levels of P+-MUS, Baskin says. On the other hand, in tumour cells the vast majority of the pro-drug is converted into P+-MUS, which essentially traps the drug inside their mitochondria where it attacks the mitochondrial DNA.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We found that we could achieve profound effects with MP-MUS at very low concentrations, around 75 micromolar,&rdquo; says Baskin, professor of Neurological Surgery, Weill Cornell Medical College. &ldquo;By contrast, temozolomide must be used at concentrations two to three times that to be of any use to patients. Our approach is designed to capitalise on what is going inside the cells. Tumour cells have much more MAO-B, and when challenged, make even more MAO-B as a sort of defensive response. We hope that we are one step ahead of the cancer cells, as we are using that very fact to kill them.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The researchers reported MP-MUS&rsquo;s toxicity to healthy cells remained low at concentrations as high as 180 micromolar. This information will be useful to the researchers as they consider safety and efficacy trials in human patients.</span></p> <p><span style="font-size: 10pt;"><br />Houston Methodist and Baskin and Sharpe entered into an agreement with Virtici, LLC to develop MP-MUS and are currently preparing toxicology studies which are required prior to clinical trials.</span></p> <p><span style="font-size: 10pt;"><br />While human clinical trials have not yet begun for MP-MUS, Houston Methodist Neurological Institute doctors are overseeing participation in a number of clinical trials related to gliomas and glioblastomas.</span></p> </div> Use of stent, compared to medications, increases risk of stroke in VISSIT trial 2015-03-25T10:27:00Z 2015-03-25T10:27:00Z <div id="ImageMain36" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction36" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The VISSIT study has shown that among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy (clopidogrel and aspirin) resulted in an increase of stroke or transient ischaemic attack.&nbsp;The&nbsp;study was published in the 24/31 March issue of the <em>Journal of the American Medical Association</em>&nbsp;(<em><a href="" target="_blank">JAMA</a>).</em></strong></span></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Intracranial arterial stenosis is a common cause of stroke worldwide. The recurrent stroke risk with severe symptomatic intracranial stenosis may be as high as 23% at one year, despite medical therapy, according to background information in the study.</span></p> <p><span style="font-size: 10pt;"><br />Osama O Zaidat of the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, USA and colleagues randomly assigned 112 patients with symptomatic intracranial stenosis (narrowing of 70% or greater) to receive a balloon-expandable stent plus medical therapy (stent group; n=59) or medical therapy alone (medical group; n=53). Medical therapy consisted of clopidogrel (75mg daily) for the first three months after enrolment and aspirin (81-325mg daily) for the study duration. This international trial, with sites in the United States, China and Europe, enrolled patients from 27 sites (January 2009&ndash;June 2012) with last follow-up in May 2013. <br /><br />Enrolment was halted by the sponsor after negative results from a similar&nbsp;trial (SAMMPRIS) prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled.</span></p> <p><span style="font-size: 10pt;"><br />The 30-day safety endpoint of any stroke within 30 days or hard transient ischaemic attack (defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischaemia lasting at least 10 minutes but resolving within 24 hours) within two to 30 days was 9.4% (5/53) in the medical group and 24.1% (14/58) in the stent group. Ischaemic stroke was observed in three patients (5.7%) in the medical group and in 10 patients (17.2%) in the stent group. Intracranial haemorrhage occurred in five patients (8.6%) in the stent group and in zero in the medical group. The one-year outcome of stroke or hard transient ischaemic attack occurred in more patients in the stent group (36.2%) vs the medical group (15.1%).</span></p> <p><span style="font-size: 10pt;"><br />Thirty day all-cause death was three of 58 patients (5.2%) in the stent group and zero in the medical group. A measure of disability worsened in more patients in the stent group than in the medical group.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These findings do not support the use of a balloon-expandable stent for patients with intracranial arterial stenosis,&rdquo; the authors conclude.</span></p> <p><span style="font-size: 10pt;"><br />In an accompanying editorial (Endovascular therapy for atherosclerotic intracranial arterial stenosis&mdash;Back to the drawing board), Marc I Chimowitz of the Medical University of South Carolina, Charleston, and Colin P Derdeyn of the Washington University School of Medicine, St Louis, both USA, state: &ldquo;For endovascular therapy (eg., angioplasty alone or new stents) to have any role, multicentre pilot studies will be required to establish the safety and potential efficacy of these devices in carefully defined patient populations. Given the disappointing performance of intracranial stenting in both VISSIT and SAMMPRIS, it is difficult to foresee how these necessary steps will happen anytime soon.&rdquo;</span></p></div> Troops who do not pass the smell test are likely to have traumatic brain injury 2015-03-23T11:29:00Z 2015-03-23T11:29:00Z <div id="Introduction37" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Decreased ability to identify specific odours can predict abnormal neuroimaging results in blast-injured troops, according to a new study by US federal researchers released online in the journal&nbsp;<em><a href="">Neurology</a></em>.</strong></span></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The US Department of Defense-funded study, led by Michael Xydakis, associate professor of Surgery in the F Edward Hebert School of Medicine at the Uniformed Services University of the Health Sciences (USU), and his colleagues from USU, Walter Reed National Military Medical Center, and the National Institutes of Health, found that testing the sense of smell can be used to assess memory impairment following trauma.</span><br /><br /></p> <p><span style="font-size: 10pt;">The team, which included Lisa P Mulligan, Walter Reed National Military Medical Center Department of Neurosurgery; Alice B Smith, Cara H Olsen, and Dina M Lyon, from the Uniformed Services University of the Health Sciences, and Leonardo Belluscio, National Institute of Neurological Disorders and Stroke, NIH, studied more than 231 acutely injured polytrauma inpatients at Walter Reed National Military Medical Center who had been air-evacuated from combat zones in Afghanistan or Iraq. Each soldier was evaluated for traumatic brain injury and then administered a test of their sense of smell using the University of Pennsylvania Smell Identification Test.</span><br /><br /></p> <p><span style="font-size: 10pt;">The olfactory system processes thousands of different odours, sending signals to the brain which interprets the smell by linking it to a past memory. If memory is impaired, as is the case with Alzheimer&rsquo;s disease, sleep deprivation, and acute traumatic brain injury, the task is not entirely possible. When the smell test was abnormal in a subject, those soldiers were all found to have abnormalities on their brain scans.&nbsp;</span><br /><br /><span style="font-size: 10pt;">&ldquo;Although it may seem far-fetched that the sense of smell can be used to identify a concealed brain injury, olfactory impairment was commonly used by neurosurgeons in attempts to localize certain brain tumours prior to the use of advanced neuroimaging in the 1980s,&rdquo; said Xydakis.<br /><br /></span></p> <p><span style="font-size: 10pt;">The investigators then concluded that this kind of methodology could be used in combat theatres to assist deployed physicians in determining which injured troops would require immediate neuroimaging, thus significantly enhancing frontline neurologic combat casualty care.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Getting a CT scan in a combat zone is often the equivalent distance of placing a soldier on a helicopter in Washington, DC, and sending them to Boston. It requires a significant investment in personnel and aviation resources; not to mention flying troops over hostile terrain. Using abnormalities with the sensory systems has opened up an entirely new avenue of investigation for diagnosing brain injuries,&rdquo; Xydakis said.<br /><br /></span></p> <p><span style="font-size: 10pt;">The study was funded by the Department of Defense Combat Casualty Care Medical Research and Development Program.</span></p></div> Use of anti-clotting drug more than three hours after stroke should be re-evaluated, say researchers 2015-03-20T15:33:00Z 2015-03-20T15:33:00Z <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>Advice to use the anti-clotting drug alteplase more than three hours after an acute stroke should be re-evaluated, say researchers writing in <em><a href="" target="_blank">The BMJ</a></em>&nbsp;this week.</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Alteplase is a tissue plasminogen activator (tPA) that helps to disperse blood clots in a process called thrombolysis.</span></p> <p><span style="font-size: 10pt;"><br />Most major stroke guidelines support use of alteplase up to 4.5 hours after stroke onset, but Brian Alper and colleagues believe that current guidance is based on uncertain evidence and they call for urgent reconsideration of the available data to guide policy decisions.</span></p> <p><span style="font-size: 10pt;"><br />The UK regulator, the Medicines and Healthcare Regulatory Agency (MHRA), is planning to analyse all relevant sources of evidence and reassess the balance of benefits and risks for alteplase.</span></p> <p><span style="font-size: 10pt;"><br />Alper and his team examined the most comprehensive sources of evidence and advice that working clinicians are likely to turn to for guidance on whether to use alteplase after stroke.</span></p> <p><span style="font-size: 10pt;"><br />These included American Heart Association and American Stroke Association guidelines, a 2014 Cochrane review, and a 2014 meta-analysis of individual patient trial data. Each of these sources suggests that alteplase is more beneficial than harmful when given 3&ndash;4.5 hours after the onset of ischaemic stroke.</span></p> <p><span style="font-size: 10pt;"><br />The researchers analysed the data supporting these conclusions and found inconsistent evidence on the effects of alteplase at 3&ndash;4.5 hours after stroke.</span></p> <p><span style="font-size: 10pt;"><br />For example, some data support an increase in good functional outcome at three months, and others show a worse functional outcome at six months. As such, any single estimate of effect from currently available data is therefore likely to be unreliable, they write.</span></p> <p><span style="font-size: 10pt;"><br />They say the key to resolving uncertainty about the benefits and harms of alteplase 3&ndash;4.5 hours after stroke &ldquo;lies in publishing more of the underlying data forming the basis of the 2014 meta-analysis and reanalysing them transparently.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />They acknowledge this may not &ldquo;settle&rdquo;the issue, but conclude: &ldquo;Unless and until there are data showing unequivocal benefits to outweigh known harms, we believe that there should not be any strong recommendation or encouragement for use of alteplase beyond three hours after stroke.&rdquo;</span></p></div> More neurosurgeons will be required to handle increased brain bleeds 2015-03-20T15:17:00Z 2015-03-20T15:17:00Z <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>By 2030, chronic subdural haemorrhage will be the most common adult brain condition requiring neurosurgical intervention in the USA, according to a new study conducted by researchers at&nbsp;NYU Langone Medical Center, USA, and hospitals and neurosurgeons may be under-manned to handle the projected onslaught of patients.</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The researchers are publishing their findings 20 March online in the&nbsp;<a href="" target="_blank">Journal of Neurosurgery</a><em>.</em></span></p> <p><span style="font-size: 10pt;"><br />Subdural haemorrhage is more common in the elderly because of increased brain atrophy, greater use of anti-coagulant medications and thinning of the delicate vessels stretching between the surface of the brain and its coverings. As a consequence, even minor head injuries can result in bleeding on the surface of the brain that can accumulate over time and lead to serious complications. The causative trauma can be so minor that, in fact, many people with subdural haemorrhages have no history or recollection of a head or brain trauma incident.</span></p> <p><span style="font-size: 10pt;"><br />Subdural haemorrhages are also more common in military veterans and in people with a history of alcohol abuse.</span></p> <p><span style="font-size: 10pt;">While clinicians know that certain populations have a greater likelihood of subdural haemorrhages, precise incidence rates in the United States are unknown.</span></p> <p><span style="font-size: 10pt;"><br />Research led by&nbsp;Uzma Samadani, chief of neurosurgery at New York Harbor Health Care System and assistant professor in the Departments of Neurosurgery, Psychiatry, Neuroscience and Physiology at NYU Langone, sought to quantify the future incidence rates for chronic subdural haemorrhage in US Veterans Administration (VA) and civilian populations. They looked at current data from VA hospital visits where subdural haemorrhages were diagnosed, as well as civilian incidence rates from Finland and Japan where accurate incidence records are available to create a mathematical model. This model, which accounted for age, gender and alcohol consumption, was designed to predict the incidence of subdural haemorrhage that would occur from 2012-2040 as the population ages.</span></p> <p><span style="font-size: 10pt;"><br />Records from VA hospital visits from 2000-2012 showed that 695 new subdural haemorrhages were identified, with 29% of these cases requiring a surgical drainage procedure. This translated to 79.4 subdural haemorrhages per 100,000 veterans. In addition, more than 70% of subdural haemorrhages occurred in patients 65 years of age and older. Based on this information, Samadani and her team determined that by 2030, when the US population has aged to the extent that as many as 25% of people will be older than 65, the incidence of chronic subdural haemorrhage will reach approximately 121.4 cases per 100,000 people in the VA population and 17.6 cases per 100,000 people in the general US population.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study suggests that the medical community, particularly those caring for our ageing veterans, may need to dedicate more healthcare resources for the prevention and management of subdural haemorrhage,&rdquo; says Samadani, who is also co-director of the&nbsp;Steven and Alexandra Cohen Veterans Center&nbsp;for the Study of Post-Traumatic Stress and Traumatic Brain Injury at NYU Langone. &ldquo;In 15 years, drainage for subdural haemorrhage will likely be the most common type of adult brain surgery performed, surpassing the number of operations required for brain tumours. If we can identify patients at risk and prevent brain atrophy from occurring as Americans age, we may be able to slow this trend. If not, we are going to need increased neurosurgical and rehabilitation capacity to manage these patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Subdural haemorrhage surgical patients also are more likely to have lengthy hospital stays as determined by an assessment of patients treated for subdural haemorrhages at the New York Harbor VA during 2008-2010, which showed that subdural haemorrhage patients were in the hospital significantly longer than patients being surgically treated for brain tumours. The subdural haemorrhage patients tended to require more intensive physical therapy and rehabilitation than other cranial surgery patients.</span></p> <p><span style="font-size: 10pt;"><br />Samadani adds: &ldquo;We have a very large population of elderly and the last of the 77 million baby boomers will have turned 65 by 2030. We can anticipate that 60,000 Americans per year will develop chronic subdural haemorrhages. Knowing what is ahead of us gives us time to prepare.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />In addition to Samadani, co-authors of this study include: David Balser; Sameer Farooq; Talha Mehmood; and Marleen Reyes.</span></p></div> UCSF team finds key to making neurons from stem cells 2015-03-20T11:39:00Z 2015-03-20T11:39:00Z <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>A research team at UC San Francisco has discovered an RNA molecule called Pnky that can be manipulated to increase the production of neurons from neural stem cells.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The research, led by neurosurgeon Daniel A Lim, and published on 19 March, 2015 in <em>Cell Stem Cell</em>, has possible applications in regenerative medicine, including treatments of such disorders as Alzheimer&rsquo;s disease, Parkinson&rsquo;s disease and traumatic brain injury, and in cancer treatment.</span></p> <p><span style="font-size: 10pt;"><br />Pnky is one of a number of newly discovered long noncoding RNAs (lncRNAs), which are stretches of 200 or more nucleotides in the human genome that do not code for proteins, yet seem to have a biological function.</span></p> <p><span style="font-size: 10pt;"><br />The name, pronounced &ldquo;Pinky,&rdquo; was inspired by the popular American cartoon series Pinky and the Brain. &ldquo;Pnky is encoded near a gene called &lsquo;Brain,&rsquo; so it sort of suggested itself to the students in my laboratory,&rdquo; says Lim. Pnky also appears only to be found in the brain, he noted.</span></p> <p><span style="font-size: 10pt;"><br />Co-first authors Alex Ramos, and Rebecca Andersen, who are students in Lim&rsquo;s laboratory, first studied Pnky in neural stem cells found in mouse brains, and also identified the molecule in neural stem cells of the developing human brain. They found that when Pnky was removed from stem cells in a process called knockdown, neuron production increased three to four times.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It is remarkable that when you take Pnky away, the stem cells produce many more neurons,&rdquo; says Lim, an assistant professor of neurological surgery and director of restorative surgery at UCSF. &ldquo;These findings suggest that Pnky, and perhaps lncRNAs in general, could eventually have important applications in regenerative medicine and cancer treatment.&rdquo;</span></p> <p><span style="font-size: 10pt;">Lim observed that Pnky has an intriguing possible connection with brain tumours.</span></p> <p><span style="font-size: 10pt;"><br />Using an analytical technique called mass spectrometry, Ramos found that Pnky binds the protein PTBP1, which is also found in brain tumours and is known to be a driver of brain tumour growth. In neural stem cells, Pnky and PTBP1 appear to function together to suppress the production of neurons. &ldquo;Take away one or the other and the stem cells differentiate, making more neurons,&rdquo; says Lim. &ldquo;It is also possible that Pnky can regulate brain tumour growth, which means we may have identified a target for the treatment of brain tumours.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Lim said that the larger significance of the research is that it adds to a growing store of knowledge about lncRNAs, previously unknown sections of the genome that some biologists have referred to as the &ldquo;dark matter&rdquo; of the human genome.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Recently, over fifty thousand human lncRNAs have been discovered. Thus, there may be more human lncRNAs than there are genes that code for proteins,&rdquo; says Lim. &ldquo;It is possible that not all lncRNAs have important biological functions, but we are making a start toward learning which ones do, and if so, how they function. It is a new world of experimental biology, and the students in my lab are right there on the frontier.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Lim had particular praise for Ramos, an MD-PhD student in the UCSF Medical Scientist Training Program, and Andersen, who has a fellowship from the prestigious National Science Foundation (NSF) Graduate Research Fellowship Program. &ldquo;They have been a great collaborative team and an inspiration to others in my lab,&rdquo; says Lim. &ldquo;I think they represent the pioneering, investigative spirit of the UCSF student body.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Co-authors of the study are Siyuan John Liu, Tomasz Jan Nowakowski, Sung Jun Hong, Caitlin Gertz, Ryan D Salinas, Hosniya Zarabi and Arnold Kriegstein, all of UCSF.</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by funds from the National Institutes of Health, US Department of Veterans Affairs, NSF, UCSF, San Francisco State University and the Howard Hughes Medical Institute.</span></p></div> John Theurer Cancer Center joins study exploring novel delivery of cancer-selective gene therapy to treat brain cancer 2015-03-19T15:39:00Z 2015-03-19T15:39:00Z <div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Physicians at the John Theurer Cancer Center (JTCC) at Hackensack University Medical Center have announced their involvement in a promising multicentre phase 1 study assessing the safety and tolerability of Toca 511 in patients with glioblastoma, the most common and lethal form of brain cancer. Toca 511 is a retroviral replicating vector that has been engineered to deliver a therapeutic gene selectively to brain tumour cells while sparing healthy brain tissue.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this study, sponsored by Tocagen Inc, Toca 511 is injected directly into the brain tumour through a stereotactic biopsy needle. Once injected, Toca 511 infects tumour cells, sparing healthy functioning brain cells. During the following weeks, patients are then given cycles of an oral medication, 5-flucytosine (5-FC), an antifungal drug that readily enters the brain. The infected tumour cells now carry genetic instructions for an enzyme that converts 5-FC into 5-fluorouracil (5-FU), a highly-potent chemotherapy that destroys cancer cells, which may lead to activation of the immune system against the tumour.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Over the past 40 years, we have seen new developments for glioblastoma, but none that have successfully improved the long-term outlook for our patients. One of the main challenges to finding a breakthrough is the difficulty of delivering chemotherapy across the blood-brain barrier,&rdquo; says Samuel A Goldlust, medical director, Brain and Spine Institute at JTCC. &ldquo;The infective power of viruses has evolved over millions of years. By using that power to infect and destroy brain cancer, we hope to make a significant impact upon survival.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />JTCC is one of only 10 institutions across the USA involved in this study, and the only site in the northeast. &ldquo;The clinical trial allows us to offer patients a less invasive procedure compared to traditional surgery, and most patients are able to return home the next day,&rdquo; says George J Kaptain, surgical director, Brain and Spine Institute at JTCC.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Currently ongoing, the study will enrol up to 50 patients with glioblastoma and other aggressive high-grade gliomas (Grade 3 or 4) who have already undergone surgery, radiation therapy and chemotherapy. Among the estimated 13,000 new cases of high-grade glioma each year in the United States, glioblastoma is the most common and aggressive, with only five percent of patients surviving to five years after diagnosis.</span></p></div> Is it dementia, or just normal aging? New tool may help triage 2015-03-19T15:23:00Z 2015-03-19T15:23:00Z <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>Researchers at Mayo Clinic developed a new scoring system to help determine which elderly people may be at a higher risk of developing the memory and thinking problems that can lead to dementia. The study is published in the 18 March, 2015, online issue of&nbsp;<em>Neurology</em>, the medical journal of the American Academy of Neurology.</strong></span></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Our goal is to identify people who are at the highest risk for dementia as early as possible,&rdquo; says study author Ronald Petersen, Chester and Debbie Cadieux director of the Mayo Clinic Alzheimer&rsquo;s Disease Research Center, Cora Kanow professor of Alzheimer&rsquo;s Disease Research and a member of the American Academy of Neurology. &ldquo;Early detection of individuals at high risk of developing memory and thinking problems that we call mild cognitive impairment (MCI) is crucial because people with MCI are at a greater risk of developing dementia. This allows for a wider window of opportunity to initiate preventative measures.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The study involved 1,449 randomly selected people from Olmsted County, Minnesota, USA between the ages of 70 and 89 who did not have memory and thinking problems. At the start of the study and at visits every 15 months for an average of 4.8 years, participants were given memory and thinking tests. During the study, 401 people&mdash;nearly a third&mdash;developed MCI.</span></p> <p><span style="font-size: 10pt;"><br />The scoring system took into account factors that could be easily obtained from medical records, such as years of education, number of medications, history of stroke or diabetes, and smoking. Researchers also factored in information obtained at the clinic visit, such as a test of thinking abilities, symptoms of depression and anxiety, and slow gate. Factors were assigned a score based on how much they contributed to the risk of developing thinking problems. For example, being diagnosed with diabetes before age 75 increased the risk score by 14 points, while having 12 or fewer years of education increased the risk by two points.</span></p> <p><span style="font-size: 10pt;"><br />Many predictive factors were different for men and women. While the risk of MCI increases with age overall, younger men were at a higher risk of developing MCI than younger women. Conversely, older women have a somewhat higher risk than older men.</span></p> <p><span style="font-size: 10pt;"><br />Variables such as age, diabetes, heart health risk factors, slow gate, depression and anxiety disorders, stand out as contributing most to the risk score. The APOE gene, which has been linked to a higher risk of dementia, was determined in the study to be only a moderate risk factor.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This risk scale provides an inexpensive and easy way for doctors to identify people who should be referred to more advanced testing for memory issues or may be better candidates for clinical trials,&rdquo; says Petersen.</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by the National Institutes of Health, the Robert Wood Johnson Foundation, the Robert H and Clarice Smith and Abigail van Buren Alzheimer&rsquo;s Disease Research Program and the Rochester Epidemiology Project.</span></p></div> Feinstein Institute researcher to receive Potamkin Prize for Alzheimer’s research 2015-03-18T17:27:00Z 2015-03-18T17:27:00Z <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><span style="font-size: 11pt;"><strong>The American Academy of Neurology (AAN) and the American Brain Foundation will present the 2015 Potamkin Prize for Research in Pick&rsquo;s, Alzheimer&rsquo;s and Related Diseases to&nbsp;Peter Davies, investigator at&nbsp;The Feinstein Institute for Medical Research. He will receive the prize in Washington, DC, at the American Academy of Neurology (AAN)&rsquo;s 67th&nbsp;Annual Meeting (18&ndash;25 April).</strong></span></p> </div><div id="Text143" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Potamkin Prize honours researchers for their work in helping to advance the understanding of Pick&rsquo;s disease, Alzheimer&rsquo;s disease and related disorders. The AAN and the American Brain Foundation are awarding the 2015 Potamkin Prize to Davies and Reisa A Sperling, of the Brigham and Women&rsquo;s Hospital in Boston, USA. The US$100,000 prize&mdash;Davies and Reisa will each receive US$50,000&mdash;is an internationally recognised tribute for advancing dementia research. Davies&rsquo; research examines the process of Alzheimer&rsquo;s disease.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;The problems with memory and other intellectual function that occur in Alzheimer&rsquo;s disease are accompanied by the development of two abnormal structures in the brain called plaques and tangles,&rdquo; said Davies. &ldquo;In contrast to other work in the field, my guiding hypothesis has been that both these abnormalities derive from a disease process in the nerve cells and are consequences of disease, not the cause. Therefore, my research has largely focused on the disease process, and attempting to define points at which intervention is possible. A more detailed understanding of the process is essential to the development of drugs to slow, stop, or even prevent it.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">Davies is the director of the Litwin-Zucker Research Center for the Study of Alzheimer&rsquo;s Disease at the&nbsp;Feinstein Institute&nbsp;and professor of pathology and neuroscience at the&nbsp;Hofstra North Shore-LIJ School of Medicine. Davies has published more than 250 research papers and has been particularly interested in the development of new treatments and diagnostic tests for Alzheimer&rsquo;s disease.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;I am very grateful to the Potamkin family for the encouragement this award offers,&rdquo; said Davies. &ldquo;Funding for research in Alzheimer&rsquo;s disease and related disorders is vitally important. The Potamkin family has continued to support this work in hopes of helping the millions affected by these diseases.&rdquo;</span></p></div> Cover device proves more effective than guide catheter in stroke model 2015-03-18T12:06:00Z 2015-03-18T12:06:00Z <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>In an <em>in vitro</em> stroke model comparison, the use of the Cover accessory device (Lazarus Effect) in conjunction with a stent retriever resulted in higher successful recanalisation rates, no embolic events and proved to be more effective than the use of a conventional guide catheter or a balloon guide catheter.</strong></span></p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The recently CE mark approved Cover device is a nitinol braided mesh that surrounds the stent retrieval device and its captured thrombus during retrieval to help prevent clot fragmentation and embolisation.</span></p> <p><span style="font-size: 10pt;"><br />In their investigation, published in the <em>Journal of NeuroInterventional Surgery</em>, Maxim Mokin and colleagues used a previously developed cerebrovascular model with intracranial circulation based on patient derived anatomy, into which they introduced fresh clot into the middle cerebral artery, to compare rates of target vessel recanalisation and embolisation in new (non-affected and distal) territories (areas in which clot had not been introduced) achieved with a stent retriever (Solitaire flow restoration device, Medtronic) in conjunction with the use of a conventional guide catheter (control group), a balloon guide catheter (BGC group), and the Cover device (Cover group).</span></p> <p><span style="font-size: 10pt;"><br />According to the investigators, the Cover device is employed as follows: &ldquo;First, the stent retrieval device is delivered and unsheathed to capture the thrombus. Next, the stent retriever delivery microcatheter is removed. The Cover device is loaded and delivered over the 0.014-inch stent retriever. An intermediate catheter can be used to facilitate the delivery process in cases with tortuous anatomy of the intracranial vasculature. Withdrawal of the stent retriever causes the mesh of the Cover device to invert, wrapping around the stent retriever and protecting the clot from fragmentation.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />In the study, the control group consisted of thrombectomy experiments performed using a conventional guide catheter (6F Cook shuttle, Cook Medical), which was placed into the segment corresponding to the cervical internal carotid artery. In the BGC group, thrombectomy was performed with an 8F balloon guide catheter (Merci, Concentric Medical/Stryker Neurovascular, or Cello, Covidien/Medtronic). The balloon was inflated prior to withdrawal of the stent retriever, and manual aspiration was applied using a 20mL syringe. Finally, in the Cover device group, an intermediate catheter was utilised (0.057 inch distal access catheter, Concentric Medical/Stryker Neurovascular) to facilitate delivery of the Cover device. The investigators write that no aspiration was applied through the intermediate catheter of the guide catheter while thrombectomy was attempted.</span></p> <p><span style="font-size: 10pt;"><br />Primary outcomes included the degree of recanalisation and the occurrence of emboli in a new, previously unaffected territory in which clot was not introduced.</span></p> <p><span style="font-size: 10pt;"><br />The authors report on a total of 51 thrombectomy experiments (20 in the control group, 20 in the BGC group and 11 in the Cover device group). &ldquo;Successful delivery and inversion of the Cover device around the stent retriever was achieved in all cases. Successful recanalisation (TICI 2b-3) on first pass was achieved in 50% of control cases, 45% of BGC cases and 91% of Cover device cases.&rdquo; This is quite impressive, the authors say, given the fact that most previous stent retrieval trials required multiple passes for final results.</span></p> <p><span style="font-size: 10pt;"><br />They further state that the rate of successful recanalisation was similar between the control group and the BGC group, occurring in 10 of 20 versus nine of 20 experiments, respectively (p=0.020). In comparison, successful recanalisation was achieved more frequently in the Cover device group, occurring in 10 of 11 experiments.&nbsp;<br /><br /></span></p> <p><span style="font-size: 10pt;">No embolisation of new territories was seen with the use of the Cover device. On the other hand, the authors report that embolisation occurred in five (25%) experiments from the control group and in three (15%) experiments from the BGC group.</span></p></div><div id="Text244" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Mokin <em>et al</em> state, &ldquo;Our <em>in vitro</em> results demonstrate that the use of the Cover device was more effective than the use of the BCG with respect to reducing the number of embolic events, thus leading to higher recanalisation rates. Moreover, adjunctive use of the Cover device does not prolong the duration of the interventional procedure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Study author Adnan Siddiqui (University at Buffalo, State University of New York, Buffalo, USA) spoke to <em>NeuroNews</em> about the way forward.</span></p> <p><br /><span style="font-size: 10pt;"><strong>What is the next step in your research?</strong></span></p> <p><br /><span style="font-size: 10pt;">The recent trials have demonstrated that stent retrieval has clearly passed superiority to intravenous thrombolytics or best medical therapy. However, when we look at good outcomes they achieve only 35% in unselected cohorts such as MR CLEAN and the best we can do with careful selection based on perfusion is 60% -70% as shown in SWIFT PRIME, ESCAPE and EXTEND-IA. This means that despite careful selection of patients most likely to benefit we are failing in up to 40%. We believe that multiple passes, clot fragmentation with emboli in non-affected and distal territories play a major role in these poor outcomes. We plan to study different strategies for rapid and complete revascularisation using this model, which duplicates not only proximal arch, cervical and intracranial tortuosity but also collaterals which naturally exist in the form of ACom and Pcom arteries.</span></p> <p><br /><span style="font-size: 10pt;"><strong>Do you think that the Cover device, or similar devices, will be used in conjunction with stent retrievers in all thrombectomy procedures in the future?</strong></span></p> <p><br /><span style="font-size: 10pt;">We believe that stent retrievers are the next iterative step in the evolution of the optimal stroke revascularisation strategy. We suspect that we would need a tool kit for fastest and most complete revascularisation. Clearly, addition of the Cover device almost doubles the effectiveness of the first pass and significantly enhances embolic protection during use of current stent retrievers in our <em>in vitro</em> stroke model. We believe given the high degree of corroboration between device effectiveness in patients and its replication in our model that we would expect similar results in patients. We look forward to results from clinical usage of the Cover device.</span></p></div> New technique could lead to long-lasting localised stimulation of brain tissue without external connections 2015-03-16T15:31:00Z 2015-03-16T15:31:00Z <div id="Introduction45" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at MIT have developed a method to stimulate brain tissue using external magnetic fields and injected magnetic nanoparticles&mdash;a technique allowing direct stimulation of neurons, which could be an effective treatment for a variety of neurological diseases, without the need for implants or external connections.</strong></span></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The research, conducted by Polina Anikeeva, an assistant professor of materials science and engineering, graduate student Ritchie Chen, and three others, has been published in the journal&nbsp;<em>Science</em>.</span></p> <p><span style="font-size: 10pt;"><br />Previous efforts to stimulate the brain using pulses of electricity have proven effective in reducing or eliminating tremors associated with Parkinson&rsquo;s disease, but the treatment has remained a last resort because it requires highly invasive implanted wires that connect to a power source outside the brain.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In the future, our technique may provide an implant-free means to provide brain stimulation and mapping,&rdquo; Anikeeva says.</span></p> <p><span style="font-size: 10pt;">In their study, the team injected magnetic iron oxide particles just 22 nanometres in diameter into the brain. When exposed to an external alternating magnetic field&mdash;which can penetrate deep inside biological tissues&mdash;these particles rapidly heat up.</span></p> <p><span style="font-size: 10pt;"><br />The resulting local temperature increase can then lead to neural activation by triggering heat-sensitive capsaicin receptors&mdash;the same proteins that the body uses to detect both actual heat and the &ldquo;heat&rdquo; of spicy foods. (Capsaicin is the chemical that gives hot peppers their searing taste.) Anikeeva&rsquo;s team used viral gene delivery to induce the sensitivity to heat in selected neurons in the brain.</span></p> <p><span style="font-size: 10pt;"><br />The particles, which have virtually no interaction with biological tissues except when heated, tend to remain where they are placed, allowing for long-term treatment without the need for further invasive procedures.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The nanoparticles integrate into the tissue and remain largely intact,&rdquo; Anikeeva says. &ldquo;Then, that region can be stimulated at will by externally applying an alternating magnetic field. The goal for us was to figure out whether we could deliver stimuli to the nervous system in a wireless and noninvasive way.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The new work has proven that the approach is feasible, but much work remains to turn this proof-of-concept into a practical method for brain research or clinical treatment.</span></p> <p><span style="font-size: 10pt;"><br />The use of magnetic fields and injected particles has been an active area of cancer research; the thought is that this approach could destroy cancer cells by heating them. &ldquo;The new technique is derived, in part, from that research,&rdquo; Anikeeva says. &ldquo;By calibrating the delivered thermal dosage, we can excite neurons without killing them. The magnetic nanoparticles also have been used for decades as contrast agents in MRI scans, so they are considered relatively safe in the human body.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The team developed ways to make the particles with precisely controlled sizes and shapes, in order to maximize their interaction with the applied alternating magnetic field.&nbsp;They also developed devices to deliver the applied magnetic field: Existing devices for cancer treatment&mdash;intended to produce much more intense heating&mdash;were far too big and energy-inefficient for this application.</span></p> <p><span style="font-size: 10pt;"><br />The next step toward making this a practical technology for clinical use in humans &ldquo;is to understand better how our method works through neural recordings and behavioural experiments, and assess whether there are any other side effects to tissues in the affected area,&rdquo; Anikeeva says.</span></p> <p><span style="font-size: 10pt;"><br />This is &ldquo;a completely novel approach for deep brain stimulation,&rdquo; says Bianxiao Cui, an assistant professor of chemistry at Stanford University who was not involved in this research. &ldquo;The new method is significant in that it is relatively more easily administered and induces less brain-tissue responses as compared with electrode implantation. More importantly, the stimulation could be remotely controlled, a highly appealing feature for deep brain stimulation.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />In addition to Anikeeva and Chen, the research team also included postdoc Gabriela Romero, graduate student Michael Christiansen, and undergraduate Alan Mohr. The work was funded by the Defense Advanced Research Projects Agency, MIT&rsquo;s McGovern Institute for Brain Research, and the National Science Foundation.</span></p></div> Neuralstem announces topline results of phase II ALS trial 2015-03-13T10:38:00Z 2015-03-13T10:38:00Z <div id="ImageMain46" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction46" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuralstem has announced top line data from the phase II trial of NSI-566 spinal cord-derived neural stem cells under development for the treatment of amyotrophic lateral sclerosis (ALS). The study met primary safety endpoints&ndash;the maximum tolerated dose of 16 million transplanted cells and the surgery was well tolerated.</strong></span></p> </div><div id="Text146" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Secondary efficacy endpoints at nine months post-surgery indicate a 47% response rate to the stem cell treatment, as measured by either near-zero slope of decline or positive slope of ALSFRS score in seven out of 15 patients and by either a near-zero decline, or positive strengthening, of grip strength in seven out of 15 patients. Grip strength is an indicator of direct muscle strength of the lower arm. ALSFRS is a standard clinical test used to evaluate the functional status of ALS patients. The average ALSFRS score for responders at nine months after treatment was 37. Non-responders scored an average of 14. These scores represent 93%, versus 35%, of the baseline score retained, respectively, by the responders versus non-responders at nine months, which is a statistically significant difference. As measured by an average slope of decline of ALSFRS, responders&rsquo; disease progression was -0.007 point per day, while non-responders&rsquo; disease progression was -0.1 per day, which was again statistically significant. Lung function as measured by Seated Vital Capacity shows that responder patients remained within 94% of their starting scores, versus 71% for non-responder patients. The trial met its primary safety endpoints. Both the surgery and cells were well-tolerated, with one patient experiencing a surgical serious adverse event.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In this study, cervical intervention was both safe and well-tolerated with up to eight million cells in 20 bilateral injections,&rdquo; says Karl Johe, Neuralstem chief scientific officer. &ldquo;The study also demonstrated biological activity of the cells and stabilisation of disease progression in a subset of patients. As in the first trial, there were both responders and non-responders within the same cohort, from patients whose general pre-surgical presentation is fairly similar. However, we believe that through the individual muscle group measurements, we may now be able to differentiate the responders from the non-responders.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Our therapy involves transplanting NSI-566 cells directly into specific segments of the cord where the cells integrate into the host motor neurons. The cells surround, protect and nurture the patient&rsquo;s remaining motor neurons in those various cord segments. The approximate strength of those remaining motor neuron pools can be measured indirectly through muscle testing of the appropriate areas, such as in the grip strength tests. We believe these types of endpoints, measuring muscle strength, will allow us to effectively predict patients that will respond to treatment, adding a sensitive measure of the therapeutic effects after treatment. Testing this hypothesis will be one of the primary goals of our next trial.&rdquo; The full data is being compiled into a manuscript for publication.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We believe the top-line data are encouraging,&rdquo; says Eva Feldman director of the A Alfred Taubman Medical Research Institute and director of Research of the ALS Clinic at the University of Michigan Health System, and an unpaid consultant to Neuralstem. &ldquo;We were able to dose up to 16 million cells in 40 injections, which we believe to be the maximum tolerated dose. As in the first trial, the top-line data show disease stabilisation in a subgroup of patients. Perhaps equally as important, we believe the top-line data may support a method of differentiating responders from non-responders, which we believe will support our efforts as we move into the next, larger controlled trial expected to begin this summer.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The top-line data look very positive and encouraging. If this proportion of patients doing well after treatment can be corroborated in future therapeutic trials, it will be better than any response seen in any previous ALS trials,&rdquo; says site principal investigator, Jonathan D Glass, director of the Emory ALS Center. &ldquo;Elucidating which factors define a patient who may have a therapeutic response to the stem cell treatment will be the next key challenge. We are hopeful that a set of predictive algorithms can be established to help pre-select the responders in our future trials.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The open-label, dose-escalating trial treated 15 ambulatory patients, divided into five dosing cohorts, at three centres, Emory University Hospital in Atlanta, Georgia, the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston, Massachusetts, all USA, and under the direction of principal investigator (PI), Eva Feldman. Dosing increased from one million to eight million cells in the cervical region of the spinal cord. The final trial cohort also received an additional eight million cells in the lumbar region of the spinal cord.</span></p> <p><span style="font-size: 10pt;"><br />The company anticipates commencing a later-stage, multicentre trial of NSI-566 for treatment of ALS in 2015. Neuralstem has received orphan designation by the FDA for NSI-566 in ALS.</span></p></div> Stimwave announces first full body 3-Tesla MRI conditional neuromodulation medical implantable device 2015-03-11T09:04:00Z 2015-03-11T09:04:00Z <div id="ImageMain47" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction47" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The first US patients have been successfully implanted with Stimwave&rsquo;s Wireless Pain Relief technology, the Freedom stimulator, for long-term treatment of chronic back and leg pain. The technology means that chronic pain patients are able to have 3-Tesla full body magnetic resonance imaging (MRI) examinations with the device.</strong></span></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The ability to have a full body, 3-Tesla MRI examination with this implant represents a significant advancement in the fields of diagnostic imaging and pain management, allowing for scans of the spine as well as functional MRI examinations. Other neuromodulation systems with MR-conditional labelling typically limit exams to just the head or limbs, or to older 1.5-Tesla MRIs. However, the majority of patients will be in need of an MRI procedure of the torso or spine regions during their lifetimes. The Stimwave MR labelling now allows patients with pain derived from cancer or cancer treatment, or severe spinal structural compromise, to benefit from neuromodulation without decreasing the long-term ability to diagnose and treat anatomical and structural issues.</span></p> <p><span style="font-size: 10pt;">The MRI evaluation was conducted by Frank G Shellock, a physiologist with over 30 years&rsquo; experience in the field. In a peer-reviewed paper published in <em><a href="">Neuromodulation: Technology at the Neural Interface</a></em>, Shellock concluded that, &ldquo;in comparison with the current FDA approved MRI labelling for other neurostimulation systems used for spinal cord stimulation that may have extensive restrictions, the MR conditions allowing patients to undergo MRI are substantially less limited [for the Stimwave device] and essentially allow MRI examinations to be performed on all body parts of the patient.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The full-body 3-Tesla MR conditional rating for Stimwave&rsquo;s Freedom stimulator was instrumental for the first US patients implanted under the care of Sunil Panchal in January 2015 at the National Institute of Pain in Tampa, Florida.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;Having a fully MRI compatible system opens up neuromodulation as a therapy for patients that were not previously able to take advantage of such treatment because they need ongoing scans,&rdquo; said Panchal. &ldquo;Even if patients with chronic pain do not require ongoing MRI scans now, choosing Stimwave&rsquo;s Wireless Pain Relief technology keeps the door open for any MRI testing that patients may need in the future. Further, the option to consider neuromodulation systems rather than opioids to manage chronic pain is particularly important for human health as we learn more about the negative impact of continued drug use, which has been proven to increase and accelerate osteoporosis, elevate the risk of bone fractures, and contribute to cancer spreading faster.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;As the population ages, serial sophisticated diagnostic imaging, such as 1.5 and 3-Tesla imaging, becomes a necessary diagnostic tool to follow the evolution of our interventional therapies to determine treatment efficacy,&rdquo; said Ralph Rashbaum, an orthopaedic surgeon at Texas Back Institute. &ldquo;Such is the case in patients being treated for severe intractable pain who have been responsive to spinal cord stimulators only to be later diagnosed with cancer. With the availability of Stimwave&rsquo;s MR-conditional neuromodulation devices, such disorders as chronic pain in this patient population can treat their cancer while monitored by MRI.&rdquo;</span></p></div> Using robots for stroke rehabilitation 2015-03-10T15:24:00Z 2015-03-10T15:24:00Z <div id="ImageMain48" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction48" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the UK&rsquo;s University of Hertfordshire and a team of European partners have developed a prototype of a robotic glove which stroke sufferers can use in their own home to support rehabilitation and personal independence in receiving therapies.</strong></span></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">At the chronic stages of stroke, patients are not likely to be receiving treatment, though they continue to live with some impairment. The purpose of the glove is to provide therapies to target these impairments.</span><br /><br /></p> <p><span style="font-size: 10pt;">Over the past three years the team developed two prototype robotic gloves, which facilitate repetitive movement and exercise of the hand and wrist. The device also records the patient&rsquo;s performance and sends the data to a therapist for tailoring treatment remotely and arranging follow-up.</span><br /><br /></p> <p><span style="font-size: 10pt;">Farshid Amirabdollahian, an expert in rehabilitation robotics and assistive technologies and a senior lecturer in adaptive systems at the University&rsquo;s School of Computer Science, coordinated the &euro;4,643,983 SCRIPT (Supervised care and rehabilitation involving personal tele-robotics) project.</span><br /><br /></p> <p><span style="font-size: 10pt;">Amirabdollahian said: &ldquo;This project focused on therapies for stroke patients at home. Our goal was to make motivating therapies available to people to practise at home using this system, hoping that they have a vested interest to practise and will do so. We tried this system with 30 patients and found that patients indeed practised at home, on average around 100 minutes each week, and some showed clinical improvements in their hand and arm function.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The overall aim of the project was to provide an educational, motivational and engaging interaction, making a more positive therapy session for the patient, while providing feedback to them and their health care professionals. Given the results achieved, the team is now considering a follow-up project to improve recovery outcomes, while also searching for funding to turn this prototype into a product for home rehabilitation.<br /><br /></span></p> <p><span style="font-size: 10pt;">The team have passed the proof-of-concept stage and are now looking at getting the glove into production.</span></p></div> World-renowned doctor heads neurosurgery clinic at European Medical Center 2015-03-05T17:02:00Z 2015-03-05T17:02:00Z <div id="ImageMain49" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction49" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>European Medical Center (GEMC) is the first institution among private clinical groups to open the clinic of neurology and neurosurgery as part of its multifunctional hospital in Moscow.</strong></span></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Under the supervision of neurosurgeon and member of Russian Academy of Sciences, Alexey Krivoshapkin, the hospital carries out complex neurosurgical interventions. Its international team of surgeons includes Jean-Michel Derlon (GEMC, France), Vladimir Shabalov (GEMC, Russia), Dmitry Dzukaev (GEMC, Russia) and Evaldas Česnulis (Hirslanden, Switzerland).</span><br /><br /></p> <p><span style="font-size: 10pt;">The grant-supported project &ldquo;Hardware system to determine the completeness of tumour resection in neurosurgery&rdquo; helps to improve the results of surgical treatment of malignant brain tumours. Krivoshapkin&rsquo;s research projects and inventions, which help to perform highly technological operations on the structures of the brain and its vessels, are currently supported by the Skolkovo Innovation Centre, GEMC and a number of other major research institutions.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;We are creating automated technologies to simplify the course of neurosurgeries and make the most accurate evaluation of the intervention results. The prospects of a specific patient depend on the correctness of the assessment. This is the direct way we can increase the percentage of long-survivors who live more than five years after having the neuro-oncological surgeries with malignant brain gliomas,&rdquo; said Krivoshapkin. Preclinical trials have demonstrated safety and efficacy, and further clinical studies will now be carried out at GEMC. A PET-CT diagnostics centre will start operating in the coming months, which will diagnose cancer at the earliest stages.&nbsp;</span></p></div> One-third of Americans do not have access to stroke centre within one hour 2015-03-05T16:56:00Z 2015-03-05T16:56:00Z <div id="Introduction50" style="clear:both;"> <p><strong><span style="font-size: 11pt;">One-third of the US population does not have access to a primary stroke centre within one hour by ambulance, and even under optimal conditions, a large proportion of the population would be unable to access a stroke centre within this window, according to a new study published in <em>Neurology</em>.</span></strong></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Research has shown that specialised stroke care has the potential to reduce death and disability,&rdquo; said study author Michael T Mullen, with the Perelman School of Medicine at the University of Pennsylvania, USA and a member of the American Academy of Neurology. &ldquo;Stroke is a time-critical disease. Each second after a stroke begins, brain cells die, so it is critically important that specialised stroke care be rapidly accessible to the population.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study examined data from 2010, when there were 811 primary stroke centres and no comprehensive stroke centres in the USA. Mullen and his colleagues created models to estimate what proportion of the population would have access to a comprehensive stroke centre within an hour under optimal circumstances.</span></p> <p><br /><span style="font-size: 10pt;">The study found that converting up to 20 optimally located primary stroke centres per state into comprehensive stroke centres would result in 63% of the population living within a one-hour drive and an additional 23% within a one-hour flight of a centre. There was however substantial variability in access, with some states lagging behind the national average.</span></p> <p><span style="font-size: 10pt;">&ldquo;Even under optimal conditions, many people may not have rapid access to comprehensive stroke centres, and without oversight and population level planning, actual systems of care are likely to be substantially worse than these optimised models,&rdquo; said Mullen. He also noted that access to care in the models was lowest in the south eastern USA, an area often referred to as the &ldquo;Stroke Belt.&rdquo;</span></p> <p><span style="font-size: 10pt;">&ldquo;There are geographic differences in stroke incidence, especially in rural areas and in the Stroke Belt,&rdquo; Mullen said. &ldquo;Reduced access to specialised stroke care in these areas has the potential to worsen these disparities. This emphasises the need for oversight of developing systems of care.&rdquo;</span></p> <p><span style="font-size: 10pt;">Mullen said he is hopeful that optimisation modelling studies, such as this one, could help policy makers and health planners identify areas of need, with the ultimate goal of ensuring that specialised stroke care is accessible throughout the USA.</span></p> <p><br /><span style="font-size: 10pt;">The study was supported by the Agency for Healthcare Research &amp; Quality.</span></p></div> electroCore non-invasive vagus nerve stimulation is effective in treating cluster headaches 2015-03-05T12:28:00Z 2015-03-05T12:28:00Z <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>A twelve-month open-label study in the journal&nbsp;<em><a href=";;esheet=51051225&amp;newsitemid=20150303005778&amp;lan=en-US&amp;anchor=Neurology&amp;index=1&amp;md5=382b32b751528cf33b44cd1b8351fd2b">Neurology</a></em> reports that&nbsp;electroCore&rsquo;s non-invasive vagus nerve stimulation device,&nbsp;gammaCore, is practical and effective as an acute and preventative treatment in cluster headache. Seventy-nine per cent of patients who completed the trial (15 out of 19) reported an overall improvement in their condition.</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study into cluster headache, which is considered to be one of the most painful conditions known to medical science, was led by&nbsp;Peter Goadsby&nbsp;and was conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin, Ireland.</span><br /><br /></p> <p><span style="font-size: 10pt;">Of the 25 patients enrolled 19 patients completed the study, 11 of whom had chronic cluster headache, and eight were classified as episodic. Seven of the chronic cluster patients were drug refractory having previously failed to respond to at least five different preventative agents. Of all acute attacks treated, 47% were aborted within an average of 11 minutes. Ten patients reduced their acute use of high flow oxygen by 55% with nine reducing triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in estimated mean attack frequency from 4.5 attacks every 24 hours to 2.6 after treatment.</span><br /><br /></p> <p><span style="font-size: 10pt;">Goadsby who is lead author of the paper commented: &ldquo;Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">The treatment, which is self-administered by the patient for&nbsp;120 seconds at home, involves placing the small, hand-held gammaCore device on the skin of the neck over the vagus nerve. In this study, patients carried out either two or three 120-second doses of stimulation twice per day&mdash;morning and evening&mdash;while acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious adverse events.</span><br /><br /></p> <p><span style="font-size: 10pt;">JP Errico, founder and chief executive officer of electroCore, commented: &ldquo;The success of this pioneering study led to our large-scale randomised&nbsp;<a href=";;esheet=51051225&amp;newsitemid=20150303005778&amp;lan=en-US&amp;anchor=PREVA&amp;index=6&amp;md5=169d3180320845f1b2afdea05b1c4655">PREVA</a>&nbsp;trial, which was presented at the International Headache meeting in September 2014. The results of that study demonstrated nearly the same efficacy in treating and preventing cluster headaches. The full results of the PREVA trial will shortly be published.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">gammaCore, which is presently seeking Food and Drug Administration approval for the treatment and prevention of cluster headache, currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the EU, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada.</span></p></div> Direct brain neurostimulation for partial onset seizures provides long-term benefit 2015-02-27T11:41:00Z 2015-02-27T11:41:00Z <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>A study of the long-term effectiveness of the first direct brain responsive neurostimulator for partial onset, or focal, seizures that cannot be controlled with medication has found that responsive direct cortical stimulation reduces seizures and improves quality of life over an average of 5.4 years. The study is published in&nbsp;<em><a href="">Neurology</a></em>.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The results are part of the Long-Term Treatment (LTT) study, an ongoing seven-year multicentre prospective open-label study to evaluate the long-term efficacy and safety of the RNS system (NeuroPace). The technology, FDA-approved for adults with focal seizures, continuously monitors electrical activity in the brain, detects patterns programmed by the physician and delivers brief pulses of stimulation to help prevent seizures from starting. Only after a comprehensive assessment of a patient&rsquo;s epilepsy&nbsp;and medical history, neurosurgeons implant the programmable neurostimulator under the scalp and place the lead or wires in the area of the brain where seizures begin.</span><br /><br /></p> <p><span style="font-size: 10pt;">A total of 256 participants were implanted with the&nbsp;neurostimulator&nbsp;and leads, and 230 of these participants enrolled in the LTT study. A total of 191 participants continued to participate as of this data cut-off date, resulting in an accumulated experience of 1,389 patient implant years and 1,293 patient stimulation years. The median per cent reduction in seizures was 44% at one year and 53% at two years post-implant, a significant improvement over time. The median per cent reduction in seizures was 60% at the beginning of year three and 66% at the beginning of year six. The responder rates at the same time points were 58% and 59%, respectively.</span><br /><br /></p> <p><span style="font-size: 10pt;">Seizure frequency decreased in the majority of participants treated with responsive stimulation. Based on the most recent three months of available data for each participant (a last observation carried forward analysis for those with three complete months of data), 84% of participants (207/247) had some improvement, 60% (146/247) had a 50% or greater reduction (compared to 8% [19/247] with a 50% or greater increase), and 16% of participants (40/247) were seizure-free. Some participants had extended periods of seizure freedom. Over one-third (36.7%) of the 256 implanted participants had at least one seizure-free period of three months or longer, 23% had at least one seizure-free period of six months or longer, and 12.9% had at least one seizure-free period of one year or longer. No participants were seizure-free over the entire follow-up.</span><br /><br /></p> <p><span style="font-size: 10pt;">According to the Centers for Disease Control and Prevention, about 2.3 million people in the USA have epilepsy. About 1 in 26 people will be diagnosed with epilepsy at some point in their lives. About 150,000 new cases of epilepsy will be diagnosed in the United States each year. While most people with epilepsy live a full life, the risk of early death is higher for some. Falls or other injuries resulting from seizures can be life-threatening. Uncontrolled&nbsp;focal epilepsy&nbsp;causes physical, psychological, social challenges as well.</span><br /><br /></p> <p><span style="font-size: 10pt;">The Institute of Medicine concluded that at least 30% of adults with partial onset seizures&nbsp;do not achieve seizure control with antiepileptic medications, and a similar percentage has significant medication-related side effects.</span></p></div> Mouth guards gather new information that may lead to more accurate prediction of traumatic brain injury 2015-02-27T09:36:00Z 2015-02-27T09:36:00Z <div id="ImageMain53" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction53" style="clear:both;"> <p><span style="font-size: 8pt;">Safety standards and previous research have only used 3DOF measurements (the blue, red, and yellow lines) of mTBI to predict incidence, but researchers at Stanford have found that 6DOF measurements may improve mTBI prediction. The rotational movements (turquoise, orange, and green lines) seem critical in predicting mTBI.<strong><br /><br /><span style="font-size: 11pt;">A preliminary study conducted by researchers funded by the National Institute of Biomedical Imaging and Bioengineering may improve predictions of mild traumatic brain injury (mTBI).</span></strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Most often mTBI affects those with jobs where repeated jolts and impacts can cause the brain to move inside the skull with enough force to cause damage, such as professional athletes. However, recent research has shown that even those playing sports not usually considered contact sports such as baseball, as well as amateur athletes, are suffering from neurodegenerative diseases that seem consistent with mTBI. </span></p> <p><span style="font-size: 10pt;"><br />The problem is that while some patients with mTBI experience a loss of consciousness or concussion at the time of the injury, many do not. This can mean that those who have mTBI may not immediately realise the extent of their injury since the appearance of symptoms can occur hours or even days later. Others may feel some symptoms earlier, but do not report them because they do not want to be pulled from the game. As a result, the only criteria most doctors can reliably use to diagnose mTBI at the time of injury is loss of consciousness.</span><br /><br /></p> <p><span style="font-size: 10pt;">Devices that can measure the force of impact have been implanted in helmets and mouth guards and given to athletes in the hope that they can gather real-time data to predict and prevent brain injury. However, researchers are yet to find a standard of head motion measurements that can accurately predict whether or not someone has sustained brain injury. Current safety standards use three degrees of freedom&mdash;up and down, forward and backward, and left and right&mdash;to measure the acceleration of impact and try to predict the amount of head acceleration necessary to cause mTBI.</span><br /><br /></p> <p><span style="font-size: 10pt;">David Camarillo and his team at Stanford University provided 31 collegiate football players, two professional boxers and one professional mixed martial artist with mouth guards that were able to measure six degrees of freedom, which includes rotational movement (roll, pitch, and yaw).</span><br /><br /></p> <p><span style="font-size: 10pt;">The researchers say that this was the first time a study was conducted that included rotational head motion measurements of clinically-diagnosed mTBI in the analysis, allowing researchers to study how to best predict the two cases of mTBI in the 518 measured impacts at 19 different athletic events over the course of three years. The researchers were able to gather a set of preliminary data detailing more exact criteria on the head accelerations required to cause mTBI&mdash;specifically that peak strain in the corpus callosum seemed to be the best predictor of mTBI.</span><br /><br /></p> <p><span style="font-size: 10pt;">&ldquo;While this is only a small study and further research is necessary, I think that it is an exciting step forward in understanding what needs to be considered to better predict mTBI,&rdquo; said Grace Peng, programme director for mathematical modelling and simulation and analysis at NIBIB. &ldquo;The ability to diagnose mTBI at the time of injury could help protect athletes from further brain damage, reducing their risk of neurodegenerative diseases.&rdquo;</span><br /><br /></p> <p><span style="font-size: 10pt;">This research was supported in part by the National Institute of Biomedical Imaging and Bioengineering award #EB017611.</span></p></div> Long sleepers may have an increased risk of stroke 2015-02-26T16:40:00Z 2015-02-26T16:40:00Z <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>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="Text154" 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="ImageMain55" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction55" 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="Text155" 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="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>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="Text156" 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="Text256" 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="Introduction57" 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="Text157" 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="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>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="Text158" 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="ImageMain59" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction59" 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="Text159" 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="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>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="Text160" 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> Saluda Medical secures US$10 million in new financing 2015-02-20T12:04:00Z 2015-02-20T12:04:00Z <div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Saluda Medical has announced that it has received US$10 million in Series B financing bringing a breakthrough treatment for chronic pain one step closer to reality.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The company, a successful spin-out from NICTA, Australia&rsquo;s Information Communications and Technology (ICT) Research Centre of Excellence, is developing world-first neuromodulation technologies that will improve the treatment of chronic pain, Parkinson&rsquo;s disease, epilepsy and other debilitating disorders.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Neuromodulation generates therapeutic nerve activity through the delivery of electrical stimulation to targeted sites in the body. Saluda is developing a neuromodulation device that measures nerve signals and adjusts stimulation in real time to achieve optimal outcomes for patients. With 1.5 billion people suffering from chronic pain worldwide, Saluda&rsquo;s research will bring an increased quality of life to many across the globe.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />New investor Biosciences Managers led the funding round, in which existing investors also participated. Saluda intends to use the funds to conduct chronic clinical trials and support commercialisation plans for its Evoke spinal cord stimulation system to treat chronic pain of the trunk and limbs.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Saluda chief executive officer John Parker comments: &ldquo;We are delighted to welcome Biosciences Managers as a key shareholder. Their knowledge and experience in the world of medical devices will complement our extraordinary group of existing investors to support Saluda through its next phases of evolution.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With the new funding support we are able to open the next chapter of research into chronic pain, bringing us closer to commercialising a revolutionary treatment that promises to help many people,&rdquo; continue Parker.</span></p></div> Development of personalised cellular therapy for brain cancer 2015-02-19T16:49:00Z 2015-02-19T16:49:00Z <div id="Introduction62" 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="Text162" 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="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>Caputron Medical has entered into an agreement to distribute&nbsp;Neurosoft&nbsp;products for&nbsp;transcranial magnetic stimulation.</strong></span></p> </div><div id="Text163" 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="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>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="Text164" 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="ImageMain65" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction65" 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="Text165" 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="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>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="Text166" 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="ImageMain67" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction67" 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="Text167" 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="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>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="Text168" 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="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>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="Text169" 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> Groundbreaking studies find that neurointerventional surgery reduces stroke mortality 2015-02-11T17:37:00Z 2015-02-11T17:37:00Z <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>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="Text170" 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="Introduction71" 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="Text171" 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> Trial results show Brainsway deep TMS to be efficacious and safe for drug-resistant depression 2015-02-10T14:53:00Z 2015-02-10T14:53:00Z <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>A multicentre double blinded randomised controlled trial has shown Brainsway deep TMS (transcranial magnetic stimulation) to be efficacious and safe for drug-resistant depression, with a stable effect over three months of maintenance treatment.</strong></span></p> </div><div id="Text172" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This multicentre study examined Brainsway deep TMS as a treatment for major depressive disorder. The study included over 200 patients who were randomly assigned for real or sham Deep TMS (20 sessions) over a period of a month. Thereafter, patients underwent a maintenance period that included an additional two sessions per week over three months.&nbsp;</span><br /><span style="font-size: 10pt;"> <br />The study found that the real deep&nbsp;transcranial magnetic stimulation&nbsp;treatment was superior to the sham treatment and induced a beneficial effect that was evident after&nbsp;both the acute phase and the maintenance phase. The results indicate that Brainsway deep TMS is effective and safe as a treatment for major depressive disorder.</span></p></div> FDA clears Enroute transcarotid neuroprotection system 2015-02-10T14:37:00Z 2015-02-10T14:37:00Z <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><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="Text173" 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="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>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="Text174" 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="ImageMain75" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction75" 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="Text175" 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="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>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="Text176" 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="Introduction77" 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="Text177" 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="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>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="Text178" 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="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>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="Text179" 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="ImageMain80" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction80" 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="Text180" 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="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>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="Text181" 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="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>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="Text182" 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="ImageMain83" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction83" 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="Text183" 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="ImageMain84" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction84" 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="Text184" 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="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>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="Text185" 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="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>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="Text186" 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="ImageMain87" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction87" 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="Text187" 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="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>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="Text188" 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="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>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="Text189" 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="Introduction90" 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="Text190" 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="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>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="Text191" 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> Mainstay Medical applies to start US clinical trial of ReActiv8 2015-01-26T09:48:00Z 2015-01-26T09:48:00Z <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><span style="font-size: 11pt;"><strong>Mainstay Medical has submitted an application to the US Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (IDE).</strong></span></p> </div><div id="Text192" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">ReActiv8 is an implantable neurostimulation device designed to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. The goal of ReActiv8 is to reduce pain and disability by addressing the root cause of chronic low back pain in many people by helping to restore control to the muscles that dynamically stabilise the lumbar spine.</span></p> <p><br /><span style="font-size: 10pt;">The clinical trial protocol submitted to the FDA as part of the IDE submission is for an international, multicentre, prospective randomised controlled trial designed to show safety and efficacy of ReActiv8. The IDE submission includes details of the extensive preclinical and clinical testing conducted on ReActiv8. Upon successful completion of the trial and if the results support it, the company plans to submit an application for a pre-market approval which is the final step to allow the start of commercialisation in the USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We anticipate that there may be one or more rounds of review by the FDA as we work together to develop a clinical trial that meets the needs of the company, the FDA, and the millions of people who could potentially benefit from ReActiv8,&rdquo; said&nbsp;Peter Crosby, chief executive of Mainstay Medical.</span></p> <p><br /><span style="font-size: 10pt;">Currently, ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. The ReActiv8-A trial is ongoing in Europe and Australia to gather data to support an application for a CE mark which, if granted, would allow start of commercialisation in Europe.</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="ImageMain93" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction93" 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="Text193" 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="ImageMain94" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction94" 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="Text194" 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="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>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="Text195" 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="Introduction96" 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="Text196" 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="ImageMain97" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction97" 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="Text197" 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="ImageMain98" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction98" 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="Text198" 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="ImageMain99" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction99" 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="Text199" 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="Text299" 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="Introduction100" 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="Text1100" 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>