90 NeuroInterventions aims to deliver faster stroke care By AMANDA PEDERSEN <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong> Staff Writer In the business world the old cliché is that “time is money.” In the world of stroke treatment, that expression becomes “time is brain,” – and it is the driving principal behind one early-stage company’s quest to speed up the delivery of post-stroke countermeasures in order to minimize brain damage. Michele Migliuolo, president/CEO of NeuroInterventions (NIT; Pittsburgh) described the development in a presentation at AdvaMed 2009 in Washington. He says the technology enables surgeons to reach and remove clots in much less time than conventional approaches. “When a patient stuffers a stroke – and by stroke I mean ischemic stroke – [there is a] time window of about nine hours in which something can be done to help that patient,” Migliuolo told <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong>. He noted that stroke is the third most frequent cause of death and the number-one cause of permanent disability. “Every second can mean a drop in brain function,” when a clot blocks the flow of oxygen-rich blood in the brain, Migliuolo said. “Even after a patient reaches a hospital, it can take up to 60 minutes just to introduce a conventional catheter through the femoral artery and steer it to the site, before you can deal with the clot,” he said. According to NIT, its system, which is capable of dissolving or extracting clots and delivering medication, takes a shorter, faster path to the brain. With “exceptional maneuverability for negotiating the circulatory system,” the company said its devices “will benefit patients, physicians, hospitals and insurance companies by improving outcomes through shorter, more effective treatment; by permitting more complex procedures; and by reducing recovery times.” Migliuolo declined to explain to MDD how the patentpending technology works. However, he said that following his presentation at AdvaMed he was approached by three potential new investors who wanted to learn more about it. NIT says it is prototyping a family of patent-pending catheters for addressing deep vein thrombosis, carotid stenting, and traumatic brain injury, in addition to stroke. The technology also facilitates localized drug and stem cell delivery, the company noted. The company is hoping to begin testing its devices in animals in January or February of 2010, Migliuolo said. NIT says that three medical professionals who “realized that simpler and easier to use thrombectomy devices could potentially have a dramatic effect on patient outcomes” founded the company in December 2007. <strong>MEDICAL</strong> <strong>DEVICE</strong> <strong>INNOVATION</strong> 2010 The company’s management team includes Lawrence Wechsler, MD, chair of the Department of Neurology and director of the Stroke Institute at the University of Pittsburgh <strong>Medical</strong> Center (UPMC); Mark Wholey, MD, founder and director of the Pittsburgh Vascular Institute; Tudor Jovin, MD, co-director of the Center for Neuroendovascular Therapy at the UPMC; Ender Finol, PhD, associate research professor for the Institute for Complex Engineered Systems and Biomedical Engineering Department at Carnegie Mellon University (Pittsburgh); and Migliuolo, a high-tech entrepreneur and former executive in residence at the Pittsburgh Life Sciences Greenhouse. Until recently the only FDA-approved drugs to treat ischemic stroke – Genentech’s (South San Francisco, California) tissue plasminogen activator (tPA) – had to be given within three hours after the onset of symptoms and the majority of patients miss that window of opportunity to receive the clot-busting drug. But in June the American Heart Association (Dallas) extended the tPA treatment window for stroke patients based on studies proving that the drug could be given to suitable candidates up to 4.5 hours after symptom onset. Still, several companies are working to widen the treatment window for ischemic stroke patients even more. Last year Penumbra (San Leandro, California) received FDA clearance for its Penumbra system – a drug-free approach that can be used up to eight hours after symptom onset. The Penumbra system is a package of tools used by neuro interventional specialists to remove occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works on the proximal surface of the occlusion, optimizing safety and eliminating the need for navigation beyond the occlusion, according to the company. The system is comprised of an aspiration platform containing multiple devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels. The Penumbra system is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of symptom onset. CoAxia (Maple Grove, Minnesota) also is trying to give ischemic stroke patients more time to get treatment with its NeuroFlo Perfusion Augmentation Therapy. Over the summer the company reported continued enrollment in its SENTIS pivotal trial of its NeuroFlo technology for acute ischemic stroke (MDD, June 24, 2009). The company said at that time that it had enrolled more than 75% of its goal of about 500 patients, with enrollment expected to conclude in early 2010, and PMA submission later that year. The company also reported then that it had completed two pilot studies of its NeuroFlo catheter in additional stroke patient populations – those treated as late as 24 hours after stroke onset and those who received NeuroFlo treatment in conjunction with intravenous tPA. To subscribe, please call <strong>MEDICAL</strong> <strong>DEVICE</strong> DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
<strong>MEDICAL</strong> <strong>DEVICE</strong> <strong>INNOVATION</strong> 2010 91 Another competitor in the ischemic stroke market is Concentric <strong>Medical</strong> (Mountain View, California), a company that originally received FDA approval for its Mechanical Embolus Removal in Cerebral Ischemia Retriever (Merci) device in 2004. The device is a catheter that contains a corkscrew-like wire designed to snare clots and pluck them from the artery. Concentric launched its third-generation of Merci retrievers, the V series, last year. (This story originally appeared in the Oct. 16, 2009, edition of <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong>) To subscribe, please call <strong>MEDICAL</strong> <strong>DEVICE</strong> DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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