Lazarus Effect ReCover Thrombectomy Device Receives CE Mark
Lazarus Effect, a medical device company focused on improving treatment of acute ischemic stroke through effective removal of the blood clots that cause a stroke, announced today that the Lazarus ReCover™ Thrombectomy Device has received CE Mark. The Lazarus ReCover is a next-generation ischemic stroke device that addresses a major limitation of stent-based clot retrieval, the current gold-standard technology for clot removal, by integrating a protective cover intended to prevent clot fragmentation or embolism and the potential for secondary stroke.
Lazarus Effect plans to launch the Lazarus ReCover in Europe during Q1 2013. The company is currently evaluating distribution partners.
Stent-based thrombectomy (clot removal) devices have demonstrated success "capturing" clots within the affected vessel, but often lose thrombus as the device is extracted. Among 124 Solitaire™ stent retriever cases evaluated during a recent European study, lost clot pieces traveled into an area of the brain previously not affected nine percent of the time, causing new areas of brain to experience stroke.
The ReCover device comprises a nitinol wire-wrapped stent with a highly visible, radio-opaque core and a nitinol mesh cover that surrounds the stent and thrombus during retrieval to help prevent clot fragmentation and embolization. The device will be presented for the first time at the Society for Neurointerventional Surgery (SNIS) Annual Meeting, July 23-27 in San Diego, CA.
"The Lazarus ReCover is a significant advancement in the stent-based retriever category," said Martin Dieck, chairman and CEO, Lazarus Effect. "By integrating protection directly onto the proven stent retriever design, Lazarus Effect has reduced the number of devices that may be needed for the procedure, decreasing complexity and saving critical time while simultaneously creating a device that should be more effective at preventing thrombus loss during removal."
Approximately two million strokes occur in Europe each year. Seventy-eight percent of these are ischemic and caused by a dislodged blood clot or arterial plaque debris traveling to the brain and blocking a cerebral artery.
"In the past few years we have seen a dramatic increase in the number of ischemic strokes treated in Europe. This is partly due to treatment centers experiencing improved recanalization rates with stent retrievers," said J Mocco, MD, MS, FAHA, FAANS, a leading stroke interventionalist and the principal investigator of THERAPY, an international randomized stroke trial. "However, there are still serious concerns over the loss of thrombus during clot retrieval. The ReCover device offers innovative, easy-to-use technology designed to address these concerns and thereby improve patient outcomes."
Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment with the ReCover.