Lazarus Effect Cover™ Device Receives CE Mark
- Device designed to assist during interventional retrieval procedures -
CAMPBELL, Calif., Nov. 6, 2014 /PRNewswire/ -- Lazarus Effect, a medical device company focused on the development of novel vascular interventional devices, announced today that the Lazarus Cover™ accessory device has received CE Mark. The Lazarus Cover is a unique, nitinol-mesh cover that surrounds a retriever device and captured material during removal from a blood vessel.
"The Lazarus Cover provides a unique solution to what has been a major limitation of current retrieval systems, and it does so without requiring physicians to switch from their favorite stent or other retriever device," said Martin Dieck, chairman and CEO, Lazarus Effect. "It is among a series of disruptive devices Lazarus Effect is developing to overcome longstanding challenges associated with current vascular interventional procedures."
Stent-based thrombectomy devices have demonstrated success in "capturing" clots within an affected blood vessel, but often lose thrombus as the device is extracted. Recent results from a 500-patient, multi-center, randomized European ischemic stroke trial (MR CLEAN) presented at the 9th World Stroke Congress in Istanbul revealed that direct vascular intervention (97 percent used retrievable stents) generated better outcomes than standard stroke therapy alone. The study also demonstrated that, despite generating better outcomes for patients, there is still room for improvement in vascular intervention. Clot particles were lost during interventional procedures, resulting in an ischemic stroke to a new region of the brain 5.6 percent of the time, vs. 0.4 percent of the time in the control (i.e., standard therapy) group.
Lazarus Effect plans to launch the Lazarus Cover, which can be used with a variety of available retriever devices, in Europe during Q1 2015.
The United States Patent and Trademark Office recently issued a new patent (U.S. Patent Number 8,795,305) covering core technology behind the Lazarus Cover, as well as the Lazarus ReCoverTM device. The Lazarus Cover is a generalized device and can be used with a number of retriever types, whereas the ReCover is designed specifically for the retrieval of thrombus during an ischemic stroke.
About Lazarus Effect
Lazarus Effect is developing a complete portfolio of interventional vascular products based on a patented, wire-frame technology platform. The company currently has six issued US patents and numerous pending US and worldwide patent applications. The Lazarus Funnel™ Guide Catheter, Lazarus ReCover and Lazarus Cover devices have CE Mark for use in Europe, and the Funnel is cleared for use in the United States. Neither the ReCover nor the Cover is approved for sale in the United States. More information is available at www.lazarus-effect.com.
Forward-looking Statements
Statements contained in this press release about Lazarus Effect, Inc. that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include changes in market or financial conditions, and other changes beyond the control of the Company. The Company specifically disclaims any obligation to update these forward-looking statements.
Contact:
Michele Parisi
for Lazarus Effect
925-429-1850
[email protected]
SOURCE Lazarus Effect
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