About WISE LE
WISE LE (WIRION™ EPS in Lower Extremities Arteries) was a multicenter study, performed in the United States and Germany and included all commercially-available atherectomy systems. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures.
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About Gardia Medical Ltd. and Allium Medical Solutions Ltd.
Gardia Medical Ltd. develops specialized catheter-based delivery systems to Deliver, Lock and Deploy devices on any guidewire, anywhere on the wire, in minimally-invasive interventional procedures. Allium Medical Solutions Ltd. develops, manufactures and markets minimally invasive products internationally in various medical disciplines. These innovative products serve the need for minimally invasive interventions benefitting the patient by improving their recovery process and shortening it. Allium Medical Solutions’ products are used by physicians to treat a wide range of diseases and patients worldwide.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 450,000 of CSI’s devices have been sold to leading institutions worldwide.
WIRION™ Embolic Protection System: