Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients in the U.S. have been treated with the WIRION® Embolic Protection System.
WIRION is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy. Physicians typically use embolic protection devices in vessels located above the knee with long lesions, high plaque burden and poor run off.
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.
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