AngioScore Receives Premarket Approval (PMA) for AngioSculpt(R) Scoring Balloon Catheter.Company's Flagship Device Approved for Use in Coronary Artery Disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. FREMONT, Calif. -- AngioScore, Inc, a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its flagship product, the AngioSculpt[R] Scoring Balloon Catheter, has received Premarket Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). perfusion. PMA approval allows AngioScore to begin marketing the AngioSculpt in the U.S. for the treatment (as indicated) of coronary artery disease (CAD), one of the largest opportunities in the medical device market. More than one million coronary angioplasty procedures are performed in the U.S. each year, with an additional 1.5 million procedures performed worldwide. In 2005, AngioScore obtained FDA 510(k) clearance to market the AngioSculpt in the U.S. for balloon dilatation of lesions in infra-popliteal arteries, one of the key segments of the rapidly growing peripheral artery disease (PAD) market. In addition, the company has also been granted the CE Mark for the AngioSculpt allowing the product to be sold in Europe and the Middle East. The AngioSculpt represents a significant improvement in the state-of-the-art for both coronary and peripheral angioplasty catheters. A semi-compliant angioplasty balloon is surrounded by a unique scoring element which works in tandem with the balloon to deliver a "scoring" effect to the target lesion upon balloon inflation. As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol scoring element. This results in luminal expansion that is precise, predictable and controlled. Barotrauma barotrauma /baro·trau·ma/ (-traw´mah) injury due to pressure, as to structures of the ear, in high-altitude flyers, owing to differences between atmospheric and intratympanic pressures; see barosinusitis and barotitis. is reduced resulting in lower dissection rates. Device slippage, which is commonly seen with traditional balloon catheters and may result in "geographic miss", is eliminated with the AngioSculpt. The U.S. multi-center clinical trial was a prospective study evaluating the safety and effectiveness of the AngioSculpt in 200 patients with single or multiple vessel coronary artery disease, in both de novo lesions and in-stent restenosis lesions. The study's principal investigator was Martin B. Leon, M.D., Professor of Medicine at Columbia University and Chairman of the Cardiovascular Research Foundation (CRF). The participating study sites included nine of the leading interventional cardiology centers in the U.S.: Columbia University Medical Center Columbia University Medical Center is the name of the medical complex associated with Columbia University, and covers several blocks (primarily between 165th and 168th Streets from the Henry Hudson Parkway to Audubon Avenue) in the Washington Heights section of Manhattan. , Minneapolis Heart Institute, Scripps Clinic and Research Foundation, Swedish Medical Center
Swedish Medical Center is a large nonprofit health care provider located in Seattle, Washington. , Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. (Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. ), Stanford University Medical Center Stanford University Medical Center (Stanford Hospital & Clinics) is one of four hospitals affiliated with Stanford University and Stanford University School of Medicine, along with the Lucile Packard Children's Hospital, the Veteran's Administration Hospital in Palo Alto, and Santa , University of Oklahoma University of Oklahoma, abbreviated OU, is a coeducational public research university located in the U.S. state of Oklahoma. Founded in 1890, it existed in Oklahoma Territory near Indian Territory 17 years before the two became the state of Oklahoma. , Washington Adventist Hospital, and the Washington Hospital Center Washington Hospital Center Washington Hospital Center is the largest private hospital in Washington, D.C.. A member of MedStar Health, the not-for-profit Hospital Center is licensed for 926 beds and, on average, operates near capacity. . "We are very pleased to have had the opportunity to provide a leadership role in the U.S. clinical trial of the AngioSculpt," said Dr. Leon. "The results of the clinical trial indicate that the AngioSculpt is a promising new addition for the treatment of coronary artery disease, particularly for challenging lesions and in facilitating precise stent placement and expansion." Gary Gershony, M.D., AngioScore's Chief Medical Officer, added: "More than 75% of the lesions treated in the U.S. clinical trial were classified as type B2 or C, which are the most difficult and complex lesions facing physicians who perform angioplasty procedures. Yet even in this very challenging clinical trial, the AngioSculpt achieved a procedural success rate of 98.5% and a cumulative freedom from MACE (major adverse cardiac events) of 97.5% at follow-up, highlighting the excellent safety profile of this product." "Earning a PMA for the AngioSculpt is a major step forward for AngioScore," said Thomas R. Trotter, President and CEO of AngioScore. "We expect 2007 to be a very significant year for the AngioSculpt as we ramp-up our sales efforts around the world." About AngioScore AngioScore, Inc (www.angioscore.com) is a privately funded endovascular company located in Fremont, California. The company's first product is the AngioSculpt Scoring Balloon Catheter. AngioScore can be contacted at (510) 933-7900 or info@angioscore.com. Note: This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain. Actual results and timing of events could differ materially from current expectations and forward-looking statements. |
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