AngioScore Receives FDA Clearance to Market AngioSculpt PTA Scoring Balloon Catheter for Additional Peripheral Indications.FREMONT, Calif. -- AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its AngioSculpt[R] Percutaneous Transluminal transluminal /trans·lu·mi·nal/ (trans-loo´mi-n'l) through or across a lumen, particularly of a blood vessel. trans·lu·min·al adj. Passing or occurring across a lumen. Angioplasty (PTA) Scoring Balloon Catheter has received 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. ) 510(k) clearance to market the device for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal popliteal /pop·lit·e·al/ (pop?lit´e-il) pertaining to the area behind the knee. pop·lit·e·al adj. Relating to the poples. , and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous arteriovenous /ar·te·rio·ve·nous/ (-ve´nus) both arterial and venous; pertaining to or affecting an artery and a vein. ar·te·ri·o·ve·nous adj. Abbr. dialysis fistulae. The PTA catheter is not labeled for use in the coronary or neuro-vasculature. The PTA Scoring Balloon Catheter received initial FDA 510(k) clearance to market for the treatment of infra-popliteal peripheral arterial disease in September 2005. In January 2007, AngioScore's companion product, the AngioSculpt[R] Percutaneous Transluminal Coronary Angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ) Scoring Balloon Catheter, received FDA Pre-market Application (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 ) Approval for 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. Both AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty catheters. Their innovative nitinol elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding "geographic miss" through its unique anti-slippage properties. The AngioSculpt catheters provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters. "We are very pleased to have achieved this significant milestone," said Thomas R. Trotter, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of AngioScore. "This latest 510(k) clearance to market for our AngioSculpt PTA catheter now enables us to address several of the largest and fastest growing segments of the peripheral artery disease (PAD) market in the U.S., including the superficial femoral artery (SFA) and stenoses involving hemodialysis of synthetic or native arteriovenous fistulae (A/V fistula). In 2007 an estimated 275,000 SFA and 300,000 A/V fistula procedures were performed in the United States." Trotter added: "AngioSculpt catheters have now been used in more than 15,000 procedures worldwide and have achieved an outstanding performance record in the treatment of both coronary and peripheral artery disease." About AngioScore AngioScore, Inc. (www.angioscore.com) is a privately funded endovascular company located in Fremont, California. 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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