AngioScore Receives FDA Clearance to Market AngioSculpt(R) Scoring Balloon Catheter for the Treatment of Infrapopliteal Peripheral Arterial Disease.ALAMEDA, Calif. -- AngioScore Inc. announced today that the company 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 AngioSculpt Scoring Balloon Catheter balloon catheter n. A catheter with an inflatable balloon at its tip, used especially to expand a partially obstructed blood vessel or bodily passage and to measure blood pressure in a blood vessel. Also called balloon-tip catheter. (AngioSculpt(R)) for the treatment of infrapopliteal peripheral arterial disease. The AngioSculpt joins a new class of specialty medical devices aimed at treating peripheral arterial disease (PAD), one of the fastest-growing segments in the worldwide interventional marketplace. An estimated 10 million patients suffer from PAD in the U.S. alone, of whom only approximately 800,000 undergo a revascularization or amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly procedure each year. The AngioSculpt family of devices for PAD has the potential to favorably improve the clinical outcomes of a large portion of these patients. "We are extremely pleased to have successfully achieved this very important milestone," said Thomas R. Trotter, 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. "We believe that the AngioSculpt represents a major advancement in the state of the art, and will provide physicians worldwide with an outstanding new medical device for use in the treatment of PAD. We are in the process of completing all the steps necessary to launch distribution of the AngioSculpt in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , which is expected to begin in the first quarter of 2006." The Market Opportunity Trotter added: "This entry of the AngioSculpt into the U.S. market for infrapopliteal PAD is expected to be only the first in a series of applications of the technology for the worldwide interventional market. We recently filed a 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 application with the FDA for a coronary indication for the AngioSculpt and have already begun pre-clinical testing of a similar device for superficial femoral femoral /fem·o·ral/ (fem´or-al) pertaining to the femur or to the thigh. fem·o·ral adj. Of or relating to the femur or thigh. arterial (SFA See sales force automation. SFA - Sales Force Automation ) applications. "In addition, we have received the CE mark for the AngioSculpt and have initiated sales activities in Europe for both coronary and peripheral indications. Finally, through our recently announced strategic partnership with USCI USCI United States Colored Infantry USCI University College Sedaya International USCI United States Computers, Incorporated Japan, the registration process is now underway for the AngioSculpt in Japan, a market which is well-suited for this advanced technology." The Road Ahead Trotter concluded: "We are very optimistic about the prospects for AngioScore in general and the AngioSculpt in particular. We believe that the AngioSculpt technology will have widespread application in the worldwide interventional device market, and we are moving rapidly to address a number of important indications. Having clearance to market the device for infrapopliteal PAD in the United States is a very important first step in that process." About AngioScore AngioScore Inc. (www.angioscore.com) is an endovascular therapy company located in Alameda. The company's first product is the AngioSculpt Scoring Balloon Catheter. AngioSculpt is an investigational device in the United States for all indications other than the treatment of infrapopliteal peripheral arterial disease (PAD). AngioScore can be contacted at 510-263-0480 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 from any forward-looking statements. |
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