AngioScupt® Scoring Balloon Catheter Receives FDA Clearance
Alameda, CA–September 14, 2005
AngioScore, Inc. announced today that the company has received U.S. Food and Drug Administration (FDA) 510(K) clearance to market the AngioSculpt Scoring Balloon Catheter (AngioSculpt®) 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 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 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, 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 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 arterial (SFA) 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 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. is an endovascular therapy company located in Alameda, California. 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). For more information, please visit the AngioScore Web site.
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.
9/16/2005
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