Healthcare Industry News: Scoring Balloon Catheter
News Release - January 9, 2007
AngioScore Receives Premarket Approval (PMA) for AngioSculpt(R) Scoring Balloon Catheter
Company's Flagship Device Approved for Use in Coronary Artery DiseaseFREMONT, Calif.--(HSMN NewsFeed)--AngioScore, Inc, a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its flagship product, the AngioSculpt® Scoring Balloon Catheter, has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) 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 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 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, Minneapolis Heart Institute, Scripps Clinic and Research Foundation, Swedish Medical Center, Brigham and Women's Hospital (Harvard Medical School), Stanford University Medical Center, University of Oklahoma, Washington Adventist Hospital, and the Washington Hospital Center.
"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.
Source: AngioScore
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