Jan. 11, 2007 — AngioScore’s flagship product, the AngioSculpt Scoring Balloon Catheter, has received FDA Premarket Approval (PMA) 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.
With the PMA approval, AngioScore can begin marketing the AngioSculpt in the U.S. for the treatment (as indicated) of coronary artery disease (CAD). The company says that more than one million coronary angioplasty procedures are performed every year in this country, and another 1.5 million procedures are performed worldwide.
AngioSculpt was 510(k) approved in 2005 for balloon dilatation of lesions in infra-popliteal arteries, a key segment 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.
Martin B. Leon, M.D., professor of Medicine at Columbia University and chairman of the Cardiovascular Research Foundation (CRF), served as the principal investigator for the device’s U.S. multicenter clinical trial, a prospective study that evaluated 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.
“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.”
For more information visit www.angioscore.com.