AngioScore Receives FDA Clearance To Market AngioSculpt PTA Scoring Balloon Catheter For Additional Peripheral Indications

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 05 May 2008 - 1:00 PDT

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AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced that its AngioSculpt® Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the device for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous 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® Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter, received FDA Pre-market Application (PMA) 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 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 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. is a privately funded endovascular company located in Fremont, California.

AngioScore, Inc.