AngioScore Launches New Longer And Larger AngioSculpt(R) Devices For Treatment Of Peripheral Artery Disease

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 14 Jul 2008 - 4:00 PDT

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AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced the launch of new longer and larger AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD).

The new devices have received U.S. Food and Drug Administration (FDA) 510(k) clearance to market for the 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.

AngioScore has received prior Pre-Market Approval (PMA) of smaller versions of the AngioSculpt PTCA Scoring Balloon Catheter for treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

The new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in the larger- diameter (4.0 mm and 5.0 mm) balloons. These new sizes are expected to be particularly useful in treating long and diffuse lesions typically encountered in the treatment of complex PAD. Mark W. Mewissen, M.D., Director of the Vascular Center at St. Luke's Medical Center in Milwaukee, commented, "These new longer and larger AngioSculpt devices represent a significant improvement over conventional angioplasty balloons for the treatment of complex lesions because of their ability to achieve more predictable luminal expansion and a lower rate of dissection, thereby minimizing the need to perform adjunctive stenting. They are a welcome addition to the armamentarium of interventionalists treating peripheral artery disease."

Thomas R. Trotter, president and CEO of AngioScore, added, "The peripheral artery disease market is one of the most rapidly growing segments of the overall interventional cardiovascular market worldwide. Nearly one million percutaneous peripheral procedures are now being performed annually in the United States, and the growth rate is accelerating due to improved diagnosis and the increasing incidence of important risk factors, such as adult-onset diabetes mellitus. We believe that the AngioSculpt line of Scoring Balloon Catheters is particularly useful in treating this very challenging and serious disease."

The AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty balloon catheters for both coronary and peripheral artery disease. Their innovative nitinol scoring 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 their unique anti-slippage properties. The AngioSculpt balloon catheters provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters.

AngioSculpt devices have now been used in more than 20,000 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.

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.

AngioScore