July 11, 2008 - AngioScore Inc. today 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 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 received prior FDA pre-market approval 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 mm and 5 mm) balloons. The company said these new sizes are expected to be particularly useful in treating long and diffuse lesions typically encountered in the treatment of complex PAD.
“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,” said Mark W. Mewissen, M.D., director of the Vascular Center at St. Luke’s Medical Center in Milwaukee “They are a welcome addition to the armamentarium of interventionalists treating peripheral artery disease.”
The maker said the AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty balloon catheters for both coronary and peripheral artery disease. Their nitinol scoring elements provide 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.
For more information: www.angioscore.com