AngioScore Inc. has introduced longer and larger AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD).
The FDA 510(k) cleared devices are 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.
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.
June 13, 2024 
