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.