July 11, 2008
AngioScore Introduces New AngioSculpt Devices
AngioScore has launched new longer and larger AngioSculpt percutaneous transluminal angioplasty scoring balloon catheters for the treatment of peripheral artery disease.
The new devices have received the 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 new AngioSculpt devices incorporate longer (40mm) balloons and scoring elements in the larger- diameter (4mm and 5mm) balloons. These new sizes are expected to be particularly useful in treating long and diffuse lesions typically encountered in the treatment of complex peripheral artery disease.
The percutaneous transluminal angioplasty catheter is not labeled for use in the coronary or neuro-vasculature.
AngioScore has received prior 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.