AngioScore, a developer of angioplasty catheters for use in the treatment of cardiovascular disease, has received FDA 510(k) clearance to market its AngioSculpt PTA Scoring Balloon Catheter for dilatation of lesions in renal arteries.
AngioScore previously had received 510(k) clearance to market the AngioSculpt device for 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 510(k) clearance adds renal arteries to the indications for use statement.
AngioScore said that AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. Its nitinol scoring element provides anti-slipping properties while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types. The AngioSculpt provides the versatility and effectiveness of a new technology together with the simplicity and deliverability of a high-performance balloon catheter.
Gary Gershony, chief medical officer of AngioScore, said: “The AngioSculpt may be particularly useful in treating renal artery stenotic disease, which is often associated with medically refractory hypertension or a serious deterioration in kidney function. Due to the frequency of significant calcification and the ostial location of these lesions, renal arteries present a unique challenge for the interventional physician caring for these patients.
“The design of the AngioSculpt is particularly useful in treating resistant fibro-calcific lesions and permitting precise device deployment in the ostial location by avoiding slippage. The AngioSculpt should prove to be a very welcome addition to the armamentarium of physicians treating renal artery stenosis.”
Thomas Trotter, president and CEO of AngioScore, said: “We are very pleased to have received this important 510(k) clearance. Sales of AngioSculpt devices for the treatment of Peripheral Artery Disease (PAD) have been growing rapidly, and the opportunity to now include renal arteries is a major positive development for the company.”