AngioScore receives FDA marketing clearance for PTA Scoring Balloon Catheter

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AngioSculpt® PTA Scoring Balloon Catheter for dilatation of lesions in renal arteries.

“We are very pleased to have received this important 510(k) clearance”

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. This new 510(k) clearance adds renal arteries to the indications for use statement.

According to Gary Gershony, M.D., AngioScore’s Chief Medical Officer, 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,” said Dr. Gershony.

“We are very pleased to have received this important 510(k) clearance,” said Thomas R. Trotter, President and CEO of AngioScore. “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. PAD is one of the fastest-growing segments of the Endovascular Market, with over two million annual procedures worldwide, including an estimated 300,000 renal interventions.”

The AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. Its innovative nitinol scoring element provides unique 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.

Source:

AngioScore

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