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
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.