March 26, 2010 – The FDA granted 510(k) market clearance for the AngioSculpt PTA Scoring Balloon Catheter for dilatation of lesions in renal arteries.
AngioScore previously 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 use indications.
The company said the device may be useful in treating renal artery stenotic disease, which is often associated with medically refractory hypertension or a serious deterioration in kidney function. There is frequently significant calcification and the ostial location of these lesions makes them difficult to treat.
The AngioSculpt Scoring Balloon Catheter uses a nitinol scoring element to provide anti-slipping properties, while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types.
For more information: www.angioscore.com