FDA clears AngioScores balloon catheter for renal indications

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AngioScore, a developer of angioplasty catheters for use in the treatment of cardiovascular disease, has received 510(k) clearance from the FDA 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, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, according to the Fremont, Calif.-based company. This new 510(k) clearance adds renal arteries to the indications for use statement.