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news.AngioScore has received the FDA 510(k) clearance to market its AngioSculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter for balloon 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.
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The Percutaneous Transluminal Angioplasty (PTA) catheter is not labeled for use in the coronary or neuro-vasculature.
Thomas Trotter, president and CEO of AngioScore, said: “This latest 510(k) clearance to market for our AngioSculpt PTA catheter now enables us to address several of the largest and fastest growing segments of the peripheral artery disease market in the US, including the superficial femoral artery and stenoses involving hemodialysis of synthetic or native arteriovenous fistulae.”