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June 16, 2020
Infinity Angioplasty Balloon Catheter Receives 510(k) Clearance
June 16, 2020—Infinity Angioplasty Balloon Co., LLC announced that the FDA has cleared the Infinity angioplasty balloon catheter for percutaneous transluminal angioplasty treatment of peripheral arterial disease in the peripheral vasculature, including iliac, femoral, popliteal, and infrapopliteal arteries, and for the treatment of arteriovenous dialysis fistulas.
The company will initially launch an uncoated angioplasty balloon, followed by a drug-coated balloon platform of similar design—a protected balloon to assure the precise delivery of drug to the lesion site.
Vascular surgeon, John Pigott, MD, is the founder of the company. “The Infinity catheter represents a game-changing innovation in percutaneous angioplasty balloon design and utility,” stated Dr. Pigott in the announcement. “A single SKU to treat lesions from 40 mm to 250 mm in length is adjustable to the millimeter in vivo, assuring precision angioplasty while addressing over 95% of real-life clinical cases.”
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