INFINITY’s Angioplasty Balloon Catheter Cleared

Ohio-based INFINITY Angioplasty Balloon Co. has received 510(k) clearance from the FDA for its balloon catheter for treatment of peripheral arterial disease.

The catheter can be precisely adjusted during surgery to treat lesions from 40mm to 250mm in length, the company said, calling it “a game-changing innovation in percutaneous angioplasty balloon design.”

More than 12 million individuals in the U.S. and 30 million worldwide are affected by the disease, which most commonly affects the arteries of the pelvis and legs.