Boston Scientific’s Drug-Coated Balloon Gets FDA Clearance
Boston Scientific has received 510(k) marketing clearance for its Ranger drug-coated balloon for treating patients with peripheral artery disease (PAD).
The device, which uses a proprietary coating to deliver a low dose of a drug into the tissue, is designed for treating PAD in the superficial femoral artery in the upper leg and the proximal popliteal artery behind the knee.
The company plans to immediately launch the drug-coated balloon in the U.S. It has been available in Europe since 2014.