MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE:BCR) today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for the Lutonix® drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.
The Lutonix® 035 DCB—the first FDA-approved DCB— is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.
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