October 13th, 2014
First Drug-Coated Balloon Approved by FDA for Leg Blockages
Larry Husten, PHD
The FDA today announced that it had approved for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012. “Peripheral artery disease can be quite serious. Preventing […]
June 13th, 2014
FDA Advisory Panel Supports Novel Drug-Coated Balloon
Larry Husten, PHD
The FDA’s Circulatory System Devices advisory panel voted unanimously on Thursday to support approval of CR Bard’s Lutonix Drug-Coated Balloon (DCB). It would be used to enlarge arteries in a subset of patients who have peripheral arterial disease — including obstructive de novo or nonstented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries […]
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