FDA Advisory Panel Supports Novel Drug-Coated Balloon — Physician’s First Watch
FDA Advisory Panel Supports Novel Drug-Coated Balloon
By Larry Husten
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 or less in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm.
If it is approved, Lutonix would become the first DCB available in the U.S.
Adapted from CardioExchange.