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FDA Advisory Panel Supports Novel Drug-Coated Balloon — Physician’s First Watch

Medical News |
June 16, 2014

FDA Advisory Panel Supports Novel Drug-Coated Balloon

By Larry Husten

Edited by Susan Sadoughi, MD, and Jaye Elizabeth Hefner, MD

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.

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