FDA Advisory Committee recommends Lutonix DCB paclitaxel-coated angioplasty balloon for PAD - C.R.Bard Inc.

C. R. Bard, Inc. has announced that the FDA Circulatory System Devices Advisory Panel provided a unanimous favourable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB) in the U.S.

The Lutonix DCB is currently under review by FDA for improving luminal diameter and reducing the incidence of restenosis for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm. If approved, it is expected that the Lutonix DCB will be the first and only FDA-approved DCB available in the U.S.

The FDA will consider the positive recommendation of the advisory panel in its review of the PreMarket Approval (PMA) Application that was submitted by C. R. Bard in November 2013. Currently, the Lutonix DCB is available commercially in Europe.

The Lutonix DCB is a standard angioplasty balloon that is coated with a low dose of the anti-restenotic agent, paclitaxel, and is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. Successful treatment of Peripheral Artery Disease in the femoropopliteal arteries requires improved blood flow (patency) for longer periods of time.