C.R. Bard receives favorable recommendation from FDA panel for Lutonix DCB C. R. Bard announced that the FDA Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter, or 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 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.
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