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CR Bard Inc announces that circulatory system devices advisory panel provides unanimous favorable recommendation to FDA for lutonix drug coated balloon


Thursday, 12 Jun 2014 07:34pm EDT 

CR Bard Inc:Says that U.S. Food and Drug Administration's (FDA) circulatory system devices advisory panel provided unanimous favorable recommendation to FDA for use of Lutonix((reg))Drug Coated Balloon PTA Catheter (DCB) in U.S.Lutonix((reg))DCB is currently under review by FDA for improving luminal diameter and reducing incidence of restenosis for 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 Lutonix((reg))DCB will be the first and only FDA-approved DCB available in the U.S. 

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30 Mar 2015