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C.R. Bard Submits Final PMA Module To The FDA For The Lutonix Drug-Coated Balloon


11/26/2013 9:38:21 AM

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MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced that its Lutonix technology center submitted the final module of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) to support approval for the Lutonix® Drug-Coated PTA Dilatation Catheter (DCB). The Lutonix® DCB is being clinically evaluated in the global, multicenter LEVANT 2 randomized clinical trial (http://www.levant2.com). The purpose of this pivotal investigational device exemption (IDE) trial is to compare the safety and efficacy of the Lutonix® DCB to standard angioplasty balloons for the treatment of peripheral arterial disease (PAD) in superficial femoral (SFA) and popliteal arteries.

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