C.R. Bard Submits Final PMA Module To The FDA For The Lutonix Drug-Coated Balloon
Published: Nov 26, 2013
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.
Help employers find you! Check out all the jobs and post your resume.