C.R. Bard Announces Enrollment Completion of First Ever IDE-Approved Drug-Coated Balloon Clinical Trial and Initiation of Large Continuation Registry Study
Published: Jul 26, 2012
MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced that its Lutonix technology center completed patient enrollment into its global, multicenter LEVANT 2 randomized clinical trial (www.levant2.com). The purpose of this pivotal IDE trial is to compare the safety and efficacy of the Lutonix® Drug Coated PTA Dilatation Catheter (DCB) to a standard angioplasty balloon for the treatment of peripheral arterial disease. LEVANT 2 was the first drug-coated balloon IDE trial approved by the FDA. The trial randomized 476 patients with diseased femoropopliteal leg arteries at 55 centers worldwide. Randomized patients in LEVANT 2 will be followed for five years and independent laboratories will verify trial outcomes. The Lutonix® DCB was first studied in the LEVANT 1 trial, a 101-patient first-in-human multicenter randomized trial. The company expects to release two-year follow up data from LEVANT 1 later this year.