Bard Announces Enrollment Completion of First Ever IDE-Approved Drug-Coated Balloon Clinical Trial and Initiation of Large Continuation Registry Study
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 (). 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.
In addition, the company also announced that it has obtained FDA approval and has initiated enrollment in the LEVANT 2 Continued Access Registry study. The first subject was enrolled on June 19, 2012 in Belgium. This new study will enroll an additional 650 patients at 70 centers worldwide. Together with the randomized patient cohort, the company expects the combined studies to deliver a scientifically significant dataset for this first of its kind technology.
The co-principal investigators for the LEVANT 2 randomized clinical trial are Dr. Kenneth Rosenfield (Massachusetts General Hospital, Boston, MA) and Prof. Dierk Scheinert (Heart Center Leipzig/Park Hospital, Leipzig, Germany). Dr. Rosenfield stated that "LEVANT 2 has been carried out to a degree of academic rigor that is unprecedented in this disease state. The controlled design of this trial is one that will offer us the first-in-kind results and insights on the role of drug-coated balloons for this population. I congratulate my fellow investigators and colleagues around the world for this major accomplishment, as well as Lutonix for conducting such a model clinical trial". Professor Scheinert adds, "We have been discussing for several years the need for a definitive clinical trial to assess the true benefit of this potentially game-changing technology, and I'm proud to be part of the first team to achieve this scientifically significant milestone."
Timothy M. Ring, Bard's chairman and CEO, commented, "We're pleased with the continued progress of our DCB program, and I congratulate the entire team on yet another major milestone achievement."
About the Lutonix® Drug Coated PTA Dilatation Catheter
The Lutonix DCB is similar to a standard angioplasty balloon, but is coated with an anti-restenotic drug (paclitaxel) designed to help keep arteries open and free from reblockage. During the procedure, the Lutonix DCB is briefly inflated during which time it opens up the artery to restore blood flow, and delivers the drug to the artery wall. The Lutonix DCB is then removed from the body leaving nothing behind but the drug, which is designed to work inside the artery over time to prevent restenosis. The Lutonix DCB is not commercially available in the United States and is limited to investigational use under an investigational device exemption (IDE). The Lutonix DCB is commercially available in Europe.
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