News | July 27, 2012

Bard Completes Enrollment in IDE Drug-Coated Balloon Trial

Large continuation registry study initiated to monitor patients treated with Lutonix drug-eluting balloon

July 27, 2012 — C. R. Bard Inc. announced that its Lutonix technology center has completed patient enrollment into its global, multicenter LEVANT 2 randomized clinical trial. The purpose of the pivotal investigational device exemption (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 (PAD).

LEVANT 2 was the first drug-coated balloon IDE trial approved by the U.S. Food and Drug Administration (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 initiated enrollment in the LEVANT 2 continued access registry study. The first subject was enrolled 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 Kenneth Rosenfield (Massachusetts General Hospital, Boston) and Dierk Scheinert (Heart Center Leipzig/Park Hospital, Leipzig, Germany).

“LEVANT 2 has been carried out to a degree of academic rigor that is unprecedented in this disease state," said Rosenfield. "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.”

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