Bard Finalizes FDA Application for Approval of the Lutonix DCB

November 25, 2013—Bard Peripheral Vascular (Tempe, AZ) announced that it has submitted the final module of the premarket approval (PMA) application to the US Food and Drug Administration (FDA) to support approval for the Lutonix drug-coated percutaneous transluminal angioplasty dilatation catheter balloon (DCB).

The Lutonix DCB is being clinically evaluated in the global, multicenter LEVANT 2 randomized clinical trial. 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 in superficial femoral arteries and popliteal arteries. The company provides more information about the LEVANT 2 trial online.

Bard advised that the Lutonix DCB is currently available in Europe and several other countries worldwide. It is limited to investigational use in the United States under the IDE from the FDA.

According to the company, the Lutonix DCB is part of a global clinical evaluation program that includes LEVANT 2, which randomized 476 patients with diseased femoropopliteal leg arteries at 55 centers worldwide. Data from LEVANT 2, combined with LEVANT I and the LEVANT Continued Access Safety Registry, culminated in more than 1,000 patients and are the foundation of the submission to the FDA.