C. R. Bard's Lutonix technology center has completed enrolling patients in its pivotal investigational device exemption (IDE) LEVANT 2 trial, designed to evaluate Lutonix drug coated PTA dilatation catheter (DCB) as a treatment for peripheral arterial disease.
The Lutonix DCB, which is coated with an anti-restenotic drug (paclitaxel), is designed to help keep arteries open and free from reblockage.
The Lutonix DCB is inflated during the time it opens up the artery to restore blood flow and to deliver the drug to the artery wall.
The multicenter trial, which has randomized 476 patients with diseased femoropopliteal leg arteries over 55 centers, is designed to compare the safety and efficacy of the Lutonix DCB to a standard angioplasty balloon.
The company said randomized patients in LEVANT 2 will be followed for five years and independent laboratories will verify trial outcomes.
Bard has also started enrolling patients for its FDA approved LEVANT 2 continued access registry study.
The new study is expected to enroll an additional 650 patients over 70 centers.
C. R. Bard chairman and CEO Timothy M. Ring said, "We’re pleased with the continued progress of our DCB program, and I congratulate the entire team on yet another major milestone achievement."