July 8, 2015 - C.R. Bard Inc. announced the publication of results from the LEVANT 2 study in the June 24, 2015, online issue of The New England Journal of Medicine. Results from LEVANT 2 demonstrated superior primary patency for the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty (PTA) catheter over standard PTA, as well as safety consistent with standard PTA balloons. The Lutonix 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.
The device was the first drug coated balloon approved by the U.S. Food and Drug Administration (FDA) in October 2014. This approval followed a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel.
The LEVANT 2 pivotal study is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol, comparing the Lutonix 035 DCB with standard PTA.
According to Kenneth Rosenfield, M.D., M.H.C.D.S., section head, vascular medicine and intervention, in the Division of Cardiology and Fireman Vascular Center at Massachusetts General Hospital, who was principal investigator for the study, "LEVANT 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores."
For more information: www.crbard.com