C. R. Bard: Clinical Data Reinforces Superior Results For Lutonix 035 DCB

(RTTNews) - C. R. Bard, Inc. (BCR) said the results from its LEVANT 2 study has demonstrated superior primary patency for Lutonix 035 Drug Coated Balloon PTA Catheter over standard percutaneous transluminal angioplasty or PTA, as well as safety consistent with standard PTA balloons. The LEVANT 2 pivotal study is a global, prospective, single-blind, randomized, 54-site study that enrolled all patients under one protocol, comparing Lutonix 035 DCB with standard percutaneous transluminal angioplasty.

The Lutonix 035 DCB was the first drug coated balloon approved by the U.S. FDA in October 2014. It is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel. It utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease in the femoropopliteal arteries.

"This should provide additional confidence to clinicians looking to use a drug coated balloon in treating peripheral arterial disease in the femoropopliteal arteries," said John DeFord, Senior Vice President, Science, Technology & Clinical Affairs, C. R. Bard, Inc.