Panel Unanimously Endorse Bard’s Lutonix Drug-Coated Peripheral Balloon
This article was originally published in The Gray Sheet
Executive Summary
Bard has the inside track to having the first drug-coated balloon catheter on the U.S. market after FDA’s Circulatory System Device’s panel unanimously voted to endorse a PMA for the Lutonix paclitaxel-coated balloon based primarily on the one-year results of the LEVANT 2 trial.