FDA Approves 6-Month Primary End Point for the Lutonix® Below-the-Knee Drug Coated Balloon

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a 6-month time point for the Lutonix® 014 Drug Coated Balloon PTA Catheter (DCB). The Lutonix® 014 device is currently the only DCB in an IDE clinical trial in the U.S. for treatment of arteries below the knee (BTK).