C. R. Bard Receives FDA Premarket Approval of the LUTONIX® 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE:BCR) today announced the LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication and is now available for sale in the United States. With this approval, the LUTONIX® 035 DCB Catheter becomes the first and only drug coated balloon that is FDA approved as safe and effective in end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. This latest approval adds to the prior FDA indication of the LUTONIX® 035 DCB Catheter for the treatment of superficial femoral artery (SFA) and popliteal artery disease.