FDA grants premarket approval for Lutonix 035 Drug Coated Balloon PTA Catheter to treat end stage renal disease .-C.R.Bard

C. R. Bard, Inc. announced the Lutonix 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the 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.

The FDA approval was based on the results of the Lutonix AV Clinical Trial, the first investigational device exemption (IDE) trial using drug coated balloons in patients with stenotic lesions in AV fistulae. The follow-up results from randomized patients who were treated with the Lutonix 035 DCB Catheter demonstrated safety comparable to uncoated balloons. The Lutonix 035 DCB Catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months.