FDA OKs Bard’s Lutonix drug-coated balloon for renal disease complication

C.R. Bard scored FDA premarket approval for its Lutonix drug-coated balloon to treat a new indication: stenosis in the arteriovenous (AV) fistulae of patients with end-stage renal disease.

The Lutonix 035 Drug Coated Balloon PTA catheter is an angioplasty balloon coated with the drug paclitaxel. It was first approved by the FDA in 2014 for the treatment of femoropopliteal occlusive disease, which can reduce or completely block blood flow to the lower leg and foot.

Many patients with end-stage renal disease rely on an AV fistula to undergo hemodialysis treatments. An AV fistula is a connection between an artery and a vein created by a surgeon as an access point for hemodialysis. However, the stenosis, or narrowing, of the blood vessel can hinder treatment. A 2016 study shows that some patients need as many as eight reinterventions each year to preserve the function of their fistula.

The new approval is based on trial results showing patients with the Lutonix balloon fared better than those treated with traditional angioplasty. Specifically, the patients had 71% target lesion primary patency and 31% fewer reinterventions six months after treatment. Patients treated with Lutonix also had 217 reintervention-free days, nearly two months more than the 163 days reported for patients who underwent traditional angioplasty.

"For patients undergoing hemodialysis for kidney failure—who already spend a significant portion of their time undergoing dialysis and other treatments—repeated reinterventions to maintain AV access can be an added burden, with many patients returning as frequently as every other month," said Scott Trerotola, M.D., a professor of radiology, associate chair and chief of interventional radiology at the University of Pennsylvania’s Perelman School of Medicine. Trerotola also served as the principal investigator of the Lutonix AV clinical trial.

"The Lutonix 035 DCB Catheter provides another option for physicians. It’s intended to offer patients with end-stage renal disease fewer interruptions in treatment and less time undergoing access maintenance, potentially leading to improved patient satisfaction and quality of life," he said.