C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S.
The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat superficial femoral artery and popliteal artery disease.
The latest clearance was supported by data from the Lutonix AV clinical trial – the first investigational device exemption trial to use DCBs in patients with stenotic lesions in AV fistulae.
The Lutonix 035 DCB catheter had a sustained clinical benefit compared to conventional angioplasty, including 31.3% fewer reinterventions compared to PTA at 6 months.
“This approval offers a new treatment option for patients suffering from end-stage renal disease. In line with our continued commitment to deliver products that improve patient care, we are proud to extend the benefits of the Lutonix 035 DCB Catheter to help preserve treatment options for U.S. patients,” chairman & CEO Timothy Ring said in prepared remarks.
To receive hemodialysis treatments, some patients require an AV fistula – the connection of an artery to a vein created by a vascular surgeon. Blockages created by restenosis or by repeated access are a common problem, according to Bard, and some patients need up to eight reinterventions each year to maintain AV fistula function.
“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,” Dr. Scott Trerotola, principal investigator of the Lutonix AV trial, added. “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.”
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