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DCB approved to treat lesions in dialysis fistulae
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C.R. Bard announced that the FDA has approved a new indication for its drug-coated balloon to treat patients with end-stage renal disease who have stenotic lesions in dialysis arteriovenous fistulae.
The DCB (Lutonix 035 Drug-Coated Balloon PTA Catheter) was previously approved for treatment of lesions in the superficial femoral and popliteal arteries, according to a press release issued by the company.
Approval was based on results from the LUTONIX AV trial, the first to test a DCB as a treatment for stenotic lesions in dialysis arteriovenous fistulae, according to the release.
In that trial, the DCB was similar in safety to uncoated balloons and, compared with uncoated balloons, conferred a higher rate of target lesion primary patency, fewer reinterventions and more reintervention-free days, the company stated in the release.
“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 [arteriovenous] access can be an added burden, with many patients returning as frequently as every other month,” Scott O. Trerotola, MD, FACR, Stanley Baum Professor of Radiology, associate chair and chief of interventional radiology at the Perelman School of Medicine at the University of Pennsylvania, said in the release. “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.”
Disclosure: Trerotola reports he receives personal fees from Bard Peripheral Vascular/Lutonix, B. Braun, Cook Medical, MedComp, Orbimed and W.L. Gore & Associates and royalties from Cook and Teleflex.