Medtronic announced the FDA has issued an investigational device exemption for a study of its drug-coated balloon for treatment of patients with end-stage renal disease.
The DCB (IN.PACT Admiral) will be evaluated as a treatment for failing arteriovenous fistulas in patients with end-stage renal disease compared with plain balloon angioplasty.
According to a press release from Medtronic, thickening of the vessel walls over time can limit the utility of a dialysis site, which requires repeat interventions, which are associated with increased costs, high technical failure rates and reduced quality of life.
“Patients on dialysis need alternatives to help reduce and manage stenosis of their [arteriovenous] access sites,” Andrew Holden, MD, director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University, said in the release. “It is important to effectively evaluate options such as this DCB, which already has clinical evidence in patients with peripheral artery disease in the upper leg.”
The study will evaluate the safety and efficacy of the DCB at 30 sites in the United States, Japan and New Zealand. It aims to enroll 330 patients. The primary endpoints are patency of dialysis fistulas at 6 months and major adverse events at 30 days.
Disclosure: Holden reports no relevant financial disclosures.