Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease.
The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint for the 330-patient study is patency of dialysis fistulas through 6 months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events.
“In the past, when the AV access site became narrowed, the only option was use of a standard percutaneous transluminal angioplasty (PTA) balloon to re-open and regain access for dialysis. This would often result in restenosis and high rates of reintervention,” Dr. Andrew Holden, director of interventional radiology at Auckland Hospital, said in prepared remarks. “Patients on dialysis need alternatives to help reduce and manage stenoses of their AV access sites. It is important to effectively evaluate options such as this DCB, which already has clinical evidence in patients with peripheral artery disease (PAD) in the upper leg.”
“In.Pact Admiral DCB has demonstrated superior clinical outcomes in patients with PAD in the upper leg. Through our In.Pact clinical program, we are looking at ways this DCB technology can address challenging lesions, and we have specifically designed the DCB with extended sizes for use in AV access,” Mark Pacyna, general manager of Medtronic’s peripheral business, added. “Following receipt of the CE Mark for this indication last year, the IDE approval and study initiation reflects our commitment to innovation and, most importantly, to our patients. This is an exciting new opportunity for our unique DCB with the potential to reduce rates of repeat procedures, while improving patient quality of life and quality of care in the healthcare system.”
Yesterday, Medtronic touted data for its In.Pact Admiral DCB in patients with peripheral arterial disease. The company presented outcomes from its In.Pact Global study patient cohorts in Asia and Belgium, concluding that its DCB demonstrated consistent outcomes across patient populations.
More than 96% of the 114-patient study group in Asia achieved positive outcomes, which was consistent with results from the full global study cohort. Low clinically-driven target lesion revascularization at 1 year, nearly 4%, was also in line with the results of the 1,406 patients in the global study group.
Belgium was the 1st country to enroll patients in the In.Pact study. After 1 year, the rate of clinically-driven target lesion revascularization was consistent with the global group. Nearly 91% of patients achieved positive outcomes, meeting the study’s primary safety endpoint.