US FDA grants Medtronic investigational device exemption for new In.Pact Admiral study


Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the In.Pact Admiral drug-coated balloon for a potential new indication in patients with end-stage renal disease.

The randomised study will evaluate the In.Pact Admiral drug-coated balloon as a treatment for failing arteriovenous fistulas in these patients as compared to plain balloon angioplasty. The IDE approval enables Medtronic to initiate the study and gain safety and effectiveness data for the device in this investigational indication.

“In the past, when the arteriovenous access site became narrowed, the only option was use of a standard percutaneous transluminal angioplasty balloon to re-open and regain access for dialysis. This would often result in restenosis and high rates of reintervention,” says Andrew Holden, director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University, Auckland, New Zealand. “Patients on dialysis need alternatives to help reduce and manage stenoses of their arteriovenous access sites. It is important to effectively evaluate options such as this drug-coated balloon, which already has clinical evidence in patients with peripheral artery disease in the upper leg. ”

 The IDE study will evaluate the safety and efficacy of the In.Pact drug-coated balloon for up to two years at approximately 30 sites in USA, Japan, and New Zealand. Principal investigators include: Holden, Robert Lookstein, professor of radiology and surgery, vice-chair of interventional services, and medical director of clinical supply chain at Mount Sinai Healthcare System, New York City, USA, and Hiroaki Haruguchi, clinic director at Haruguchi Vascular Clinic, Tokyo, Japan.

The study will aim to enrol 330 patients with a 1:1 randomisation to either treatment with In.Pact Admiral drug-coated balloon or standard balloon angioplasty. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events including repeat procedures.