Medtronic to Begin IDE Study for In.Pact Admiral DCB AV Fistula Indication
January 26, 2017—Medtronic announced it has received an investigational device exemption from the US Food and Drug Administration (FDA) to commence a new study of its In.Pact Admiral drug-coated balloon (DCB) for a potential indication in patients with end-stage renal disease. The study will evaluate the safety and efficacy of the DCB as a treatment for failing arteriovenous (AV) fistulas in patients with end-stage renal disease compared with standard balloon angioplasty.
"In the past, when the AV access site became narrowed, the only option was the use of a standard percutaneous transluminal angioplasty (PTA) balloon to reopen and regain access for dialysis. This would often result in restenosis and high rates of reintervention," commented Andrew Holden, MD, Director of Interventional Radiology at Auckland Hospital and Associate Professor of Radiology at Auckland University, in the company's announcement. "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."
The IDE study will aim to enroll 330 patients at approximately 30 institutions in United States, Japan, and New Zealand. Patients will be randomized 1:1 for either treatment with In.Pact Admiral DCB or standard balloon angioplasty. The primary efficacy endpoint 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, including repeat procedures. The study is planned to last up to 2 years.
The In.Pact Admiral DCB has FDA approval to treat PAD in certain superficial femoral and popliteal arteries, including in-stent restenosis. The In.Pact Admiral DCB has also previously received CE Mark approval for AV access and the treatment of PAD.