Medtronic has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin IN.PACT Admiral drug-coated balloon’s (DCB) study for new indication in patients with end-stage renal disease.
The randomized study will evaluate the IN.PACT Admiral DCB as a treatment for failing arteriovenous (AV) fistulas in these patients as compared to plain balloon angioplasty.
The IDE approval allows the company to gather safety and effectiveness data for the device in this investigational indication.
Medtronic will assess the safety and efficacy of the IN.PACT DCB for around two years through trial in about 30 sites of the US, Japan and New Zealand.
The firm is planning to recruit 330 patients with a 1:1 randomization to either treatment with IN.PACT Admiral DCB or standard balloon angioplasty.
According to the company, the primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is major adverse events through 30 days, while additional endpoints include reducing access circuit related events including repeat procedures.
Last year, the firm secured CE mark approval for IN.PACT Admiral DCB for AV access and, as well as in 2009 to treat PAD.
Medtronic’s aortic and peripheral vascular division peripheral business general manager Mark Pacyna said: "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.”