Medtronic’s IN.PACT AV Access Postapproval Study Reports 12-Month Outcomes

April 15, 2026—Medtronic announced that 12-month findings from the IN.PACT AV Access postapproval study of the company’s In.Pact AV drug-coated balloon (DCB) demonstrated the device’s safety and effectiveness in the treatment of arteriovenous (AV) fistula stenoses in patients with end-stage renal disease (ESRD) on dialysis.

The prospective multicenter study was conducted across 17 United States clinical sites with independent core laboratory and clinical events committee oversight, noted the company.

The findings were presented by Robert Lookstein, MD, in a late-breaking session at SIR 2026, the Society of Interventional Radiology annual scientific meeting in Toronto, Canada.

Sanjay Misra, MD, is Principal Investigator of the postapproval study.

“Real-world evidence is essential to understanding how therapies perform outside of controlled trial settings,” commented Dr. Misra in the Medtronic press release. “The IN.PACT AV postapproval study provides important confirmation that DCB treatment can deliver consistent, safe outcomes for AV fistula maintenance in everyday clinical practice in this complex dialysis population.”

The company stated that in the real-world postapproval study, most treated AV fistulas were brachiocephalic (51.6%), followed by brachiobasilic (20.8%) and radiocephalic (20.8%); most common lesion locations were the cephalic arch (25.8%) and venous outflow (25.2%); and lesions were de novo (59.5%) or nonstented restenotic (40.5%).

As outlined in Medtronic’s press release, the 12-month primary cohort highlights included the following:

• Target lesion primary patency was 70.2%.
• Access circuit primary patency was 52.6%.
• Target lesion and access circuit patency rates were aligned with the 12-month outcomes observed for the In.Pact AV DCB in the pivotal IN.PACT AV Access randomized controlled trial (65.3% and 55.1%, respectively) and better than percutaneous transluminal angioplasty rates (46.3% and 35%, respectively).
• Less than one reintervention was required per patient; by contrast, the average is 1.5 reinterventions per year.
• The serious infection rate was 13.4%; by contrast, the rates reported in the literature range from 19% to 23%.

The In.Pact AV DCB is not available for sale outside the United States, Canada, or Japan. Outside of those markets, the In.Pact Admiral DCB has CE Mark approval for the treatment of failing AV fistulas in patients with ESRD undergoing dialysis, advised Medtronic.