Medtronic Shares Positive 12-Month Outcomes for IN.PACT AV Drug-Coated Balloon

Medtronic has announced new real-world data from the IN.PACT AV Access Post-Approval Study, demonstrating strong safety and effectiveness outcomes for the IN.PACT AV drug-coated balloon (DCB) for treating arteriovenous fistula (AVF) stenoses in dialysis patients with end-stage kidney disease.

A study intended to expand real-world experience, the prospective, multicenter trial evaluated the IN.PACT AV DCB across 17 U.S. clinical sites, with independent core laboratory and clinical events committee oversight. 

Building on the safety and effectiveness demonstrated in the pivotal randomized controlled trial,^1-3 the post‑approval study was intentionally designed as a confirmatory extension—further strengthening the evidence base by evaluating performance in a real‑world AV access population with high comorbidity burden.

“Real-world evidence is essential to understanding how therapies perform outside of controlled trial settings,” said Sanjay Misra, M.D., professor of radiology at Mayo Clinic and principal study investigator. “The IN.PACT AV post-approval study provides important confirmation that drug-coated balloon treatment can deliver consistent, safe outcomes for AV fistula maintenance in everyday clinical practice in this complex dialysis population.”

Key 12-month primary cohort highlights:

• The most treated AV fistulas were brachiocephalic (51.6%), followed by brachiobasilic (20.8%) and radiocephalic (20.8%)
• The most common lesion locations were the cephalic arch (25.8%) and venous outflow (25.2%)
• Lesions were de novo (59.5%) or non-stented restenotic (40.5%)

Target lesion primary patency at 12 months was 70.2% and access circuit primary patency at 12 months 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 RCT (65.3%, 55.1%, respectively) and better than PTA rates (46.3%, 35.0%, respectively).¹

Less than one reintervention per patient was required through 12 months, which is below the average of 1.5 reinterventions per year.⁴

The serious infection rate^§ at 12 months was 13.4%, below literature reports ranging from 19-23%.^5,6

“These strong real-world data are an important contribution to the body of clinical data supporting the role of the IN.PACT AV DCB for AV fistula maintenance,” said David Moeller, senior vice president and president of Peripheral Vascular Health, part of Medtronic’s Cardiovascular Portfolio. “We are proud to lead the industry in generating long-term clinical evidence in this space and grateful to improve durable AV fistula patency for patients with ESKD requiring dialysis, reducing their need for reinterventions.”

The IN.PACT AV Access Post-Approval Study, a prospective, multicenter trial, evaluated the IN.PACT AV DCB across 17 U.S. clinical sites on the Medtronic Product Surveillance Registry (PSR) platform, with independent core laboratory and clinical events committee oversight.

The device used in this study is commercialized under the name IN.PACT AV drug coated balloon (DCB), which is not available for sale outside the United States, Canada, or Japan. Outside of the United States, Canada and Japan, the IN.PACT™ Admiral DCB is CE marked for treating failing arteriovenous fistulas in dialysis patients with end-stage kidney disease. 

Headquartered in Galway, Ireland, Medtronic is the the world’s largest healthcare technology company. It employs a global team of more than 95,000 workers across more than 150 countries. The company’s technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Medtronic delivers innovative technologies that transform the lives of two people every second, every hour, every day.

^§ The primary endpoint was chosen by the U.S. Food and Drug Administration (FDA) and used the MedDRA system organ class coding convention that is common for FDA-mandated post-approval studies.

References
¹ Holden et al. J Vasc Interv Radiol. 2022;33(8):884-894.e7.
² Lookstein et al. N Engl J Med. 2020; 383(8):733-742.
³ Lookstein et al. J Vasc Interv Radiol. 2023;34(12):2093-2102.e7.
⁴ Sorber et al. Ann Vasc Surg. 2021;76:142–151
⁵ Sibbel et al. BMC Nephrology;2016:17:199.
⁶ Locham et al. J Vasc Surg. 2021;73(3):1016-21.e3.