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September 7, 2019

Medtronic's IN.PACT AV Access Trial Meets Primary Safety and Efficacy Endpoints

September 7, 2019—Medtronic announced that the first results from the IN.PACT AV Access clinical study were presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7–11 in Barcelona, Spain.

The study, which met its primary safety and effectiveness endpoints, is comparing Medtronic's investigational In.Pact AV drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in end-stage renal disease patients with de novo or nonstented restenotic arteriovenous (AV) fistula lesions.

In the company's announcement, Andrew Holden, MD, commented, “Maintaining patency and limiting the frequency of reinterventions needed to keep AV access sites functioning properly remain significant treatment challenges for physicians treating AV fistulae lesions. These results demonstrate the promise of In.Pact AV DCB to not only address these critical issues, but to potentially improve the quality of life of patients undergoing dialysis.” Dr. Holden is Director of Interventional Radiology at Auckland Hospital and Associate Professor of Radiology at Auckland University in Auckland, New Zealand.

According to Medtronic, the IN.PACT AV Access study is a randomized controlled trial that has enrolled 330 patients at 29 sites in the United States, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis measured through 6 months postprocedure. The primary safety endpoint was defined as the serious adverse event rate involving the AV access circuit through 30 days postprocedure. Additional endpoints include but are not limited to: access circuit primary patency, cumulative target lesion revascularizations, and number of interventions required to maintain target lesion patency.

The study enrolled a challenging patient population who had been undergoing dialysis for an average of 4.3 years. Overall, the In.Pact AV DCB group demonstrated clinical benefit compared to the PTA control group. Key data include:

  • The primary patency rate of the target lesion at 180 days was 86.1% in the In.Pact AV DCB group versus 68.9% in the PTA control group, per Kaplan-Meier estimates (P < .001).
  • The primary patency rate of the target lesion at 210 days was 81.4% in the In.Pact AV DCB group versus 59.0% in the PTA control group, per Kaplan-Meier estimates (P < .001).
  • Patients in the In.Pact AV DCB group required 56% fewer reinterventions to maintain target lesion patency through 210 days compared to those in the PTA control group.
  • A low rate of access circuit–related serious adverse events, with 4.2% in the In.Pact AV DCB study group compared to 4.4% in the PTA control group through 30 days.
  • Freedom from all-cause death through 360 days was 90.6% in the In.Pact AV DCB study group and 90.4% in the PTA control group, per Kaplan-Meier estimates.

This data adds to the initial safety data presented at the FDA Advisory Committee meeting of the Circulatory System Devices Panel in June that show no difference in mortality rates in this patient population.

In the United States, In.Pact AV DCB is an investigational device and not yet approved for commercial use. In Europe in January 2016, the CE Mark–approved indication for the In.Pact Admiral DCB was expanded for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.

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