Medtronic revealed its IN.PACT AV Access clinical study has met primary safety and effectiveness endpoints. The Dublin-based company’s study is evaluating the use of the IN.PACT AV drug-coated balloon (DCB) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions.

The IN.PACT AV study is a randomized controlled trial that has enrolled 330 subjects at 29 sites in the U.S., Japan, and New Zealand. Medtronic said the study enrolled a challenging patient population who had been undergoing dialysis for an average of 4.3 years. Results show the IN.PACT AV DCB group demonstrated clinical benefit compared to the percutaneous transluminal angioplasty control group.

“The primary effectiveness endpoint (target lesion primary patency) was evaluated through six months and the primary safety endpoint (serious adverse event rate) was evaluated through 30 days,” Mark Pacyna, VP and General Manager of the Peripheral Vascular Business at Medtronic, told MD+DI via e-mail. “However, the IN.PACT AV Access trial will follow patients for up to five years.”

Other key data highlights from the In.PACT AV Access Trial include:

Endpoints and data were presented a few days ago at the Cardiovascular and Interventional Radiology Society of Europe annual meeting in Barcelona, Spain.

“The data from this study were included in our filing with FDA,” Pacyna said. “We expect approval in the second half of FY20. (Note: Medtronic is currently in FY20, which ends on April 24, 2020).

Medtronic’s study results shortly after Concept Medical was granted breakthrough device designation for MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Tampa, FL-based Concept Medical's MagicTouch AVF is coated with sirolimus and could be a competitor for Medtronic’s IN.PACT AV.

“If commercially approved for similar indications, MagicTouch AVF would be a potential competitor to IN.PACT AV, however, it is important to point out key differences between the two products,” Pacyna said. “IN.PACT AV is coated with paclitaxel—a drug that has been studied extensively in peripheral indications, including AVF. While -limus drugs (including sirolimus) have been used more frequently in the coronaries, there is little long-term evidence supporting their efficacy in AV fistulae lesions.”

Medtronic’s IN.PACT AV data comes on the heels of FDA easing up on paclitaxel device recommendations in August. Previously paclitaxel-coated balloon and paclitaxel-eluting stents were under fire after a meta-analysis showed an increased risk of death for patients treated with the technology.

The report could have also led to FDA's rejection of Becton, Dickinson and Company's BD Lutonix paclitaxel-coated balloon for below the knee peripheral artery disease.