Medtronic (NYSE:MDT) today touted safety and effectiveness results from a 24-month study of its In.Pact AV drug-coated balloon.
Fridley, Minn.-based Medtronic said in a news release that the data demonstrated that the In.Pact AV DCB is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty (PTA) in end-stage renal disease (ESRD) patients with de novo or non-stented restenotic native arteriovenous fistulae (AVF) in the upper extremity.
The In.Pact AV Access prospective, global, single-blinded randomized controlled trial enrolled 330 subjects across 29 sites in the U.S., Japan and New Zealand. Six-month data demonstrating that the DCB reached primary endpoints were presented in September 2019.
Over two years, the group in the trial receiving treatment with the In.Pact AV DCB demonstrated a continued clinical benefit compared to the PTA control group. Target lesion primary patency through 24 months came in at 52.2% in the In.Pact AV group, compared to 36.2% in the PTA control group.
Additionally, access circuit primary patency was 39.5% in the In.Pact AV group, topping the 25.4% registered in the PTA control. However, freedom from all-cause mortality through 24 months was 82.4% in the In.Pact AV group, compared to a slightly better 82.8% in the PTA control group.
“Medtronic is committed to providing physicians and patients with technology to improve dialysis access maintenance outcomes and reduce disruptions to care. Both our investment in this study as well as its results are a clear testament to this,” Medtronic president of the peripheral vascular health business Dave Moeller said in the release. “These results are significant not only because In.Pact AV is the only DCB to meet both safety and effectiveness endpoints through six months, but also because it demonstrates that at two years, In.Pact AV does better than PTA in helping to keep critical lifelines open and reduce the number of times a patient needs to return to their physician for a reintervention.”