Medtronic has unveiled positive safety and effectiveness results for its IN.PACT AV drug-coated balloon (DCB) in IN.PACT AV Access trial conducted in the US, Japan and New Zealand.

The randomised controlled trial (RCT) enrolled 330 patients with end-stage renal disease (ESRD), with non-stented restenotic native arteriovenous fistulae (AVF).

According to the study data, IN.PACT AV is the first and only DCB to show sustained and superior effectiveness through two years, compared to standard percutaneous transluminal angioplasty (PTA).

Auckland University associate professor of radiology Andrew Holden said: “A patient who receives haemodialysis will often need to have several reinterventions each year to maintain patency and keep critical access sites open and functioning properly.

“Being able to show these results at two years will ultimately impact standard of care for patients undergoing dialysis. For my patients, these durable results translate into fewer reinterventions and a better quality of life.”

AV fistulae are created and used to deliver haemodialysis to ESRD patients, where the vessel restenosis developed over time will limit the effective usability of AV fistulae.

Patients usually undergo one to three AV fistula maintenance (reintervention) procedures annually, which may result in disruptions to critical haemodialysis care.

Drug-coated balloons are capable of extending the time between reinterventions as they maintain AV access site patency, and facilitates uninterrupted access to dialysis care.

Medtronic said that its IN.PACT AV DCB arm showed superior clinical benefit compared to the PTA control arm in the clinical trial.

In the IN.PACT AV Access trial, patients in IN.PACT AV DCB group showed target lesion primary patency of 52.2% compared to 36.2% in the PTA control group.

Also, the DCB resulted in 39.5% access circuit primary patency compared to 25.4%, and 82.4% freedom from all-cause mortality compared to 82.8% for the PTA control group.

Medtronic peripheral vascular health business president Dave Moeller said: “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.

“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.”