A new version of Medtronic’s drug-coated balloon, designed specifically to help reopen the collapsing fistulas used by patients as access ports for dialysis treatments, has met its primary endpoints in its first large study.
The medtech giant’s IN.PACT AV balloon is being developed for the U.S. market, as well as Japan and New Zealand, in different sizes compared to Medtronic’s paclitaxel-coated IN.PACT Admiral device.
The Admiral balloon previously received a CE mark clearing it for use in arteriovenous fistulas in January 2016, and Medtronic currently has no plans to replace that product in the European market, according to a company spokesperson.
IN.PACT AV’s clinical study enrolled 330 patients who had been receiving hemodialysis treatments for an average of 4.3 years. Compared to traditional percutaneous transluminal angioplasty, patients who received treatment with the drug-coated balloon needed 56% fewer reinterventions to maintain their access fistula over 210 days.
According to Medtronic, narrowing fistulas can interrupt critical dialysis treatments, with end-stage renal disease patients having to undergo one to three maintenance procedures each year.
In the study, the target vessel remained open in 86.1% of treated patients after 180 days, compared to 68.9% in the control group. After 210 days, the IN.PACT arm had a patency rate of 81.4%, versus 68.9% with traditional angioplasty, while safety data were similar. The results were presented at the annual meeting of the Cardiovascular and Interventional Radiology Society of Europe in Barcelona, Spain.