Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints.
The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona on September 7.
The randomized, controlled trial included 330 subjects across 29 sites in the U.S., Japan and New Zealand. The patient population had been undergoing dialysis for an average of 4.3 years, according to Medtronic.
Kaplan-Meier estimates the primary patency rate of the target lesion in the In.Pact AV DBC group was 86.1% at 180 days and 81.4% at 210 days. The patency rate in the PTA control group was 68.9% at 180 days and 59% at 210 days.
The study also notes that patients in the In.Pact group required 56% fewer reinterventions to maintain target lesion patency through 210 days, compared to the PTA group. After 360 days, freedom from all-cause death was 90.6% in the In.Pact group and 90.4% in the PTA group, which Medtronic said is in line with initial data presented in June.
“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,” Dr. Andrew Holden, director of interventional radiology at Auckland Hospital & associate professor of radiology at Auckland University, said in a news release. “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.”
“The data presented today at CIRSE demonstrate the potential of In.Pact AV DCB to address restenosis in high-risk patients who currently have few long-term treatment options available to them,” added Mark Pacyna, VP & general manager of the peripheral vascular business of the aortic, peripheral, and venous division at Medtronic. “As part of our commitment to improving outcomes, we look forward to generating further clinical evidence in support of this therapy.”
The In.Pact AV DBC has CE Mark approval in Europe and was approved in Japan, where it was launched in August 2018, but it remains an investigational device in the U.S.
Shares of MDT were down -0.8% at $107.82 per share in early-morning trading today.
