Study Published in The New England Journal of Medicine Demonstrates Patients Experience Fewer Disruptions to Dialysis Therapy When Treated with Medtronic Drug-Coated Balloon

Results Showed IN. PACT AV DCB Is Safe, Reduces Reinterventions, and Helps Maintain Dialysis Access for Those Living with End-Stage Renal Disease

DUBLIN, Aug. 19, 2020 (GLOBE NEWSWIRE) --  Medtronic announced today the publication of the primary endpoint results from the IN.PACT AV Access trial in The New England Journal of Medicine.¹ The results reinforce that the IN.PACT AV drug-coated balloon (DCB) limits the number of reinterventions needed to maintain blood flow (patency) in patients with end-stage renal disease (ESRD) who have arteriovenous (AV) fistulae, leading to fewer interruptions to their dialysis therapy.

Nearly 2.5 million ESRD patients worldwide regularly undergo hemodialysis² — many of whom require AV fistulae in order to receive continuous dialysis. For these patients, AV fistulae serve as lifelines, and maintaining access to these sites is essential. Vessels that feed the access site can narrow (restenose) over time, however, and patients often undergo multiple maintenance procedures per year to restore access site function. The need for frequent reinterventions can result in repeated hospital visits and significant disruptions to critical hemodialysis care. Therefore, by being able to maintain access site patency, patients may experience longer periods of successful, uninterrupted dialysis.

“The six-month data demonstrate that with IN.PACT AV DCB, we can cut the number of reinterventions required to maintain vessel patency in half. This technology may positively impact patients’ quality of life, and demonstrate meaningful reductions in projected costs to the healthcare system,” said Robert Lookstein, M.D., M.H.C.D.L., U.S. study principal investigator, professor of radiology and surgery, executive vice-chair in the Department of Diagnostic, Molecular, and Interventional Radiology at the Icahn School of Medicine at Mount Sinai in New York, New York. “Right now, this is very important for ESRD patients on hemodialysis, who are at especially high risk of acquired infections. This technology may have the potential to allow these patients to experience continued, uninterrupted access to life-saving dialysis care, including fewer hospital visits to get their access sites maintained.”