“In many cases, AV fistula are considered lifelines for patients with [end-stage renal disease] as they are the primary access point for life-saving dialysis treatment. When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning,” said Dr. Vincent Gallo, an interventional radiologist at Holy Name Medical Center in Teaneck, N.J., and an investigator for the IN.PACT AV Access trial.
“With this approval physicians now have access to a safe and extremely effective therapy to slow the progression of restenosis, which results in fewer reinterventions and disruptions in care for these patients,” Gallo said in a Medtronic news release yesterday.
The IN.PACT AV Access trial involved 330 subjects at 29 sites in the United States, New Zealand and Japan. People treated with the IN.PACT AV balloon maintained patency longer and required 56% fewer reinterventions compared to those treated with standard percutaneous transluminal angioplasty through six months, according to Medtronic.
“Until now, there were virtually no therapies available to treat AV fistulae lesions that had demonstrated an ability to maintain primary patency and reduce reinterventions over time,” said Dr. Robert Lookstein, national principal investigator in the U.S. and professor of radiology and surgery at Mount Sinai Healthcare System in New York.
Mark Pacyna, VP and general manager of the Peripheral Vascular business in the Medtronic Cardiac & Vascular Group, described FDA approval of the IN.PACT AV as a significant step forward for paclitaxel-coated devices. “Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery.”