Medtronic plc has received approval from the FDA for its IN.PACT AV drug-coated balloon, which was designed to prevent vessel restenosis, thereby enabling arteriovenous access sites to continue functioning properly for patients on hemodialysis. The company's IN.PACT Admiral device already received a CE mark for the treatment of failing AV access in 2016.
“The FDA approval of IN.PACT AV DCB marks a significant step forward for paclitaxel-coated devices,” Mark Pacyna, vice president and general manager of the peripheral vascular business in the Medtronic Cardiac & Vascular Group, said in a company press release. “Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery. We are excited to bring this technology to physicians in the U.S. and to help improve the lives of patients living with ESRD.”
According to the release, the approval follows results from a prospective, global, multicenter trial that randomized 330 patients to treatment with IN.PACT AV drug-coated balloon or percutaneous transluminal angioplasty. While the trial demonstrated comparable safety (with no difference in mortality) between the two treatments, those treated with the drug-coated balloon required 56% fewer reinterventions during the course of 6 months.
“In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment,” Vincent Gallo, MD, an interventional radiologist at Holy Name Medical Center in Teaneck, New Jersey, and an investigator for the IN.PACT AV Access trial, said. “When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning. 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.”