Medtronic has received FDA approval for a new version of a drug-coated balloon, designed specifically to help clear the venous access points used by patients undergoing dialysis treatments.
The IN.PACT AV paclitaxel-coated balloon will be offered in different sizes for the U.S. market compared to the company’s similar Admiral balloon catheter, which previously received a CE mark for reopening collapsed arteriovenous fistulas in patients with end-stage renal disease. In September, a Medtronic spokesperson told FierceMedTech that it had no plans to replace that device with IN.PACT.
Fistulas are surgically created bridges that channel blood directly from an artery into a vein within the arm to help the blood vessels endure the pressures involved in regular hemodialysis. However, these vessels still narrow over time, requiring patients to undergo maintenance procedures as needed over the course of a year, which can also interrupt critical treatments.
“The FDA approval of IN.PACT AV DCB marks a significant step forward for paclitaxel-coated devices,” said Mark Pacyna, vice president and general manager of Medtronic’s peripheral vascular business. “Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery.”
The approval was based on a randomized clinical study of 330 participants, presented in September, that showed target vessels staying open in 86.1% of treated patients after 180 days, compared to 68.9% in those receiving traditional percutaneous transluminal angioplasty.
“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 Robert Lookstein, the study’s national principal investigator in the U.S. and professor of radiology and surgery at New York’s Mount Sinai Healthcare System.
“With this evidence and approval in hand, we now have a technology that provides a significant clinical benefit of a 56% reduction in repeat interventions, which I believe is a huge win for the hemodialysis community and the patients we treat,” Lookstein said in a statement.
Additionally, the IN.PACT group showed no difference in mortality rates compared to the control group through 12 months, according to Medtronic.