The study results showed IN. PACT AV DCB is safe, reduces reinterventions, and helps maintain dialysis access for people living with end-stage renal disease
Medtronic has unveiled primary endpoint results from the IN.PACT AV Access trial, which evaluated the company’s IN.PACT AV drug-coated balloon (DCB).
The study, published in The New England Journal of Medicine, demonstrated that the company’s DCB reduced the number of reinterventions required in patients with end-stage renal disease (ESRD) who have arteriovenous (AV) fistulae, leading to fewer interruptions to their dialysis therapy.
Medtronic peripheral vascular business vice president and general manager Mark Pacyna said: “The publication of the six-month results in The New England Journal of Medicine adds to the body of evidence of the safety and clinical benefit of this paclitaxel-coated platform.
“The IN.PACT AV DCB extends the time between reinterventions and reduces hospital visits. These clinical benefits are critically important for this patient population, especially in today’s environment, and Medtronic is committed to helping people with ESRD maintain access to life-saving dialysis.”
The IN.PACT AV DCB trail is a randomised controlled trial (RCT) in 330 participants
Medtronic claimed that its IN.PACT AV DCB is the only approved DCB intended for the treatment of failing AV access.
The IN.PACT AV Access trail is a randomised controlled trial (RCT) that enrolled 330 subjects at 29 sites in US, Japan, and New Zealand.
In the study, a high rate of target lesion primary patency (86.1%) was observed in participants treated in the IN.PACT AV DCB group than those in the PTA control group (68.9%) based on Kaplan-Meier estimates for the dataset.
Patients treated with IN.PACT AV DCB required 56% reduced reinterventions to maintain lesion patency than those treated with standard PTA at six months.
The study reached primary safety endpoint with IN.PACT AV DCB group showing non-inferiority than PTA control group in the rate of severe adverse events (SAEs) within 30 days.
US study principal investigator Robert Lookstein said: “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.
“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.”