The approval allows Medtronic to move forward with the IN.PACT AV balloon to treat failing arteriovenous access for patients with end-stage renal disease undergoing dialysis.
The US Food and Drug Administration (FDA) is giving the green light to the IN.PACT AV drug-coated balloon to maintain arteriovenous (AV) access in patients undergoing dialysis with end-stage renal disease (ESRD).
AV fistulae are created and used to enable hemodialysis for patients with ESRD, but vessel restenosis eventually limits the ability to use AV fistulae effectively.
To restore function, patients may have to undergo as many as 3 maintenance procedures annually, resulting in significant disruptions to critical hemodialysis care and increased costs to the healthcare system.
The approval is based on a prospective, global, multicenter, blinded, randomized investigational device exemption study involving 330 patients.
Data from the clinical trial shows that the balloon can extend the time between reinterventions by maintaining AV access site patency, maximizing a patient’s uninterrupted access to dialysis care.
Patients treated with IN.PACT AV DCB maintained patency longer and required 56% fewer reinterventions than those treated with standard percutaneous transluminal angioplasty through 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, interventional radiologist at Holy Name Medical Center and an investigator for the IN.PACT AV Access trial, said in a statement. “When these access sites fail, patients experience delays in their dialysis treatment and require multiple reinterventions to keep the site functioning.”
The investigators also found no difference in mortality rates between the 2 groups after 12-months.
The device works by increasing blood flow and reducing the thickening of the vessel wall by delivering the anti-proliferative drug paclitaxel. The drug penetrates deep into the vessel wall to prevent restenosis, which could potentially extend the time between reinterventions.