The IN.PACT Admiral drug-eluting balloon (DEB) has been granted CE mark for arteriovenous (AV) access to help maintain haemodialysis access in patients with end-stage renal disease, according to a Medtronic press release.
The IN.PACT Admiral DEB is designed to prevent restenosis by opening the artery and delivering paclitaxel—an anti-proliferative agent—to the vessel wall. Medtronic will release a new 40cm catheter shaft to the European market under the expanded indication, which is specifically designed for AV access. In the USA, the device is approved for the treatment of superficial femoral arteries and popliteal arteries.
“For patients with haemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. In the past, when the access site became stenosed, the only option was the use of a standard percutaneous transluminal angioplasty (PTA), which can result in the need for repeat procedures,” says Konstantinos Katsanos, Guy’s and St. Thomas’ Hospital, London, UK. “The IN.PACT Admiral DEB, in my experience, provides a safe and more effective way of managing AV access by preventing vascular restenosis, improving patency of dialysis fistulas and grafts, and reducing the need of repeat PTA procedures.”
“IN.PACT Admiral DEB is now indicated in Europe for the treatment of AV access, providing a durable primary intervention that aids in extending time to re-intervention while preserving future treatment options,” says Brian Verrier, vice president and general manager of the Peripheral business, within the Aortic and Peripheral Vascular division at Medtronic.