January 18, 2016 — Medtronic plc announced that the IN.PACT Admiral drug eluting balloon (DEB) has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Globally, more than 2.5 million end-stage renal disease patients are undergoing hemodialysis, a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy. AV access sites are used to provide hemodialysis to patients. However, thickening of the vessel walls and restenosis, due to repeated access for needed dialysis, can limit the ability to use and eventually shut down the dialysis access site. IN.PACT Admiral DEB aids in preventing restenosis, by opening the artery and delivering paclitaxel, an anti-proliferative agent, to the vessel wall. A new 40 centimeter catheter shaft will also be made commercially available in Europe under the expanded indication, which is specifically designed for AV access.
In the United States, IN.PACT Admiral DEB is approved to treat superficial femoral and popliteal arteries.
"For patients with hemodialysis, 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," said Konstantinos Katsanos, M.D., Ph.D., Guy's and St. Thomas' Hospital, London, United Kingdom. "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."
The device is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication, restenosis and alleviate pain from superficial femoral artery (SFA) disease. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.
For more information: www.medtronic.com