CE Mark Approved for Medtronic’s In.Pact Admiral DCB to Treat AV Access in Hemodialysis Patients
January 11, 2016—Medtronic plc announced that the In.Pact Admiral drug-coated balloon (DCB) has received European CE Mark approval for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. A new 40-cm catheter shaft will also be made commercially available in Europe under the expanded indication, which is specifically designed for AV access.
The In.Pact Admiral DCB aids in preventing restenosis by opening the artery and delivering antiproliferative paclitaxel to the vessel wall. In 2009, the In.Pact Admiral DCB received CE Mark approval to treat peripheral artery disease. In December 2014, the device was approved by the US Food and Drug Administration to treat superficial femoral and popliteal arteries.
In Medtronic’s press release, Konstantinos Katsanos, MD, of Guy’s and St. Thomas’ Hospital in London, United Kingdom commented, “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. The In.Pact Admiral DCB, 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.”