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Medtronic device gets CE mark for AV access in dialysis patients
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Medtronic PLC has received a CE Mark for its IN.PACT Admiral drug eluting balloon (DEB) for arteriovenous (AV) access in hemodialysis patients. The device is known as the IN.PACT Admiral drug-coated balloon in non-European markets.
The device aids in preventing restenosis in dialysis patients' access sites 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.
A spokesperson from Medtronic told NN&I that the company will be pursuing FDA approval for a drug-coated balloon for AV Access in the United States
“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, MD, PhD, from Guy's and St. Thomas' Hospital in London. "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.”