EC Grants Expanded Indication to Medtronic’s Balloon Device

Irish devicemaker Medtronic has scored the CE Mark for its IN.PACT Admiral drug-eluting balloon with an expanded indication for the prevention of restenosis.

The device helps to provide arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease by opening the artery and delivering paclitaxel to the vessel wall.

A new 40 centimeter catheter specifically designed for AV access will also be available in Europe under the expanded indication.

The device is approved in the U.S. to treat superficial femoral and popliteal arteries. — Michael Cipriano