Medtronic receives new CE Mark approval for IN.PACT Admiral balloon

Medtronic has announced that its new IN.PACT Admiral drug-eluting balloon has been approved in Europe for arteriovenous access to help maintain haemodialysis access in patients with end-stage renal disease.

The device has been granted CE Mark approval for this expanded indication, with a new 40 cm catheter shaft also set to be made commercially available that is specifically designed for arteriovenous access.

Medtronic's IN.PACT Admiral balloon aids in preventing restenosis by opening the artery and delivering paclitaxel, an anti-proliferative agent, to the vessel wall, thus making the haemodialysis process safer.

Brian Verrier, vice-president and general manager of Medtronic's peripheral business, said: "Improving lives and alleviating pain is a core piece of Medtronic's mission, and through IN.PACT Admiral DEB, we can help physicians treat patients with end-stage renal disease."

The device is the world's most studied drug-coated balloon, with more than 20 individual studies having demonstrated its durability, safety and clinical benefits. To date, more than 70,000 patients have been treated with the IN.PACT Admiral balloon.