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

Medical Company Product News

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 drug-eluting balloon has received CE Mark approval for the treatment of end-stage renal disease.“

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.

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