Medtronic launches new CoreValve Evolut R 34 mm valve in Europe

Medtronic has announced that its new CoreValve Evolut R 34 mm valve has received European CE Mark approval.

The company is launching the new device in Europe for the treatment of severe aortic stenosis patients with large anatomies. It becomes the largest-sized transcatheter aortic valve implantation (TAVI) system available in the region.

It is approved for use in severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm. This segment is estimated to account for around 20 to 25 percent of the eligible TAVI patient population.

Previously, some of these individuals were unable to receive a TAVI due to the larger size of their native diseased aortic valve, meaning this valve offers an important new option for this group.

Rhonda Robb, vice-president and general manager of Medtronic's heart valve therapies business, said: "With this approval, the Evolut R platform now treats the broadest annulus range of any TAVI system on the market and expands the patient population that can now receive this lifesaving therapy."

The device was previously approved by the US Food and Drug Administration in October 2016.

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