Medtronic Gets CE Mark for Larger Expanding Valves

Thursday, February 5, 2015

Source: FDA News

Medtronic said Monday that it has received a CE mark for its 26mm and 29mm sizes of the CoreValue Evolut R System, a self-expanding valve that enhances performance and deliverability during transcatheter aortic valve implantation procedures.

The CoreValve Evolut provides physicians the option of resheathing the valve back into the catheter and moving it to a new position during procedures. The larger valves join a 23 mm version and are delivered via the lowest profile delivery system on the market, less than 1/5 of an inch, Medtronic said. This allows small vessels to be accessed and offers an extended sealing skirt to further promote valve sealing at the annulus, the company said.

The 23 mm size was CE-marked in September. The system is currently undergoing clinical trials in the U.S.

Rhonda Robb, vice president and general manager of heart valve therapies at Medtronic, said the additional valve sizes have been highly anticipated by physicians since the launch of the 23 mm last fall. The company will support heart teams using the device through training, education, imaging and patient evaluation program, she added.

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