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CoreValve Evolut nets CE mark

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Medtronic has announced today that its self-expanding transcatheter aortic valve replacement system CoreValve Evolut has gained CE mark approval.

The 23-mm valve incorporates TruFit technology that optimizes fit and promotes sealing between the prosthetic and native valves.

Currently, Medtronic offers TAVR valves in four sizes — 23 mm, 26 mm, 29 mm and 31 mm — that can each be delivered via transfemoral, subclavian and direct aortic access through a low-profile, 18F delivery catheter. With the approval, the company’s valves can now treat the broadest range of TAVR patient valve sizes (annulus diameters from 18 mm-29 mm), according to a company-issued press release.

“The CoreValve System has been successfully implanted in tens of thousands of patients worldwide, and this new valve builds on that experience,” Eberhard Grube, MD, of the University Hospital Bonn in Germany, said in the release. “Because the CoreValve Evolut technology customizes anatomical fit, it conforms to the patient’s anatomy and promotes sealing.”

The CoreValve Evolut is currently investigational in the United States.