Medtronic Gains CE Mark for Corevalve Evolut 23 mm Transcatheter Valve


September 27, 2012
Medtronic Inc. CoreValve Evolut Heart Valve Repair

September 27, 2012 — Medtronic Inc. announced it has received CE mark for its Medtronic CoreValve Evolut 23 mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system. The new valve incorporates technology that optimizes fit, thereby promoting sealing between the prosthetic valve and the native valve (TruFit Technology). The Medtronic CoreValve System is currently limited to investigational use in the United States.

With the introduction of the CoreValve Evolut valve, Medtronic can now treat the broadest range of TAVI patient valve sizes (annulus diameters from 18 mm to 29 mm).

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

The Medtronic CoreValve System received CE mark in 2007.

Medtronic now offers TAVI in four valve sizes (23 mm, 26 mm, 29 mm and 31 mm), each deliverable via transfemoral, subclavian and direct aortic access through a low-profile, 18 French delivery catheter. The CoreValve System has been implanted in more than 30,000 patients in more than 60 countries outside of the United States.

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