Medtronic Gains CE Mark for CoreValve® Evolut™ 23 mm Transcatheter Aortic Valve
CoreValve Evolut Designed for Optimal Fit; With 23mm the CoreValve Family Treats Broadest Range of Patient Valve Sizes
MINNEAPOLIS – September 26, 2012 – Medtronic, Inc. today announced it has received CE (Conformité Européenne) Mark for its Medtronic CoreValve® Evolut™ 23mm 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 18mm to 29mm).
“The CoreValve System has been successfully implanted in tens of thousands of patients worldwide, and this new valve builds on that experience,” said Prof. Eberhard Grube, MD, 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 (Conformite Europeenne) Mark in 2007. Medtronic now offers TAVI in four valve sizes (23mm, 26mm, 29mm and 31mm), each deliverable via transfemoral, subclavian and direct aortic access through a low-profile, 18Fr delivery catheter. The CoreValve System has been implanted in more than 30,000 patients in more than 60 countries outside of the U.S.