Medtronic has received CE Mark approval in Europe to introduce its CoreValve Evolut 23mm transcatheter aortic valve implantation (TAVI) system. It’s a slightly evolved device over the previously available CoreValves, being the smallest of the bunch and featuring TruFit technology to help produce an optimal fit between the failing valve and the new prosthetic. The valve is designed to be delivered to the heart via transfemoral, subclavian or direct aortic access using an 18Fr catheter.
The CoreValve system is still under investigational status in the U.S. and not cleared for sale.
From the press release:
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, 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 (Conformite Europeenne) Mark in 2007.
Press release: Medtronic Gains CE Mark for CoreValve® Evolut™ 23mm
Product page: CoreValve system…