Medtronic, Inc. has announced it has received CE Mark for its CoreValve® Evolut™ 23mm valve, the company’s latest self-expanding transcatheter aortic valve implantation (TAVI) system.
Medtronic gained CE mark clearance for its CoreValve System in 2007 and has seen it used in more than 30,000 patients in more than 60 countries outside of the U.S. It 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 new valve incorporates technology that optimises fit, thereby promoting sealing between the prosthetic valve and the native valve (TruFit™ Technology).
With the introduction of the CoreValve Evolut valve, Medtronic can now treat the broadest range of TAVI patient valve sizes, covering 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 is currently limited to investigational use in the United States.
Source: Medtronic, Inc.