Medtronic's CoreValve Evolut 23-mm TAVI Device Gains CE Mark Approval

September 26, 2012—Medtronic, Inc. (Minneapolis, MN) announced it has received CE Mark approval for the CoreValve Evolut 23-mm valve, which is the company's latest self-expanding transcatheter aortic valve implantation (TAVI) system. The new valve incorporates TruFit technology intended to optimize fit and promote sealing between the prosthetic valve and the native valve.

In its press release, Medtronic advised that with the introduction of the CoreValve Evolut valve, it now offers TAVI devices that can treat a wide range of patient valve sizes (annulus diameters of 18 to 29 mm). The CoreValve TAVI system, which received CE Mark approval in 2007, is available 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-F delivery catheter.

The Medtronic CoreValve system is currently limited to investigational use in the United States.