Medtronic has announced that it has received the CE mark for its CoreValve Evolut 23mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system.
According to Medtronic, the new valve incorporates technology that optimises 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.
The CoreValve Evolut valve is available in annulus diameters ranging 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 Eberhard Grube, University Hospital Bonn in Bonn, Germany. “Because the CoreValve Evolut technology customises anatomical fit, it conforms to the patient’s anatomy and promotes sealing.”
The Medtronic CoreValve System received the CE 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.