CE mark for recapture CoreValve Evolut system


Medtronic has announced that it has received the CE mark for its 23mm CoreValve Evolut R system for transcatheter aortic valve implantation (TAVI). A company press release states that the novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that advance valve performance and deliverability during the procedure, while providing the option to recapture (re-sheath the valve back into the catheter) and reposition (move the valve to a new position either above or below its current placement) the valve during deployment phase, if needed.

“The CoreValve Evolut R system offers improvements to a proven TAVI technology platform,” said Eberhard Grube, Center of Innovative Interventions in Cardiology (CIIC), University Hospital Bonn, Germany. “The system’s new recapture-enabled capabilities and advancements in valve delivery provide physicians with added procedural confidence. It’s a significant advance to know there is the option to redeploy the valve in the ideal position if necessary.”

According to the press release, the novel system consisting of the CoreValve Evolut R transcatheter aortic valve and the EnVeo R delivery catheter system is designed for first-time positioning accuracy and also offers a new InLine sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch); a smaller profile size is believed to minimise the risk of major vascular complications. The new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing, while maintaining supra-annular valve position for improved haemodynamic performance.

The 23mm CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system are now available in Europe and other countries that recognise the CE mark.