US-based Medtronic has received CE mark approval for its 23mm CoreValve Evolut R System for transcatheter aortic valve implantation (TAVI).
The new 14FR equivalent delivery system provides an 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.
Germany’s University Hospital Bonn Center of Innovative Interventions in Cardiology (CIIC) head Eberhard Grube said: "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."
The system, which features CoreValve Evolut R transcatheter aortic valve and EnVeo R Delivery Catheter System, also offers a new InLine Sheath that minimises the risk of major vascular complications.
Medtronic heart-valve therapies vice-president and general manager Rhonda Robb said the new next-generation device offers heart teams with meaningful advancements that will increase the potential for optimal device placement.
"Built on the proven foundation and procedural success of the CoreValve System with more than 65,000 implants worldwide, the CoreValve Evolut R System is the future of transcatheter aortic valve replacement," Robb added.
Currently, the 23mm CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery are available in Europe and other countries that recognize the CE mark, while the system is not approved for commercial use in the US.