Medtronic (NYSE:MDT) said it won CE Mark approval for the latest version of its transcatheter aortic valve implant, the CoreValve Evolut R, meaning the repositionable replacement heart valve is now available on the European market.
The CoreValve Evolut R is designed to allow implanting physicians to return the device to its EnVeo R delivery catheter and reposition it as needed, according to a press release.
"The CoreValve Evolut R system offers improvements to a proven TAVI technology platform," Dr. Eberhard Grube of the University Hospital in Bonn said in prepared remarks. "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 CoreValve Evolut R also uses Medtronic’s InLine sheath, which has a smallest profile on the market, according to the release.
"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," heart valve therapies general manager Rhonda Robb said in a statement. "A truly next-generation device, CoreValve Evolut R provides heart teams with meaningful advancements that will increase the potential for optimal device placement."
Medtronic is running a clinical trial of the CoreValve Evolut R in the U.S., ahead of a bid for FDA approval of the device. The company has carved out a 40% share of the U.S. TAVI market since the 1st CoreValve iteration was approved in January.