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| Medtronic's CoreValve Evolut R System--Courtesy of Medtronic |
Medtronic ($MDT) said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation (TAVI) paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.
The regulatory approval means the device is available in Europe and other countries around the world that recognize the CE mark, but not the U.S.
"The CoreValve Evolut R System offers improvements to a proven TAVI technology platform," said Dr. Eberhard Grube, of Bonn, Germany's Center of Innovative Interventions in Cardiology, in a statement. "The system's new recapture-enabled capabilities and advancements in valve delivery provide physicians with added procedural confidence. It's a significant advance to know there is the option to redeploy the valve in the ideal position if necessary."
Medtronic said the device's profile (less than one-fifth of an inch) is the lowest on the market, which should result in fewer complications. It is "built on the proven foundation and procedural success of the (first generation) CoreValve System, with more than 65,000 implants worldwide," said Medtronic vide president Rhonda Robb in a statement.
The CoreValve competes with Edwards Lifesciences' ($EW) Sapien artificial valve in the market for alternatives to open heart surgery. It is among the fiercest rivalries in med tech. Edwards has the upper hand, as evidenced by the $750 million one-time payment it received from Medtronic over a patent dispute. The payment (and promise of future royalties) also eliminated the threat of an injunction against the first generation CoreValve in the U.S. market.
But with the upgraded CoreValve Evolut R, Medtronic hopes to gain ground against its rival.
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