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California medical device maker Direct Flow Medical lands CE Mark approval in the European Union for its transcatheter aortic valve implantation system.

Direct Flow's TAVI system

California-based medical device maker Direct Flow Medical touted European regulatory approval for its transcatheter aortic valve implantation system, which the company says "virtually eliminates aortic regurgitation."

The device touts a metal-free frame and a low-profile delivery system, as well as a double-ring design that is both repositionable and retrievable after full deployment.

European healthcare officials cleared 2 sizes of the Direct Flow valve and both will be on the market immediately, according to a press release.

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