Direct Flow lands Euro win for TAVI system

January 28, 2013 by MassDevice staff

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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Direct Flow recently unveiled 30-day clinical trial results for its TAVI system, reporting that 95% of its enrolled patients experienced mild or less aortic regurgitation.

Valve leakage, which can lead to aortic regurgitation, is one of the chief challenges with 1st-generation TAVI systems and one that many next-generation devices are looking to address.

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