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