Edwards SAPIEN XT Transcatheter Heart Valve FDA Approved

June 17, 2014 9:41 PM

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Edwards Lifesciences received FDA approval for its SAPIEN XT transcatheter aortic heart valve for implantation in patients with symptomatic aortic stenosis who are poor candidates for traditional surgery. The same device has recently been approved in Europe for valve-invalve aortic and mitral procedures.

The SAPIEN XT is implanted using the NovaFlex+ system, that can be delivered via a 16-French expandable sheath, and the Ascendra+ transcapical and transaortic delivery systems. The new valve is available in sizes up to 29mm, allowing for treatment of patients with particularly large native annuli.

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