Transcatheter Heart Valves and Delivery System
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Internal CECP dossier #
Date of reception of the dossier
Field of expert panel
Medical device type
The application concerns the […] and […] transcatheter heart valves (THV) as well as the […] Delivery System and accessories […] and […] are […] The devices are designed to be delivered via transcatheter approaches to the target treatment site in the heart using the […] Delivery System and accessories.
“The current MDR application is for the following additional intended purposes: -Failure of an aortic surgical bioprosthetic valve at any or all levels of surgical risk für open-heart surgery for both […] -Failure of an aortic transcatheter bioprosthetic or surgical mitral bioprosthetic valve in patients at high or greater risk for open surgical for […]”