Transcatheter Heart Valves and Delivery System

Notified Body #

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.

Intended purpose

“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 […]”

Risk class / type

Screening step:
appropriate medical field
/ competence area

Novelty of device
and/or of related clinical procedure