Transcatheter Heart Valves and Delivery System
Notified Body #
- 0344
Internal CECP dossier #
Date of reception of the dossier
- 23.03.2022
Field of expert panel
- Circulatory system
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
- class III implantable
Screening step:
appropriate medical field
/ competence area
- Circulatory system
Novelty of device
and/or of related clinical procedure
- Novelty: Procedure is novel