Native Tricuspid Valve Replacement
Notified Body #
- 0344
Internal CECP dossier #
Date of reception of the dossier
- 28.04.2022
Field of expert panel
- Circulatory system
Medical device type
The […] system is designed to replace the natice tricuspid valve. […] The […] valve consists of a trileaflet bovine pericardial tissue valve […] to be implanted in the native valve position.
Intended purpose
The […] tricuspid valve replacement system is intended for the reduction of tricuspid regurgitation (TR) for patients who remain symptomatic on medical therapie and in whom no other surgical or transcatheter treatment option exists per heart team decision.
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 and Device are novel