Native Tricuspid Valve Replacement

Notified Body #

Internal CECP dossier #

Date of reception of the dossier

Field of expert panel

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

Screening step:
appropriate medical field
/ competence area

Novelty of device
and/or of related clinical procedure