Percutanoeus Pulmonary Valve and Delivery System
Notified Body #
- 0344
Internal CECP dossier #
Date of reception of the dossier
- 05.10.2022
Field of expert panel
- Circulatory system
Medical device type
“The valve system consists of the following two components: 1) Percutaneous Pulmonary Valve (PPV) 2) Delivery System (DS), including Delivery Catheter System (DCS) and Compression Loading System (CLS) The PPV is a self-expanding heart valve designed to replace the native pulmonary heart valve without the need for open-heart surgery. The PPV is first crimped down by the CLS into the DCS and then moved through a femoral vein in the groin and into the right side of the heart where it is placed into position within the pulmonary valve.”
Intended purpose
“The intended purpose of the valve system is to replace the pulmonary heart valve with an artificial valve using a minimally invasive percutaneous approach, to treat right ventricular outflow tract (RVOT) dysfunction and specifically for the dilated outflow tracts to restore pulmonary valve function.”
Risk class / type
- class III implantable
Screening step:
appropriate medical field
/ competence area
- "Circulatory system:
- cardiovascular / lymphatic system;
- Prosthetic heart valves,
- and devices for heart valve repair"
Novelty of device
and/or of related clinical procedure
- Novelty: Device is novel