P+F Products + Features has received the CE mark for its medical device, the TricValve Transcatheter Bicaval Valves System.
As well as the CE mark the TricValve has been granted the FDA Breakthrough Device Designation in December 2020.The TricValve Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with haemodynamically relevant tricuspid insufficiency and caval reflux.
Dr. Katharina Kiss, CEO of P+F, said: “It is a huge milestone to receive the CE mark for the TricValve. This could be a big change in the treatment of patients with haemodynamically relevant tricuspid insufficiency and caval reflux.”
The two dedicated bioprostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve.
They are especially intended for use in patients at extreme risk or who are inoperable for open heart surgical therapy. P+F uses its “Dry Pericardium”, which enables the TricValveTranscatheter Bicval Valves System to come fully pre-mounted, thus facilitating the use of this device in daily clinical practice.
