Investigational device. Limited by Federal (or United States) law to investigational use.
TricValve® – Transcatheter Bicaval Valve System is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the superior and inferior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy.
SUPERIOR VENA CAVA VALVE
- Available Sizes: 25 mm and 29 mm Valves
- Treatment Range SVC 25: superior vena cava from 22 mm to 31 mm
- Treatment Range SVC 29: superior vena cava from 27 mm to 34 mm
- Frame Height (at relaxed state) SVC 25: 67 mm
- Frame Height (at relaxed state) SVC 29: 69 mm
- Leaflet Material: Bovine pericardium
- Skirt Material: Bovine pericardium - long skirt to prevent para valvular leak (PVL)
- Frame Material: Nitinol
INFERIOR VENA CAVA VALVE
- Available Sizes: 31 mm and 35 mm valves
- Treatment Range IVC 31: inferior vena cava from 24 mm to 31 mm
- Treatment Range IVC 35: inferior vena cava from 28 mm to 35 mm
- Frame Height (at relaxed state) IVC 31: 65 mm
- Frame Height (at relaxed state) IVC 35: 65 mm
- Leaflet Material: Bovine pericardium
- Skirt Material: Bovine pericardium + PET - short skirt to prevent hepatic vein occlusion
- Frame Material: Nitinol
Publications
- Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation, One-year outcomes, Sara Blasco-Turrión, Kasparas Briedis, et. al., JACC: Cardiovascular interventions, Vol.,(1) 60–72, 2024
- Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. Ignacio J. Amat-Santos, Rodrigo Estévez-Loureiro, Angel Sánchez-Recalde et. al., Euro Intervention, 2023;19,e450-e452, August 2023
- 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation, Rodrigo Estévez-Loureiro, Angel Sánchez-Recalde, Ignacio J. Amat-Santos, et. al., JACC: Cardiovascular interventions Vol. 15, No. 13, 2022