Table 1.
List of transcatheter tricuspid valve devices currently in development and testing.
| Device | Manufacturer | Composition | Anchor design features | Sizes (mm) | Access | Published data | Registered clinical trials | Patients | Primary endpoints |
|---|---|---|---|---|---|---|---|---|---|
| Orthotopic | |||||||||
| Cardiovalve | Boston Medical | Nitinol frame, bovine pericardial leaflets | Leaflet grasping and atrial flange delivery | 3: M/45, L/50, XL/55 (XL <60 in development) | 28Fr transfemoral | Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation (NCT04100720) | 15 single arm | Intra-procedural technical success, SADE at 30 days | |
| Evoque | Edwards | Bovine pericardial leaflets | Intra-annular sealing skirt and anchors | 2 (44, 48) | 28Fr transfemoral | 1st in-human performed Mar 2020 | N/A (mitral valve only) | ||
| Lux-Valve | Jenscare Biotechnology | Self-expanding bovine pericardial tissue valve on nitinol stent covered by layer of polyethylene terephthalate | Leaflet fixation: 2 anterior leaflet clampers; septal anchoring: via interventricular anchorage | Annular 3 (50, 60, 70); leaflet inner diameter 2 (26, 28) | Transatrial insertion via minimally invasive right thoracotamy | 35 patients, compassionate use | N/A | ||
| NaviGate | NaviGate Cardiac Structures | Tapered nitinol stent with xenogenic pericardial leaflets | Atrial winglets, ventricular graspers | 4 (36–52); oversize 2–5% | 42Fr introducer via transjugular or transatrial (R thoracotomy) | 32 patients, compassionate use | N/A | ||
| TriSol | TriSol Medical | Self-expanding conical nitinol stent, porcine pericardium ventricular and polyester atrial skirts; single bovine pericardial dome shaped leaflet attached in 2 opposite central commisures (bileaflet) | Axial force; retrievable, repositionable | 30Fr transjugular | N/A | ||||
| Intrepid | Medtronic | Dual stent system with 29mm bovine pericardial valve | Recoverable any time before final release | 43, 46, 50 | 35 Fr transfemoral (29Fr in development) | N/A (mitral valve only) | |||
| TRiCares | TriCares SAS | Self-exapanding bovine pericardial valve mounted on nitinol stent frame | N/A | ||||||
| Heterotopic | |||||||||
| Sapien XT | Edwards | Balloon-expandable, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET) fabric skirt | Requires preceding stent implantation | 20, 23, 26, 29 | 14Fr or 16Fr | TRICAVAL ended prematurely due to high rate of dislodgement (not published) | HOVER (NCT02339974) | 15 Single Arm | Procedural success: device success and no device/procedure related SAEs (30 days), patient success: no right heart failure related hospitatlization or advanced therapies; improvement in KCCQ, 6MWT or peak VO2 |
| TricValve | P + F Products + Features | Self-expanding pericardial tissue on nitinol stents | N/A | SVC- 30 with variable hip protrusion up to 45; IVC- up to 43 | 27Fr transfemoral | First in-human | TRICUS (NCT03723239) | 10 Single Arm | Major SAE (30 days), change in NYHA class (6 months) |
| TRICUS Euro (NCT04141137) | 35 single arm | Major SAE, KCCQ (30 days), KCCQ (3 months) | |||||||
| Tricento | New Valve Technology | 13.5cm covered stent with landing zones in SVC and IVC and low intra-atrial porcine bicupsid valve segment. Short non-covered segment for hepatic vein inflow | N/A | Custom made up to 48 | 24Fr Transfemoral | First in-human | N/A | ||