TRIFORMIS RESILIA tricuspid valve
Tackling the leading causes of structural valve deterioration
RESILIA tissue*1, created through a novel preservation technology applied to bovine pericardium, has been shown in pre-clinical studies to significantly reduce both calcification and pannus.2,3
These pre-clinical and clinical studies are part of a growing base of evidence supporting the durability and hemodynamic performance of RESILIA tissue valves.1,2,3,4
*Clinical data on valves with RESILIA tissue up to 7-year follow-up have been published, with additional follow-up of up to 10 years in process.
Pannus formation pre-clinical study
Pre-clinical study performance of the TRIFORMIS RESILIA valve in the tricuspid position demonstrated:
TRIFORMIS RESILIA tricuspid valve specifications
See model numbers and dimensions
References
- Beaver T, Bavaria J, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2023;x:1-11. doi: 10.1016/j.jtcvs.2023.09.047
- Tod TJ, Gohres RA, Torky M et al. Influence of tissue technology on pannus formation on bioprosthetic heart valves. Cardiovasc Eng Technol. 2021; 12: 418-25. doi: 10.1007/s13239-021-00530-1
- Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340-345. doi: 10.1016/j.jtcvs.2014.09.062
- Heimansohn DA, Baker C, Rodriguez E, et al. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. JTCVS Open. 2023;15:151-163. doi: 10.1016/j.xjon.2023.05.008
Important Safety Information
TRIFORMIS RESILIA Tricuspid Valve
Indications: For use in replacement of native or prosthetic tricuspid heart valves.
Contraindications: The TRIFORMIS RESILIA tricuspid valve is contraindicated in patients who have untreatable hypersensitivity to nitinol alloys (nickel and titanium).
Complications and Side Effects: Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.
CAUTION: US law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information.