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Limited by Federal (or United States) law to investigational use only.
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Clinical References

1
Jenney, C., Millson, P., Grainger, D. W., Grubbs, R., Gunatillake, P., McCarthy, S. J., Runt, J., & Beith, J. (2021). Assessment of a siloxane poly(urethane-urea) elastomer designed for implantable heart valve leaflets. Advanced NanoBiomed Research, 1(1), 2000032. https://doi.org/10.1002/anbr.202000032
2
Rezvova, M. A., Klyshnikov, K. Y., Gritskevich, A. A., & Ovcharenko, E. A. (2023). Polymeric heart valves will displace mechanical and tissue heart valves: A new era for the medical devices. International Journal of Molecular Sciences, 24(4), 3963. https://doi.org/10.3390/ijms24043963
3
Foldax Inc., Data on file.
4
Yakubov, S. J., Wittel, J., & Johnson, G. (2022). CRT-700.20 Foldax TRIA TAVI: A novel-polymer transcatheter aortic valve: Pilot chronic ovine model study. JACC: Cardiovascular Interventions, 15(Supplement), S59–S60.
5
George, I. (2024). Surgical mitral valve replacement with a novel polymeric valve: 30-day results from an Indian clinical study of the Foldax® TRIA™ valve. Presentation at New York Valve Presentation 2024.
6
Malvindi PG, Mastro F, Kowalewski M, Ringold M, Margari V, Suwalski P, Speziale G, Paparella D. Durability of Mitral Valve Bioprostheses: A Meta-Analysis of Long-Term Follow-up Studies. Ann Thorac Surg. 2020 Feb;109(2):603-611. doi: 10.1016/j.athoracsur.2019.07.024. Epub 2019 Aug 28. PMID: 31472130.
7
Coisne, A., Lancellotti, P., Habib, G., & others. (2023). ACC/AHA and ESC/EACTS guidelines for the management of valvular heart diseases: JACC guideline comparison. Journal of the American College of Cardiology, 82(8), 721–734. https://doi.org/10.1016/j.jacc.2023.05.061
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Foldax® is reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs between tissue and mechanical valves.

For more information on current clinical investigations, please go to: ClincialTrials.gov

TRIA™ Heart Valves are Investigational devices. Limited by Federal (or United States) law to investigational use. TRIA™ Mitral Valves are approved for use in India by CDSCO

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