Summary: First Commercial Approval of a Polymer Heart Valve (Tria Mitral Valve).
Summary:
First Commercial Approval of a Polymer Heart Valve (Tria Mitral Valve).
The device received approval in India, announced on June 5, 2025, following positive clinical data first presented at the New York Valves Summit in 2024—marking a major step forward in polymer valve technology.
1. Historic Milestone:
• Foldax’s Tria mitral valve, made from proprietary LifePolymer, has received commercial approval in India—the first-ever regulatory approval for a polymer heart valve globally.
2. Material and Design:
• The valve is animal tissue-free and robotically manufactured to match each patient’s native mitral anatomy.
• LifePolymer is engineered to resist calcification and degradation, enhancing long-term durability.
3. Anticoagulation Needs:
• Tria is expected to require anticoagulant only for a short period after surgery, similar to tissue valves, offering a safer option for many patients—especially those who cannot tolerate lifelong anticoagulation.
4. Durability Expectations:
• While long-term data is still being gathered, the valve is expected to have a lifespan of 15–20 years or more, based on its resistance to structural degeneration.
5. Clinical Trial Data:
• Approval was supported by clinical data from 67 patients (ages 19–67), mostly women, presented at New York Valves 2024.
• Results showed good short-term outcomes and potential for broad applicability, including in young adults and women of childbearing age.
6. Manufacturing and Partnership:
• The Tria valves will be locally manufactured in India by Dolphin Life Sciences.
7. Future Expansion:
• Foldax aims to extend the LifePolymer and robotic manufacturing platform to additional structural heart applications, including transcatheter valve technologies and other valve positions.
8. U.S. Regulatory Status:
• The Tria valve has not yet received FDA approval for commercial use in the United States.