The valve replacement space keeps adding contenders, and Foldax’s polymer-based TRIA Mitral Valve replacement showed compelling one-year results in its India Clinical Trial presented at New York Valves 2025, suggesting we could soon have an alternative to bovine tissue valves.
- Foldax’s TRIA surgical mitral valve recently received commercial use approval in India, making it the first polymer heart valve to go to market anywhere in the world.
- TRIA is built using LifePolymer, which doesn’t include animal tissue and its leaflets and frame are robotically generated to match each patient’s native mitral valve.
- The new polymer helps reduce valve calcification and could potentially allow patients to avoid long-term anticoagulant use.
Researchers tested the new surgical TRIA polymer valve on 67 patients (aged 19 to 67) across India and found that the mitral valve replacement led to no valve-related mortality or reinterventions, among other encouraging results like…
- A >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg).
- A >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies.
- 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant QoL improvements.
When it came to adverse outcomes, only two thrombotic events and three ischemic strokes occurred, all in patients with subtherapeutic vitamin K antagonist levels.
While these results are encouraging, Foldax’s TRIA still has to contend with some of the biggest medtech companies in the world, many of which already have a start in the MV space.
- For example, Abbott already produces the MitraClip for mitral valve repair and the Tendyne transcatheter mitral valve replacement system.
- Meanwhile, Edwards Lifesciences manufactures the MITRIS RESILIA surgical mitral valve and the PASCAL transcatheter valve repair system.
The Takeaway
A new mitral valve replacement option might be on the way following these successful trial results, but it’s still an uphill climb for Foldax to gain U.S. regulatory approval and then compete in a market dominated by medtech giants. Still, its innovative polymer and custom profile might give TRIA a chance.
