The Tria mitral valve, a novel polymer heart valve from Foldax, demonstrated encouraging one-year results in patients undergoing surgical mitral valve replacement (SMVR), according to data presented at New York Valves 2025 and published in the Journal of the American College of Cardiology.
The valve, made from Foldax’s proprietary LifePolymer material and designed to match patients’ native mitral anatomy, became the first polymer heart valve to receive commercial approval—granted recently in India.
The analysis involved 67 patients treated in India in 2023, with a mean age of 42 and predominance of rheumatic heart disease. Technical success was 100%. One-year outcomes included 9.1% all-cause mortality, 7.5% thromboembolic events, 4.9% stroke, and no structural valve deterioration or reintervention. Functional measures showed a mean inflow gradient of 4.6 mmHg and improved Kansas City Cardiomyopathy Questionnaire scores.
“These results validate our strategy of innovation in heart valve therapy,” said Foldax CEO Ken Charhut. The valve has not yet received FDA approval.
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