Polymer heart valve, the first of its kind to gain commercial approval, linked to positive 1-year data
A new-look polymer heart valve is associated with encouraging one-year outcomes in patients undergoing surgical mitral valve replacement (SMVR), according to new data presented at New York Valves 2025 and published in the Journal of the American College of Cardiology.[1]
The Tria mitral valve from Utah-based Foldax is built using LifePolymer, a proprietary material that does not include any animal tissue. Both the frame of the valve and its leaflets are robotically generated to match the patient’s native mitral valve.
The valve made headlines in early June when it was approved for commercial use in India. This represented the first time a polymer heart valve had ever gained such an approval anywhere in the world.
The new analysis was based on 67 SMVR patients who underwent treatment in India from April to November 2023. The mean patient age was 42 years old, 64% were women and the mean Society of Thoracic Surgeons risk score was 1.4%. A majority of patients presented with rheumatic heart disease.
The technical success rate was 100%. After one year, the rates of all-cause mortality, thromboembolic events, stroke, structural valve deterioration and valve reintervention were 9.1%, 7.5%, 4.9%, 0% and 0%, respectively. None of the patient deaths were linked to the valve. The one-year effective orifice area was 1.4 cm2, and the one-year mean inflow gradient was 4.6 mmHg.
In addition, the valve was associated with consistent improvements in Kansas City Cardiomyopathy Questionnaire scores.
“It is exciting to see the positive clinical outcomes associated with this novel polymer valve,” first author Isaac George, MD, surgical director of the Heart Valve Center at Columbia University, said in a statement. “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”
“These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally,” added Ken Charhut, CEO of Foldax.
This Tria surgical mitral valve has not yet gained U.S. Food and Drug Administration (FDA) approval to be used commercially in the United States.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.