Polymer heart valve trial shows promising results after one year

Polymer heart valve shows promise: ©Yodiyim - stock.adobe.com

Foldax Inc. announced one-year results from its India clinical trial of the TRIA Mitral Valve, marking the first published long-term data from a multicenter clinical study of a polymer heart valve. The findings, presented at the New York Valves 2025 conference and published in the Journal of the American College of Cardiology, showed strong safety outcomes, sustained hemodynamic performance, and significant improvement in patient quality of life.

The prospective study enrolled 67 patients aged 19 to 67 across eight sites in India. More than 60% of the participants were women, with nearly half of those of childbearing age—a group traditionally underrepresented in such trials. 73% of patients had rheumatic heart disease, a condition prevalent in developing regions.

Key results included no valve-related mortality or reinterventions, a greater than 50% reduction in mean mitral valve gradient, and over a 90% increase in effective orifice area. Patients also experienced substantial gains in function and well-being, with a 24-point improvement in their Kansas City Cardiomyopathy Questionnaire score and a 65% increase in their Six-Minute Walk Test distance.

“It is exciting to see the positive clinical outcomes associated with this novel polymer valve,” said Isaac George, surgical director of the Heart Valve Center at Columbia University. “This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions.”

Foldax’s TRIA valve uses a proprietary polymer known as LifePolymer, designed for durability and resistance to calcification. The valve is robotically manufactured for consistency and precision.

“This trial provides hope for Indian patients—including younger patients and many women of childbearing age—for whom current valve options often fall short,” said Kaushal Pandey, principal investigator for the India trial.

Innovation accelerates in heart valve replacement technologies

The heart valve replacement field is experiencing rapid innovation, with emerging technologies aiming to overcome long-standing challenges associated with traditional mechanical and tissue valves. A key area of focus is improving durability while reducing the need for long-term anticoagulation therapy, a major drawback of mechanical valves. New materials—especially proprietary polymers—are being developed to resist calcification and degradation, allowing valves to last longer and potentially appeal to younger, more active patients.

Another major advance is the increased use of minimally invasive techniques and robotic manufacturing. These approaches not only improve the precision and consistency of valve construction but also allow for scalable production to meet global demand. For patients, especially those in underserved regions, this could translate into more accessible and reliable valve replacements.

Researchers are also working on valves that better accommodate special populations, such as women of childbearing age and patients with rheumatic heart disease. Many of these individuals face limitations with existing options due to complications with pregnancy or poor durability of current solutions in certain disease settings.

Finally, the integration of real-world data from clinical studies across diverse populations is helping drive regulatory pathways and future product development. With ongoing trials and longer-term follow-ups, the sector is poised to deliver heart valve technologies that not only save lives but also dramatically improve quality of life across a broader spectrum of patients.