Polymer heart valve developer Foldax has introduced the TRIA mitral valve in India in collaboration with Dolphin Life Science.
This is claimed to mark the first commercial availability of a polymer heart valve for patients worldwide.
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It received approval from the Indian Central Drugs Standard Control Organisation (CDSCO) in June 2025. Dolphin Life Science India is responsible for the local manufacturing.
This launch addresses the limitations associated with traditional valves that are made using animal tissue and are susceptible to calcification and degradation, often necessitating repeat surgeries, specifically in younger patients.
The TRIA mitral valve is designed to provide patients with a durable alternative that does not impose the lifestyle restrictions associated with mechanical valves.
According to Foldax, clinical studies on the valve indicate positive safety profiles and stable haemodynamics.
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By GlobalDataTo support the launch, the company has established the Evolve Training & Certification Program to prepare surgeons for the implantation of the valve.
Physicians who complete the training will receive certification to perform the procedure at designated hospitals.
Foldax Asia and MEA senior vice-president Laxmikant Khanolkar said: “We are honoured to work with India’s top cardiovascular surgeons and Dolphin Life Science to bring next-generation medical solutions to the Indian population.
“This is the first in a series of heart valve solutions we intend to introduce into the market.”
The valve remains limited to investigational use in the US.
Foldax’s range of valves under development, which includes both transcatheter and surgical options, is based on its LifePolymer, a specially engineered polymer designed to be calcium-resistant, biostable, and biocompatible.
