Foldax® Launches TRIA™ Mitral Valve in India, the World’s First Commercial Polymer Heart Valve

Foldax® Inc., in partnership with local manufacturer Dolphin Life Science LLP, has launched the TRIA™ Mitral Valve in India. 

This is the first time a polymer heart valve has been made commercially available anywhere in the world.

Conventional heart valves made from animal tissue are prone to calcification and wear, which can lead to repeat surgery, particularly in younger patients. 

Mechanical valves last longer but carry a higher risk of blood clots and require lifelong anticoagulation therapy. 

Foldax’s polymer heart valves are designed to overcome these limitations by improving durability and aiming to reduce the need for long-term anticoagulation.

Mitral valve disease is a growing health issue in India, with rising surgical volumes and increasing demand for durable treatment options.
 
The TRIA™ Mitral Valve offers patients a new alternative that combines longevity with fewer lifestyle restrictions than mechanical valves.

To support the launch, Foldax has introduced the Evolve™ Training & Certification Program to prepare surgeons and ensure consistent outcomes. 

Only physicians who complete the programme will be certified to implant the valve at participating hospitals.

The TRIA™ Mitral Valve is approved for use in India by the Central Drugs Standard Control Organisation (CDSCO). In the United States it remains limited to investigational use.