Foldax Receives CDSCO Approval for TRIA™ Mitral Valve in India

Foldax® has obtained approval from India’s Central Drugs Standard Control Organization (CDSCO) for its TRIA™ Mitral Valve.

The valve will be manufactured locally in India through Foldax’s partner, Dolphin Life Science India LLP.

Current mitral valve replacements often use animal tissue, which tends to degrade and calcify over time. This can lead to repeated surgeries, especially in younger patients. 

Mechanical valves, although more durable, require lifelong use of blood-thinning medication, which may affect long-term quality of life.
 
Foldax seeks to address these challenges by developing a polymer heart valve intended to provide long-term durability while eliminating the need for ongoing anticoagulation treatment.

The TRIA Mitral Valve uses Foldax’s LifePolymer™ material. This polymer has been developed specifically for heart valve use, offering resistance to calcium build-up, long-term stability in the body, and compatibility with human tissue. 

All valves are produced using robotic technology, ensuring high precision and manufacturing consistency.

Clinical research conducted in India has demonstrated that the TRIA Mitral Valve is safe, ensures consistent blood circulation, and contributes to significant enhancements in patients’ quality of life.

It is considered suitable for a wide range of patients, including younger individuals and women of childbearing age who often face valve damage due to conditions like rheumatic fever.

With this approval, Foldax plans to expand the use of its LifePolymer technology and robotic production methods into other valve types and transcatheter applications.