US-based medical devices firm Foldax Inc., a pioneer in the development of innovative, polymer heart valves, has announced a manufacturing agreement with Dolphin Life Science India to enable in-country manufacturing of the TRIA polymer mitral surgical heart valve outside of the US for the first time.

The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary polymer LifePolymer, with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants.

The novel LifePolymer material and computer-designed valve help to democratise the manufacturing process, minimizing the people and processes associated with animal-based tissue valve manufacturing, enabling manufacturing in any location, and improving product variability, precision, repeatability, and quality.

Surat-based Dolphin Life Science India is an expert in manufacturing medical devices. The company is registered with the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).