Foldax, a Utah-based medtech company focused on developing surgical and transcatheter treatments for structural heart disease, announced that its polymer mitral valve has been approved for commercial use in India. This represents the first time a polymer heart valve has secured a regulatory approval of that kind anywhere in the world.
The Tria surgical mitral valve is built using LifePolymer, a proprietary material that does not include animal tissue. Both the frame of the valve and its leaflets are robotically generated to match each patient’s native mitral valve. This new polymer is designed to reduce the long-term risk of valve calcification and degradation, making the valves more durable. In addition, patients should be able to bounce back after surgery without requiring the long-time use of anticoagulants.
According to Foldax, the valves will be manufactured locally by Dolphin Life Science India.
