Foldax, a US-based developer of polymer heart valves, has received approval from the Indian Central Drugs Standard Control Organisation (CDSCO) for its TRIA Mitral Valve.
The valve will be manufactured locally by Dolphin Life Science India.
According to Foldax, traditional heart valves, often made from animal tissue, face challenges such as calcification and degradation, leading to limited durability and potentially necessitating repeat surgeries.
Mechanical valves, while offering durability, are associated with thrombosis risk and require lifelong anticoagulation therapy, which can affect patients’ quality of life. Foldax aims to overcome these issues with its polymer heart valves designed to enhance durability without the need for lifelong medication.
The company’s range of developing valves, including those intended for transcatheter and surgical procedures, employ its LifePolymer material. This material is specifically designed for heart valve applications and engineered for calcium resistance, biostability, and biocompatibility.
Foldax executive chairman and CEO Ken Charhut said: “Gaining approval with our partner Dolphin Life Sciences for the world’s first polymer heart valve marks a defining moment in the evolution of heart valve therapy and disrupts long-standing paradigms in the heart valve industry.
“We intend to extend our unique platform utilizing LifePolymer material and proprietary robotic manufacturing into additional applications in transcatheter devices and other valve positions. We look forward to making a transformative impact in India and other geographies where we can fill critical unmet clinical needs.”
Foldax said that it manufactures all its valves using robotic technology to ensure precision and uniformity on a large scale. Clinical studies on the TRIA Mitral Valve have indicated positive safety outcomes, stable haemodynamics, and significant improvements in patient quality of life.
Currently, the TRIA Mitral Valve is designated for investigational use only and is not yet available for commercial purchase in the US.
