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The product is limited to investigational use in the United States.
September 26, 2025
By: Michael Barbella
Managing Editor
Foldax Inc., along with its local manufacturing partner Dolphin Life Science LLP, has released the TRIA Mitral Valve in India. The launch is a world first for a polymer heart valve, according to the company.
Traditional valves made from animal tissue are prone to calcification and degradation, limiting their durability and often leading to repeat surgeries, especially for younger patients. Mechanical valves, while durable, are prone to thrombosis and require lifelong anticoagulation therapy that can impact a patient’s long-term quality of life. Foldax’s vision for its polymer heart valves is to address the limitations of tissue and mechanical valves by making its valves durable while avoiding a lifelong anticoagulation therapy requirement.
Mitral valve disease is a concern in India, with rising surgical volumes and increased need for long-term treatment solutions. The TRIA Mitral Valve is positioned to offer a new option for patients seeking a durable solution without the lifestyle limitations of mechanical valves.
“We are honored to work with India’s top cardiovascular surgeons and Dolphin Life Science to bring next generation medical solutions to the Indian population,” said Laxmikant Khanolkar, senior vice president of Foldax Asia and MEA. “This is the first in a series of heart valve solutions we intend to introduce into the market.”
As part of the launch, Foldax has initiated the Evolve Training & Certification Program to ensure high-quality outcomes and surgeon preparedness. Physicians who complete training will be certified to implant the valve at participating hospitals.
Headquartered in Salt Lake City, Utah, Foldax aims to reinvent every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves that potentially last a lifetime, thereby addressing limitations of tissue and mechanical valves.
Headquartered in India, Dolphin Life Science partners with global innovators to introduce advanced medical technologies that elevate care standards. With a focus on structural heart, interventional cardiology, and critical care, Dolphin is striving to transform access and delivery of therapies.
* The TRIA Mitral Valve is limited to investigational use only in the United States.
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