Foldax® Brings World’s First Commercially Available Polymer Mitral Valve to India
Foldax® Inc., a U.S.-based leader in the development of next-generation heart valve technologies, has officially launched the TRIA™ Mitral Valve in India in collaboration with its local manufacturing partner, Dolphin Life Science LLP. This milestone marks the first time a polymer-based heart valve has been made commercially available to patients anywhere in the world, opening the door to new possibilities in long-term treatment for mitral valve disease.
The launch represents not only an important achievement for Foldax but also a potential paradigm shift in cardiovascular care, particularly in countries like India where mitral valve disease remains a growing health challenge.
Addressing Longstanding Challenges in Heart Valve Replacement
For decades, patients in need of mitral valve replacement have had to choose between two main options: bioprosthetic (tissue) valves or mechanical valves. Each of these choices carries significant limitations.
- Tissue valves, which are made from animal tissue (typically bovine or porcine), are biologically compatible but suffer from calcification and degradation over time. This means their durability is limited, and younger patients often face the prospect of repeat surgeries within their lifetime. Repeat surgeries carry additional risks and costs, making them an imperfect solution.
- Mechanical valves, by contrast, are highly durable but come with their own set of trade-offs. They are prone to blood clot formation (thrombosis), requiring patients to remain on lifelong anticoagulation therapy. While anticoagulants reduce the risk of clotting, they also increase the risk of bleeding events, restrict lifestyle choices, and add to long-term healthcare burdens.
Foldax’s TRIA™ heart valves are designed to overcome these challenges by using a proprietary, next-generation polymer material. The company’s vision is to provide durability without the compromises associated with either tissue or mechanical valves, and ultimately to reduce or even eliminate the requirement for lifelong anticoagulation therapy.
Why the Launch in India Matters
India has one of the world’s highest burdens of cardiovascular disease, and mitral valve disease is a growing concern due to rising life expectancy, lifestyle-related health changes, and increased diagnosis. Surgical volumes for valve replacement have been increasing steadily, but the country still faces a significant treatment gap, particularly in terms of access to advanced long-term solutions.
By introducing the TRIA™ Mitral Valve in India, Foldax is not only making a new treatment option available but is also positioning the country as the first in the world to provide patients with access to polymer valve technology on a commercial scale. This highlights India’s role as an early adopter of innovative healthcare solutions and underscores the importance of global partnerships in advancing medical technologies.
Foldax’s Partnership with Dolphin Life Science
The launch has been made possible through Foldax’s collaboration with Dolphin Life Science LLP, a well-established manufacturing partner in India. Local partnerships are critical for ensuring reliable production, distribution, and support within the healthcare system.
Speaking on the collaboration, Laxmikant Khanolkar, Senior Vice President of Foldax Asia and MEA, emphasized the importance of this initiative:
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. This is the first in a series of heart valve solutions we intend to introduce into the market.
This partnership represents Foldax’s strategy of not only providing technology but also building ecosystems of training, support, and innovation within the regions it serves.
The TRIA™ Mitral Valve: Features and Promise
The TRIA™ Mitral Valve incorporates Foldax’s proprietary polymer technology, which was engineered to mimic the natural function of the human mitral valve while resisting the limitations of existing replacement options. Some of the key intended advantages include:
- Durability: The polymer is designed to resist calcification and degradation, potentially extending the lifespan of the valve and reducing the need for repeat surgeries.
- Reduced Anticoagulation Needs: The valve’s material and design aim to minimize thrombosis risk, with a long-term goal of reducing dependence on lifelong anticoagulation therapies.
- Improved Patient Quality of Life: By addressing the durability and medication challenges associated with current valves, the TRIA Mitral Valve offers patients the possibility of a more normal lifestyle post-surgery.
- Scalability: Polymer valves are engineered for consistent production, which can help address shortages and quality variation sometimes associated with biological tissue valves.
These benefits could make polymer valves particularly attractive for younger patients and those in emerging economies where long-term treatment costs and repeat surgeries pose significant barriers to care.
Training and Certification for Surgeons
Recognizing that successful adoption of new medical technologies depends on physician expertise, Foldax has launched the Evolve™ Training & Certification Program alongside the valve’s commercial release.
This program is designed to ensure that surgeons are fully prepared to implant the TRIA™ Mitral Valve and can achieve the best possible patient outcomes. Participating physicians undergo specialized training, and only those who complete the program are certified to implant the valve at authorized hospitals.
By setting this standard, Foldax is aiming to foster confidence in both patients and physicians, ensuring that the technology is introduced responsibly and with consistent results.
Regulatory Context
In the United States, the TRIA™ Mitral Valve remains limited to investigational use only, as clinical studies continue to evaluate its performance and safety in accordance with U.S. Food and Drug Administration (FDA) requirements.
However, in India, the valve has been granted approval for use by the Central Drugs Standard Control Organization (CDSCO), the country’s regulatory authority for pharmaceuticals and medical devices. This regulatory approval has enabled Foldax and its partners to make the TRIA Mitral Valve available to Indian patients ahead of broader global rollouts.
