Foldax Launches TRIA, the World’s First Commercialized Polymer Mitral Valve, in India

Sep 04, 2025 22:15 CST Updated 22:15

Foldax

Heart Valve Developer

FoldaxAnnouncing its polymer mitral valve --TRIAFormalIn IndiaLaunches World's First Commercially Applied Polymer Heart Valve.TRIAIn June this year, receivedIndiaCentral Drugs Standard Control Organization (CDSCO) approved for marketing, and commercialization began just two months later. ClearlyFoldaxFor their own products and production workersArtistic Confidence。

Executive Evaluation

"We are honored to collaborate with India's top cardiac surgery experts and Dolphin Life Sciences to bring the next generation of medical solutions to the people of India. This is just the first product in a series of heart valve solutions we plan to introduce to the market."

---Laxmikant Khanolkar FoldaxSenior Vice President of Asia, Middle East and Africa

Traditional animal tissue valves are prone to calcification and degeneration, with limited durability, often leading to the need for reoperation in patients, especially younger ones. Mechanical valves, while highly durable, are prone to thrombosis, requiring patients to undergo lifelong anticoagulation therapy, which affects their long-term quality of life.FoldaxThe innovative polymer heart valve, with its durability advantages, aims to overcome the limitations of tissue and mechanical valves, with the future goal of eliminating the need for lifelong anticoagulation therapy for patients.

Mitral valve disease is gaining increasing attention in India, with a continuous rise in surgical volumes and a growing market demand for long-term treatment solutions.TRIAWill provide a new option for patients seeking durable solutions but unwilling to be restricted by the lifestyle limitations of mechanical valves.

To ensure the surgical outcome and the standardization of the doctor's operation,FoldaxLaunched the Evolve training certification program simultaneously. Doctors who complete the training can implement it in certified hospitals.TRIAValve implantation surgery.

TRIA

TRIAAdoptFoldaxThe Revolutionary Polymer Material Developed ----LifePolymer，Lifepolymer not only has performance similar to biological valves, but also some properties superior to biological valves., such asExcellent tissue compatibility, excellent mechanical properties, long service life.

LifepolymerIs a uniqueSilicone Polyurethane, withThree-phase morphology, high resistance to creep deformation, and ease of forming films through solvent casting.

Lifepolymer Physical and Chemical Properties

Number-average molecular weight (Mn) is approximately 120,000 Da (Detected by GPC).
Glass Transition Temperature (Tg) Below 0°C (Between -4°C and -10°C)
Ultimate Tensile Strength: ≥30MPa
Elongation:≥500%
Tear Strength:≥50N/mm
Hardness:~80A Shore A)
MoveStateModulus:25-35MPa

Lifepolymer also changed the valve processing method from purely handcrafted to automated production, which not only reduced costs but also made the valve quality more reliable.Will be the numberMillions of patients with aortic, mitral, and tricuspid valve diseases have been treated.More economical, safer, and more effective treatment。

At the same timeTRIAIt is also the first heart valve manufactured by a robotic system. Therefore, its polymeric leaflets can be consistently produced with precise thickness, designed to achieve predictable valve performance and last a lifetime for the patient.

TRIA Advantages

AdoptAn Advanced Biopolymer Material---LifePolymer，The valve is more durable., without the need to apply any animal tissue;
Will reduce or eliminate the need for lifelong anticoagulant medication；
Providing a larger opening area than traditional valves, establishingSimilar hemodynamics and blood flow to human heart valves；
CanVia catheter or surgical procedureMethod for treating heart valve disease;
AdoptMechanized Production and Manufacturing，Better Precision and Quality Control, while eliminating the uncontrollability of manual production;
With more competitive economic value;
EO Sterilization;
Smaller Profile.

Foldax

FoldaxFoldax, Inc., an innovative medical device company based in Salt Lake City, Utah, which designs and developsTria heart valvesPlatformIs the global firstPolymer heart valve platform. This platform technology can be applied to valve replacement for aortic, mitral, and tricuspid valve diseases.FoldaxThe PurposeIt is to revolutionize the structural heart market by expanding patient access, improving product performance, and significantly reducing costs through new materials, design, and manufacturing technologies.。