TRIA™ Mitral Valve
Made with LifePolymer™

The TRIA™ Mitral Valve is the only replacement heart valve that combines LifePolymer™, computer-aided design, and robotic manufacturing. It is deliberately different—designed to last a lifetime without compromising quality of life.

The mitral valve allows oxygen-rich blood to flow smoothly from the lungs, through the heart, and to the rest of the body. When it stops functioning properly due to stenosis (narrowing) or regurgitation (leakage), it can cause heart failure, arrhythmias, stroke, and other complications. Replacing the valve can restore heart function and enhance quality of life.

Engineered for Performance

Dolphin Life Science India LLP is the legal manufacturer of the TRIA™ Mitral Valve in India. In partnership with Foldax Inc.®, Dolphin brings in-country expertise and advanced manufacturing capability to support the world’s first polymer surgical mitral valve made with LifePolymer™. This collaboration enables localized production that ensures precision, quality, and availability for Indian patients.

The TRIA™ Mitral Valve
is deliberately different.

  • LifePolymer™ Material: A non-animal-based synthetic polymer formulated for heart valves. Biostable, biocompatible, and resists calcification.1
  • Computer-Aided Design: Finite Element Analysis (FEA) models real-world conditions to optimize leaflet geometry, opening/closing dynamics, and hemodynamics.
  • Robotically Manufactured: Robotic precision ensures tight tolerances, high repeatability, and reduced human error across every valve produced.

TRIA™ leaflets and frames are computer designed and robotically manufactured to handle the specific blood flow and pressure of the mitral valve.

The TRIA™ Mitral Valve
Benefits

  • No Animal Tissue: Avoids variability and risks associated with animal origin derivatives
  • Resists Calcification: No phospholipids, no platelet aggregation1
  • No Clicking: No hinges or hard surface contact
  • Valve-in-Valve Compatible: Supports future valve replacement opportunity
  • Flexible Leaflet Design: Trileaflet configuration evenly distributes stress and maintains central flow, reducing breakdown or destruction of red blood cells2

Clinical
Outcomes3

Strong Performance After 1 Year
A clinical study was conducted with 67 patients in 8 cities across India. The patients were between 19 and 67 years old, and more than 60% were women, including many of childbearing age.
Here’s what was observed one year after surgery with the TRIA™ Mitral Valve:

  • Comparable Safety to Other Heart Valves at 1 Year:

    • No patients needed a replacement valve.
    • The valve stayed in excellent condition, with no signs of wear or failure.
  • Improved Heart Function at 1 Year:

    • Blood flowed through the heart more easily after valve replacement.
    • There was over 50% improvement in how hard the heart had to work to push blood through the valve.
    • These improvements were seen across all valve sizes, meaning the benefits were consistent no matter the size of the valve used.
  • Improved Quality of Life at 1 Year:

    • 81% of patients had no symptoms or only mild symptoms one year later (NYHA Class I).
    • Patients were able to walk farther and reported feeling better overall in daily life, based on standard health surveys.
  1. Jenney, C., Millson, P., Grainger, D.W., Grubbs, R., Gunatillake, P., McCarthy, S.J., Runt, J. and Beith, J. (2021), Assessment of a Siloxane Poly(urethane-urea) Elastomer Designed for Implantable Heart Valve Leaets. Adv. NanoBiomed Res., 1: 2000032. https://doi.org/10.1002/anbr.202000032
  2. Data on File with Foldax®, Inc.
  3. George, I, Rao, D, Jain, A. et al. 1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve: Insights Into New Technology. JACC. null2025, 0 (0) https://doi.org/10.1016/j.jacc.2025.06.017
  4. TRIA™ Mitral Valve Instructions for Use