Structural Heart

Foldax’s TRIA Mitral Valve Impresses at NYV

The valve replacement space keeps adding contenders, and Foldax’s polymer-based TRIA Mitral Valve replacement showed compelling one-year results in its India Clinical Trial presented at New York Valves 2025, suggesting we could soon have an alternative to bovine tissue valves.

  • Foldax’s TRIA surgical mitral valve recently received commercial use approval in India, making it the first polymer heart valve to go to market anywhere in the world.
  • TRIA is built using LifePolymer, which doesn’t include animal tissue and its leaflets and frame are robotically generated to match each patient’s native mitral valve. 
  • The new polymer helps reduce valve calcification and could potentially allow patients to avoid long-term anticoagulant use.

Researchers tested the new surgical TRIA polymer valve on 67 patients (aged 19 to 67) across India and found that the mitral valve replacement led to no valve-related mortality or reinterventions, among other encouraging results like…

  • A >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg).
  • A >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies.
  • 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant QoL improvements.

When it came to adverse outcomes, only two thrombotic events and three ischemic strokes occurred, all in patients with subtherapeutic vitamin K antagonist levels.

While these results are encouraging, Foldax’s TRIA still has to contend with some of the biggest medtech companies in the world, many of which already have a start in the MV space.

  • For example, Abbott already produces the MitraClip for mitral valve repair and the Tendyne transcatheter mitral valve replacement system.
  • Meanwhile, Edwards Lifesciences manufactures the MITRIS RESILIA surgical mitral valve and the PASCAL transcatheter valve repair system.

The Takeaway

A new mitral valve replacement option might be on the way following these successful trial results, but it’s still an uphill climb for Foldax to gain U.S. regulatory approval and then compete in a market dominated by medtech giants. Still, its innovative polymer and custom profile might give TRIA a chance.

Get twice-weekly insights on the biggest stories shaping cardiology.

You might also like

Cardiovascular Disease August 4, 2025

The Impact of Physical Activity Before and After CV Events August 4, 2025

A long-term analysis of the CARDIA study revealed that moderate-to-vigorous physical activity steadily declines from young adulthood through midlife, but patients destined to develop cardiovascular disease experience rapid activity decreases more than a decade before their first event. Collecting data over 37 years, researchers tracked ~3k participants from young adulthood to middle age and paired […]

Cardiology Pharmaceuticals July 31, 2025

AstraZeneca’s Anselamimab Comes Up Short in Phase 3 Trial July 31, 2025

In a setback to one of its rarer disease pipelines, AstraZeneca’s amyloidosis antibody, anselamimab, failed to significantly reduce all-cause mortality and CV hospitalizations in the CARES Phase 3 trial’s overall patient population.  The CARES clinical program was the largest prospective cardiac AL amyloidosis investigation to date, enrolling 406 patients to test whether anselamimab could reduce […]

Cardiology Pharmaceuticals July 28, 2025

SGLT2i Prescriptions Increase for HF, With Some Exceptions July 28, 2025

Three years after SGLT2 inhibitors were added to the heart failure treatment guidelines, a JAMA Cardiology study reveals significant new prescriptions, with a few key patient sub-groups falling behind. Researchers analyzed prescribing patterns of SGLT2 inhibitors for 760k HF patients in the National Cardiovascular Data Registry and found significant and rapid uptake in the last […]

This content is exclusive to subscribers

Log in or join by entering your email below.

Completely free. Every Monday and Thursday.

CW Phone Square

You might also like..

Select All

You're signed up!

It's great to have you as a reader. Check your inbox for a welcome email.

-- The Cardiac Wire Team

You're all set!