Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions.

Limited by Federal (or United States) law to investigational use only.
Continue To Site

You are switching to a website for another country and will be subject to the terms and policies therein. Products on that website may or may not be available or approved for your location. Please contact your Foldax representative if you have questions about the availability of products in your location. By continuing, you acknowledge and agree to the terms of this notice.

Go Back
Continue

Clinical Evidence

A clinical trial conducted in India with 67 patients across 8 centers highlights the performance of the TRIA™ Mitral Valve in treating patients with symptomatic moderate to severe mitral valve stenosis and/or regurgitation.

Compelling 1 year results demonstrate a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality-of-life. 5

Clinical Sites

  • Fortis Hospital - New Delhi
  • SMS Hospital - Jaipur
  • Epic Hospital - Ahmedabad
  • Hinduja -Mumbai
  • KLE Hospital - Belagavi
  • Six Sigma - Nashik
  • NRS Hospital - Kolkata
  • Indo US Hospital - Hyderabad

Comparable Safety to Other Valves at 1 Year

TRIA™  Mitral Valve

(India Clinical Trail)5 N=67

Meril Life Sciences
Dafodil™ Valve6

N=30

All-Cause Mortality

6 (9.1%)

4 (13.3%)

Valve Reintervention

0 (0%)

0 (0%)

Structural Valve Deterioration

0 (0%)

0 (0%)

30-Day Follow-Up

TRIA™  Mitral Valve

(India Clinical Trail) N=67

All-Cause Mortaliity
1.4% (1)
Valve Related Mortality
0
Valve Reintervention / Reoperation
0
Study Valve Explant
0
Thromboembolism
Ischemic Stroke
1.4% (1)
Hemorrhagic Stroke
0
TIA
0
Valve Thrombosis
0
Endocarditis
0
All Bleeding
1.4% (1)
Major Bleeding
1.4% (1)
Hemolysis
0
Non-Structural Valve Dysfunction
0
Structural Valve Deterioration
0
Hospital ReAdmission
2 (CVA, Pl. Effusion)
New Atrial Fibrillation
0
New Pacemaker
0
Event rates expressed as n events (KM Rate)

TRIA™ Design Optimizes Hemodynamics 3

  • Leaflets are 1/3 the thickness of biological tissue 1
  • Valve has cylindrical opening vs. conical opening with bioprosthetic valves
  • Leaflets open early and remain open longer than bioprosthetic valves 3

Echocardiography Mean Gradient and EOA5 at 1 Year

Excellent Hemodynamics Maintained Over Time 5

1-Year Follow-Up

Mean Gradients (mmHg)

EOA (cm2)

Improved Quality-of-Life at 1 Year

81% of Patient are
NYHA I at 1 Year5

Patients Walk Farther and Have Improved KCCQ Scores at 1 Year 5

Pre-Op
MS with MR Dilated

Post-Op
1-Year

Pre-Implant

Restricted flow through valve

Post-Implant

Good flow through valve

Physician Experience

“Before the TRIA™ Mitral Valve, patients faced tough choices: tissue valves made from porcine or pericardial tissue with limited durability and cultural concerns in India, or mechanical valves that audibly click and require lifelong blood thinners. With increasing positive clinical outcomes, the TRIA™ Mitral Valve is emerging as a transformative option for patients of all ages with mitral valve disease of any etiology.”

Kaushal Pandey M.D.
P.D. Hinduja Hospital in Mumbai, India

"Offering the TRIA™ Mitral Valve to women of child-bearing age is incredibly rewarding. This valve is designed to provide a lifetime solution without the possible need for long-term blood thinners or it may not require lifetime anticoagulation. With the TRIA™ Mitral Valve, women can embrace the hope of having children while avoiding the challenges of repeat surgeries."

Dasari Prasada Rao M.D.
Chief Cardiac Surgeon at Apollo Spectra Hospital in Ameerpret, Hyderabad, India

“The TRIA™ Mitral Valve provides excellent and sustained hemodynamic performance, maintaining stable gradients and efficient blood flow over time.  This consistency is critical for optimizing patient outcomes and long-term valve function.”

Anil Jain MS DNB (CTVS)
Founder Director Epic Hospital, Ahmedabad, India