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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.

With robust 30-day follow-up results demonstrating low mortality and thromboembolism rates, stable valve function by echocardiography, and excellent hemodynamic performance, this study underscores the potential of the TRIA™ Mitral Valve as a safe, effective alternative to traditional options. 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

Positive 30 Day Results 5

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

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 EOA 5

Excellent Hemodynamics Maintained Over Time 5

30-Day Follow-Up

Mean Gradients (mmHg)

EOA (cm2)

Pre-Op
MS with MR Dilated

Post-Op
30-Day

Laminar flow with cylindrical opening

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