Meril Life Sciences has unveiled the one-year results from its pivotal LANDMARK randomized controlled trial (RCT) at PCR London Valves 2025, one of the world’s leading structural heart conferences. This trial is the first-ever multicenter RCT to directly compare:
- Myval THV series (balloon-expandable)
- Sapien THV series (balloon-expandable)
- Evolut THV series (self-expanding)
The trial focuses on patients with symptomatic severe aortic stenosis, offering a rare head-to-head analysis across the most widely used transcatheter heart valve (TAVI) platforms.
Key One-Year Results: Myval Performs on Par with Sapien and Evolution
1. Primary Clinical Efficacy Endpoint
Composite endpoint: freedom from:
- all-cause mortality
- any stroke
- procedure- or valve-related hospitalization
Results:
- Myval THV: 87%
- Sapien THV: 86.9%
- Evolut THV: 86.9%
2. Expanded Clinical Efficacy Endpoint
Includes quality-of-life deterioration in addition to the above.
Results:
- Myval THV: 80.5%
- Sapien THV: 75.0%
- Evolut THV: 79.7%
3. Lowest Rate of Moderate Aortic Regurgitation
A critical indicator of valve performance:
- Myval THV: 1.6% (lowest among all platforms)
Strong Outcomes in Patients with Small Aortic Annulus
A post-hoc subgroup analysis showed comparable efficacy:
- Myval THV: 91%
- Sapien THV: 89%
- Evolut THV: 91%
This suggests Myval’s sizing range and implantation predictability support a wider spectrum of anatomies, including more complex cases.
Expert Insights
Prof. Patrick W. Serruys, Chair & Study Director
“The LANDMARK trial gives the TAVI community rigorous comparative data. The Myval THV’s low aortic regurgitation rate and stable hemodynamic profile are particularly noteworthy.”
Prof. Andreas Baumbach, Global Lead Researcher
“This head-to-head comparison across balloon-expandable and self-expanding valves is unique. Myval’s versatility, hemodynamic performance and size options make it a valuable tool for clinicians.”
Sanjeev Bhatt, SVP – Corporate Strategy, Meril
“The Myval THV series continues to show strong, consistent performance across diverse and complex anatomies. These results reinforce Myval’s role as a next-generation TAVI solution.”
Why the LANDMARK Trial Matters?
The LANDMARK trial fills a long-standing evidence gap for clinicians: direct comparison of leading TAVI platforms under identical conditions.
The data confirms:
- Myval is non-inferior to Sapien and Evolut
- It offers excellent valve stability, especially in reducing aortic regurgitation
- It performs well across standard, complex and small-annulus anatomies
This strengthens its position as a global TAVI contender and supports individualized valve selection.
About the LANDMARK Trial
- First randomized non-inferiority RCT comparing Myval vs. Sapien & Evolut
- Prospective, multicenter, open-label design
- 768 patients, 31 global centers, 16 countries
- Enrolment: Jan 2021–Dec 2023
- Primary 30-day outcome published in The Lancet and EuroIntervention
- One-year results published in JACC
- Follow-up planned for 10 years, focusing on:
- valve durability
- long-term clinical stability
- echocardiographic performance
About Meril Life Sciences
Meril is a global medical technology leader headquartered in India. With innovations across 135+ countries and subsidiaries across major continents, Meril develops evidence-backed devices driven by R&D excellence and international quality standards. Its mission is clear: expand access to advanced, high-quality structural heart solutions worldwide.
