Meril Unveils Groundbreaking Heart Valve Trial Results at PCR London Valves 2025
Meril Life Sciences has just unveiled groundbreaking one-year results from the LANDMARK trial, a randomized controlled study that is set to revolutionize the understanding of heart valve therapies. This trial, presented at the prestigious PCR London Valves 2025 conference, compared the Myval THV series, a balloon-expandable valve, with two other leading valve types: the balloon-expandable Sapien THV series and the self-expanding Evolut THV series.
But here's where it gets controversial... The LANDMARK trial found that the Myval THV series held its own against these established valve platforms, showing comparable clinical efficacy at one year. The composite clinical efficacy, which includes freedom from mortality, stroke, and hospitalization, was reported at an impressive 87% for Myval THV, 86.9% for Sapien THV, and 86.9% for Evolut THV. And this is the part most people miss: the Myval THV series also demonstrated sustained clinical benefits over time, with extended clinical efficacy outcomes remaining consistent across all three valve types.
The trial's extended clinical efficacy endpoint, which includes freedom from mortality, stroke, hospitalization, and quality of life deterioration, showed remarkable consistency: 80.5% for Myval THV, 75.0% for Sapien THV, and 79.7% for Evolut THV. Furthermore, Myval THV showcased its superiority in terms of hemodynamic stability, with the lowest incidence of moderate aortic regurgitation (1.6%).
A post-hoc analysis focused on patients with small aortic annulus, a challenging anatomical condition, further confirmed the Myval THV's prowess. The one-year composite efficacy outcomes remained comparable, with Myval THV achieving 91%, Sapien THV 89%, and Evolut THV 91%.
These findings solidify the Myval THV series as a reliable and versatile transcatheter valve platform, offering sustained safety and effectiveness for a wide range of patient anatomies. Professor Patrick W. Serruys, Chairman and Study Director of the LANDMARK Trial, emphasized its clinical significance, stating that the low rate of aortic regurgitation is a crucial factor in valve performance and clinical decision-making.
Professor Andreas Baumbach, Global Principal Investigator, highlighted the trial's uniqueness in benchmarking different valve types under identical conditions. He noted that the Myval THV's performance is on par with established global systems, providing clinicians with a valuable treatment option. As the study continues, it will offer even more insights into long-term valve performance, a critical aspect given the trend towards younger and lower-risk patients undergoing transcatheter aortic valve implantation (TAVI).
Mr. Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, underscored the company's commitment to evidence-based medicine. The LANDMARK trial, he said, is a testament to Meril's dedication to developing globally relevant innovations. The Myval THV's performance across diverse patient populations, including those with complex anatomies, positions it as a next-generation therapy solution, expanding access to advanced structural heart care.
The LANDMARK trial will continue to follow patients for ten years, providing invaluable insights into long-term valve performance and clinical stability. This trial is a landmark achievement in the field of structural heart interventions, offering a comprehensive comparison of leading valve technologies and paving the way for more personalized treatment approaches.
About the LANDMARK Trial:
The LANDMARK trial is a groundbreaking, randomized non-inferiority study, the first of its kind to directly compare the Myval THV series with other contemporary balloon-expandable and self-expandable valve series in patients with severe aortic stenosis. The trial enrolled 768 patients across 16 countries, making it a truly global endeavor. The 30-day primary composite endpoint demonstrated the non-inferiority of Myval THV, and these findings have been published in top-tier medical journals, including The Lancet and EuroIntervention. The one-year results, published in the Journal of the American College of Cardiology (JACC), further validate the Myval THV's clinical efficacy.
About Meril Life Sciences:
Meril Life Sciences is a leading global medical device company headquartered in India, dedicated to pushing the boundaries of healthcare innovation. With a strong R&D focus, Meril delivers cutting-edge medtech solutions to over 135 countries, with a significant presence in the USA, Brazil, Europe, Asia, Africa, and Australia. Through strategic partnerships and adherence to international quality standards, Meril is reshaping the healthcare landscape.
