Meril Life Sciences Unveils Landmark One-Year Results for Myval THV Series at PCR London Valves 2025

LONDON, November 22, 2025 — During the prestigious PCR London Valves 2025 conference, which focuses on structural heart disease, Meril Life Sciences made significant advancements known. The company presented the one-year results from the LANDMARK randomized controlled trial (RCT), which holds the distinction of being the first multicenter RCT to directly compare the balloon-expandable Myval-THV series with both the balloon-expandable Sapien-THV series and the self-expanding Evolut-THV series in patients suffering from symptomatic severe aortic stenosis.

After a year of study, the Myval-THV exhibited a combined clinical effectiveness rate of 87%, comparable to the 86.9% rates achieved by both the Sapien and Evolut series. This efficacy was defined as freedom from overall mortality, any stroke, and hospitalizations related to the procedure or valve complications.

The LANDMARK study also introduced an expanded endpoint for clinical efficacy, considering not just mortality or stroke, but also quality of life improvements over time. These findings revealed consistent outcomes across all series—80.5% for Myval, 75.0% for Sapien, and 79.7% for Evolut. Notably, Myval distinguished itself with the lowest rate of moderate aortic regurgitation at just 1.6%, emphasizing its hemodynamic stability and valve performance over the span of one year.

Furthermore, a post-hoc analysis examining patients with small aortic annuli highlighted comparable combined efficacy results at one year: 91% for the Myval series against 89% for Sapien and 91% for Evolut. These one-year findings underscore the Myval series as a clinically reliable and hemodynamically stable transcatheter heart valve platform that demonstrates enduring safety and effectiveness across diverse patient anatomies.

Insights from Experts

Professor Patrick W. Serruys, the chair and lead investigator of the LANDMARK study, emphasized the importance of the trial in delivering valuable comparative insights for the global TAVI community. He stated, “By aggregating three leading THV platforms in a rigorously designed randomized study, we are better positioned to understand clinically relevant differences, especially concerning valve stability and sustained hemodynamic performance.” Serruys noted the one-year results bolster the credibility of the Myval THV series, highlighting its low aortic insufficiency rate, which is crucial for valve performance.

Professor Andreas Baumbach, the global principal investigator, remarked on the unique nature of the study, which compared the effectiveness of balloon-expandable and self-expanding heart valves under identical conditions. The agreement in results across both standard and extended clinical efficacy endpoints indicates that the Myval THV series is on par with established global systems. “Its hemodynamic profile, combined with predictable implantation and various size options, offers clinicians a valuable and versatile treatment option.”

Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, stated, “The LANDMARK study highlights our commitment to generating robust clinical data that support safe clinical decision-making. The sustained performance of the Myval THV series across varied patient sets, including those with complex or smaller anatomical considerations, reinforces its role as a next-generation therapy. At Meril, we aim to innovate globally relevant, scientifically validated solutions that expand access to advanced structural heart care.”

The LANDMARK study will continue patient follow-up over a decade to assess the valve's performance, long-term clinical stability, and echocardiographic outcomes.

About the LANDMARK Study

The LANDMARK study is recognized as the first randomized non-inferiority study comparing the balloon-expandable Myval-THV series against contemporary balloon-expandable Sapien-THV series and self-expanding Evolut-THV series in patients with symptomatic severe aortic stenosis. It is a prospective, randomized, multicenter, open-label, non-inferiority study involving 768 patients who underwent transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis. The initial patient was enrolled on January 6, 2021, and the last patient on December 5, 2023, spanning 31 centers across 16 countries, including Brazil, New Zealand, and multiple European locations. The primary 30-day composite endpoint demonstrating the non-inferiority of the Myval-THV series to Sapien and Evolut series has been successfully published in esteemed peer-reviewed medical journals including The Lancet and EuroIntervention. The one-year results were also published in the Journal of the American College of Cardiology (JACC), further confirming the non-inferiority of Myval-THV concerning clinical efficacy.

About Meril Life Sciences

Meril is a global medical technology company based in India dedicated to advancing healthcare through innovation. With an intense focus on research and development, Meril provides cutting-edge solutions in over 135 countries, supported by a robust international network, including subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril actively shapes the future of healthcare.