LONDON, Nov. 21, 2025 /PRNewswire/ — Meril Life Sciences today presented the one-year outcomes from the pivotal LANDMARK Randomized Controlled Trial (RCT) during the Late-Breaking Trial sessions at PCR London Valves 2025, a globally recognized structural heart conference. The LANDMARK trial represents the first-ever 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 with symptomatic severe aortic stenosis.
At one-year, the Myval THV series demonstrated comparable composite clinical efficacy, defined as freedom from all-cause mortality, all stroke, and procedure- or valve-related hospitalization, when compared to the Sapien and Evolut THV series, with outcomes reported at 87% for Myval THV Series, 86.9% for Sapien THV series, and 86.9% for Evolut THV series.
The trial also assessed an extended clinical efficacy endpoint (Freedom from all-cause mortality, all stroke, procedure- or valve-related hospitalization and QOL deterioration) reflecting sustained clinical benefit over time. These extended outcomes remained consistent across platforms, measured at 80.5% for Myval THV Series, 75.0% for Sapien THV Series, and 79.7% for Evolut THV Series. Importantly, the Myval THV series demonstrated the lowest incidence of moderate aortic regurgitation, recorded at 1.6%, reinforcing the system’s hemodynamic stability and valve performance at one-year.
Moreover, a post-hoc analysis in patients with small aortic annulus further confirmed comparable one-year composite efficacy outcomes (Freedom from all-cause mortality, all stroke, and procedure- or valve-related hospitalization), with results of 91% for Myval THV Series versus 89% for Sapien THV series, and 91% for Evolut THV series.
These one-year findings reinforce the Myval THV series as a clinically dependable and hemodynamically stable transcatheter valve platform, demonstrating sustained safety, effectiveness and well suited for diverse patient anatomies.
Professor Patrick W. Serruys, Chairman and Study Director of the LANDMARK Trial, said:
“The LANDMARK trial continues to provide the global TAVI community with meaningful comparative insight. By bringing together three leading THV platforms in a rigorously designed randomized study, we are able to better understand differences that matter clinically, particularly in valve stability and sustained hemodynamic performance. The one-year findings reinforce the reliability of the Myval THV series, including its low rate of aortic regurgitation, which is of significant relevance for valve performance. These data support informed clinical decision-making and expand the conversation on how to personalize valve selection according to patient anatomy.”
Professor Andreas Baumbach, Global Principal Investigator, said:
“This study is unique in its ability to benchmark performance across balloon-expandable and self-expanding valves under identical trial conditions. The consistency seen in both standard and extended clinical efficacy endpoints demonstrates that the Myval THV series performs on par with established global systems. Its hemodynamic profile, combined with predictable deployment and sizing options, provides clinicians with a valuable and versatile treatment choice. As the study progresses over the coming years, it will further contribute to greater clarity on long-term valve performance, which is increasingly important given the demographic shift toward younger and lower-risk TAVI patients.”
Mr. Sanjeev Bhatt, Senior Vice President – Corporate Strategy at Meril, said:
“The LANDMARK trial reflects our commitment to building robust clinical evidence that enables confident clinical decision-making. The continued performance of the Myval THV series across diverse patient populations, including those with complex or smaller anatomies, reinforces its role as a next-generation therapy solution. Our focus at Meril is to develop globally relevant, scientifically driven innovations that expand access to advanced structural heart care. These results further strengthen the foundation for Myval’s continued adoption across different geographies and clinical practice environments.”
The LANDMARK trial will continue patient follow-up for a period of ten years to evaluate valve performance, long-term clinical stability, and echocardiographic performance.
About THE LANDMARK TRIAL:
The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic native aortic stenosis. The first patient was enrolled in the LANDMARK trial on 6 January 2021 and the last patient was enrolled on 5 December 2023. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30-day primary composite endpoint demonstrating the non-inferiority of the Myval THV series to both SAPIEN and Evolut THV series in the LANDMARK trial have been successfully published in The Lancet and EuroIntervention, two of the most prestigious peer-reviewed medical journals. The one-year results of the LANDMARK trial have also been published in the Journal of the American College of Cardiology (JACC), demonstrating the non-inferiority of the Myval THV series compared with contemporary THVs for the clinical efficacy endpoint.
About Meril Life Sciences:
Meril is a global medical device company based in India, committed to advancing healthcare through innovation. With a strong focus on research and development, Meril delivers cutting-edge medtech solutions across more than 135 countries and has a robust presence through subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril is helping reshape the future of healthcare.
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SOURCE Meril Life Sciences
