Meril Life Sciences has revealed encouraging one-year findings from its groundbreaking LANDMARK trial, presented during the prestigious Late-Breaking Trial session at EuroPCR 2025 in Paris. This is the first randomized, head-to-head non-inferiority study comparing the next-generation balloon-expandable Myval THV series with both balloon-expandable Sapien and self-expanding Evolut THV devices in patients with symptomatic severe aortic stenosis.

The Myval THV series demonstrated non-inferior performance in one-year clinical efficacy compared to other transcatheter heart valves (13% vs. 13.1%). Quality-of-life metrics also remained comparable (19.5% vs. 22.7%), and hemodynamic indicators such as orifice area, pressure gradient, and aortic regurgitation showed consistent outcomes across all groups. Survival rates and quality of life improvements were nearly identical, affirming the Myval series’ safety, reliability, and real-world clinical relevance.

Experts hailed the trial as a pivotal step in structural heart research. Professor Patrick Serruys emphasized the study’s precision and adherence to VARC-3 standards, while Professor Andreas Baumbach noted the global benchmarking achieved.

With 768 patients across 31 sites in 16 countries, the LANDMARK trial is designed for a 10-year follow-up, promising critical insights into long-term valve durability. Meril sees this milestone as a leap forward for global TAVI innovation, reinforcing Myval’s adaptability for diverse patient anatomies and healthcare systems.