Meril Life Sciences Achieves Major Milestone with LANDMARK RCT Results Presented at EuroPCR 2025

In a groundbreaking development for transcatheter aortic valve implantation (TAVI), Meril Life Sciences has unveiled the one-year results from their pivotal LANDMARK trial at EuroPCR 2025, one of the most esteemed cardiology conferences globally, held in Paris, France. The study stands out as the first randomized non-inferiority trial comparing their innovative balloon-expandable Myval Transcatheter Heart Valve (THV) series against contemporary valve designs, including the Sapien and Evolut series, specifically in patients suffering from symptomatic severe aortic stenosis.

The findings from the LANDMARK trial addressed key clinical efficacy endpoints, revealing that the Myval THV series demonstrated non-inferiority compared to its counterparts. Specifically, the data indicated a clinical efficacy composite outcome of 13% for the Myval series against 13.1% for other THVs, showcasing a remarkable margin with a difference of just -0.1%. Furthermore, the quality of life (QoL) assessment in conjunction with clinical efficacy revealed similarities in outcomes, with 19.5% of Myval THV patients reporting positive results compared to 22.7% from contemporary products, a difference that underscores the competitiveness of the Myval series in improving patient health.

An essential aspect of the trial was the stability of hemodynamic parameters among all treatment groups. Key metrics, such as effective orifice area, mean pressure gradient, and the rate of moderate or greater aortic regurgitation, remained consistent across both the Myval THV and the other evaluated valve series, further enhancing the reliability of these findings.

Survival rates showed minimal variation, almost identical at 92.8% for Myval THV users versus 92.9% for contemporary devices. The enhancements in quality of life were noted to be on par with those found in patients receiving other current TAVI options, fortifying the argument for the Myval THV series being a safe and durable choice for routine clinical application.

Dr. Patrick Serruys, the study's chairman, emphasized the significance of these findings in shaping future valve research. He noted that the rigorous adherence to VARC-3 standards, including key quality of life indicators, marks the LANDMARK trial as a cornerstone study for advancing TAVI technology. He remarked, “The data not only validate the safety and efficacy of the Myval THV series but also spotlight its adaptability to complex anatomies, which clinicians require for diverse patient groups.”

Professor Andreas Baumbach, the global principal investigator of the study, described this trial as a monumental step in evaluating TAVI options against established platform technologies. The encouraging one-year results establish that the next-generation Myval THV can compete with global standards concerning safety and efficacy in heart valve procedures.

Meril’s Senior Vice President for Corporate Strategy, Sanjeev Bhatt, stressed the importance of the trial, regarding it as a pivotal moment not only for their company but also for the global TAVI community. The one-year outcomes reaffirm the Myval THV series as a trailblazing solution that consistently offers safety and clinical effectiveness while improving patient QoL across various healthcare settings. With comprehensive data from a head-to-head trial that encompasses both balloon-expandable and self-expanding platforms, Myval THV’s versatility is further substantiated for different patient anatomies.

The LANDMARK trial is structured for a ten-year duration, aiming to provide substantial insights on both clinical and echocardiographic outcomes, with a pronounced focus on valve longevity and sustained performance metrics. Conducted across 31 sites in 16 countries, including locations in Brazil, New Zealand, and Europe, the landmark study involved 768 participants who underwent TAVI for aortic stenosis treatment. The primary safety and efficacy endpoints from the trial have also been documented in prominent peer-reviewed journals, namely The Lancet and EuroIntervention—signifying the study's broad acceptance in the medical community.

Overall, the LANDMARK trial results are a testament to Meril Life Sciences' commitment to revolutionizing cardiovascular care through innovation and cutting-edge technology, paving the way for better health outcomes in patients worldwide who rely on advanced transcatheter treatments.