Meril Life Sciences Reveals One-Year Results from LANDMARK Trial at PCR London Valves 2025

Meril Life Sciences Reveals One-Year Results from LANDMARK Trial

Meril Life Sciences has recently showcased the one-year outcomes of its pivotal LANDMARK Randomized Controlled Trial (RCT) during the Late-Breaking Trial sessions at the esteemed PCR London Valves 2025 conference. This trial marks a significant milestone as it is the first multicenter RCT aimed at comparing the balloon-expandable Myval Transcatheter Heart Valve (THV) series against both the balloon-expandable Sapien THV series and the self-expanding Evolut THV series in patients suffering from symptomatic severe aortic stenosis.

Data presented at the conference have established that, after one year, the Myval THV series demonstrated efficacy similar to that of its competitors. The composite clinical efficacy, which consists of factors including all-cause mortality, all stroke, and hospitalizations related to procedures or valve issues, was reported at 87% for the Myval THV series. In comparison, the Sapien and Evolut THV series both showed slightly lower rates at 86.9%.

Furthermore, the trial evaluated an extended clinical efficacy endpoint, incorporating quality of life deterioration along with previous categories. The resulting figures indicated that Myval retained a solid performance at 80.5%, compared to 75.0% for Sapien and 79.7% for Evolut. These figures signify the remarkable sustained clinical benefit witnessed over time with the Myval THV series.

Another critical finding of the trial was the Myval valve's exceptionally low incidence of moderate aortic regurgitation, recorded at just 1.6%. This highlighted the valve's favorable hemodynamic stability and overall performance at the one-year checkpoint.

In addition, the post-hoc analysis conducted on patients with smaller aortic annulus further corroborated the Myval series' reliability. The composite effectiveness rate remained high at 91% for the Myval series, similar to the corresponding rates of 89% for Sapien and 91% for Evolut. This underscores the versatility and dependable nature of the Myval THV system, accommodating patients with varying anatomical complexities.

Professor Patrick W. Serruys, Chairman and Study Director of the LANDMARK Trial, conveyed that the ongoing value derived from the LANDMARK trial significantly benefits the global Transcatheter Aortic Valve Implantation (TAVI) community. By parsing through differences between three leading THV platforms, the study provides insights into critical factors like valve stability and sustained hemodynamic performance. He emphasized the Myval series' reduced rate of aortic regurgitation as a pivotal aspect of its favorable performance.

Additionally, Professor Andreas Baumbach, the Global Principal Investigator, recognized the LANDMARK trial's uniqueness in its ability to benchmark valve performance across different categories under identical conditions. The consistency observed in both standard and extended efficacy endpoints further validates that the Myval THV series meets or exceeds the performance of established competitors. Coupled with its predictable deployment and sizing approaches, Myval represents a potent option for clinicians treating diverse patient populations.

Mr. Sanjeev Bhatt, Senior Vice President – Corporate Strategy at Meril, expressed that the LANDMARK trial reflects Meril's dedication to fostering robust clinical evidence for better clinical decision-making. The sustained efficacy shown by the Myval series across various patient demographics emphasizes its potential as a next-generation therapeutic solution. He reaffirmed Meril's commitment to developing globally relevant innovations aimed at enhancing healthcare access.

The follow-up for this significant trial is set to extend over a decade, allowing a comprehensive evaluation of valve performance, long-term clinical stability, and echocardiographic results.

About the LANDMARK Trial

The LANDMARK trial stands out as the pioneering randomized non-inferiority trial that juxtaposes the balloon-expandable Myval THV series with the contemporary balloon-expandable Sapien THV series and self-expanding Evolut THV series in patients diagnosed with symptomatic severe aortic stenosis. The multi-center, open-label trial involved 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI). The project initiated patient enrollment on January 6, 2021, and concluded with the last enrollment on December 5, 2023. Over its course, the trial successfully enrolled patients at 31 sites located in 16 countries across the globe, including regions like Brazil, New Zealand, and multiple European nations. The foundational 30-day primary composite endpoint results demonstrating Myval's non-inferiority to both SAPIEN and Evolut THV series have already been disseminated in respected medical journals such as The Lancet and EuroIntervention. Furthermore, the one-year outcomes have been featured in the Journal of the American College of Cardiology (JACC).

About Meril Life Sciences

Meril Life Sciences is an innovative global medical device company headquartered in India. With a strong emphasis on research and development, Meril is dedicated to improving healthcare by delivering cutting-edge medical technology solutions across more than 135 countries worldwide. The company maintains a solid presence through its subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia, positioning itself as a leader in the field of medical advancements. Through strategic partnerships and adherence to international quality standards, Meril continues to shape the future of healthcare.