Myval THV Series Shows Promising One-Year Outcomes in LANDMARK RCT Presented at PCR London Valves 2025

Meril Life Sciences presented the one-year outcomes from the LANDMARK Randomized Controlled Trial at PCR London Valves 2025, attracting interest from clinicians and industry experts. During the Late-Breaking Trial session, investigators reported that the India-developed, balloon-expandable Myval Transcatheter Heart Valve (THV) Series delivered outcomes comparable to major international TAVR systems. The data pointed to steady hemodynamic performance and dependable results across a wide range of patient anatomies. These results published in the Journal of the American College of Cardiology (JACC) concurrently with the presentation, strengthen Myval THV Series standing as a well-supported option in TAVR care and underscore Meril’s ongoing effort to deliver meaningful advances in structural heart therapies worldwide.

The one-year results from the LANDMARK Trial indicate that the Myval THV Series performs comparably to two widely used global TAVR systems: the Sapien THV Series and Evolut THV Series platforms. Myval achieved an 87% success rate in the composite clinical efficacy endpoint (which is defined as a composite of freedom from all-cause death, freedom from stroke, and freedom from procedure- or valve-related hospitalizations). This outcome closely aligns with the 86.9% reported for the contemporary valve control group (comprising both Sapien and Evolut data).

When quality-of-life deterioration was included in the extended clinical efficacy endpoint, Myval THV Series maintained a performance rate of 80.5%, compared with 75.0% for Sapien THV Series and 79.7% for Evolut THV Series. The Myval THV Series also exhibited the lowest rate of moderate aortic regurgitation at 1.6% among the three valves, indicating stable hemodynamic behavior at one year.

Another LBT presented at LV2025 showed post-hoc analysis of the LANDMARK trial in patients with small aortic annulus demonstrated.

“The LANDMARK trial continues to provide the global TAVR community with meaningful comparative insight,” commented Prof. Serruys in Meril’s press release. “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 1-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.”
— Prof. Patrick W. Serruys, Chairman & Study Director, LANDMARK Trial

“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 TAVR patients.”
— Prof. Andreas Baumbach, Global Principal Investigator, LANDMARK Trial

“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.”
— Mr. Sanjeev Bhatt, Senior Vice President – Corporate Strategy, Meril Life Sciences

The one-year results presented at PCR London Valves 2025 mark an important milestone for the Myval THV Series and for the evolution of transcatheter aortic valve therapy. Demonstrating performance equivalent to established global TAVR platforms under the rigor of a multinational randomized trial, Myval THV Series has established itself as a dependable and versatile option, particularly for patients with challenging anatomy such as small aortic annulus.

These findings highlight Meril’s engineering excellence and reinforce India’s growing influence in shaping the future of cardiovascular innovation. As the LANDMARK Trial continues to gather long-term data, the insights will further guide clinical decision-making and strengthen confidence in Myval THV Series durability and real-world performance.