Groundbreaking Findings from the Myval THV Series
LONDON – Meril Life Sciences is proud to unveil the compelling outcomes from the pivotal LANDMARK Randomized Controlled Trial (RCT), which took place at the prestigious PCR London Valves 2025 conference. This study marks the first multicenter RCT aimed at directly comparing the balloon-expandable Myval THV series with the renowned balloon-expandable Sapien THV series and the self-expanding Evolut THV series. The focus was on patients suffering from severe aortic stenosis.
Clinical Efficacy at One-Year Mark
After one year, the Myval THV series exhibited comparable clinical efficacy results, reflecting freedom from all-cause mortality, stroke, and hospitalizations related to the procedure or valve. Specifically, results revealed 87% efficacy for Myval compared to 86.9% for both Sapien and Evolut THV series. The consistency of these results is a testament to the reliability of Meril's innovative heart valve technology.
Extended Clinical Efficacy Assessment
The trial also included an extended clinical efficacy metric, encompassing not only major adverse events but also quality of life considerations. Findings for Myval THV series were at 80.5%, while Sapien achieved 75%, and Evolut reached 79.7%. Notably, the Myval THV series displayed the lowest recorded incidence of moderate aortic regurgitation at just 1.6%, highlighting its robust performance.
Insights from Leading Experts
Professor Patrick W. Serruys, the Chairman of the LANDMARK Trial, emphasized the importance of this study in providing critical insights to the TAVI community. "This trial sheds light on the differences that matter most clinically, especially concerning valve stability and hemodynamic performance. The one-year data reinforce the efficacy of Myval THV series, particularly its low rate of aortic regurgitation, which is vital for clinical decision-making," he remarked.
Benchmarking Valve Performance
Professor Andreas Baumbach, the Global Principal Investigator, praised the trial's unique ability to benchmark performance under uniform conditions. This consistency reinforces that Myval THV is competitive with existing global systems, offering clinicians versatile treatment options for a diverse patient demographic. As follow-up continues, more insights into long-term valve performance are anticipated, especially as the population of TAVI patients evolves.
Meril Life Sciences' Vision for the Future
Mr. Sanjeev Bhatt, Senior Vice President – Corporate Strategy at Meril, articulated the company's dedication to building robust clinical evidence. He stated, "The performance of Myval across varied patient anatomies illustrates its significance as a next-generation therapeutic solution. Our mission reflects a commitment to delivering innovative healthcare solutions that expand access to advanced heart care around the world. These positive results fuel the expectations for broader adoption of Myval across different clinical settings."
Long-term Commitment to Patient Care
The LANDMARK trial has an ambitious follow-up period of ten years to continue evaluating valve performance, ensuring patients receive the best possible care.
About the LANDMARK Trial
This innovative trial stands out as the first randomized non-inferiority study comparing the Myval THV series with both the balloon-expandable Sapien THV series and the self-expanding Evolut THV series. It involved 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) across 31 sites in 16 countries. The success of trial outcomes was recognized in esteemed medical journals.
About Meril Life Sciences
Meril Life Sciences is a pioneering global medical device company based in India, dedicated to advancing healthcare through innovative technology. With a firm research and development focus, Meril provides state-of-the-art medtech solutions in over 135 countries, supported by a robust presence across various international regions. By fostering partnerships and adhering to the highest quality standards, Meril aims to transform the future of healthcare.
Frequently Asked Questions
What is the LANDMARK trial?
The LANDMARK trial is a randomized controlled trial comparing the Myval THV series to other leading transcatheter heart valves.
What were the one-year outcomes for Myval THV series?
The Myval THV series demonstrated an 87% efficacy rate for freedom from all-cause mortality, stroke, and hospitalization at one year.
Who are the key figures involved in the LANDMARK trial?
Notable figures include Professor Patrick W. Serruys, Professor Andreas Baumbach, and Mr. Sanjeev Bhatt, contributing to the trial's critical insights.
What sets Myval THV series apart?
The Myval THV series exhibited the lowest incidence of moderate aortic regurgitation and demonstrated strong clinical efficacy comparable to established competitors.
How long will the LANDMARK trial continue?
The trial will maintain patient follow-up for ten years to monitor valve performance and clinical stability over the long term.
