Meril Life Sciences Reports Landmark One-Year Results for THV Valve Technology at PCR London Valves 2025

Meril Life Sciences Presents Landmark One-Year Outcomes

In a significant step for transcatheter heart valve technology, Meril Life Sciences today unveiled the one-year outcomes from their pivotal LANDMARK Randomized Controlled Trial (RCT) at the PCR London Valves 2025 conference, renowned for addressing advances in structural heart disease. This trial represents a pioneering multicenter RCT that directly compared the balloon-expandable Myval Transcatheter Heart Valve (THV) series against both the balloon-expandable Sapien and self-expanding Evolut THV series in patients suffering from symptomatic severe aortic stenosis.

Key Findings of the LANDMARK Trial

After one year, the Myval THV series showed comparable clinical efficacy outcomes to both the Sapien and Evolut series. The results indicated an impressive clinical efficacy rate of 87% for the Myval THV series, slightly outperforming its competitors, who reported rates of 86.9% each. This crucial efficacy metric was defined as freedom from all-cause mortality, all strokes, and hospitalization related to procedures or valve issues.

The trial also introduced an extended clinical efficacy endpoint that assessed long-term health outcomes such as overall mortality, stroke prevalence, valve-related hospitalizations, and quality of life. The Myval series scored 80.5%, compared to 75% for Sapien and 79.7% for Evolut, demonstrating sustained clinical benefits over time.

Moreover, the trial highlighted that the Myval THV series exhibited the lowest incidence of moderate aortic regurgitation at only 1.6%, reinforcing its stable hemodynamic performance over the one-year period.

In a post-hoc analysis focusing on patients with small aortic annuli, Myval again showcased its competitive edge, registering a one-year composite efficacy of 91%, surpassing the 89% and 91% for Sapien and Evolut, respectively.

Expert Insights

Professor Patrick W. Serruys, the Chairman and Study Director of the LANDMARK trial, praised the contribution of the trial in providing critical insight for the international TAVI (Transcatheter Aortic Valve Implantation) community. He emphasized the reliability of the Myval THV series, particularly its low regurgitation rates, a vital consideration in valve performance. "These findings not only support informed clinical decision-making but also expand the dialogue regarding personalized valve selection based on individual patient anatomy,” he stated.

Globally recognized investigator, Professor Andreas Baumbach, attributed the uniqueness of the study to its capability to benchmark the performance of both balloon-expandable and self-expanding valves under identical conditions. He remarked, "The consistency highlighted in both standard and extended endpoints confirms that the Myval THV series performs comparably to established systems."

Mr. Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, reiterated the company's dedication to substantiate strong clinical evidence that empowers confident decision-making among healthcare professionals. He mentioned that the Myval THV series consistently performs well across a varied patient demographic, including those with complex or smaller anatomies.

Future Directions of the LANDMARK Trial

The LANDMARK trial is set to continue its patient follow-up for a decade, allowing further evaluation of valve performance, long-term stability, and echocardiographic assessments. This ongoing commitment to research underscores the potential of the Myval THV series as a therapeutic solution well-suited for a wide range of patients.

About the LANDMARK Trial

The LANDMARK trial stands as a first-of-its-kind randomized non-inferiority comparison of the Myval THV series versus other contemporary options, including the balloon-expandable Sapien and self-expanding Evolut THV series. This prospective, multicenter, open-label trial involved 768 patients who underwent TAVI procedures across 31 clinical sites in 16 countries from January 2021 to December 2023. The trial’s primary endpoint, demonstrating the non-inferiority of Myval to the comparison valves, has been published in renowned medical journals, reinforcing the THV series' alignment with contemporary clinical needs.

About Meril Life Sciences

Meril Life Sciences is a leading global medical device company headquartered in India, focused on enhancing healthcare through innovative solutions. Their commitment to research and development enables them to offer advanced medical technologies in over 135 countries, thereby reshaping the future of healthcare.