#India #Meril Life Sciences #Vapi #Myval THV #LANDMARK Trial

Meril Life Sciences Showcases LANDMARK Trial Success at EuroPCR 2025

In a milestone event for cardiac medicine, Meril Life Sciences presented the one-year outcomes from the LANDMARK trial at EuroPCR 2025, one of the foremost cardiology conferences held in Paris, France. This landmark study is the first of its kind, centered on the comparison of the Myval transcatheter heart valve (THV) series against both contemporary balloon-expandable and self-expanding THVs for patients suffering from symptomatic severe aortic stenosis.

The LANDMARK Trial: A Comprehensive Overview

The LANDMARK trial is a randomized, non-inferiority study that meticulously evaluated the performance of the Myval THV series in contrast to the widely used Sapien THV series and Evolut THV series. It involved nearly 800 patients across 31 sites in 16 countries, marking it as a significant collaborative effort in assessing valve performance on a global scale.

Following the rigorous standards established by VARC-3, the study aimed to establish the safety and effectiveness of the Myval THV series, emphasizing not just clinical outcomes, but also the quality of life (QoL) improvements for patients undergoing transcatheter aortic valve implantation (TAVI).

Key Findings from the One-Year Results

The results unveiled during the Late-Breaking Trial session indicated that the Myval THV series showed non-inferiority when compared to contemporary alternatives. Among the results, it was found that:

• - The composite clinical efficacy endpoint achieved by the Myval THV series was 13%, closely matching the 13.1% seen in the contemporary THV cohort.
• - In terms of QoL metrics, there was a similarity observed with Myval demonstrating 19.5% compared to 22.7% for other contemporary options, which asserted the valve’s overall performance in real-world applications.
• - Importantly, survival rates were almost equivalent, with Myval recorded at 92.8% while contemporary THVs reported 92.9%, emphasizing the safety associated with the Myval series.

Professor Patrick Serruys, who headed the trial, articulated the significance of these findings, noting that the exhaustively designed study represents a new era in valve research, strengthening the landscape of heart valve therapy.

Perspectives from Key Contributors

This important trial captured a degree of enthusiasm amongst the medical community. Professor Andreas Baumbach, the Global Principal Investigator of the trial, remarked on the pioneering nature of this research, explaining how it benchmarks the Myval against both leading balloon-expandable and self-expanding platforms. He noted, 'The results affirm that the new generation Myval THV series meets global standards for safety and clinical efficacy.'

Mr. Sanjeev Bhatt, Senior Vice President for Corporate Strategy at Meril, echoed these sentiments, emphasizing that the trial represents a substantial milestone not just for their company, but for the overall TAVI community. He spoke to the commitment that Meril Life Sciences has in continuously advancing healthcare through innovative technologies that cater to diverse patient needs.

Looking Ahead: Future Directions for the LANDMARK Trial

The LANDMARK trial plans to extend its observational framework for ten years, allowing researchers to collect extensive insights into long-term clinical and echocardiographic outcomes, particularly focusing on the durability and sustained performance of the Myval THV series.

In summary, the successful demonstration of the Myval THV's capabilities at EuroPCR 2025 is indicative of Meril Life Sciences' robust presence in the cardiology field. The findings of the LANDMARK trial provide noteworthy validation of their advancements in valve technology, promising significant contributions to the management of aortic stenosis globally.

As the field of cardiac care continues to evolve, these developments provide hope for countless patients in need of safe and effective treatment options.

About Meril Life Sciences

Meril Life Sciences is a pioneering medical device company headquartered in India, dedicated to integrating innovation into healthcare. With a strong foundation in research and development, and presence in over 135 countries, Meril remains committed to improving patient care with cutting-edge medical technologies.