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The Landmark RCT marks a milestone for Meril’s Myval THV series

LANDMARK RCT

The 30-day primary outcomes of the LANDMARK trial were presented on May 15th at EuroPCR 2024 in Paris, France, Marking a significant milestone for Meril Life Sciences’ Myval THV series.

Recognized by EuroPCR as one of the top three late-breaking trials likely to impact current practices in Interventional Cardiology, the LANDMARK RCT demonstrated that the safety and effectiveness of the Myval THV series were non-inferior in comparison to contemporary THV series.

Professor Serruys, Chairman & study Director of The LANDMARK trial, said, "Myval THV series are novel next-gen THV devices; non-inferior to the Sapien and Evolut THV series. Myval THV series have a unique size matrix incorporating conventional, intermediate and extra-large diameters with increasing diameter steps of 1.5mm that match and fit precisely the multi-slice CT scan-defined aortic annulus area of each individual patient, as a result, provides a superior effective orifice area on echocardiography, which may impact on durability and long-term clinical outcomes. Additionally, the Myval Octacor, with its 2 rows of octagonal cells and a minimal foreshortening of 19% during expansion, has unique features not paired by any other contemporary design."

A Key highlight of the presentation included the versatility of valve sizes to compliment diverse anatomies among patients; the Myval THV series offers a nuanced range of sizes, including traditional options (20 mm, 23 mm, 26 mm, 29 mm), intermediate sizes (21.5 mm, 24.5 mm, 27.5 mm), and extra-large sizes (30.5 mm and 32 mm). This tailored sizing matrix empowers cardiologists to choose an appropriate valve size, reducing the possibility of over- or under-sizing. In the LANDMARK trial, 48.1% of patients received an intermediate size from the Myval THV series.

Published in the Lancet

The findings from the landmark trial of the Myval THV series were accepted and published in The Lancet, one of the most prestigious medical journals globally. The publication detailed the safety and effectiveness of the Myval THV series, demonstrating its non-inferiority compared to the contemporary THV series. This publication validates the rigorous research and development that went into the Myval THV series and solidifies Meril's commitment to uplifting patient outcomes.

Mr. Sanjeev Bhatt, Sr. Vice President - Corporate Strategy at Meril, said, "In a successful development in structural heart interventions, the LANDMARK RCT has revealed compelling results for the novel Myval transcatheter heart valve (THV) series, confirming its non-inferiority to other contemporary THV devices. The results of the LANDMARK trial are not just a win for us but for the entire medical community and, most importantly, for patients undergoing TAVI. This study not only reinforces the safety and efficacy of the Myval THV series but also highlights its adaptability to challenging anatomical structures.”

Commitment to Innovation

At Meril Life Sciences, we believe in advancing research and development to obtain better patient outcomes and meet the diverse and unmet needs of patient subsets across geographies. Stay tuned for more updates on our achievements in the field of medical technology.

Explore in-depth coverage regarding the LANDMARK trial. Access the complete articles here:

https://bit.ly/3VzbBb6

https://bit.ly/3VC9C5L

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