Meril Life Sciences Unveils Breakthrough Results from LANDMARK Study at EuroPCR 2025
Meril Life Sciences has recently shared the promising one-year results of its groundbreaking LANDMARK study during the prestigious EuroPCR 2025 conference held in Paris, one of the leading cardiovascular events worldwide. This innovative study represents the first randomized head-to-head trial comparing the performance of the balloon-expandable Myval-THV series against other modern heart valve replacement systems, including the balloon-expandable Sapien-THV and self-expanding Evolut-THV series, specifically targeting patients suffering from symptomatic severe aortic stenosis.
The findings from the LANDMARK study are particularly notable, as they confirm the non-inferiority of the Myval-THV series regarding clinically meaningful efficacy endpoints after one year. The study reported similar outcomes in clinical effectiveness, with the Myval series achieving a 13% success rate compared to 13.1% for the contemporary THV alternatives, demonstrating robust stability across various treatment arms. Furthermore, the combined endpoint of clinical efficacy and quality of life (QoL) metrics showed parallel results, with Myval THV series at 19.5% versus contemporary THVs at 22.7%.
One of the primary objectives of the LANDMARK study was to assess the hemodynamic parameters among patients, focusing on metrics such as the effective aortic valve area, mean pressure gradient, and incidence of moderate or severe aortic regurgitation. Notably, these hemodynamic parameters remained consistent and comparable across all treatment groups. The survival rates were also strikingly similar, with 92.8% for the Myval THV series versus 92.9% for contemporary devices, indicating excellent safety profiles bridging both technologies.
Professor Patrick Serruys, the chairperson and principal investigator of the study, emphasized the significance of this research in paving the way for future comparative studies in cardiac valve interventions. He noted that the rigorous design of the LANDMARK study adheres to VARC-3 standards and inclusively integrated quality-of-life endpoints, marking a significant milestone in structural heart disease research.
In addition, Professor Andreas Baumbach, the global chief investigator, remarked that this study dramatically advances TAVI (Transcatheter Aortic Valve Implantation) research. It was the first of its kind to directly compare balloon-expandable valves with self-expanding systems in a rigorously monitored environment. The one-year outcomes confirm that the new generation Myval-THV series meets globally recognized standards for safety and efficacy.
Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, added that the LANDMARK study signifies a crucial achievement not just for Meril but for the broader TAVI community. The compelling one-year data robustly supports the Myval-THV series as a next-generation solution, capable of delivering consistent safety, clinical efficacy, and an enhanced quality of life across diverse patient demographics. Being the sole head-to-head study incorporating both balloon-expandable and self-expanding valves, the research highlights the versatility of the Myval-THV series, reinforcing its relevance for varied anatomical complexities and healthcare systems.
Looking forward, the LANDMARK study aims to follow patients over a decade to extract long-term data on clinical and echocardiographic results, with a specific focus on valve durability and sustained performance.
In conclusion, the LANDMARK study is a pioneering randomized non-inferiority trial that compares the balloon-expandable Myval-THV series with current balloon-expandable Sapien-THV and self-expanding Evolut-THV series among patients diagnosed with severe aortic stenosis. Conducted as a prospective, multicenter, randomized, open-label trial, it enrolled 768 patients who underwent TAVI between January 6, 2021, and December 5, 2023, across multiple centers in 16 countries, including Brazil, New Zealand, and several European nations. The primary combined endpoints assessed at 30 days have been successfully published in renowned peer-reviewed journals, The Lancet and EuroIntervention.
Meril Life Sciences, headquartered in India, is a global med-tech company dedicated to advancing healthcare through innovation. With a strong emphasis on research and development, Meril offers state-of-the-art medical technology solutions in over 135 countries, boasting a significant presence across the Americas, Europe, Asia, Africa, and Australia. Through strategic partnerships and a commitment to cutting-edge technology, Meril aims to reshape the future of healthcare.
The findings from the LANDMARK study are particularly notable, as they confirm the non-inferiority of the Myval-THV series regarding clinically meaningful efficacy endpoints after one year. The study reported similar outcomes in clinical effectiveness, with the Myval series achieving a 13% success rate compared to 13.1% for the contemporary THV alternatives, demonstrating robust stability across various treatment arms. Furthermore, the combined endpoint of clinical efficacy and quality of life (QoL) metrics showed parallel results, with Myval THV series at 19.5% versus contemporary THVs at 22.7%.
One of the primary objectives of the LANDMARK study was to assess the hemodynamic parameters among patients, focusing on metrics such as the effective aortic valve area, mean pressure gradient, and incidence of moderate or severe aortic regurgitation. Notably, these hemodynamic parameters remained consistent and comparable across all treatment groups. The survival rates were also strikingly similar, with 92.8% for the Myval THV series versus 92.9% for contemporary devices, indicating excellent safety profiles bridging both technologies.
Professor Patrick Serruys, the chairperson and principal investigator of the study, emphasized the significance of this research in paving the way for future comparative studies in cardiac valve interventions. He noted that the rigorous design of the LANDMARK study adheres to VARC-3 standards and inclusively integrated quality-of-life endpoints, marking a significant milestone in structural heart disease research.
In addition, Professor Andreas Baumbach, the global chief investigator, remarked that this study dramatically advances TAVI (Transcatheter Aortic Valve Implantation) research. It was the first of its kind to directly compare balloon-expandable valves with self-expanding systems in a rigorously monitored environment. The one-year outcomes confirm that the new generation Myval-THV series meets globally recognized standards for safety and efficacy.
Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, added that the LANDMARK study signifies a crucial achievement not just for Meril but for the broader TAVI community. The compelling one-year data robustly supports the Myval-THV series as a next-generation solution, capable of delivering consistent safety, clinical efficacy, and an enhanced quality of life across diverse patient demographics. Being the sole head-to-head study incorporating both balloon-expandable and self-expanding valves, the research highlights the versatility of the Myval-THV series, reinforcing its relevance for varied anatomical complexities and healthcare systems.
Looking forward, the LANDMARK study aims to follow patients over a decade to extract long-term data on clinical and echocardiographic results, with a specific focus on valve durability and sustained performance.
In conclusion, the LANDMARK study is a pioneering randomized non-inferiority trial that compares the balloon-expandable Myval-THV series with current balloon-expandable Sapien-THV and self-expanding Evolut-THV series among patients diagnosed with severe aortic stenosis. Conducted as a prospective, multicenter, randomized, open-label trial, it enrolled 768 patients who underwent TAVI between January 6, 2021, and December 5, 2023, across multiple centers in 16 countries, including Brazil, New Zealand, and several European nations. The primary combined endpoints assessed at 30 days have been successfully published in renowned peer-reviewed journals, The Lancet and EuroIntervention.
Meril Life Sciences, headquartered in India, is a global med-tech company dedicated to advancing healthcare through innovation. With a strong emphasis on research and development, Meril offers state-of-the-art medical technology solutions in over 135 countries, boasting a significant presence across the Americas, Europe, Asia, Africa, and Australia. Through strategic partnerships and a commitment to cutting-edge technology, Meril aims to reshape the future of healthcare.
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