PRNewswire
Vapi (Maharashtra) [India], November 25: Underscoring India’s rising influence in global cardiovascular innovation, Meril Life Sciences presented the one-year outcomes from the pivotal LANDMARK Randomized Controlled Trial (RCT) during the Late-Breaking Trial sessions at PCR London Valves 2025, one of the world’s most respected structural heart conferences. This milestone marks a significant moment for Indian MedTech, as the indigenous, balloon-expandable Myval THV series is directly compared with leading international transcatheter valve platforms from Edwards Lifesciences and Medtronic. As the first-ever multicenter RCT to evaluate an Indian-developed THV against these established global systems, the LANDMARK trial highlights the growing confidence, capability, and clinical credibility of India’s cardiac device ecosystem on a global stage.
At one-year, the Myval THV series demonstrated comparable composite clinical efficacy, defined as freedom from all-cause mortality, all stroke, and procedure- or valve-related hospitalization, when compared to the Sapien and Evolut THV series, with outcomes reported at 87% for Myval THV Series, 86.9% for Sapien THV series, and 86.9% for Evolut THV series.
The one-year outcomes from the LANDMARK randomized controlled trial represent a defining moment for India in the global cardiovascular arena. As one of the most extensive head-to-head TAVI evaluations–spanning 768 patients across 31 centres in 16 countries–the trial places an Indian-developed Myval THV series in direct comparison with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series under identical clinical conditions. This scale and scientific rigor elevate India from being a participant in global cardiovascular innovation to being a key contributor shaping its evidence base.
Across critical endpoints such as mortality, stroke, hospitalization, valve stability, and hemodynamic performance, the trial shows that the indigenous THV performs at par with internationally established platforms. These consistent outcomes demonstrate that India is capable of engineering advanced cardiac solutions that deliver dependable results across diverse and complex anatomies. For the clinical community, this reinforces that Indian technology can stand shoulder-to-shoulder with global leaders when subjected to stringent, real-world clinical testing.
Importantly, the study’s findings signal a broader shift in how Indian medical devices are viewed in high-precision, niche segments like structural heart therapy. The success of an Indian THV in a multicountry, randomized, comparative trial underscores that India is no longer only manufacturing cardiac devices–it is producing innovations that meet global standards of safety, efficacy, and long-term reliability. The LANDMARK trial positions India firmly on the global stage, demonstrating that its homegrown technologies are ready to compete, influence, and contribute meaningfully to the future of cardiovascular care worldwide.
Professor Patrick W. Serruys, Chairman and Study Director of the LANDMARK Trial, said:
“The LANDMARK trial continues to provide the global TAVI community with meaningful comparative insight. By bringing together three leading THV platforms in a rigorously designed randomized study, we are able to better understand differences that matter clinically, particularly in valve stability and sustained hemodynamic performance.”
Professor Andreas Baumbach, Global Principal Investigator, said:
“This study is unique in its ability to benchmark performance across balloon-expandable and self-expanding valves under identical trial conditions. The consistency seen in both standard and extended clinical efficacy endpoints demonstrates that the Myval THV series performs on par with established global systems. The continued follow-up will deepen our understanding of long-term valve behaviour, a key factor as TAVI use grows among younger and lower-risk patient groups.”
Mr. Sanjeev Bhatt, Senior Vice President – Corporate Strategy at Meril, said:
“The LANDMARK trial reflects our commitment to building robust clinical evidence that enables confident clinical decision-making. The continued performance of the Myval THV series across diverse patient populations, including those with complex or smaller anatomies, reinforces its role as a next-generation therapy solution. Our focus at Meril is to develop globally relevant, scientifically driven innovations that expand access to advanced structural heart care.”
The LANDMARK trial will continue patient follow-up for a period of ten years to evaluate valve performance, long-term clinical stability, and echocardiographic performance.
About THE LANDMARK TRIAL:
The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic native aortic stenosis. The first patient was enrolled in the LANDMARK trial on 6 January 2021 and the last patient was enrolled on 5 December 2023. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30-day primary composite endpoint demonstrating the non-inferiority of the Myval THV series to both SAPIEN and Evolut THV series in the LANDMARK trial have been successfully published in The Lancet and EuroIntervention, two of the most prestigious peer-reviewed medical journals. The one-year results of the LANDMARK trial have also been published in the Journal of the American College of Cardiology (JACC), demonstrating the non-inferiority of the Myval THV series compared with contemporary THVs for the clinical efficacy endpoint.
About Meril Life Sciences:
Meril is a global medical device company based in India, committed to advancing healthcare through innovation. With a strong focus on research and development, Meril delivers cutting-edge medtech solutions across more than 135 countries and has a robust presence through subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril is helping reshape the future of healthcare.
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HINDI, MARATHI, GUJARATI, TAMIL, TELUGU, BENGALI, KANNADA, ORIYA, PUNJABI, URDU, MALAYALAM
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