Salute e Benessere
Meril Life Sciences Presents One-year Outcomes from the LANDMARK Randomized Controlled Trial at PCR London Valves 2025
The trial also assessed an endpoint (Freedom from all-cause mortality, all stroke, procedure- or valve-related hospitalization and QOL deterioration) reflecting sustained clinical benefit over time. These extended outcomes remained , measured at , , and . Importantly, the Myval THV series demonstrated the , recorded at , reinforcing the system's hemodynamic stability and valve performance at one-year.
Moreover, a post-hoc analysis in patients with further confirmed comparable one-year composite efficacy outcomes (Freedom from all-cause mortality, all stroke, and procedure- or valve-related hospitalization), with results of versus , and .
These one-year findings reinforce the Myval THV series as a clinically dependable and hemodynamically stable transcatheter valve platform, demonstrating sustained safety, effectiveness and well suited for diverse patient anatomies.
Professor , Chairman and Study Director of the LANDMARK Trial, said:
Professor , Global Principal Investigator, said:
Mr. , Senior Vice President – Corporate Strategy at Meril, said:
The trial will continue patient follow-up for a period of to evaluate
, long-term clinical stability, and echocardiographic performance.
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 and , two of the most prestigious peer-reviewed medical journals. The one-year results of the LANDMARK trial have also been published in the the non-inferiority of the Myval THV series compared with contemporary THVs for the clinical efficacy endpoint.
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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