Myval TAVR valve outperforms Sapien and Evolut in the late-breaking LANDMARK trial
In a first-of-its-kind multicenter clinical trial directly comparing three leading transcatheter aortic valve replacement (TAVR) valve systems, the Myval valve from India-based Meril Life Sciences outperformed both the market-leading Edwards Lifesciences Sapien and Medtronic Evolut valves. The one-year data from the LANDMARK trial was presented as a late-breaker during the PCR London Valves 2025 meeting over the weekend.
The pivotal, randomized controlled trial (RCT) showed Myval had comparable efficacy at 87% versus Sapien and Evolut at 86.9%. The trial also assessed an extended clinical efficacy endpoint, which included freedom from all-cause mortality, all stroke-, procedure- or valve-related hospitalization and quality of life deterioration, designed to show sustained clinical benefit over time. It also had the lowest regurgitation rate at 1.6%. In patients with small aortic annulus, Myval was comparable with a composite efficacy outcome for freedom from all-cause mortality, all stroke-, and procedure- or valve-related hospitalization, with results of 91% for Myval, versus 89% for Sapien and 91% for Evolut.
“The LANDMARK trial continues to provide meaningful comparative insight. By bringing together three leading transcatheter heart valve (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. The one-year findings reinforce the reliability of the Myval THV series, including its low rate of aortic regurgitation, which is of significant relevance for valve performance," explained Professor Patrick W. Serruys, chairman and study director of the LANDMARK Trial, and professor of interventional medicine and innovation at University of Galway, in a statement.
Serruys said this data will be used to better inform decisions as to which valve is best for each patient.
Trial Global Principal Investigator Professor Andreas Baumbach, interventional cardiologist at Barts Heart Center, London, said the trial is unique and greatly adds to the understanding of how these valves work in a comparable format.
“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," Baumbach explained in a statement. "Its hemodynamic profile, combined with predictable deployment and sizing options, provides clinicians with a valuable and versatile treatment choice."
The LANDMARK trial will continue to follow patients over 10 years to better understand long-term valve stability and echocardiographic performance.
Meril Life Sciences has been manufacturing its Myval for years for use in both India and Europe. The company has not yet gained U.S. Food and Drug Administration approval. The valve has gained notice by cardiology experts because of its continued success in clinical trials.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]