Meril Announces One-Year Landmark Trial Results Demonstrating Myval TAVR Non-Inferiority and Potential Advantages Over Edwards and Medtronic Platforms

LANDMARK Trial Aims to...Comparison of the performance of the Myval balloon-expandable transcatheter heart valve series (produced in China) with the balloon-expandable Sapien (Edwards) and the self-expanding Evolut (Medtronic) in patients with symptomatic severe aortic stenosis.

Specific Research Data

• One-year data showed that Myval was comparable to Sapien and Evolut in composite clinical efficacy (defined as the composite endpoint of freedom from all-cause mortality, all strokes, and surgery- or valve-related rehospitalization), with the three groups showing 87%, 86.9%, and 86.9%, respectively.

• The trial also evaluated extended clinical efficacy endpoints (freedom from all-cause mortality, all strokes, surgery or valve-related rehospitalization, and deterioration in quality of life) to reflect sustained clinical benefit. The results of the extended endpoints were consistent across platforms, with rates of 80.5%, 75%, and 79.7% for the Myval, Sapien, and Evolut groups, respectively.

• Myval had the lowest incidence of moderate aortic regurgitation, at only 1.6%.

• A post-hoc analysis of patients with small aortic annuli showed comparable performance for the one-year composite efficacy endpoint (freedom from all-cause mortality, all strokes, and surgery- or valve-related rehospitalization): 91% in the Myval group vs 89% in the Sapien group, with the Evolut group also reaching 91%.

PI Evaluation

"The LANDMARK trial continues to provide valuable comparative data for the global TAVI field. By incorporating three major valve platforms into a rigorously designed randomized study, we can more accurately understand clinically significant differences, particularly in terms of valve durability and sustained hemodynamic performance. The one-year results confirm the reliability of the Myval valve series, with its low incidence of paravalvular leakage being crucial to valve performance. These data support clinical decision-making and promote discussions on personalized valve selection based on patient anatomy."

---Patrick W Serruys  National University of Ireland

"The unique value of this study lies in its ability to benchmark the performance of balloon-expandable and self-expanding valves under identical test conditions. The consistency between standard and extended clinical efficacy endpoints demonstrates that Myval has reached the level of internationally established systems. Its hemodynamic characteristics, combined with predictable deployment operations and size selection, offer clinicians significant diversified treatment options. As research progresses in the coming years, we will gain clearer insights into the long-term performance of the valve — a crucial factor for the increasingly younger and lower-risk TAVI patient population."

---Andreas Baumbach  Queen Mary University of London

Executive Evaluation

"The LANDMARK trial reflects our commitment to building a robust clinical evidence system. The consistent stability demonstrated by Myval across different patient populations, including those with complex anatomies or small annuli, underscores its value as a next-generation therapeutic solution. Medtronic is dedicated to developing scientifically innovative products with global applicability, promoting the accessibility of advanced structural heart disease diagnosis and treatment technologies. These results will lay an even stronger foundation for the widespread adoption of Myval across various regions and clinical settings worldwide."

---Sanjeev Bhatt  MerilSenior Vice President of Corporate Strategy

The LANDMARK trial will continue with a ten-year patient follow-up to evaluate valve performance, long-term clinical stability, and echocardiographic outcomes.

MyvalIn addition to the unique design of the valve stent, another feature is the variety of specifications. In addition to the four standard sizes of 20 mm, 23 mm, 26 mm, and 29 mm, there are also three intermediate sizes: 21.5 mm, 24.5 mm.mmAnd 27.5 mm；And two extra-large sizes of 30.5 mm and 32 mm. Such a wide range of specifications enables doctors to...This enables clinicians to select the most appropriate valve size for different native annulus geometries.

MyvalAlso equipped with a dedicated delivery system---Navigator ，Myval was pre-installed inOn the Navigator. The distal end of the delivery system can bend over 180° while navigating the aortic arch and passing through the native valve.NavigatOR BalloonBoth ends have two opposing soft plugs, forming a shallow crimping area that provides precise and tight fitting for crimping valves.These plugs prevent accidental migration of the valve and minimize the risk of valve displacement while traversing the sheath and aorta.