Meril Life Sciences today announced one-year results from a pivotal trial evaluating its balloon-expandable Myval THV system.
Investigators shared findings from the LANDMARK trial at EuroPCR 2025 in Paris. LANDMARK is the first randomized non-inferiority trial comparing the balloon-expandable Myval transcatheter heart valve (THV) with other contemporary valves — Edwards’ balloon-expandable Sapien series and Medtronic’s self-expandable Evolut series in patients. The study evaluated the valves head-to-head in patients with symptomatic severe aortic stenosis.
India-based Meril said the first-of-its-kind head-to-head trial reinforced the performance and safety of the next-generation Myval THV series. Myval demonstrated non-inferiority to contemporary THVs in terms of the one-year clinical efficacy composite endpoint.
Additionally, Meril said Myval delivered comparable outcomes when combining clinical efficacy with quality of life. Hemodynamic parameters, including effective orifice area (EOA), mean pressure gradient (PG), and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms.
The trial delivered nearly identical survival rates (Myval: 92.8%, other THVs: 92.9%). Quality of life improvements also proved comparable.
“The LANDMARK trial represents a significant milestone not just for Meril, but for the global TAVI community. The strong one-year results affirm the Myval THV series as a next-generation solution that delivers consistent safety, clinical efficacy, and improved quality of life across geographies,” said Sanjeev Bhatt, SVP – corporate strategy at Meril. “As the only head-to-head trial of its kind to include both balloon-expandable and self-expanding valves, it reinforces Myval THV series’s versatility and real-world relevance for diverse patient anatomies and healthcare systems. At Meril, we are proud to contribute innovative, evidence-based technologies that are reshaping patient care and expanding access to advanced structural heart therapies worldwide.”
Meril plans for LANDMARK to follow patients for 10 years to generate long-term insights with a focus on valve durability and sustained performance.
