Meril’s Myval Devices for TAVR Evaluated at 1 Year in LANDMARK RCT

May 29, 2025—Meril Life Sciences recently announced 1-year results from its LANDMARK pivotal trial of its series of Myval transcatheter heart valves (THVs) for transcatheter aortic valve replacement (TAVR).

The company stated that the randomized, noninferiority trial is comparing the company’s series of balloon-expandable Myval THVs with contemporary TAVR device series—balloon-expandable Sapien TAVR systems (Edwards Lifesciences) and self-expandable Evolut TAVR systems (Medtronic)—in patients with symptomatic, severe aortic stenosis.

The LANDMARK findings were presented at the EuroPCR 2025 conference held May 20-23 in Paris, France.

According to the company, the Myval series of devices demonstrated noninferiority to the contemporary device series in the 1-year clinical efficacy composite endpoint (Myval, 13% vs contemporary devices, 13.1%; difference, -0.1%; one-sided 95% CI, 3.9%; P for noninferiority < .0001).

Additionally, Meril reported that in the composite endpoint of clinical efficacy combined with quality-of-life (QoL) outcomes were comparable (Myval, 19.5% vs contemporary devices, 22.7%; difference, -3.2%; 95% CI, -9.2 to 2.9; P = .33). Hemodynamic parameters, including effective orifice area, mean pressure gradient, and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms.

Survival rates were approximately the same (Myval, 92.8% vs contemporary devices, 92.9%) and QoL improvements were comparable, reinforcing the overall safety and durability of the Myval THV series in everyday clinical use for TAVR, stated Meril.

The LANDMARK trial is composed of 768 patients who underwent the TAVR procedure for the treatment of aortic stenosis. Patients were enrolled from January 2021 to December 2023 at 31 sites across 16 countries, including Brazil, New Zealand, and some countries in Europe. The trial is designed to follow patients for 10 years.

Professor Patrick W. Serruys, MD, is Chairman and Study Director of the LANDMARK trial. Professor Andreas Baumbach, MD, is the trial’s Global Principal Investigator.

Merit noted that early outcomes data from LANDMARK have been published. In July 2024, the company announced that the 30-day primary composite endpoints highlighting the safety and efficacy outcomes of the LANDMARK trial were published in The Lancet. Previously, the company announced the presentation of the 30-day primary outcomes at EuroPCR 2024. Early outcomes from the trial were also published in EuroIntervention in January 2025, advised the company.