LANDMARK trial, highlights the safety and effectiveness of the Myval Transcatheter Heart Valve Series

The trial involving 768 patients across 31 sites underscores Meril’s dedication to research and patient well-being.

The LANDMARK study showed that the performance of Myval THV series in terms of safety and effectiveness was non-inferior to the contemporary THV series (24.7% vs. 27.0%, occurrence of primary composite endpoint which is composite of deaths, stroke, major bleeding, acute kidney injury, major vascular complications, moderate or severe valve regurgitation, and the need for new permanent pacemaker implantation as per the third Valve Academic Research Consortium consensus) with no difference in the itemized components of the primary composite endpoints. The other secondary endpoints including technical success at exit from procedure room, device success at 30 days and early safety at 30 days were comparable in both the groups.

The results from the trial have been accepted for publication in The Lancet.

Professor Serruys, Chairman & study director of the LANDMARK trial, said “Myval THV series are novel next-gen THV devices; non-inferior to the Sapien and Evolut THV series. Myval THV series have a unique size matrix incorporating conventional, intermediate and extra-large diameters with increasing diameter steps of 1.5mm that match and fit precisely the multi slice CT scan-defined aortic annulus area of each individual patient, as a result, provides a superior effective orifice area on echocardiography, which may impact on durability and long-term clinical outcomes. Additionally, the Myval Octacor, with its 2 rows of octagonal cells and a minimal foreshortening of 19% during expansion, has unique features not paired by any other contemporary design.”