Meril Life Sciences’ MyVal THV Devices Evaluated in LANDMARK Trial

May 15, 2024—Meril Life Sciences announced 30-day primary outcomes from the LANDMARK trial comparing the company’s MyVal transcatheter heart valve (THV) series compared with contemporary THV devices.

The company stated that the LANDMARK trial was a prospective, randomized, multicenter, open-label, noninferiority trial composed of patients who underwent transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis. The trial enrolled 768 patients at 31 sites across 16 countries including Brazil, New Zealand, and some countries of Europe. The first patient in the trial was enrolled on January 6, 2021. The last patient was enrolled on December 5, 2023.

The 30-day findings were presented as a late-breaking trial at EuroPCR 2024 held May 14-17 in Paris, France.

According to Meril Life Sciences, the primary endpoint is a 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.

Meril stated that the LANDMARK data showed that the performance of the MyVal THV series in terms of safety and effectiveness was noninferior to the contemporary THV series in the occurrence of primary composite endpoint (24.7% vs 27.0%) 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 company advised that the MyVal THV series includes traditional sizes (20, 23, 26, and 29 mm), intermediate sizes (21.5, 24.5, and 27.5 mm), and extra-large sizes (30.5 and 32 mm). In the LANDMARK trial, 48.1% of the patients were implanted with the intermediate size of the MyVal THV series.

The hemodynamic outcomes in terms of valve effective orifice area were significantly better for the 23-, 26-, and 29-mm MyVal THV series as compared to Sapien THV (Edwards Lifesciences) series, while there were no significant differences in the pre-procedural annular area. The long-term benefits of the intermediate sizes of THV will be further studied during the subsequent follow-up up to 10 years.

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

“MyVal THV series are novel next-gen THV devices; noninferior to the Sapien and Evolut THV (Medtronic) series,” commented Prof. Serruys in the company’s press release. “MyVal THV series have a unique size matrix incorporating conventional, intermediate, and extra-large diameters with increasing diameter steps of 1.5 mm that match and fit precisely the multislice 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 two rows of octagonal cells and a minimal foreshortening of 19% during expansion, has unique features not paired by any other contemporary design.”

Prof. Baumbach stated, “The Landmark trial showed that the MyVal THV series performed as safe and effective as contemporary THV series. It is a valve made for everyday clinical practice and an all-comers population. The special feature of intermediate diameters allows for more accurate sizing, which has the potential to translate into improved long-term outcomes. Our patients will be followed up for 10 years and it will be interesting to see the long-term results in the three treatment arms.”