8th July 2024  Vapi, Gujarat, India  Exciting news from Meril Life Sciences! The LANDMARK trial’s 30-day primary outcomes were presented on 15th May at EuroPCR 2024, Paris, France. LANDMARK was recognized by EuroPCR as one of the top three late-breaking trials poised to transform and revolutionize current practices in the field of Interventional Cardiology.

The LANDMARK study showed that the performance of the 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 the procedure room, device success at 30 days and early safety at 30 days were comparable in both groups.

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.”

Myval THV series has a versatile range of sizes offering not only traditional sizes (20 mm, 23 mm, 26 mm, 29 mm) but also intermediate (21.5 mm, 24.5 mm, 27.5 mm) and extra-large sizes (30.5 mm and 32 mm). This tailored sizing matrix allows cardiologists to select the appropriate valve size, thus avoiding excessive over- or under-sizing. 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 (EOA) were significantly better for the 23, 26, and 29 mm Myval THV series as compared to the Sapien THV 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.

As per the Global Principal Investigator, Prof. Andreas Baumbach, “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.”

Mr. Sanjeev Bhatt, Sr. Vice President – Corporate Strategy at Meril said, “In a successful development in structural heart interventions, the LANDMARK RCT has revealed compelling results for the novel Myval transcatheter heart valve (THV) series, confirming its non-inferiority to other contemporary THV devices. The results of LANDMARK trial are not just a win for us but for the entire medical community and, most importantly, for patients undergoing TAVI. This study not only reinforces the safety and efficacy of the Myval THV series but also highlights its adaptability to challenging anatomical structures,”.