Meril Announces Prestigious LANCET Publication for Landmark RCT of the MYVAL THV Series, Researched and Developed by INDIA

Meril Life Sciences is proud to announce that its LANDMARK randomized controlled trial (RCT) for the MYVAL THV series has been published in the prestigious medical journal The Lancet. This recognition underscores the significance and impact of the MYVAL THV series, a pioneering medical device researched and developed entirely in India.

Meril Life Sciences' LANDMARK non-inferiority trial key early outcomes data has been published in The Lancet, showcasing the safety and effectiveness of the Myval Transcatheter Heart Valve (THV) Series. The Myval THV Series provides an expanded range of intermediate and extra-large sizes as part of Meril’s commitment to providing accessible and tailored solutions to a wider range of patients.

[Vapi, xx-05-24] – Published in The Lancet on 22 May 2024 (Baumbach A, et al. The Lancet. https://doi.org/10.1016/S0140-6736(24)00821-3), early outcomes data from Meril Life Sciences’ LANDMARK trial shows non-inferiority to contemporary THV series. The trial, involving 768 patients with severe symptomatic native aortic stenosis across 31 sites, underscores Meril’s commitment to innovation and greater choice in structural heart interventions and interventional cardiology. The Indian medical device company’s Myval THV Series may help to provide solutions for patients with complex anatomy, including small annuli and bicuspid aortic valves.

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%, 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 (VARC-3) the third Valve Academic Research Consortium consensus) with no significant difference in the individual 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 groups.

Professor Serruys, Chairman and 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 1.5 mm 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 two 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% of the patients were implanted with the intermediate size of 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 Sapien THV series, while there were no significant differences in the pre-procedural annular area. The long-term benefits in patient prognosis and valve durability of the intermediate sizes of THV will be further studied during the subsequent follow-up for 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."

Meril’s LANDMARK trial was chosen by EuroPCR as one of the top three major late breaking trials poised to transform current practices in the field of Interventional Cardiology. The primary outcomes were previously presented on 15 May at EuroPCR 2024 in Paris, France.

About THE LANDMARK TRIAL:

The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis. The first patient was enrolled in the LANDMARK trial on 6 January 2021 and the last patient was enrolled on 5 December 2023. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30 days primary composite endpoints reporting the safety and effectiveness of LANDMARK trial is accepted for publication in The Lancet.

About Meril Life Sciences:

Meril is a leading global medical device manufacturing company based in India that has been pivotal in establishing India as a leader in the global medical devices industry. The company's strong focus on research and development (R&D) and commitment to quality have allowed it to offer cutting-edge med-tech solutions in more than 135 countries. Additionally, Meril has a large presence in India with wholly-owned subsidiaries in the USA, UK, Europe, Middle East, Africa, Brazil, South America, Australia & Asia.

With its strong commitment to innovation and quality, Meril has transformed healthcare in India and created significant footprints across the globe. Through global partnerships and the use of advanced technology, the company prioritizes quality and adherence to international standards, fostering a thriving R&D environment. Meril's efforts have effectively established India as a center for medical device innovation and production.

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