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

Chennai, June 2024: Meril Life Sciences, an India-based global medical device company, recently conducted a trial study titled ‘Comparison of Early Outcomes of Newer-Generation Myval Transcatheter Heart Valve Series with Contemporary Valves (Sapien and Evolut) THV Series in Real-World Individuals with Severe Symptomatic Native Aortic Stenosis: A Randomised Non-Inferiority Trial’. The LANDMARK randomized controlled trial for the MYVAL THV series has been published in The Lancet, a prestigious medical journal.

Sharing details about the same, Prof. Andreas Baumbach, Global Principal Investigator said, “The Landmark trial showed that the Myval THV series performed as safely and effectively 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.”

This pivotal research compares early outcomes of the new-generation Myval THV series with contemporary (Sapien and Evolut) THV series in real-world patients suffering from severe symptomatic native aortic stenosis (AS). The findings highlight that the Myval THV series is non-inferior to global giants.

On the milestone achievement Interventional cardiologist DrG.Sengottuvelu, said, “We are elated and proud at being the first medical device company in India to research and develop MYVAL THV series. Being featured in Lancet underscores the significance and impact of the MYVAL THV series. Also, this has proved India’s capability to set new standards in cardiovascular care, revolutionising heart valve treatment worldwide. This trial also reiterates the success of the ‘Make in India’ initiative.”

Explaining the importance of THV series, Dr John Jose E,Interventional cardiologist said, The LANDMARK Trial is a well-designed multi-center international study that has established comparable safety and effectiveness of made-in-India Myvaltrans-catheter heart valve with contemporary western manufactured ones. The results of the study and features of this valve have been well-received by the global interventional Cardiology community. As one of the leading trans-catheter aortic valve implanters’ (TAVI operator) in the country, I am not at all surprised by the results of the study. The study findings align with our clinical experiences in a multinational randomized control trial environment. A considerable number of our Indian patients have surpassed the five-year follow-up mark, and the long-term outcomes appear promising.

The release of this research is a significant milestone, not just for the Indian device sector, but also for the global aortic stenosis patient-population as a whole. The availability of an affordable, safe

and efficacious valve for trans-catheter aortic valve implantation (TAVI- a non-surgical alternative treatment) would greatly benefit patients in emerging nations like India, as well as in advanced countries around the globe.

Dr. Thomas Alexander, Consultant and Interventional Cardiologist and Head of Division of Cardiology at KovaiMedical Center and Hospital, Coimbatore said that MYVAL THV series is a novel THV that comes in various size options compared to currently available THVs, making it easier to find the right fit for different patients.

The Myval THV series is available in a wide range of sizes, including traditional sizes (20 mm, 23 mm, 26 mm, and 29 mm), intermediate sizes (21.5 mm, 24.5 mm, and 27.5 mm), and larger sizes (30.5 mm and 32 mm). This extensive range ensures that more patients receive a valve that closely matches their anatomical needs, potentially improving outcomes and making advanced heart valve treatment more accessible to a broader population.