Meril Life Sciences' Landmark MYVAL THV Study Published in The Lancet

NEW DELHI: Meril Life Sciences proudly announces the publication of its landmark randomized controlled trial (RCT) for the MYVAL Transcatheter Heart Valve (THV) series in The Lancet. This significant milestone underscores the pioneering efforts of the Indian medical device industry.

The 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," compares the MYVAL THV series with the well-established Sapien and Evolut THV series in patients with severe symptomatic native aortic stenosis (AS).

The trial demonstrated that the MYVAL THV series is non-inferior to its global counterparts. Key outcomes included a comparable primary composite endpoint occurrence (24.7% for MYVAL versus 27% for contemporary THVs, with a p-value <0.0001 indicating statistical significance). These results highlight India's ability to develop world-class medical technology, reinforcing the "Make in India" initiative.

Aortic stenosis, characterized by a narrowing of the aortic valve, restricts blood flow from the heart. Severe cases require valve replacement, often performed via minimally invasive transcatheter aortic valve implantation (TAVI). The MYVAL THV series offers a broader range of sizes, including intermediate options, ensuring a better fit and potentially improved patient outcomes.

Prof. Andreas Baumbach, the Global Principal Investigator, remarked, "The landmark trial showed the MYVAL THV series is as safe and effective as contemporary valves, with unique intermediate sizes allowing for more accurate sizing."

The trial, conducted across 31 sites in 16 countries, involved 768 patients and began in January 2021. Early outcomes published on May 22, 2024, are promising, with further long-term follow-up planned.

Meril Life Sciences' achievement marks a significant advance for the Indian medical device industry, demonstrating its capability to produce high-quality, innovative healthcare solutions on a global scale.