New Delhi: Meril Life Sciences has announced the publication of its landmark randomised controlled trial (RCT) for the MYVAL transcatheter heart valve (THV) series in The Lancet. This significant achievement underlines the pioneering efforts of the Indian medical device industry.
The study, titled “Comparison of early outcomes of the new generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolute) THV series in real individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial”, compares the Myval THV series to the well-established Sapien and Evolute THV series in patients with severe symptomatic native aortic stenosis (AS).
The trial demonstrated that the MYVAL THV series is not inferior to its global counterparts. Key results include a comparable primary composite endpoint incidence (24.7% for MYVAL vs. 27% for contemporary THVs, with 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 is characterized by narrowing of the aortic valve, which restricts blood flow out of the heart. Severe cases require valve replacement, often performed via minimally invasive transcatheter aortic valve implantation (TAVI). The MYVAL THV series offers a wide range of sizes, including intermediate options, ensuring a better fit and potentially better patient outcomes.
Global Principal Investigator Professor Andreas Baumbach said: “This landmark trial has shown that the MYVAL THV series is as safe and effective as contemporary valves, and features unique intermediate sizes that allow for more accurate sizing.”
The trial, conducted at 31 sites in 16 countries, included 768 patients and began in January 2021. Initial results published on May 22, 2024, are promising, and further long-term follow-up is planned.
Meril Life Sciences’ achievement marks a significant advancement for the Indian medical device industry, demonstrating its ability to produce high-quality, innovative healthcare solutions on a global scale.