Meril's MYVAL transcatheter heart valve series trial research published in Lancet, ET HealthWorld

New Delhi: Meril Life Sciences announced the publication of the landmark trial study in The Lancet titled “Comparison of early results of new generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolute) THV series in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial”, which showcases the indigenously developed Myval transcatheter heart valve (THV) series. According to the medical device manufacturer the Myval THV series is an indigenously developed technology that is not inferior to the global giants and there is no difference in the itemised components of the primary composite endpoints (24.7 per cent Myval THV series vs 27.0 per cent contemporary THV series, p

The testing was done on patients with more complex cases, such as those with smaller aortic valve sizes and bicuspid valves, which have only two leaflets instead of the usual three. The device in the study produced a larger valve opening for blood flow into the aorta than the Sapien THV series across a number of diameters. However, the Myval THV series produced a similar valve opening as the Evolut THV series. A 10-year follow-up study of the volunteers will be conducted to understand long-term effects.

The Myval THV Series is a new THV that comes in a variety of size options compared to currently available THVs, making it easier to find the right fit for different patients. It is available in a 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 large sizes (30.5 mm and 32 mm). This wider range ensures that more patients can find a valve that closely matches their anatomical needs, potentially improving outcomes and making advanced heart valve treatments more accessible to a wider population.

According to Global Principal Investigator, Prof. Andreas Baumbach, “This landmark trial has shown that the Myval THV series works as safely and effectively as contemporary THV series. This is a valve designed for everyday clinical practice and for all populations. The special feature of the intermediate diameter allows for more accurate sizing, which is likely to improve long-term outcomes.”

Commenting on this, Sanjeev Bhatt, Senior Vice President, Corporate Strategy, Meril, said, “A landmark RCT has revealed compelling results for the new Myval transcatheter heart valve (THV) series, confirming its non-inferiority compared to other contemporary THV devices. This study not only reinforces the safety and efficacy of the Myval THV series, but also highlights its adaptability to challenging anatomical structures.”

Aortic stenosis is a condition in which the aortic valve doesn’t open fully, restricting blood flow from the heart to the rest of the body, which can cause symptoms such as chest pain, dizziness and shortness of breath.

Severe conditions require the aortic valve to be replaced with an artificial valve, which can be done through open-heart surgery or a minimally invasive interventional procedure that uses a small tube called a catheter inserted into the common femoral artery of the leg. This procedure is called transcatheter aortic valve implantation (TAVI) and the valve used is called a transcatheter heart valve (THV).