Meril Life Sciences

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YEAR-WISE DEVELOPMENTS

Myval transcatheter heart valves (THV)

As in 2024

Akhil George, June 12, 2024: The Times of India


Here’s a great India story. Gujaratheadquartered Meril Life Sciences has successfully demonstrated, through what’s called the Landmark trial, that the Myval transcatheter heart valves (THV) it manufactures are just as good as the ones made by the biggest medical technology companies in the world. The Lancet, one of the most prestigious medical journals in the world, has published the study in a recent issue.


Myval is a balloon-expandable transcatheter heart valve that is used during transcatheter aortic valve implantation (Tavi) procedures that help improve a damaged aortic valve.


Before Tavi procedures became common, open-heart surgery was the only way to fix a damaged aortic valve. With Tavi, a small puncture is made in the thigh and the catheter is sent to the heart where the valve is deployed. Meril said that such valves have for the past many decades been dominated by a few select medical technology firms.


India imports 80% of the medical devices it uses, so domestically designing and manufacturing high-end medical products like the Myval is a huge step, notes a Meril executive, who did not want to be named. Meril was founded in 2006 by the Bilakhia Group. It started in the field of orthopaedics, offering a diverse range of orthopaedic implants, including knee and hip replacements. It has also developed devices such as drug-eluting stents, bioresorbable scaffolds, and balloon catheters, and products such as surgical sutures, tissue sealants, and absorbable hemostats. Its products are sold in over 100 countries.


The Myval THV trial results, revealed at the EuroPCR conference in Paris, showed that the heart valves were safe at 30 days and were “noninferior” to other heart valves in the market – specifically Edwards Lifesciences’ Sapien BEV and Medtronic’s Evolut SEV devices.


Landmark clinical trials are practice-changing and highly influential studies. Meril says getting accepted into the trial itself was a big deal. 
“The study is important for India, and this is a very important milestone for all those who aspire to innovate in the medical devices space and challenge the western world with newer products that can help patients in a better way,” the company says.


Meril’s heart valves, the company says, are also lighter on patients’ wallets by around 25%. “The cost to patients for the complete procedure with Meril’s valve will be about Rs 15 lakh, compared to about Rs 20 lakh when using valves of other companies,” it says.


The Landmark trial was a prospective, randomised, multicentre, openlabel, non-inferiority trial involving 768 patients who underwent a Tavi procedure for the treatment of aortic stenosis. The patients were spread across 31 sites in 16 countries.

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