Meril Announces Prestigious LANCET Publication For Landmark RCT Of The MYVAL THV Series

Meril Life Sciences has published its landmark trial study 'New-generation Myval Transcatheter Heart Valve series and modern (Sapien and Ewalt) THV series in patients with severe symptomatic aortic stenosis: a Randall non-inferiority study' in The Lancet. Indigenously developed Myval Transcatheter Heart Valve (THV) series.

This study compares the new generation Myval series and modern (Sapien and Evolt) THV series in patients with severe symptomatic localized aortic stenosis (AS). The results of the study show that the Myval THV series is no less than its world-class counterparts. The primary composite endpoint was a composite of death, stroke, major bleeding, acute kidney disease, major vascular complications, moderate or severe valve therapy, and the need for a pacemaker implant (according to the Third Valve Academic Research Consortium Consensus). Primary composite endpoint (24.7% Myvol THV series vs., 27.0% Modern THV series, non-statistical non-inferiority less than P 0.0001). This achievement reflects the success of the 'Make in India' initiative and validates India's ability to set new standards in cardiovascular care and transform heart valve treatment.

Aortic stenosis is a condition in which the aortic valve does not open completely, causing blood to not flow properly from the heart to the rest of the body. Due to this, the patient has many symptoms like chest pain, dizziness, and shortness of breath. Treatment of aortic stenosis depends on the severity of the condition. In severe aortic stenosis, the aortic valve is replaced with an artificial valve. This can be done through open heart surgery or minimally invasive procedures. A minimally invasive method of inserting a tube catheter through the femoral artery of the leg. This is called transcatheter aortic valve implantation (TAVI). The valve used in this is called the transcatheter heart valve.

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The Myval THV series is a modern THV, available in larger sizes than existing THVs. In such a situation, the right fit is easily found for each patient. It is available in conventional sizes (20 mm, 23 mm, 26 mm and 29 mm), intermediate sizes (21.0 mm, 24.5 mm and 27.5 mm) and large sizes (30.5 mm and 32 mm). This wide range ensures that more patients receive the right valve for their body needs, improving treatment outcomes. And valve treatment is becoming more accessible to more people.

According to Global Principal Investigator Professor Andreas Baumbach, "This landmark study shows that the Myval THV series is safer and more effective than existing THV series. This valve has been designed keeping in mind the daily habits and needs of the general public. The intermediate size is its special feature which gives better results with precise sizing. We 10 We follow patients for years and it will be interesting to see what the long-term results of this treatment are.

The team included in the study patients with more complex cases, such as those with short aortic valves and bicuspid valves, which have only two leaflets instead of three. The Myval THV series offers larger valve openings to allow better blood flow into the aorta compared to the Sapien THV series. However, the Myval THV series offers the same valve openings as the Evolt THV series. The intermediate sizes of the Myval THV series provide a better fit for each patient size; Additionally, studying patients over the next ten years will provide more information about its long-term effects.

Mr. Sanjeev Bhatt, Senior Vice President, Corporate Strategy, at Meril, said, "Amidst the successful development of structural cardiac interventions, this landmark RCT has yielded strong results for the Myval Transcatheter Heart Valve, demonstrating its potential compared to existing THV devices. None the less. This landmark study is a landmark study for the entire medical community, especially An important achievement for patients undergoing TAVI. "This study not only confirms the safety and efficacy of the Myval THV series but also highlights its adaptability to challenging body structures."

Professor (Dr) Ashok Seth, Chairman, of Fortis Escorts Heart Institute, said, “This landmark study meets the highest scientific standards, the results of which have been acclaimed by the interventional cardiology community worldwide. We are proud to say that the Myval Transcatheter Heart Valve has been researched and developed in India and is superior to the transcatheter heart valves traditionally used in western countries. "This is an important step for the Indian device industry and the medical community, which will make the life-saving treatment TAVI more accessible, affordable and effective for patients not only in India but worldwide."