New Delhi: In a first, Meril Life Sciences has introduced the first ever indigenously designed and manufactured Transcatheter Aortic Heart Valve (TAVR) – Myval.
With this launch, Meril, a global medical devices company becomes the First Indian Company to make Transcatheter Aortic Heart Valve Replacement (TAVR) Therapy commercially available on the world stage. Transcatheter Aortic Valve Replacement (TAVR) is an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery.
TAVR is a minimally invasive procedure in which the Doctor places a replacement valve into the patient’s native diseased valve via a catheter inserted through the femoral artery (large artery in groin). This is an alternative way to replace diseased valves without undergoing traditional open heart procedure (which some patients may not tolerate well).
Commenting on the approval, Mr. Sanjeev Bhatt (Vice President-Corporate Strategy, Meril Life Sciences) said, “Meril has always been dedicated towards design and development of novel, clinically relevant, state-of-the-art and best-in-class devices to alleviate human suffering and improve quality of life. The launch of indigenously developed Myval Transcatheter Heart Valve technology is an assertion of this fundamental belief. For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country. Through the commercialization of this technology, Meril will soon bring the next generation treatment modality to thousands of patients across the country and globally. Making India proud of this achievement.”
Commenting on the approval Dr. P K Minocha (Director, Research & Development, Meril Life Sciences) said, “Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. The Myval-TAVR technology has been developed after 6 years of extensive research and is backed by robust bench testing, pre-clinical and clinical data. We are committed to take this technology to over 100 countries and benefit thousands of patients across the globe.”
The Myval TAVR technology has been designed and developed by Meril Life Sciences, headquartered in Vapi, Gujarat, India and has recently received approval for use by Central Drugs Standard Control Organization (CDSCO). The approval was received on the basis of successful results from a clinical trial done in India. All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure (which is an important benefit for the patient already treated for valve replacement). Pacemaker is an additional device that may be placed post TAVR procedure.
Dr. Ravinder Singh Rao, Interventional Cardiologist and Director TAVR Program at Eternal Hospital, Jaipur said, “It is a great news that an Indian Transcatheter Heart Valve has been approved for clinical use. Having proctored the maximum number of Myval cases in the clinical study, we were able to prove the safety of the device when implanted via femoral artery. The first patient to receive Myval has completed 1.5 years and is living a symptom free productive life. The valve was effective in relieving the patient’s symptoms and reducing the death and hospitalization from the aortic stenosis. The patients got discharged by third day of the valve replacement. The trial was multi centric and results of the valve were reproducible. Myval TAVR technology will be a boon for millions of patients suffering from aortic stenosis.”