Meril Life Sciences, an indigenous global medical devices company, has received approval for commercialization of Myval-TAVR technology from the Central Drugs Standard Control Organization (CDSCO). The device is the First Indigenously developed and manufactured Transcatheter Aortic Heart Valve Replacement (TAVR) technology and with this launch, Meril will become the First Indian Company in the world and the Third in India to make this technology commercially available.
Headquartered in Vapi, Gujarat, India, the company received approval for the Myval TAVR technology on the basis of successful results from clinical study 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.
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.”
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).