Indian medical device company launches artificial heart valve technology
An Indian company, Meril Life Sciences, has developed TAVR technology Myval so as to provide help to thousands of patients in the country suffering from aortic valve stenosis.
Along the lines of the Make in India initiative, the global medical device maker company Meril Life Sciences has become the first Indian company to launch its first indigenously designed and manufactured artificial aortic valve a.k.a. Transcatheter Aortic Heart Valve Replacement (TAVR) for patients who face a higher level of risk or are not ready to go through an open heart valve replacement surgery. The TAVR will be sold under the brand name Myval.
TAVR is a negligibly invasive procedure where the doctor places a replacement valve into the patient’s natural diseased valve using a catheter implanted through the femoral artery.
This is a different way of replacing the ailing valves without going through the traditional open heart procedure as some patients’ body might not be able to tolerate the stress of open-heart surgery.
The company has already received an approval from the Indian drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), for commercialization of TAVR.
Speaking of the approval, Sanjeev Bhatt, the Vice President-Corporate Strategy of Meril Life Sciences said the approval has been granted based on positive and successful results from a clinical trial that was done in India and it involved 14 hospitals including Fortis and Medanta-The Medicity and Eternal Hospital, Jaipur, to name a few. He also said that Meril’s main focus has always been on designing and developing innovative and clinically significant devices and the launch of Myval TAVR is a part of it.
There were no major adverse cardiac, cerebral and renal events after six months of the follow-up and zero mortality among the patients in the trial.
Sanjeev Bhatt also assured that with the commercialization of Myval TAVR technology, Meril will soon be introducing the next generation treatment modality for thousands of patients all over India and the world.
Dr. P K Minocha, Director of Research & Development, Meril Life Sciences further added that it took six years of extensive research and testing to develop the Myval-TAVR technology. The company is aiming to take this technology to more than 100 countries and help thousands of patients all over the world.
Dr. Ashok Seth, Chairman of Fortis Escorts Heart Institute, said that the approval by the regulatory body for Myval will provide a sincere hope for thousands of patients in India and Asia who are suffering from Aortic Stenosis.
Ravinder Singh Rao, Interventional Cardiologist at Eternal Hospital, said that the first patient who received the help of Myval has now accomplished 1.5 years and is still living a great symptom-free life. The valve was quite efficacious in getting rid of the patient’s symptoms and decreasing the rate of death and hospitalization that occur from the aortic stenosis.
TAVR is progressively becoming one of the most preferred alternatives for surgical valve replacement as it is connected with a faster recovery time.
Before Meril Life Sciences came up with their TAVR technology, the TAVR was dominated by US-based medical devices makers including Medtronics and Edwards Lifesciences.
With TAVR technique, there is no need to open the chest, and it has very low risks. It does not require long hours of general anaesthesia as it is needed in case of Open Heart Surgery. The hospitalization might not extend to more than 3-4 days, and the person can go back to normal life pretty quickly.
Image credit: www.merillife.com