LUCKNOW: A team of doctors from Sanjay Gandhi Post Graduate Institute of Medical Sciences is conducting human clinical trial of first-ever 'Made in India" biological heart valve. SGPGI is the only government facility among total 16 where the bioprosthesis trial is on.
Periodic observations of the trial would be evaluated by Drug Controller General of India to check the efficacy of the valve. A positive outcome would bring a paradigm shift in valve replacement surgery. Biological valves are more beneficial for elderly patients and those with diabetes, blood pressure, sportspersons and women who want to have babies.
While metal valves cost around Rs 60-70,000, biological valves may cost Rs 2-20 lakh.
Head of cardiothoracic and vascular surgery department, SGPGI, Prof Nirmal Gupta said over 10 lakh people in India need valve replacement for congenital and acquired medical conditions.
"As on date, biological valves are imported and hence locally manufactured valve will bring down the cost significantly. Biological valve ensure better life quality, less medication and lesser risk by minimising the use of blood thinning medicines which are must for patients with metal valves," he added.
The 16-site study which includes globally acclaimed Narayana Institute of Cardiac Sciences, Bengaluru, commenced in July 2017 and involves total 60 patients. The follow would continue for next five years to study the valve's safety and performance.
In a previous interaction with TOI, chairman Narayana Health Dr Devi Shetty had drawn attention towards rheumatic heart disease, the most common cause that requires a valve replacement among children.
"The problem affects 1/1,000 children in India and is much more virulent, 28 million babies are born each year. This means 600-800 babies with heart disease are born each day," he said.
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