Health Ministry nod to MeRes100- India made bioresorbable cardiac Stent
New Delhi: Meril Life Science, a Gujarat based global medical device company has received the green signal from the Health Ministry for the country's first locally made bioresorbable cardiac scaffold, or naturally dissolving stent.
Micron-thick BVS 'MeRes100' is made of material that degrades and is absorbed by the body over three years.
In a meeting held on Tuesday, Meril Life sciences presented their case regarding the bioresorbable cardiac scaffold stent to subject expert committee (SEC), where the committee gave approval for their bioresorbable cardiac scaffold stent.
Sanjeev Bhatt, vice president (corporate strategy) at Meril Life Sciences, in an email response to ET said, "We have presented our case to the Subject Expert Committee and are awaiting feedback."
After Abbott India, Meril Life Science would be the second company with a BVS in the country which has made a bioresorbable cardiac stent.Last year in July, the USFDA approved the Abbott's first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS).
Read also: USFDA gives nod to Abott’s ABSORB stent
Speaking with ET, Sanjeev Bhatt, vice president (corporate strategy) at Meril Life Sciences said Meril had first applied for approval for MeRes100 in India in 2013.
Explaining the Benefits of bioresorbable cardiac scaffold, Bhatt said before introducing their case in from of Health Ministry, the Company conducted studies in 108 patients in India and 40 patients in Brazil, European countries and South East Asian countries. It has already received approvals to market the product in Columbia, Ecuador, Indonesia and the Philippines over the last month and is currently awaiting regulatory approvals from the European Union, he added.
Although the price of bioresorbable cardiac scaffold is higher than ordinary stents but some doctors find BVS a good choice for young patients between 25-45 years because it dissolves and could give them a relatively better quality of life than metallic drug eluting stents.
Columbia Asia senior consultant Sanjat Chiwane told ET, "If you believe in the science, a scaffold that dissolves would reduce the need for patients to be on several medications for a long time. It would be an ideal therapy for anybody because you don't have a device inside your body forever."
Talking about the efficiency of drug eluting stents, Chiwane said drug eluting stents are also efficient as BVS stent. There is no one study which had proved that BVS are more efficient than drug eluting stents. Elaborating the importance of bioresorbable cardiac stents he further said, "They're not superior to second or third generation stents, but they're not inferior either."