The Ministry of Health and Family Welfare has given its nod to the first India-made thin strut fully dissolvable stent developed by Meril Lifesciences, which addresses some of the limitations of currently available bio resorbable stents (dissolvable stents) and may have higher success and lower complication rates in the long term, a media report said.
The bio resorbable vascular scaffold (BVS) received the approval of the health ministry’s subject expert committee on Tuesday, the Economic Times reported citing a senior official.
The official approval to market this novel device is awaited and is expected to take a few weeks’ time.
The findings of the six-month clinical trial of the BVS were unveiled at the prestigious TCT — the biggest and best regarded meeting of interventional cardiologists in the world — in October last year.
The data was presented by the eminent interventional cardiologist Dr Ashok Seth, Chairman Fortis Escorts Heart Institute, who was the principal investigator of the study.
Meril had first applied for approval for MeRes100 (the name given to BVS) in India in 2013, said Sanjeev Bhatt, vice president (corporate strategy) at Meril Life Sciences.
Unlike drug-eluting stents that are made of metal and stay in the arteries forever, Meril’s 100 micron-thick BVS ‘MeRes100’ is made of material that degrades and is absorbed by the body over three years.
The BVS has a unique hybrid design featuring open cells at the centre and closed cells at the edges resulting in improved track-ability and access to side branches. It also has enhanced visibility with three circumferential radio opaque markers at each end.
Meril would be the second company with a BVS in the country after Abbott India, which had introduced its brand ‘Absorb’ in the market in 2012.