17 April 2017 | News
Union health authorities issued a medical alert cautioning patients and doctors and asking them to report any problems. Union health authorities issued a medical alert cautioning patients and doctors and asking them to report any problems.
Almost five years after the launch of the revolutionary bio-resorbable stents in India, Union health authorities have recently issued a medical alert cautioning patients and doctors and asking them to report any problems.
The Central Drugs Standard Control Organization (CDSCO)'s note posted on its website cited "safety concerns" as the reason. It has been observed that there is an over-elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.
Myocardial infarction is another term for heart attacks. The trial had compared bio-resorbable stent with drug-eluting stents, which are the most widely used cardiac devices.
A senior CDSCO official, though, clarified that this isn't a ban or restriction on use, it is merely a cautionary exercise.
The bio-resorbable stents were considered a path-breaking invention by MNC Abbott as these dissolve around three years after implantation, leaving no foreign metal like the drug-eluting stents, which are tiny scaffolding-like devices to clear blockages in arteries.While 5.6 lakh drug-eluting stents were used in India in 2015, the bio-resorbable ones account for a mere fraction. Abbott officials acknowledged that bio-resorbable stents comprise 1 per cent of their overall stent portfolio in India.
These stents were not only expensive at Rs 1.9 lakh a piece -until the capping exercise pegged them at almost Rs 30,000 -but doctors need special training to deploy these