Drug regulator asks for clinic trials of stents red-flagged by US, EU, Australia.
New Delhi: Even as reports by the US Food and Drug Administration (USFDA), European Union and Australia triggered concerns over Abbott’s absorbable stent, India’s drug regulator has decided not to withdraw controversial stent from the market instead allow “restricted access” of the stents in “high volume hospitals” only. The government is also going to direct the company to start clinical trials and come up with a future plan.
The subject experts committee which held a meeting recently after concerns were red flagged has recommended sale of the product restricted to hospitals where high volume surgeries are conducted. While it recommends that a specialized technique has to be followed by an “experienced operator” it further goes on to suggest that it should not be used in cases with narrow vessels.
Used in coronary artery disease patients, Abbott recently decided to “limit” the use of its Bioresorbable Vascular Scaffold (BVS) also known as absorbable stents from regular commercial access to only those cases registered under clinical registry in Europe recently, causing a lot of concern. The move came following the results of two big research trials that raised safety concerns in using the device. While Abbott says it is “coordinating with EU Health Authorities to collect additional real-world evidence for Absorb and will monitor their technology until summer of 2018 and review the situation then”, the Drug Controller General of India has decided not to pull it back.
“We have asked them to submit the detailed data from other countries that have raised concerns over the device for further review,” Dr G.N. Singh, DCGI told this newspaper.
The committee has also asked the company to carry follow up on patients implanted with the device. The absorbable stents are fully dissolving artery stents that are absorbed by the body over roughly three years. Its eventual disappearance in order to free the vessel of a metal cage is, according to Cardiologists, a significant benefit and that’s why it is considered better over existing technology.
The experts have also recommended submitting protocol for Phase IV trials for additional safety parameters. “The committee with review safety based on which a NoC will be issued,” said an official.