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DCGI initiates talks with Abbott on safety issues related to BVS stents subsequent to its restricted use in EU market

Shardul Nautiyal, Mumbai
Thursday, April 20, 2017, 08:00 Hrs  [IST]

Subsequent to Central Drugs Standard Control Organisation (CDSCO)'s medical device alert dated April 7, 2017, Drug Controller General of India (DCGI) has initiated talks with the manufacturer, US based Abbott Vascular and importer Abbott Healthcare to report safety issues related to Absorb Bioresorbable Vascular Scaffold (BVS) stents subsequent to its restricted use in European market.

DCGI Dr G N Singh explained, “We have asked the manufacturer to report adverse events suspected to be associated with the use of Absorb Bioresorbable Vascular Scaffold and Absorb GTl Bioresorbable Vascular Scaffold to the CDSCO based on the findings in India- centric and India-specific patients.”

The DCGI however denied that the Absorb BVS cardiac stents have been banned in the Indian market and told to be withdrawn from the Indian market.

“Based on the three years clinical data analysis from Absorb II it has been observed that there is an over elevated rate of major adverse cardiac events and scaffold thrombosis, a dangerous side effect where a blood clot forms on the stent itself,” said the CDSCO in a medical device alert dated April 7.

The CDSCO had approved Absorb BVS intended to be used as a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function artery lesions.

According to the CDSCO, the importer Abbott Healthcare recently informed the regulator that the manufacturer Abbott Vascular has initiated a field safety notice in European countries to communicate that the product Absorb BVS use will be limited to establish post-market registries to facilitate the collection of real-world evidence for Absorb BVS and Absorb GTl BVS systems.

"No further bioresorbable vascular scaffolding stents will be provided to non-registry sites after 31st march 2017 and these sites have been instructed to cease implants and existing inventory will be removed," stated an advisory from Abbott, which is "working jointly with the European Regulatory Agencies" to address concerns of increased risk of stent thrombosis and longer duration of use of blood thinners for those implanted with BVS compared to those with DES. These were the risks the studies had highlighted.

BVS used to cost Rs.2 lakh in India before price control, considerably higher than other stents. The stent industry had argued, with support from many cardiologists, that it should be outside price control as it was the latest generation stent.

In September 2012, Abbott announced the launch of its BVS called Absorb and claimed that the world's first drug eluting bioresorbable vascular scaffold has the potential to revolutionize treatment of coronary disease. Absorb was introduced in India in December that year after clinical trials on 100 patients.

Data from the Cardiology Society of India showed that in 2013, about 8,500 bioresorbable stents were used in India. This was despite their much higher cost. Indian cardiologists took to this new stent so enthusiastically that India became one of the largest markets for Absorb in 2014. India accounted for a third of Abbott's USD 132 million global revenues in 2014 from bioresorbable stents.

 

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