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Drug Controller General of India (DCGI) has started evaluating safety data submitted by US based Abbott Vascular and importer Abbott Healthcare related to Absorb Bioresorbable Vascular Scaffold (BVS) stents subsequent to their restricted use in European market.
DCGI had initiated talks with the manufacturer subsequent to Central Drugs Standard Control Organisation (CDSCO)'s medical device alert dated April 7, 2017.
“We are awaiting more safety related data associated with the use of Absorb Bioresorbable Vascular Scaffold and Absorb GTl Bioresorbable Vascular Scaffold based on Abbott’s findings,” informed DCGI Dr G N Singh,
The DCGI however denied that the Absorb BVS cardiac stents have been banned in the Indian market and sought to be withdrawn from the Indian market.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,” stated CDSCO in a medical device alert dated April 7.
Following the alert, Abbott has clarified, “Absorb BVS continues to be commercially available in Europe through the registries. Absorb is not being withdrawn from Europe and nothing has changed with the product’s regulatory status. The vast majority of hospitals that currently use Absorb in Europe will continue to have access to Absorb through the registries.”
Citing data that has been presented at major cardiology medical meetings in the US, Abbott spokesperson explained, “Post-marketing registries are being initiated in Europe to monitor implantation technique for the Absorb dissolving stent. Analyses of Absorb trials from around the world have demonstrated that optimal implantation technique resulted in outcomes comparable to the best-in-class metallic drug eluting stent, with the added feature of leaving no metal behind once it dissolves.”
Abbott has also emphasized implant techniques for Absorb in a training program for physicians globally, including India.
The objective of the EU registries is similar to post-approval observational studies and training being conducted in other parts of the world to confirm the effect of current implantation technique on clinical outcomes. The current advisory from Abbott is specific to countries in the EU. Absorb comprises a very small portion of company’s overall stent portfolio, globally and in India.
Abbott is notifying physicians that it is coordinating with EU Health Authorities to collect additional real-world evidence for Absorb. Absorb will only be available for use in the EU in a post-marketing registry setting at select sites and institutions, which will play a pivotal role in the monitoring of this technology until Summer 2018 when the situation will be reviewed.
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