CDSCO seeks additional studies to evaluate safety of BVS cardiac stents in India following its restricted use in Europe
Denying the possibility of a ban or restricted use of the latest generation Absorb Bioresorbable Vascular Scaffold (BVS) stents in India against the backdrop of its restricted use in European market due to safety concerns, the Central Drugs Standard Control Organisation (CDSCO) has clarified that additional studies are being sought from the US based Abbott Vascular based on the recommendations of a high level committee on cardiac stents.
“Drug Controller General of India (DCGI) has started evaluating some of the safety data submitted by US based Abbott Vascular and importer Abbott Healthcare but additional studies would substantiate whether it is completely safe to be used in Indian patients based on the submission and approval of the protocol submitted to the CDSCO,” according to a senior CDSCO official associated with the development.
DCGI had initiated talks with the manufacturer following CDSCO’s medical device alert dated April 7, 2017.
“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 Absorb is not being withdrawn from Europe and nothing has changed with the product’s regulatory status.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.
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.