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 Absorb is not being withdrawn from Europe and nothing has changed with the product’s regulatory status.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