Abbott has notified the Drug Controller General of India (DCGI) that post-marketing registries are being initiated in Europe to monitor implantation technique for Absorb Bioresorbable Vascular Scaffold (BVS) stents subsequent to its restricted use in European market.

According to an e-mail interaction with Abbott officials, 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 Absorb is not being withdrawn from Europe and nothing has changed with the product’s regulatory status.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.

This comes at a time when DCGI has initiated talks with Abbott on safety issues related to BVS stents subsequent to restricted use in EU.

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 our 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/ institutions, which will play a pivotal role in the monitoring of this technology until Summer 2018 when the situation will be reviewed.

Absorb is also approved for use in the USA. The US FDA’s recent letter to healthcare providers emphasized the importance of following instructions for use when implanting Absorb. When implanted in appropriately-sized vessel sizes and following current instructions for use, the results for Absorb are comparable to the leading metallic drug-eluting stent with the added feature of leaving no metal behind once it dissolves.