No violation of the law of the land in Abbott's discontinuation of global sales of BVS: CDSCO

Shardul Nautiyal, MumbaiWednesday, September 13, 2017, 08:00 Hrs  [IST]

Abbott's discontinuation of global sales of Bioresorbable Vascular Scaffold (BVS) citing low commercial sales is justified and there is no violation of the law of the land,  according to a senior Central Drugs Standard Control Organisation (CDSCO) official.

“It is the company's prerogative to stop production and sales of the first generation Absorb BVS due to commercial reasons. As of today, company has stopped manufacturing BVS and has informally communicated to us about the decision,” the official added.

CDSCO had initiated talks with the manufacturer Abbott Vascular to conduct clinical studies to address certain safety issues 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 used to be commercially available in Europe through the registries. The objective of the EU registries was 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.

Abbott also notified physicians that it was coordinating with EU Health Authorities to collect additional real-world evidence for Absorb. Abbott had also clarified that it 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.

Once hailed as the next big breakthrough in medical devices after drug eluting stents (DES) and which accounted for less than 1 % of its overall stent sales, the first-generation Absorb BVS, the first and only fully dissolving heart stent was approved by the US Food and Drug Administration (FDA) in July 2016 to treat patients with coronary artery disease.

In a statement posted on its website, the company said it is discontinuing all sizes of the Absorb bioresorbable vascular scaffold system, effective 14 September. The halt includes both the Absorb and Absorb Gt1 Bioresorbable Vascular Scaffold Systems.

In India, Abbott had earlier too filed an application with the National Pharmaceutical Pricing Authority (NPPA) to withdraw its premium stents from the market stating commercial unsustainability after the Indian government had capped the prices of coronary stents at Rs.29,600.