New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has asked patients and doctors to report adverse events suspected to be associated with the use of Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GTl Bioresorbable Vascular Scaffold (BVS) to the manufacturer (US-based Abbott Vascular), importer (Abbott Healthcare) and the CDSCO.
“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, specifically, myocardial infarction (heart attack) and scaffold thrombosis (a dangerous side effect where a blood clot forms on the stent itself),” said the CDSCO in a medical device alert dated April 7.
The CDSCO had approved Absorb BVS intended to be used as a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function artery lesions.
According to the CDSCO, the importer Abbott Healthcare recently informed the regulator that the manufacturer Abbott Vascular has initiated a field safety notice in European countries to communicate that the product Absorb BVS use will be limited to establish post-market registries to facilitate the collection of real-world evidence for Absorb BVS and Absorb GTl BVS systems.
The registries will capture data from the implantation of all sizes of Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GTl Bioresorbable Vascular Scaffold (BVS) in the European market.
According to a senior CDSCO official, the alert is merely a cautionary exercise and does not mean a ban or restriction on the use of the medical device.
He said the alert followed a European Union decision earlier this month to stop open sale of these stents and only allow its “restrictive sale” through trial registries at certain institutions. EU will monitor the stents till a review in 2018.
The US has not placed any restriction so far on the device, reports ToI quoting the official.