Absorb BVS Recalled in Australia From All Centers Not Studying Device
In consultation with regulators, Abbott issued a “hazard alert,” recalled product from non-study sites, and removed Absorb’s registration mark.
Abbott Vascular Australia, in consultation with the Therapeutic Goods Administration there, has issued a “hazard alert” for the Absorb BVS, removed it from Australia’s Register of Therapeutic Goods, and recalled all unused product from any centers not participating in clinical trials.
The announcement yesterday, like the action taken in Europe last month, stems from recent studies pointing to higher rates of scaffold thrombosis and MI among patients treated with the bioresorbable device as compared with the Xience (Abbott Vascular) drug-eluting stents.
“Absorb BVS System will now only be available for use in Australia through clinical trials and the unapproved product pathways (Special Access Scheme and Authorised Prescriber Scheme),” a notice posted to the Australian Department of Health website reads. “Limiting use of this device through clinical trials and access schemes will help reduce risks to patients by ensuring that optimal implantation technique is used, and will allow Abbott Vascular Australia to undertake additional monitoring and data collection.”
Contacted by TCTMD, an Abbott spokesperson sent a statement specifying that only a “very small percentage of patients undergoing coronary angioplasty each year in Australia receive Absorb, and the majority of hospitals currently using Absorb in Australia are already part of studies that are planned to be part of the clinical registries.”
The recall is for Absorb products “not currently being used in a clinical trial or registry,” the spokesperson specified.
Australian Government, Department of Health: Therapeutic Goods Administration. Absorb Bioresorbable Vascular Scaffold System. Published on: May 2, 2017. Accessed on: May 3, 2017.