Medical device manufacturer, Abbott, has issued a medical device safety alert concerning Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems.
The manufacturer has recently published the results of ABSORB III, a prospective randomized controlled clinical trial that compared the safety and effectiveness of the affected products to their metallic drug-eluting stent, XIENCE. Learning from an analysis of the ABSORB III data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. Implementation of the techniques is expected to facilitate optimal clinical outcome and reduced the possibility of thrombosis.
According to the manufacturer, there is no need to return the affect products and patients who have had successfully implanted of the scaffolds are not affected by this action.
The manufacturer is issuing Field Safety Notice to inform the customers about the key changes and will update the Instructions for Use.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 December 2015