The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning IN.PACT Amphirion Drug-Eluting Balloon (DEB) manufactured by Medtronic, Inc.
Based on data from clinical study, the IN.PACT Amphirion DEB did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty control.
The study also identified a potential safety signal given a trend towards an increased rate of major amputations in the DEB study arm.
The manufacturer is advising hospitals to quarantine all units of the IN.PACT Amphirion DEB that remain in their inventory.
According to the local supplier, the affected products were distributed in Hong Kong.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01153-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 November 2013