FDAnews
www.fdanews.com/articles/11642-brief

Brief

May 12, 2017

Australia Pulls Abbott’s Absorb Vascular Scaffold From Market

Australia’s Therapeutic Goods Administration has removed Abbott’s Absorb Bioresorbable Vascular Scaffold System from the Australian Register of Therapeutic Goods.

The decision to recall the device and de-list it in Australia was based on data from studies that showed elevated rates of heart attack and blood clots compared to patients treated with another stent. Abbott Vascular Australia is recalling all unused stock of the device.