FDA Safety Alert on Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note

The Food and Drug Administration (FDA) on March 18 issued a Safety Alert for Abbott Vascular’s (Santa Clara, California) Absorb GT1 Bioresorbable Vascular Scaffold (BVS).

The alert was issued to inform healthcare providers of an increased rate of major adverse cardiac events in patients receiving the BVS, when compared to patients treated with the metallic XIENCE drug-eluting stent.

The BVS, which is used to open coronary arteries, is implanted during angioplasty procedures and gradually dissolves over time.

Posted 03/18/2017] AUDIENCE: Cardiology, Surgery, Risk Manager ISSUE: The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent.