FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note

The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois), compared with the metallic XIENCE drug-eluting stent.

The manufacturer stopped global sales of the BVS as of September 14, 2017; however, health care providers with available inventory may continue to implant the BVS. Providers should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of the patient, the FDA says.

UPDATED October 31, 2017. The FDA issued an update to the March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent.

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