FDA Update about Abbott Vascualr's Absorb GT1 Bioresorbable Vascular Scaffold (BVS)

PUBLISHED: Oct 31, 2017
Relevant to: Critical Access Hospitals, Hospitals

The US Food and Drug Administration (FDA) has 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.

The FDA was made aware that the manufacturer has stopped global sales of the Absorb GT1 Bioresorbable Vascular Scaffold as of September 14, 2017. The FDA’s recommendations for health care providers outlined in the previous letter remain unchanged. Although health care providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.

See the updated letter to health care providers for more information.

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