The United States Food and Drug Administration (FDA) has issued an alert 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 14 September 2017. 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.

While the manufacturer has discontinued sales of BVS, they will continue to monitor patients currently enrolled in the ABSORB III and ABSORB IV US clinical studies through five years following BVS implantation. Patients enrolled in these studies will be followed through standard practice and care after five years.

The FDA provided the following recommendations to health care providers:

• Follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.
• Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. For more information about risks associated with the BVS, refer to the BVS physician labeling.
• Advise BVS patients to follow the recommendations for dual antiplatelet therapy (DAPT) prescribed by their health care providers.

For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm547256.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm582728.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 1 November 2017