AUDIENCE: Cardiology, Surgery, Risk Manager
ISSUE: 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.
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.
BACKGROUND: The BVS is used to open heart blood vessels (coronary arteries) blocked by scar tissue (plaque) in order to increase blood flow to the heart muscle. The BVS is implanted during an angioplasty procedure. It gradually dissolves and is fully absorbed by the body over time.
RECOMMENDATION: The FDA recommends that 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 DAPT prescribed by their health care providers.
- Report any adverse events related to the BVS that come to your attention. If you suspect a problem with the BVS, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178