FDA Issues Provider Update Letter on ABSORB Analyses
The U.S. Food and Drug Administration (FDA) issued an updated letter informing health care providers of increased rates of major adverse cardiac events in patients receiving the Absorb GT1 bioresorbable vascular scaffold (BVS) based on the latest findings from the ABSORB III three-year and ABSORB IV 30-day analyses, presented Oct. 31 at TCT 2017 in Denver. Study results showed BVS was associated with significantly more target lesion failure and other adverse events when compared to the everolimus-eluting stent.
The FDA recommends 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.
- Advise BVS patients to follow the recommendations for dual antiplatelet therapy 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, file a voluntary report through the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Keywords: Drug-Eluting Stents, Absorbable Implants, United States Food and Drug Administration, Coronary Vessels, Stents, Chest Pain, Heart, Health Personnel, Dyspnea
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