Alert on Left Atrial Appendage Occlusion Devices

FDA is alerting health care providers on recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. “The FDA is evaluating a study published in the Journal of the American Medical Association (JAMA) Cardiology,” an agency notice says. It says the real-world data analysis “indicates that procedural outcomes such as major adverse events and lengthened hospital stay may be more common in women compared to men. The causes for these differences are yet to be determined.”

FDA says it will work with LAAO device manufacturers to evaluate information from several sources, including premarket studies, mandated postmarket studies, and real-world data to provide additional information on this issue. Currently, the agency believes the benefits continue to outweigh the risks for using the devices.