FDA Still Evaluating Left Atrial Occlusion Implants

FDA says it is still evaluating information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. In 2021, the agency issued a notice saying that a 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.”

The agency has amended the 2021 notice to add information on recently published research that compares outcomes between women and men. It says it will continue to 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 the issue.

Currently, the agency believes the benefits continue to outweigh the risks of using the devices.