The U.S. Food and Drug Administration (FDA) has announced that certain WATCHMAN Access Systems have updated use instructions to address risk of air embolism.

According to Boston Scientific, there is an increased likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. The FDA notes that "the risk of air embolism is acute in nature and limited to the duration of the implant procedure."

Access the FDA webpage to learn more.

Clinical Topics: Arrhythmias and Clinical EP, Vascular Medicine

Keywords: United States Food and Drug Administration, ACC Advocacy, Positive-Pressure Respiration, Embolism, Air, Atrial Appendage, Atrial Function, Left