Atrial Management Device Cleared for Expanded Labeling
The FDA granted AtriCure 510(k) clearance for additional labeling claims for its AtriClip left atrial appendage (LAA) management device.
The expanded clearance changes the indication from occlusion of the LAA to exclusion and adds electrical isolation as a labeling claim. Occlusion plugs the opening to prevent blood flow into the LAA, whereas exclusion shuts off or eliminates the appendage from the left atrium.
The agency granted the electrical isolation claim after testing showed that when excluding the LAA using the device, the appendage can no longer conduct electrical activity.