FDA clears expanded label for AtriCure’s AtriClip

The FDA grants 510(k) clearance for additional labeling claims for AtriCure’s (NASDAQ:ATRC) AtriClip left atrial appendage (LAA) management devices, including the indication from occlusion of the LAA to exclusion and adding electrical isolation.

Exclusion shuts off and/or eliminates the appendage from the left atrium, whereas occlusion plugs the opening to prevent flow into the LAA. The electrical isolation claim was granted after testing demonstrated that when excluding the LAA using an AtriClip device, the appendage can no longer conduct electrical activity.

https://seekingalpha.com/news/3494859-fda-clears-expanded-label-atricures-atriclip