AtriCure Receives FDA Clearance for New AtriClip Device

AtriCure, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System. The new AtriClip PRO2 system has increased functionality which enhances the capability to occlude the LAA during minimally-invasive surgical (MIS) procedures.

The AtriClip PRO2 system features an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. The ambidextrous locking and trigger-style clip closing mechanism allows the operator to maintain focus on the LAA while maneuvering the device. The handle-based active articulation levers allow the operator to steer the end effector without removing the device. The hoopless end effector enhances anatomical visualization, and simplifies removal of the applier after deployment of the clip.

AtriCure was the first company to receive FDA clearance for a device designed specifically for occluding the LAA. Through the previous twelve months ending December 31, 2015, sales of AtriClip products grew at a rate of 45% on a global basis as compared to the prior period in 2014. To date, AtriClip products have been used to treat more than 70,000 patients worldwide.

A press release can be found from AtriCure website.