FDA approves left atrial appendage MIS device from AtriCure

AtriCure 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.



“We are excited to receive FDA clearance for the AtriClip PRO2 device,” said Michael Carrel, President and CEO of AtriCure. “The AtriClip franchise is the fastest growing part of our business, and we are committed to continued innovation to help our customers meet the needs of their patients. The AtriClip PRO2 system has several advancements that make it easier to use in 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.

“The AtriClip PRO2 system provides easier placement of the proven AtriClip LAA occlusion technology,” said J. Michael Smith, MD at TriHealth Heart Institute in Cincinnati. “The new deployment system facilitates less invasive treatment of the LAA, including right chest approaches in conjunction with valve replacement and cardiac ablation procedures.”

Product information can be found by following this link.