AtriCure, a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage management, announced US 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."
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.
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce outcomes that reduce the economic and social burden of atrial fibrillation.
AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures.