Business Wire06.30.16
AtriCure Inc., a developer of treatments for atrial fibrillation (Afib) and left atrial appendage management, has received CE Mark approval for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System, which offers increased functionality to occlude the LAA during minimally-invasive surgical (MIS) procedures.
The device was previously launched in April 2016 upon U.S. Food and Drug Administration (FDA) 510(k) clearance.
“We are excited to bring the AtriClip PRO2 device to the European market,” said Michael Carrel, president and CEO of AtriCure. “The U.S. launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise.”
The addition of the AtriClip PRO2 device has expanded the left atrial appendage product offerings and now provides an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. These features have improved the ease of use and time it takes to manage the left atrial appendage.
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 Dec. 31, 2015, sales of AtriClip products grew at a rate of 45 percent 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. develops atrial fibrillation (Afib) solutions. Its 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. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage.
The device was previously launched in April 2016 upon U.S. Food and Drug Administration (FDA) 510(k) clearance.
“We are excited to bring the AtriClip PRO2 device to the European market,” said Michael Carrel, president and CEO of AtriCure. “The U.S. launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise.”
The addition of the AtriClip PRO2 device has expanded the left atrial appendage product offerings and now provides an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. These features have improved the ease of use and time it takes to manage the left atrial appendage.
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 Dec. 31, 2015, sales of AtriClip products grew at a rate of 45 percent 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. develops atrial fibrillation (Afib) solutions. Its 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. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage.