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April 27, 2016

Atricure secures FDA clearance for AtriClip PRO2 LAA exclusion system

US-based medical device firm Atricure has secured US Food and Drug Administration (FDA) 510(k) clearance for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System.

Atriclip

US-based medical device firm Atricure has secured US Food and Drug Administration (FDA) 510(k) clearance for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System.

LAA closure is a treatment given by doctors to patients afflicted with atrial fibrillation, where an uncontrolled electrical impulse for the heartbeat results in the collection of blood in the pouch-like LAA which subsequently clots and once pumped out of the heart can cause a stroke.

The new AtriClip PRO2 system is said to feature an enhanced functionality which can obstruct the LAA during minimally-invasive surgical (MIS) procedures.

The system consists of 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 enables the operator to 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 improves anatomical visualisation, and makes the removal of the applier after deployment of the clip, easier.

"The new deployment system facilitates less invasive treatment of the LAA, including right chest approaches in conjunction with valve replacement and cardiac ablation procedures."

TriHealth Heart Institute Thoracic Surgery and General Surgery speclalist Dr Michael Smith said: "The AtriClip PRO2 system provides easier placement of the proven AtriClip LAA occlusion technology.

"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 is claimed to be the first company to secure FDA clearance for a device designed specifically for obstructing the LAA.

Last year saw a growth of 45% in the sales of AtriClip products 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 across the world.


Image: An atriclip attached to the left atrial appendage. Photo: courtesy of Hellerhoff.

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