New Atrial Appendage Exclusion System Receives FDA Clearance
June 16, 2010 – A new surgical device for excluding the left atrial appendage has received clearance from the U.S. Food and Drug Administration (FDA). AtriCure Inc. announced this week that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. Initial launch in the United States is anticipated to begin in late June with full commercial release planned during the third quarter of 2010.
The AtriClip system includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart’s left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During atrial fibrillation, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria. The AtriClip system has been cleared by the FDA for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open-heart cardiac procedures.
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