AtriCure, a provider of cardiac surgical ablation medical devices, has received FDA clearance for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system.
The AtriClip system includes a clip device that is designed to exclude the left atrial appendage, which has internal peaks and valleys, or trabeculations. During atrial fibrillation (AF), stagnant blood pools in the trabeculations of the left atrial appendage and form clots that can migrate to other parts of the body.
AtriCure said that the AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria. The 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.
David Drachman, president and chief executive officer, said: “Clearance of the AtriClip system in the United States represents a major product and clinical milestone for AtriCure. We believe that the AtriClip system provides a safe and efficient method to exclude the left atrial appendage.
“This key innovation represents a large and exciting new growth platform and demonstrates our steadfast commitment to developing market leading technologies to meet the needs of patients and physicians.”