AtriCure Gets FDA Approval To Evaluate Stroke Prevention In Atrial Fibrillation

(RTTNews) - AtriCure Inc. (ATRC) said the Food and Drug Administration or FDA's approval to begin enrollment in a study of AtriCure's AtriClip Left Atrial Appendage Exclusion System. The study would assess the use of the AtriClip device to revent stroke in patients with Afib.

The feasibility study would enroll Afib patients at seven medical centers country-wide. It would focus on patients with risk factors that place them at significant risk of stroke and substantial bleeding risks that contraindicate them for anticoagulation therapy. Research suggests that up to 40% of patients are unable to take oral anticoagulants due to excessive risk of bleeding.

According to the company, patients with Afib have a 500 percent increased risk of stroke over the general public. Afib related strokes are associated with higher morbidity and mortality than non-Afib related strokes. Since the left atrial appendage or LAA, a muscular pouch attached to the heart, has been found to be the source of around 90% of thrombi in Afib patients evaluated after a confirmed stroke, this study will focus on complete and permanent mechanical closure of the LAA.