Approval for the epi-sense guided coagulation system is intended for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients who are refractory or intolerant to at least one class i and/or iii antiarrhythmic drug (aad); and, in whom the expected benefit from rhythm control outweighs the potential known risks associated with a hybrid procedure such as delayed post-procedure inflammatory pericardial effusions.
|Device||EPi-Sense Guided Coagulation System|
|Generic Name||Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation|
|Applicant Address||AtriCure, Inc. 7555 Innovation Way mason, OH 45040|
|Supplement Number||Date||Supplement Type|