An FDA advisory panel voted that the overall benefits outweighed the risks in afib ablations using the AtriCure Synergy bipolar radiofrequency clamp. This was based on the results of the ABLATE clinical trial for ablation of persistent or longstanding persistent atrial fibrillation during other heart surgery. The panel recommended that the FDA approve it, setting the stage for formal FDA approval, which could come by the end of March 2012.
FDA Panel Says Bipolar Radiofrequency Surgical Ablation Effective for Persistent Atrial Fibrillation
November 9, 2011 2 Comments