AtriCure, a developer of cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, has received FDA approval of its Synergy Ablation System for the treatment of atrial fibrillation (AF).
Specifically, the Synergy Ablation System has been approved for the treatment of patients with persistent and long-standing AF during open-heart concomitant CABG and/or valve replacement or repair procedures, according to the West Chester, Ohio-based company. This is the first time a surgical ablation system has been approved for the treatment of AF and the first time any system, catheter or surgical, has been approved in the U.S. for the treatment of patients with persistent and long-standing persistent AF.
The Synergy Ablation System includes AtriCure’s Isolator Synergy clamps, a radiofrequency generator and related switchbox. The device was previously cleared in the U.S. for cardiac tissue ablation during concomitant open-heart surgical procedures.
The FDA’s approval includes the implementation of a 350-patient post-approval study, of which 46 patients have been enrolled through the ABLATE AF study.