AtriCure out of West Chester, Ohio received FDA clearance for company’s Synergy Ablation System for the treatment of persistent and long-standing persistent atrial fibrillation when performing coronary artery bypass grafts or valve procedures.
The company claims that the Isolator Synergy clamps that are part of the system create a more even and consistent lesion compared to competing ablation devices.
The Synergy Ablation System includes AtriCure’s Isolator Synergy clamps, a radiofrequency generator and related switchbox. It was previously cleared in the United States 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. Additionally, the FDA approval includes a physician training program.