The US Food and Drug Administration (FDA) has approved AtriCure’s Synergy Ablation system for the treatment of patients with persistent and long-standing persistent atrial fibrillation during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures.
According to a company press release, this is the first time any system, catheter or surgical, has been approved in the United States for the treatment of patients with persistent and long-standing persistent atrial fibrillation.
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 (AtriCure synergy bipolar RF energy lesions for non-paroxysmal forms of atrial fibrillation treatment during concomitant on-pump endo/epicardial cardiac surgery) study. Additionally, the FDA approval includes a physician training programme.
“This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of atrial fibrillation. The approval confirms the effectiveness of the Synergy Ablation system and recognises the increasing need for the surgical treatment of atrial fibrillation,” said David J Drachman, AtriCure’s president and CEO.
“We look forward to educating physicians and patients on our surgical alternative for the treatment of atrial fibrillation, which we believe will raise awareness for a large number of atrial fibrillation patients that are currently being undertreated. Importantly, we would like to thank all of our partners who worked with us to achieve this approval, particularly the FDA, physicians and their patients who participated in the ABLATE trial. Additionally, I would like to recognise the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this seminal milestone,” Drachman commented.