AtriCure announced that AtriCure’s Synergy ablation system received a vote of approval from the Circulatory System Devices Panel of the US Food and Drug Administration (FDA). The panel recommended that the FDA approve the system for the treatment of atrial fibrillation during open-heart concomitant surgical procedures. According to the company, this is the first time that the FDA’s expert panel has voted to recommend a surgical ablation system to treat atrial fibrillation.
The Synergy ablation system includes AtriCure’s Isolator Synergy clamps, a radiofrequency generator and related switchbox. It is currently cleared in the United States for cardiac tissue ablation during concomitant open-heart surgical procedures.
“We are very pleased with the panel’s approval recommendation and we look forward to working interactively with the FDA to facilitate an atrial fibrillation approval for our Synergy ablation system. An atrial fibrillation label will result in a comprehensive surgeon training programme, which we believe will optimise patient care and improve outcomes for patients with atrial fibrillation undergoing open-heart surgery,” said David J Drachman, AtriCure’s president and CEO. “We would like to thank all of our partners who worked with us on the ABLATE trial, particularly the FDA, physicians and their patients. Additionally, I would like to recognise the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this important milestone.”
The approval recommendation by the panel includes a post-approval study and a physician training programme. The FDA is not required to follow the panel’s recommendations.