AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced that AtriCure’s Synergy Ablation System received a vote of approval from the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA). The panel recommended that the FDA approve the system for the treatment of atrial fibrillation (AF) during open-heart concomitant surgical procedures. This marks the first time FDA’s expert panel has voted to recommend a surgical ablation system to treat AF.
“We are very pleased with the panel’s approval recommendation and we look forward to working interactively with the FDA to facilitate an AF approval for our Synergy Ablation System. An AF label will result in a comprehensive surgeon training program, which we believe will optimize patient care and improve outcomes for patients with AF undergoing open-heart surgery,” said David J. Drachman, President and Chief Executive Officer. “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 recognize the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this important milestone.”
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.
The approval recommendation by the panel includes a post-approval study and a physician training program. The FDA is not required to follow the panel’s recommendations.
medlatest notes: this device is already indicated for atrial fibrillation under its CE mark in Europe