The approval is backed by the results from a 350-patient post-approval study and a physician training program.
The Synergy ablation system consists of AtriCure’s Isolator Synergy clamps, a radiofrequency generator and related switchbox, approved in the US for cardiac tissue ablation during concomitant open-heart surgical procedures.
AtriCure president and CEO David Drachman said the initiative suggests the effectiveness of the Synergy ablation system and recognizes the increasing need for the surgical treatment of AF.
"We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being undertreated,” Drachman added.
