FDA OKs AtriCure’s AF Ablation System

The U.S. Food and Drug Administration (FDA) has approved the Synergy Ablation System, manufactured by AtriCure Inc. for the treatment of atrial fibrillation (AF) in patients undergoing open concomitant coronary artery bypass graft (CABG) surgery and/or valve replacement or repair.

Specifically, the Synergy Ablation System has been approved for the treatment of patients with persistent and long-standing persistent AF during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. This is the first time a surgical ablation system has been approved for the treatment of AF and 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 AF.

The agency’s approval was based on the results of ABLATE, a single-arm, multicenter, prospective, nonrandomized clinical study that included 55 patients with AF. The FDA’s OK called for the implementation of a post-approval study, ABLATE AF, a 350-patient postapproval study, in which 46 patients have been enrolled thus far.

“This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of AF. The approval confirms the effectiveness of the Synergy Ablation System and recognizes the increasing need for the surgical treatment of AF,” said David J. Drachman, cheif executive of the company. “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.”

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 Circulatory System Devices advisory panel gave a “cautious nod of approval” for the device in October, with all panelists stating they believed the ablation system was effective in restoring sinus rhythm, but they were split for the vote on safety. Overall, the panel voted 9 to 0 on efficacy and 5 to 4 on safety (with one abstention).

In the ABLATE study, the primary safety and efficacy end point was met in the 55 participants, with investigators reporting a major adverse-event rate of 9.8 percent, including two deaths, two bleeding events, and one stroke that occurred within 30 days. The primary safety end point was a composite of in-hospital death, stroke, myocardial infarction (commonly known as a heart attack), transient ischemic attack, or bleeding assessed at 30 days. The primary efficacy end point was defined as the number of patients free of AF and not taking antiarrhythmic medication at six months.

During the FDA advisory committee meeting, panelist David Slotwiner, M.D., from Long Island Jewish Medical Center in New Hyde Park, N.Y., voted in favor of the ablation system and said that he believes the benefits outweigh the risks.

“I think it’s effective at creating these ablation lesions, and I think it’s effective in many people for maintaining sinus rhythm, although what that means [clinically] for many patients remains unanswered,” Slotwiner said. “But I hope, mostly, that if approval is granted, it will allow us to get more information and to educate more surgeons, so that the procedure becomes more widely available and we understand better who will benefit the most.”

AtriCure is based in West Chester, Ohio.