FDA approves AtriCure AF ablation system
Por Michael O’Riordan
West Chester, OH, December 16, 2011.. – The US Food and Drug Administration (FDA) has approved the Synergy Ablation System, manufactured by AtriCure (Cincinnati, OH) for the treatment of atrial fibrillation (AF) in patients undergoing open concomitant coronary artery bypass graft (CABG) surgery and/or valve replacement or repair.
The indication is based on the results of ABLATE, a single-arm, multicenter, prospective, nonrandomized clinical study that included 55 patients with AF. The FDA approval requires the implementation of ABLATE AF, a 350-patient post-approval study, in which, to date, 46 patients have been enrolled.
As reported by heartwire, the FDA 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 nine to zero on efficacy and five to four 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%, 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, MI, 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 Dr David Slotwiner (Long Island Jewish Medical Center, New Hyde Park, NY) 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,” he 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,” he added when commenting on the October meeting.
Related links
* AtriCure AF ablation system gets cautious thumbs-up from FDA advisors
* US Department of Justice investigating AtriCure
* Box-lesion set during modified Cox maze significantly improves patient outcomes
* Replacing Cox-maze incisions with radiofrequency ablation effective for controlling
* Simplified maze procedure performed off-pump
Comentarios desactivados