The FDA has decided to approve the Synergy Ablation System, which is made by ActriCure. It is to be used as a treatment of atrial fibrillation (AF) in patients who are undergoing open concomitant coronary artery bypass graft (CABG) surgery.
The belief here is based on the results of a study that has been referred to as ABLATE, which comprises “single-arm, multicenter, prospective, nonrandomized clinical study that included 55 patients with AF.” In order to get the agency’s approval, the FDA needed the implementation of ABLATE AF, which is a post-approval study that consists of 350 patients. So far, only 46 patients have been enrolled to participate in the study.
For now, the FDA did give the system a cautious approval; however, all of the panelists that made the decision have stated that they believe the ablation system would be effective in helping to restore a regular sinus rhythm, but it should be noted that the panel’s votes were split when it came to the device’s safety. In the end, the panel voted 9-0 on the systems effectiveness, and 5-4 on how safe it is.
“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. 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,” said panelist Dr. David Slotwiner of the Long Island Jewish Medical Center in New Hyde park, N.Y.
Ablation systems have been getting in the news a lot lately as an alternative treatment for patients with AF. Common medications that are designed to help correct a heart’s beat rhythm have proven dangerous for many patients. Multaq is among those dangerous medications. Multaq has been linked to severe side effects, including liver failure and a worsening of the heart condition.
If you or a loved one have developed liver failure or worsening heart condition after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.
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