The FDA’s Circulatory System Devices advisory panel has narrowly approved the AtriCure Ablation System for AF. The panel gave it a “cautious” approval, signaling that some panel members still have their doubts as to its safety.
The decision was made by five panel members who ultimately found that the benefits outweighed the risks when the system is used to treat atrial fibrillation (AF) patients who are going through open concomitant coronary artery bypass graft (CABG) surgery or if they must have a valve replaced or repaired. However, three of the panelists did express some doubts about the safety and efficacy of the system beyond this specific use and cautioned the other panelists against approving it widely. One panelist refused to vote.
Specifically, all of the voting panelists believe that the ablation system is effective insofar as its ability to restore sinus rhythm, but the device’s safety caused the split votes. Panel member Dr. David Slotwiner of the Long Island Jewish Medical Center, New Hyde Park, N.Y., voted in the ablation system’s favor, saying, “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 an 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.”
Dr. Magnus Ohman of the Duke University Medical Center, Durham, N.C., agrees that the device works, but thinks that the safety information isn’t adequate enough. He says, “At the end of the day, weighing the safety and efficacy, if you can weigh one but not the other, you really are stuck.”
AF treatments are getting more and more dangerous. Multaq was once considered a good treatment for AF patients, but Multaq recently has been linked to patient deaths and liver failure. If you or a loved one have suffered from liver failure 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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