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FDA advisory committee recommends synergy ablation system
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The FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee today recommended approval of a synergy ablation system for the treatment of AF in patients undergoing open concomitant cardiac surgery.
Five out of nine committee members found that benefits of the AtriCure Synergy Ablation System outweighed the risks. There was one abstention in this vote. Nine out of nine committee members found the system effective for use.
Committee member Richard Page, MD, of the University of Wisconsin, commented that the panel was pleased with the efficacy data despite reservations about safety.
“The data are not perfect but we have got to act on the data that we have,” said “I think it goes without saying that it’s got to be within the surgeon’s skill set. The surgeon has to be trained and have experience in this procedure. If he is not, what we are seeing is a 9-minute extension of pump time, and that could be much longer.”
Page suggested more time may have impacted the outcome of the discussion. “I think if we had a half-hour extension, we wouldn’t be looking at such good data, and I would not advocate the patient undergo a procedure like this.”
The AtriCure Synergy Ablation System was first cleared in 2001 with the intent to ablate soft tissues during general surgery using radiofrequency energy. It was subsequently cleared in 2007 with the intent for the ablation of cardiac tissue during surgery. This device is used in practice as a tool in the Maze IV surgical procedure to create cardiac lesions. However, AtriCure is prohibited from training physicians on the use of the device to treat AF.
Although the FDA is not required to follow the recommendations of the advisory committees, it usually does.
Disclosure: The researchers report no relevant financial disclosure.
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