AtriCure gets some Wall Street love as Synergy wins a wary nod from the FDA's advisory panel

October 27, 2011 by MassDevice staff

AtriCure's Synergy surgical ablation system won an FDA panel recommendation for clearance, but advisors are split on the safety of the device.

AtriCure

AtriCure Inc. (NSDQ:ATRC) shares spiked almost 18 percent on news that the FDA's circulatory system devices panel voted in favor of the Synergy system.

Shares jumped to $11.76 this morning, recovering from a sudden drop in share price this week as documents leading up to the panel meeting revealed that advisors had concerns about Synergy's safety.

AtriCure shares opened at $11.61 in the morning on Monday, Oct. 24, dropping 17 percent to $9.65 by the end of the day as the circulatory system devices panel's concerns made headlines.

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The panel fully supported the efficacy of the Synergy system, but were split on the matter of safety. Synergy got by with an endorsement from five of the panel's nine members, but three cautioned against approval on concerns that the risks may outweigh the benefits. One member chose not to vote on the issue.

The thumbs up marked the first time an FDA expert panel voted to recommend surgical ablation for treatment of atrial fibrillation, but doctors have been using the Synergy system to treat atrial fibrillation off-label, Reuters reported.

"The device is being used for this indication every day ... The cat's out of the bag and I think it can only become a safer and more effective procedure with adequate training," panel member and cardiologist Dr. Richard Page said.

AtriCure's Synergy cardiac ablation system, cleared for use on soft tissue in 2001 and expanded to include cardiac tissue in 2007, uses either extreme heat or extreme cold to create precise scar tissue in the heart to correct arrhythmia, or irregular heart rhythms.

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