AtriCure Inc. (NSDQ:ATRC) expects FDA clearance for its Synergy ablation system in treatment of atrial fibrillation in the first quarter of 2012.
The device squeaked by an advisory panel with a split vote in its favor last week, with some panel members cautioning against approval on concerns that the risks may outweigh the benefits.
AtriCure’s Synergy cardiac ablation system uses either heat or cold to create precise scar tissue in the heart to correct arrhythmia, or irregular heart rhythms.
Synergy won FDA clearance in 2001 for use on soft tissues. If it gets the green light from the FDA, AtriCure will be the first company to land clearance for a surgical treatment for atrial fibrillation, president & CEO David Drachman said during the company’s third quarter earnings call.
"This approval signifies a major step forward for cardiac surgery and all interventional ablation treatments of atrial fibrillation," Drachman said. "This anticipated FDA approval will mark a new era of the expansion in growth for AtriCure."
While the device hasn’t been officially labelled for treatment in atrial fibrillation, some members of the FDA’s advisory panel noted that physicians already use Synergy in that way.
"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.