Cardiology devicemaker AtriCure (Nasdaq:ATRC) expects FDA approval of an atrial fibrillation label for a surgical ablation device in the first quarter of 2012.
U.S. Food and Drug Administration approval of the atrial fibrillation (AF) label would make AtriCure the first company to have a device approved for the surgical treatment of AF and represent a significant milestone for Cincinnati-area AtriCure.
Approval of an AF label for the company’s Synergy ablation system “will mark a new era of expansion and growth for AtriCure,” CEO David Drachman said during a conference call with analysts to discuss the company’s third-quarter earnings.
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The company’s Synergy ablation system has already received FDA approval, but without an AF label, the company doesn’t have the legal right to market the system for use with AF patients.
“An AF indication will allow us to thoroughly train surgeons, which will optimize patient care and patient outcomes,” Drachman said.
AtriCure received a boost last week when an FDA panel recommended approval of the label. The FDA isn’t obligated to follow the panel’s advice, but it usually does.
Also beneficial to AtriCure was the panel’s rejection of a competing device from Medtronic. The panel found that Medtronic’s device was effective for treating AF, but that the company’s clinical trials hadn’t established the device as being safe.
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Turning to the company’s financials, AtriCure reported a net loss per share of 7 cents, the same as last year’s third quarter. That beat analysts’ estimates by a penny. Loss from operations in the quarter was $1.2 million.
Revenues grew 5 percent to $15.2 million, slightly below analysts’ estimates of $15.9 million. International revenues grew 19 percent to $3.5 million, helped by strong demand in Europe and Asia, according to the company.
