Cardiac device maker AtriCure (NASDAQ:ATRC) saw its stock plunge Monday after an FDA report expressed “concerns” about a clinical trial for one of the company’s ablation devices. U.S. Food and Drug Administration staffers issued a (pdf) report in advance of an FDA advisory panel’s Wednesday meeting to review AtriCure’s application for approval of an atrial fibrillation label for the company’s already-approved Synergy ablation system. The report noted “several concerns” with clinical trial data in Cincinnati-area Atricure’s Premarket Approval Application (PMA) for the AF label.
