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FDA Panel to Review AtriCurea?s Synergy Ablation System on October 26

^{Published on 2011-09-19 05:46:38 - Market Wire}
 

WEST CHESTER, Ohio--([ BUSINESS WIRE ])--AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced that a U.S. Food and Drug Administrationa™s (FDA) Circulatory System Devices Panel meeting is scheduled to review AtriCurea™s Premarket Approval Application (PMA) for its Synergy Ablation System on October 26, 2011. AtriCure submitted the final module of its PMA in December 2010 for an atrial fibrillation indication during open-heart concomitant procedures.

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue and systems for the exclusion of the left atrial appendage. The Company believes cardiothoracic surgeons are adopting its ablation products for the treatment of atrial fibrillation, or AF, during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure is conducting clinical trials in support of an AF indication. However, to date, the FDA has not cleared or approved AtriCurea™s products for the treatment of AF or a reduction in the risk of stroke.

Forward-Looking Statements

This press release contains aforward-looking statementsa within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCurea™s products. Forward-looking statements are based on AtriCurea™s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCurea™s control. These risks and uncertainties include the rate and degree of market acceptance of AtriCurea™s products, AtriCurea™s ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCurea™s products, competition from existing and new products and procedures or AtriCurea™s ability to effectively react to other risks and uncertainties described from time to time in AtriCurea™s SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.