Healthcare Industry News: AtriCure
News Release - February 6, 2007
AtriCure Receives FDA 510(k) Clearance for Isolator(TM) Synergy(TM) Bipolar Ablation System and Performs First CasePulsing Electrode Pairs
Superior Performance in Thicker Tissues
More Durable Ablation Lines
WEST CHESTER, Ohio, Feb. 6 (HSMN NewsFeed) -- AtriCure, Inc. (Nasdaq: ATRC ), a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced today that it has received Food and Drug Administration 510(k) clearance for its Isolator(TM) Synergy(TM) Bipolar Ablation System for the ablation of soft tissue. The device is not yet cleared for the ablation of cardiac tissue.
The Isolator Synergy System is the next generation version of the Isolator Bipolar Ablation System. The Isolator Synergy System incorporates two pulsing pairs of electrodes in the jaws of the clamp, which the Company believes will allow physicians to ensure full thickness ablation of thicker and more diseased tissues and create more durable lines of block. Extensive pre- clinical studies using the Isolator Synergy System have demonstrated that the lesions are shaped like columns for durability and that the ablation lines are consistently transmural in thicker tissues, which the Company believes will result in superior patient outcomes.
The Isolator Synergy System also incorporates the same ergonomic design as the previous Isolator Bipolar Ablation System and features a lower profile jaw for easier placement and maneuverability around surrounding structures. It is currently available for open procedures and the Company anticipates launching a minimally invasive version during the third quarter of 2007. The first case utilizing the Isolator Synergy System was conducted on February 2, 2007 by Patrick M. McCarthy, M.D., Chief, Division of Cardiothoracic Surgery at Northwestern Memorial Hospital in Chicago, Illinois. "My initial experience with the Isolator Synergy was that the ablation line was visible and appeared robust. We successfully tested the ablation line for conduction block. I look forward to the further evaluation of this technology," said Dr. McCarthy.
David J. Drachman, President and Chief Executive Officer, said, "We believe that the Isolator Synergy System is breakthrough technology and will further position AtriCure as the market innovator. The Isolator Synergy System creates a uniform, full thickness ablation lesion shaped like a column, which we believe will result in more durable ablation lines in thicker and more diseased tissues. It has been well established that electrical impulses can propagate across narrow lesions, even if full thickness is achieved due to the reconnection of tissue across the ablation line. We believe that the ablation column created by the Isolator Synergy System will produce superior technical endpoints resulting in improved long-term outcomes and further distinguish AtriCure as the market leader."
About AtriCure, Inc.
AtriCure, Inc. is a medical device company focused on developing, manufacturing and selling innovative surgical devices to create precise lesions, or scars, in soft and cardiac tissues. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure bipolar ablation system as a standard treatment alternative during open-heart surgical procedures to safely, rapidly and reliably create lesions in cardiac, or heart, tissue to block the abnormal electrical impulses that cause atrial fibrillation "AF", a rapid, irregular quivering of the upper chambers of the heart. AF affects more than 2.4 million people in the U.S. and predisposes them to a five fold increased risk of stroke.
The FDA has cleared the AtriCure bipolar ablation system and the Isolator Synergy Bipolar Ablation System for the ablation, or destruction, of soft tissues in general and non-cardiac related surgical procedures, but to date has not cleared or approved the systems for cardiac use or for the treatment of AF. The FDA has cleared the AtriCure Isolator(TM) Transpolar(TM) Pen for the ablation of cardiac tissue and the evaluation of cardiac arrhythmias, but the Isolator(TM) Transpolar(TM) Pen has not been approved for the treatment of AF.
This press release contains "forward-looking statements" 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 AtriCure's products. Forward-looking statements are based on AtriCure'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 AtriCure's control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure's products, AtriCure'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 AtriCure's products, competition from existing and new products and procedures or AtriCure's ability to effectively react to other risks and uncertainties described from time to time in AtriCure's SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation (including the purported class action lawsuit) 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.
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