Healthcare Industry News: AtriCure
News Release - September 10, 2007
AtriCure Reports First Human Implant of the Cosgrove-Gillinov Left Atrial Appendage Occlusion SystemWEST CHESTER, Ohio, Sept. 10 (HSMN NewsFeed) -- AtriCure, Inc. (Nasdaq: ATRC ), a medical device company focused on developing, manufacturing and selling innovative cardiac surgical devices, announced today that its Cosgrove-Gillinov Left Atrial Appendage Occlusion System was successfully implanted during an open-heart surgical procedure performed by Professor Michele Genoni and Dr. Sacha Salzberg of The University of Zurich in Switzerland with the support of Dr. Marc Gillinov of the Cleveland Clinic.
Professor Genoni commented, "We were encouraged with the initial implant of the Cosgrove-Gillinov Left Atrial Appendage Occlusion System. It was easy and rapid to implant and we were able to safely and completely occlude the left atrial appendage." Dr. Gillinov commented, "We look forward to the continued investigation of the system as an effective and safe means of occluding the left atrial appendage."
It has been estimated that fifteen to twenty percent of all strokes are attributable to atrial fibrillation (AF). The Cosgrove-Gillinov Left Atrial Appendage Occlusion System is a clip device that is designed to occlude the left atrial appendage, a hollow sac-like structure attached to the heart's left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During AF, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. Published literature suggests that the majority of cardiac clots in patients with AF form in the left atrial appendage, which some physicians believe is associated with AF-related strokes. The Cosgrove- Gillinov Left Atrial Appendage Occlusion System is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria.
"This major product and clinical milestone embodies AtriCure's commitment and passion for preserving and improving life through our scientific collaboration with innovative physicians in order to develop meaningful platform technologies. We believe that the Cosgrove-Gillinov Left Atrial Appendage Occlusion System represents a safer and more effective means to permanently occlude the left atrial appendage," said David J. Drachman, President and Chief Executive Officer. "Additionally, the Cosgrove-Gillinov Left Atrial Appendage Occlusion System is a new franchise growth opportunity for our Company."
The Cosgrove-Gillinov Left Atrial Appendage Occlusion System has not yet been approved by the Food and Drug Administration (FDA) for human use.
About AtriCure, Inc.
AtriCure, Inc. is a medical device company focused on developing, manufacturing and selling innovative cardiac surgical devices designed to create precise lesions, or scars, in cardiac, or heart, tissues. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation clamps as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, leading cardiothoracic surgeons have described the AtriCure Isolator® clamps as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 2.5 million Americans and predisposes them to a five-fold increased risk of stroke.
The FDA has cleared the AtriCure Isolator® bipolar ablation system, including the new Isolator Synergy(TM) ablation clamps, for the ablation, or destruction, of soft tissues in general and cardiac related surgical procedures, but to date has not cleared or approved the system for the treatment of AF. The FDA has cleared the AtriCure multifunctional bipolar Pen for the ablation of cardiac tissue and for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias, but the multifunctional bipolar 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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