Healthcare Industry News: cardiopulmonary
News Release - January 14, 2008
Surgeons and Electrophysiologist Publish Positive Data Using AtriCure Minimally Invasive ProductsWEST CHESTER, Ohio, Jan. 14 (HSMN NewsFeed) -- AtriCure, Inc. (Nasdaq: ATRC ), a medical device company and a leader in cardiac surgical ablation products, today announced recently published results that report on AtriCure's proprietary minimally invasive products, which physicians have adopted to treat atrial fibrillation (AF). The results were published in the Journal of Interventional Cardiac Electrophysiology by two prominent cardiac surgeons, Dr. James R. Edgerton and Dr. Michael B. Mack from the cardiopulmonary Research Science and Technology Institute of Dallas, Texas in collaboration with Dr. Warren M. Jackman, a prominent electrophysiologist from the University of Oklahoma.
The authors reported the results from 83 patients who underwent a video- assisted, minimally invasive ablation procedure for the treatment of AF using AtriCure's Isolator® endoscopic bipolar ablation system. The procedure included electrical isolation of the pulmonary veins, confirmed by electrophysiology mapping techniques, targeted autonomic denervation of the left atrium and the removal of the left atrial appendage in selected patients. The study population consisted of patients with left atrial enlargement as the authors reported a mean left atrial size of 5.2cm. Left atrial enlargement is known to be one of the primary predictors of ablation failures. Additionally, 25% of the patients had at least one previous catheter ablation failure.
Of the 83 patients, 57 completed long-term monitoring at 6 months. Treatment success was defined as no episodes of AF greater than 15 seconds in duration. The minimally invasive procedure was successful in 32 of 39 (82%) of patients that presented with paroxysmal AF and 10 of 18 (56%) of patients that presented with persistent and long-standing persistent AF.
Dr. James R. Edgerton commented, "The results from this study are very encouraging and support the safety and effectiveness of this procedure and products in a selected group of AF patients. We remain enthusiastic concerning the continued development and investigation of these minimally invasive products and techniques. In particular, we have developed an expanded ablation procedure and we are encouraged by the potential for the expanded ablation procedure to improve clinical outcomes in the more difficult to treat persistent and permanent AF patients."
"The use of rigorous, long-term monitoring in a study population of patients who are not ideal candidates for ablation, underscores these encouraging results and reinforces our thesis that AtriCure is well positioned to meet a large and growing demand for safe and effective AF treatment alternatives," said David J. Drachman, AtriCure's President and Chief Executive Officer. "We are excited about the upcoming launch of our Coolrail(TM) Linear Pen ablation system which is designed to be used in conjunction with our endoscopic Isolator® bipolar ablation system in order to enhance our results in persistent and permanent patients. Further, we remain committed to pursuing AF approvals for our products from the Food and Drug Administration (FDA)."
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, 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, medical journals and 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. AtriCure's left atrial appendage clip system has not been approved for commercial use. It is currently being used in clinical evaluations in Europe.
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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