WEST CHESTER, Ohio, Jan. 7 /PRNewswire-FirstCall/ -- AtriCure, Inc. , a medical device company and a leader in cardiac surgical ablation products, today announced that results reporting on the Company’s proprietary minimally invasive products, which physicians have adopted to treat atrial fibrillation (AF), were published in The Annals of Thoracic Surgery by Dr. James H. Wudel, a prominent cardiac surgeon, and colleagues from the Nebraska Heart Hospital, Lincoln, Nebraska.
Dr. Wudel reported the results from 22 patients with symptomatic, drug refractory, intermittent AF who underwent a video assisted, minimally invasive, thoracoscopic pulmonary vein isolation procedure using the AtriCure minimally invasive bipolar ablation system. Additionally, in 21 of the 22 patients, the left atrial appendage was removed.
Of the 22 symptomatic, drug refractory, intermittent AF patients, 8 patients presented with persistent AF and 14 patients presented with paroxysmal AF. All 22 patients were followed for a minimum of one year with an average follow-up of eighteen months. Holter monitoring was applied at the final follow-up to more accurately determine the rhythm status.
At the final follow-up, 20 patients (91%) were in normal sinus rhythm and off antiarrhythmic drugs. Additionally, 20 patients (91%) were no longer taking warfarin at the end of the study period.
Dr. James H. Wudel commented, “These promising minimally invasive products and techniques provided desirable results and are a viable option for selected AF patients. On average our length of hospital stay was three days and our patients went home to an improved quality of life. We look forward to the continued development of these minimally invasive tools and the ongoing investigation of their clinical outcomes.”
“These results are consistent with previously published and presented data and further strengthen our confidence, commitment and conviction in our ability to expand the treatment options for those patients who suffer from AF and reinforce our commitment to pursuing AF approvals for our products from the Food and Drug Administration (FDA),” said David J. Drachman, AtriCure’s President and Chief Executive Officer. “During 2008 we anticipate a series of additional publications, national presentations and new products that we believe will stimulate further growth from our minimally invasive business.”
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(R) 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(R) 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(R) 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.
Forward-Looking Statements 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.
CONTACT: Julie A. Piton, Vice President and Chief Financial Officer of
AtriCure, Inc., +1-513-755-4561, jpiton@atricure.com
Web site: http://www.atricure.com/
