WEST CHESTER, Ohio, Sept. 10 /PRNewswire-FirstCall/ -- AtriCure, Inc. , a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced today that it has received CE Mark approval to market the Isolator Transpolar System for the treatment of cardiac arrhythmias, including atrial fibrillation (AF). The AtriCure(R) clamps are the only bipolar radiofrequency (RF) clamps that are approved for this indication in the European Union (EU).
The expanded EU indication provides physicians the reassurance that clinical data to support the atrial fibrillation treatment claims were reviewed and accepted by European regulatory authorities. Ongoing, multi-center US clinical trials are currently being conducted on the Isolator Transpolar System for the treatment of atrial fibrillation for expansion of the indication in the US.
The Isolator system utilizes proprietary, automated, impedance-driven ablation algorithms. As presented by surgeons from Washington University (St. Louis, MO) at the June 2006 International Society of Minimally Invasive Surgeons meeting, the Isolator system provides energy delivery tailored to the biophysics of the tissue for reliable transmural lesions without the risk of thermal spread. Building on the foundation of more than 30,000 procedures worldwide, AtriCure has achieved the market leadership position in surgical ablation.
Nicolas Doll, MD, PhD, senior cardiac surgeon at the University Leipzig Heartcenter in Leipzig, Germany, commented, "I recently successfully treated a woman who had suffered from permanent AF for three years. After using the AtriCure ablation system, her AF was eliminated, and she was discharged in normal sinus rhythm. This new AtriCure ablation system holds great promise to improve the care of patients with AF."
Dave Drachman, AtriCure's president and CEO, said, "This cardiac arrhythmia approval for our ablation clamps in Europe represents a substantial milestone toward our mission of expanding treatment options for patients who suffer from atrial fibrillation. With the prevalence of AF rising in Europe and the United States, we look forward to the opportunity to further serve the community by bringing new, innovative products to these patients and the physicians who treat them."
AtriCure's clamps with the new EU indication will be launched at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Thoracic Surgeons (ESTS) that opens in Stockholm, Sweden, today. During the EACTS Techno-College yesterday, Dr. Doll performed a live televised case to an audience of hundreds of cardiac surgeons successfully demonstrating the new AtriCure technology. Respected cardiac surgeons will make presentations at the AtriCure booth (Booth # 678). Presenters include Wim-Jan P. van Boven, MD, from Antonius Hospital, Nieuwegein, Netherlands; Ralph Damiano, MD, from Washington University School of Medicine in St. Louis MO; and Sacha P. Salzberg, MD, from University Hospital Zurich in Zurich, Switzerland.
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, Inc. 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, a rapid, irregular quivering of the upper chambers of the heart. The indications for the core product line of Isolator clamps are as follows: In the United States, The Isolator Transpolar Surgical Ablation System is composed of a radiofrequency ASU generator and a sterile, single use electrosurgery device intended to ablate soft tissue during General, ENT, Gynecological and Urological surgical procedures. In Europe, the clamp indications have been further expanded to include, "ablation of cardiac tissue during open heart and closed chest (minimally invasive) surgery including pulmonary vein isolation and atrial connecting lesions for the Maze procedure for the treatment of cardiac arrhythmias, including atrial fibrillation. For the complete list of indications for the entire AtriCure product line, please consult the appropriate individual Instructions for Use.
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 manufactures 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.
Contacts:
AtriCure: For investors:
David J. Drachman Stephanie Carrington / Nick Laudico
President & CEO 646-536-7017 / 7030
513-755-5758
