WEST CHESTER, Ohio, Oct. 31 /PRNewswire-FirstCall/ -- AtriCure, Inc. , a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced today the enrollment and treatment of the first patient in its RESTORE-SR II clinical study for the use of the AtriCure Bipolar Ablation System in a sole-therapy, minimally invasive procedure to treat atrial fibrillation (AF). AtriCure received approval for its Investigational Device Exception (IDE) from the FDA earlier this month. The prospective, non-randomized, feasibility clinical trial will enroll 25 patients at five leading U.S. medical centers. The results of the trial will be used to design and support U.S. pivotal studies of the AtriCure Bipolar Ablation System for the treatment of AF.
The initial patient, a 58-year old male with a two plus year history of paroxysmal or intermittent AF, was treated without complications by surgeons Michael Mack, MD and James Edgerton, MD at Medical City Hospital in Dallas, TX on Friday, October 21, 2005. The patient received catheter ablation over a year ago with poor results and had also not responded to three different types of drug therapy to control his AF.
Dr. Mack commented, “We are excited about the acute results of the procedure on the first patient as his normal sinus (heart) rhythm was restored by the end of the surgery. We hope to demonstrate to FDA that the procedure is safe, easily adoptable, and effective for treating AF.”
Dr. Edgerton remarked, “We are honored to be one of only five sites in this landmark feasibility trial and to provide our patients with promising alternatives to current treatments. The patient was discharged doing well, in normal sinus rhythm and free of the fatigue, palpitations, shortness of breath, and other troublesome symptoms he’d lived with for the past two years.”
This clinical trial was devised as a result of the pioneering efforts of surgeon Randall Wolf, MD at the University of Cincinnati (UC) Medical Center. Dr. Wolf is the Co-Principle Investigator of this study along with Dr. Warren Jackman, a leading electrophysiologist at the University of Oklahoma Health Sciences Center (OUHSC).
Commenting on the clinical trial, Dr. Wolf, said, “The procedure differs from other surgical techniques for lone AF in that it combines commonly accepted treatment philosophies in a minimally invasive, thoracoscopically assisted approach performed without sternotomy or use of bypass. It includes removal of the left atrial appendage (a major contributor to AF related stokes), targeted isolation of pulmonary vein triggers, ablation of the autonomic system triggers on the epicardial surface of the heart previously only attempted in catheter ablation, and EP (electrophysiology) testing to confirm results intraoperatively.”
David Drachman, President and CEO of AtriCure, stated, “AtriCure has assembled a renowned group of surgeons and electrophysiologists to participate in the trial. We believe that this minimally invasive sole therapy procedure with shorter hospital stays than with traditional surgery has the potential to significantly improve the quality of life for patients with symptomatic AF.”
Additional investigators include surgeon Marvin Peyton, MD and electrophysiologist Deborah Lockwood, MD at OUHSC; surgeon E. William Schneeberger MD at UC; surgeon Marc Gillinov at the Cleveland Clinic Foundation; and surgeon Scott Bronleewe at Tampa Community Hospital.
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. Atrial Fibrillation affects more than two million people in the U.S. and predisposes them to a three to five fold increased risk of stroke.
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 Thomas Etergino Chief Financial Officer 513-755-4561 tetergino@atricure.com The Ruth Group Stephanie Carrington / Nick Laudico (investors) (646) 536-7017 / 7030 scarrington@theruthgroup.comnlaudico@theruthgroup.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com
AtriCure, Inc.
CONTACT: Thomas Etergino, Chief Financial Officer of AtriCure,+1-513-755-4561, tetergino@atricure.com; or Stephanie Carrington,+1-646-536-7017, scarrington@theruthgroup.com, or Nick Laudico - investors,+1-646-536-7030, nlaudico@theruthgroup.com, or Jason Rando - media,+1-646-536-7025, jrando@theruthgroup.com, all of The Ruth Group forAtriCure
