Healthcare Industry News: AtriCure
News Release - December 2, 2010
First Patient Enrolled in AtriCure’s DEEP AF Feasibility TrialWEST CHESTER, Ohio--(Healthcare Sales & Marketing Network)-- AtriCure, Inc. (Nasdaq:ATRC ), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced initial patient enrollment in its DEEP AF feasibility trial. The first procedure was performed in a new, state-of-the-art hybrid room at Sentara Norfolk General Hospital in Norfolk, Virginia by Jonathan Philpott, M.D., Director of the Sentara Atrial Fibrillation Surgery Program, Ian Woollett, M.D., and John Onufer, M.D., Medical Director of Cardiac Electrophysiology. Doctors Philpott, Woollett, and Onufer are co-Principal Investigators of the DEEP AF trial at Sentara Norfolk General Hospital and are working in collaboration with Doctors Robert Bernstein and Philip Gentlesk.
The DEEP AF trial, which received approval from the Food and Drug Administration in September 2010, is designed to evaluate the safety and efficacy of a dual epicardial/endocardial procedure (DEEP), or hybrid procedure, to treat atrial fibrillation patients with persistent and long-standing persistent atrial fibrillation (AF). The hybrid procedure combines the benefits of both minimally invasive surgical ablation and catheter ablation and mapping techniques, leveraging the skills and technologies of both the cardiac surgeon and the electrophysiologist. The DEEP AF trial uses AtriCure’s minimally invasive surgical ablation product platform in conjunction with the Biosense Webster® THERMOCOOL® catheter ablation products. The feasibility trial will enroll 30 patients and is being conducted at six prominent U.S. medical centers.
Dr. Onufer commented, “We believe that this investigational hybrid procedure has the potential to represent an important advancement in the treatment of patients with persistent AF. These patients represent the largest segment of the AF population and currently have limited effective treatment alternatives. Our initial experience with this hybrid procedure suggests that it represents a highly promising AF treatment.” Dr. Philpott further commented, “Our preliminary experience has been that the procedure is both safe and effective. The partnership that this hybrid procedure creates between the electrophysiologist and the cardiac surgeon provides patients with a comprehensive ablation and mapping procedure, leveraging the skills and technologies of each specialist.”
According to the American Heart Association, AF is estimated to effect more than 5.5 million people worldwide and is the leading cause of stroke. It is estimated that more than sixty percent of AF patients have persistent AF. To date, no products have been cleared by the FDA for the treatment of patients with persistent AF.
“This trial represents AtriCure’s continued commitment to improving patient outcomes by expanding the treatment options for patients that suffer from AF. The DEEP AF hybrid ablation procedure strengthens the partnership between electrophysiologists and cardiac surgeons in the interest of improving patient care. We believe the clinical science will demonstrate that our DEEP AF hybrid ablation procedure is an important treatment alternative for a large and rapidly growing number of patients with persistent AF as well as patients that have failed catheter ablation procedures,” said David J. Drachman, AtriCure’s President and Chief Executive Officer.
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, tissue and systems for the exclusion of the left atrial appendage. The Company believes cardiothoracic surgeons are adopting its products for the treatment of atrial fibrillation, or AF, during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure is conducting clinical trials in support of an AF indication. However, to date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF or a reduction in the 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 manufacturers and suppliers, litigation (including the purported class action lawsuits) 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.
The third party trademarks used herein are the property of their respective owners. Biosense Webster, Inc. is not a sponsor of the DEEP AF trial.
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