Dec 3 2010
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.
“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.”
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.
SOURCE AtriCure, Inc.
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