AtriCure Announces Conditional Approval of DEEP AF Feasibility Trial

   AtriCure, Inc. announced that it has received conditional approval from the FDA to evaluate the safety and efficacy of a dual epicardial/endocardial procedure (DEEP), or hybrid procedure, to treat patients with persistent and long-standing persistent atrial fibrillation (AF).The trial will be conducted at five prominent U.S. medical centers and provides for the enrollment of 30 patients. Initial enrollment is expected to begin during the second half of 2010.    The hybrid procedure combines the benefits of both surgical and catheter ablation along with endovascular mapping techniques, leveraging the expertise and skills of both the cardiac surgeon and the electrophysiologist to treat patients with persistent forms of AF. The trial will use AtriCure’s minimally invasive surgical ablation product platform in conjunction with Biosense Webster’s THERMOCOOL® catheter ablation product platform.     “Patients with persistent and long-standing persistent AF represent a large and growing number of the AF population. These patients are often the most challenging and time consuming to effectively treat,” said Andrea Natale, MD, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “I am enthusiastic to participate in this important clinical trial that combines physician skills with leading technologies in order to investigate a promising hybrid treatment alternative.”     “We believe that our DEEP AF hybrid ablation procedure strengthens the partnership between electrophysiologists and cardiac surgeons, facilitates a coordinated referral development process in the interest of patient care and, most importantly, provides patients with the most comprehensive mapping and ablation procedure. We believe the clinical science will demonstrate that our DEEP AF hybrid procedure is an important advancement and that stand alone minimally invasive and hybrid procedures will become a standard of care for persistent AF patients and patients that have failed catheter ablation procedures,” said David J. Drachman, President and Chief Executive Officer.