AtriCure, a provider of cardiac surgical ablation systems, 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).
AtriCure said that the trial will be conducted at five US medical centers and provides 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 to treat patients with persistent forms of AF. The trial will use AtriCure’s minimally invasive surgical ablation product platform in conjunction with the Biosense Webster Thermocool catheter ablation product platform.
David Drachman, president and chief executive officer, said: “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 standalone minimally invasive and hybrid procedures will become a standard of care for persistent AF patients and patients that have failed catheter ablation procedures.”
Andrea Natale, executive medical director of the Texas Cardiac Arrhythmia Institute at St David’s Medical Center in Austin, Texas, said: “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. 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.”