February 11, 2008 - The first patient was successfully treated in AtriCure’s ABLATE clinical trial designed to evaluate the safety and effectiveness of AtriCure’s Isolator Synergy bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation or requiring concomitant open-heart surgery utilizing the Cox Maze IV procedure.
Richard Kaplon, M.D., is the cardiac surgeon who performed the procedure at Mercy General Hospital in Sacramento, CA. The clinician used the Isolator Synergy bipolar ablation system, which is designed to create precise lesions on heart muscle, which block irregular electrical signals and restore normal sinus rhythm.
This prospective, non-randomized clinical trial is expected to enroll approximately 70 patients at 10 medical centers in the U.S. The primary efficacy endpoints for the trial are patients being free from AF and off anti-arrhythmic drugs at six months. Upon the completion of a successful trial, the results will be submitted to the FDA as part of a Pre-Market Approval, in support of an AF indication for our Isolator Synergy bipolar ablation system when used to treat patients undergoing concomitant open-heart surgery.
For more information: www.atricure.com