WEST CHESTER, Ohio, Feb. 11 /PRNewswire-FirstCall/ -- AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation products, today announced that the first patient was successfully treated in AtriCure's ABLATE clinical trial. Dr. Richard Kaplon, a well-known cardiac surgeon, performed the procedure at Mercy General Hospital in Sacramento, California.
The purpose of the ABLATE clinical trial is to evaluate the safety and effectiveness of AtriCure's Isolator Synergy(TM) bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation, or AF, requiring concomitant open-heart surgery utilizing the Cox Maze IV procedure. The Isolator Synergy(TM) bipolar ablation system is designed to create precise lesions, or scars, 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 United States. 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, or PMA, in support of an AF indication for our Isolator Synergy(TM) bipolar ablation system when used to treat patients undergoing concomitant open-heart surgery.
Dr. Richard Kaplon commented, "Patients who have AF are at significant
risk for stroke and death when compared to patients in normal sinus rhythm.
We believe that this is an important treatment for our patients. Based on
our group's experience using the Isolator Synergy(TM) bipolar ablation
system, we believ
|SOURCE AtriCure, Inc.|
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