Surgical ablation for atrial fibrillation (AF) is investigational and has not been approved for treatment by the US Food and Drug Administration. In 1987, Dr. James Cox developed a surgical strategy for addressing atrial fibrillation. The surgery, called the Cox-Maze I, was intended to create a "maze" of small incisions along both the right and left atria. The incisions would heal; creating scar tissue that would inhibit the reentry of the irregular electrical impulses that cause atrial fibrillation. In 1992, the Cox-Maze III became a standard for surgical treatment of atrial fibrillation. Although a high success rate was established with this surgery, it is a time consuming and technically difficult procedure.1
In November 2000, an experienced and motivated team of medical device specialists came together in Cincinnati, Ohio, to find new ways to address this problem. They were charged with developing less invasive and less technically challenging ablation technologies for the surgical treatment of atrial fibrillation. Within just a few years they began developing and testing products.
AtriCure’s bipolar ablation system and Isolator® endoscopic ablation clamps have received clearance from the United States Food and Drug Administration (FDA) to ablate soft tissue during general surgical treatments, where it can create, in seconds, transmural lines. FDA has not approved or cleared our device for use in the treatment of AF. AtriCure is currently conducting clinical trials in both concomitant and minimally invasive procedures in the hopes of achieving FDA approval for these uses.
AtriCure is always interested in finding dedicated individuals to join the fast-paced team to fill challenging positions both in Cincinnati, Ohio, and in the field. If you have a desire to make a difference in the work of surgeons and the lives of patients, we want to hear from you.
1. Gaynor, SL, et al. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg 2004;128:535-42