ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products, announced initial clinical results of stand-alone ablation procedures and an overall expansion into the stand-alone market, using the ATS CryoMaze™ product line. This line of surgical products, indicated for the treatment of cardiac arrhythmias, is designed to replicate the original cut-and-sew Maze procedure (also known as Cox-Maze-III) by freezing lines in the heart to re-direct electrical impulses. The Maze procedure is a widely known surgical technique developed by Dr. James L. Cox in the 1980s to treat atrial fibrillation (AF) with a high rate of long-term success.

In Ft. Lauderdale on January 27, Dr. Evelio Rodriguez of East Carolina University presented on six-month results of stand-alone AF ablations using ATS Medical cryoablation products. In the presentation, Dr. Rodriguez described the East Carolina University technique of performing a complete stand-alone Maze procedure using cryoablation and robotic technique. This technique is facilitated by the use of the da Vinci® Surgical System from Intuitive Surgical, Inc., to manipulate the cryoablation probe inside of the heart. East Carolina University has treated 57 patients with fully robotic stand-alone cryoablation. Prior to the procedure, 54 of these patients had continuous AF, the most difficult type of AF to ablate. At six months of follow-up, over 90% of the patients were in sinus rhythm and only five of these patients were using antiarrhythmic medication. Dr. Rodriguez said, "Stand-alone ablation using the ATS cryoablation probes is a reliable method of replicating the complete Maze procedure, with initial success rates that are similar to Dr. Cox's original procedure, which was an extensive, open-chest surgical procedure."

East Carolina University is not alone in using ATS CryoMaze for stand-alone AF ablation. More than 15 centers in the United States have adopted ATS cryoablation products in stand-alone procedures. Like East Carolina University, several hospitals are leveraging the da Vinci® Surgical System as a part of the procedure while others are performing ATS CryoMaze ablations by manipulating the cryogenic probe by hand.

The strengths of the stand-alone procedure using ATS CryoMaze are that it can be done through a small incision, which is appealing to the patient, and provides clinical results similar to the original cut-and-sew full Maze procedure — even in the patient populations that are historically the most difficult to ablate, especially for cardiologists. The clinical success of this procedure, combined with the minimally invasive access site, is leading to an adoption of this procedure for surgical stand-alone procedures.

"Over the past several months ATS Medical has made significant progress in advancing its therapies for the surgical treatment of cardiac arrhythmias on a stand-alone or sole therapy basis," said Michael Dale, CEO and President of ATS Medical. "Specifically, we have proven that our current ATS CryoMaze products offer a successful, less invasive approach to treating cardiac arrhythmias.”

The most common surgical ablation procedure today is the concomitant procedure in which an ablation is performed in conjunction with other cardiac surgery, most typically a mitral valve repair or replacement. The ATS development team is focused on providing next-generation tools to provide better ergonomics and access to the lesion sites required by the Maze procedure. The company anticipates introducing a new ATS CryoMaze probe and clamp combinations during mid 2008. As described above, several approaches have been used to perform ATS CryoMaze ablations on a less invasive, closed-chest basis. The company's efforts under the guidance of Dr. Cox will be focused on supporting the procedures and bringing new products to market that enable these procedures in an easily reproducible method with the gold-standard success rates of the original Cox Maze procedure.