News | February 26, 2008

Clinical Results of Stand-Alone AF Ablations Prove Successful

February 27, 2008 - ATS Medical Inc. released 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, FL on Jan. 27, Evelio Rodriguez, M.D., 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, said ATS. Prior to the procedure, 54 of these patients had continuous Atrial Fibrillation, the most difficult type of AF to ablate. At six-months of follow-up over 90 percent of the patients were in sinus rhythm and only five of these patients were using antiarrhythmic medication, said ATS.

East Carolina University is not alone in using ATS CryoMaze for stand-alone AF ablation. More than 15 centers in the U.S. alone 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, said the company.

The strengths of the stand-alone procedure using ATS CryoMaze are that it can be done through a small incision 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, said ATS. The robust clinical success of this procedure combined with the minimally invasive access site is leading to a rapid adoption of this procedure for surgical stand-alone procedures.

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