ATS Medical’s CryoMaze: Initial Clinical Results Promising

The Cox-Maze procedure creates a series of incisions in the right and left atria of the heart to interrupt the conduction of abnormal electrical impulses which cause Atrial Fibrillation (AF). This allows sinus impulses to travel to the atrioventricular node as they normally would.

The Cox-Maze procedure has the highest success rate (≈90%) of any surgical treatment for AF. But because of its invasive open-chest nature, it is commonly performed during a concomitant procedure, most typically a mitral valve replacement or repair.

Dr. James Cox began performing the procedure at the Cleveland Clinic in 1991. As was previously announced, Cox joined ATS Medical where he is furthering the commercialization of CryoMaze, a less-invasive treatment for AF that replicates the Cox-Maze approach, making it more suitable for stand-alone procedures.

CryoMaze forgoes surgical incisions and instead freezes lines in the heart to re-direct electrical impulses. CryoMaze uses CE Marked and FDA-cleared technology ATS acquired from CryoCath back in June. The stand-alone procedure is performed through a small incision. ATS announced initial clinical results last week.

CryoMaze Initial Success Rates Similar to Cox-Maze Procedure

A study led by Dr. Evelio Rodriguez of East Carolina University used the da Vinci Surgical System from Intuitive Surgical to manipulate the CryoMaze cryoablation probe inside of the heart. Rodriguez has treated 54 patients with continuous AF thus far. At six-months of follow-up, over 90% of the patients were in sinus rhythm and only five were using antiarrhythmic medication.

Dr. Rodriguez said, “The ATS cryoablation probes is a reliable method of replicating the complete [Cox-Maze] procedure, with initial success rates that are similar to Dr. Cox’s original procedure, which was an extensive open chest surgical procedure.”

ATS reports that some 15 centers in the U.S. have adopted ATS cryoablation products in stand-alone procedures and several hospitals are leveraging the da Vinci Surgical System while others are performing ATS CryoMaze ablations by manipulating the cryogenic probe by hand.

There’s big opportunity for atrial fibrillation treatments that demonstrate advantages over the current standard of care. Red Herring reports, “Atrial fibrillation procedures are the fastest-growing form of cardiac surgery, with 25,000 operations performed each year in the United States. Surgical treatments for atrial fibrillation currently generate $105 million in global revenue, and with a 30 percent annual growth rate, that figure is estimated to hit $430 million by 2011.”

The comments are closed.