January 22, 2008 - The acute success rate for procedures using the new magnetic irrigated catheter by Stereotaxis to treat paroxysmal atrial fibrillation rose to 95 percent at sites that reported performing more than 20 cases, in a study presented at the Boston Atrial Fibrillation Symposium.
The magnetic irrigated catheter is used with its Niobe Magnetic Navigation System to treat complex arrhythmias, including atrial fibrillation. The new catheter was developed by a partner of Stereotaxis and was launched in Europe in November. The FDA approved the catheter for mapping and ablation in the United States earlier this month.
Preliminary data was presented from the first 107 procedures performed at 7 institutions using the new magnetic irrigated catheter, of which approximately 68 percent were to treat paroxysmal atrial fibrillation. Among these 107 cases, 90 percent acute success was achieved. However, at sites that reported performing more than 20 cases, the acute success rate rose to 95 percent. There have been no reported complications.
"I have been remarkably impressed by the performance of the Stereotaxis partnered magnetic irrigated catheter since the mid-November release in Europe," said J. David Burkhardt, M.D., FACC, and Chief Medical Officer of Stereotaxis. "In comparison with my experience at The Cleveland Clinic with the earlier introduction of the manual irrigated catheter, the safety profile and success rates are outstanding. The magnetic catheter has been able to achieve the difficult endpoints of numerous operators without the need of manual navigation or ablation. Clearly, the initial experience demonstrates the ability for this catheter to replace manual navigation and ablation in very complex arrhythmias."
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