Image-guided interventional surgery firm Stereotaxis of St. Louis has received clearance from the U.S. Food and Drug Administration (FDA) for a magnetic irrigated catheter.
The FDA has cleared Stereotaxis' Celsius RMT ThermoCool catheter for use with its magnetic navigation system for the treatment of type 1 atrial flutter. The catheter is the fifth to result from the agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for mapping and ablation, according to the firm.
Separately, the FDA also cleared all of Biosense Webster's magnetic catheters for use with the magnetic field strength of 0.1-tesla, an increase of 25%, which is now available in Stereotaxis navigation systems, the company said.
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