FDA further approves Stereotaxis' magnetic irrigated catheter

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The FDA has approved Stereotaxis’ Celsius RMT ThermoCool for use with the company’s magnetic navigation system for the treatment of type 1 atrial flutter.

The product is the fifth ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for mapping and ablation.

Also, the Celsius RMT ThermoCool catheter was granted CE mark for distribution in the European Union in October 2009.

The Celsius RMT and NaviStar RMT catheters are magnetic catheters matched to the navigational software of the Niobe Magnetic Navigation System for catheter manipulation, according to the St. Louis-based Stereotaxis. Localized catheters are used for more complex arrhythmias requiring 3D electro-anatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for various arrhythmias, which can be treated using basic imaging and ECG recordings.