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Stereotaxis is Notified of the FDA Approval of an Additional Magnetic Irrigated Catheter
Date:1/12/2010

ST. LOUIS, Jan. 12 /PRNewswire-FirstCall/ -- Stereotaxis (Nasdaq: STXS) announced that the Celsius® RMT ThermoCool® catheter has been approved by the U.S. Food and Drug Administration for use with Stereotaxis' magnetic navigation system for the treatment of Type 1 atrial flutter.  The product is the fifth advanced 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.  

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 the only magnetic catheters accurately matched to the navigational software of the Niobe™ Magnetic Navigation System for optimal performance and highly precise catheter manipulation.

With the Celsius® RMT ThermoCool® catheter, the family of magnetic irrigated ablation catheters offers localized and non-localized technology. Localized catheters are used for more complex arrhythmias requiring 3D electro-anatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for a broader array of arrhythmias which can be treated using basic imaging and ECG recordings.

Separately, the FDA approved all of Biosense Webster's magnetic catheters for use with the magnetic field strength of 0.1 Tesla, an increase of 25 percent, which is now available in Stereotaxis navigation systems. In European clinical evaluations conducted in the fourth quarter of 2009, clinicians noted that the new field strength enhanced catheter navigation in difficult to reach locations; enhanc
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SOURCE Stereotaxis, Inc.
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