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Stereotaxis Receives FDA Approval For ThermoCool Catheter

Stereotaxis has received FDA approval for the Celsius RMT ThermoCool catheter, for use with magnetic navigation system for the treatment of type 1 atrial flutter. The advanced ablation catheter, resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster, is 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. These 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.

The company claims that 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.

The FDA has approved all of Biosense Webster’s magnetic catheters for use with the magnetic field strength of 0.1T, an increase of 25%, which is 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; enhanced catheter stability, especially near the antrioventricular valves, and improved catheter contact along the isthmus region of both atria, said the company.

Tamas Szili-Torok, clinical head of Electrophysiology at Erasmus Medical Center in Rotterdam, said: “The 25% improvement in field strength was immediately appreciated to improve navigation and stability for a wide range of procedure types with and without 3D mapping. We have implemented 0.1T as the default setting at our institution.”

Michael Kaminski, president and CEO of Stereotaxis, said: “These two new approvals provide clinicians in the US with access to important new enhancements for magnetic navigation that we believe will enable clinical success in a broader range of arrhythmias.”