Stereotaxis Receives European Approval of an Additional Magnetic Irrigated Catheter
November 6, 2009 — Stereotaxis received notice this week that its Celsius RMT ThermoCool catheter received CE mark for distribution in the European market.
The product is the fifth advanced ablation catheter resulting from the on-going codevelopment agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for use in the Niobe Magnetic Navigation System (MNS).
A premarket approval (PMA) application supplement for the Celsius RMT ThermoCool catheter was submitted to the U.S. Food and Drug Administration in September.
The Celsius RMT and NaviStar RMT families of catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe MNS for optimal performance and highly precise catheter manipulation.
This catheter fills out the family of magnetic irrigated catheters to offer both 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 simpler arrhythmias which can be treated using basic imaging and ECG recordings.
For more information: www.stereotaxis.com