Stereotaxis Intended Use Statements, United States Labeling:
The Genesis RMN® and Niobe® ES Systems are intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature, and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside a patient’s heart when used in conjunction with a Stereotaxis magnetic navigation system. The Cardiodrive System is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
Consult the associated product labeling for the Indications for Use and instructions of other devices used in conjunction with Stereotaxis products.
Cardiodrive and Niobe are trademarks of Stereotaxis, Inc., registered in the United States, the European Community, and Japan. Genesis RMN is a trademark of Stereotaxis, Inc., registered in the United States.