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Stereotaxis announces FDA approval of Navistar RMT Thermocool catheter

Stereotaxis, a developer of cardiology instrument control systems, has announced that the FDA approved for marketing the Navistar RMT Thermocool catheter, which is manufactured by Biosense Webster, a Johnson & Johnson company.

The Navistar RMT Thermocool catheter is used with Stereotaxis’s Niobe remote magnetic navigation system for mapping and radiofrequency ablation to treat irregular heartbeats, or cardiac arrhythmias.

Stereotaxis expects that shipments of the catheter to customers will begin within the next few weeks.

Mike Kaminski, president and CEO of Stereotaxis, said: “The magnetic irrigated catheter’s approval is the tipping point for Stereotaxis technology. Together with the remote magnetic navigation system and our recently introduced software platform, Navigant 3.0 with QuikCAS, the magnetic irrigated catheter represents a quantum leap forward for remote ablation procedures and has demonstrated the potential to establish a new standard of care for treating cardiac arrhythmias in all chambers of the heart.”