FDA clears magnetic irrigated catheter from Stereotaxis, Biosense
The FDA has approved a fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe Magnetic Navigation System, designed by Stereotaxis, and the Carto RMT System by Biosense Webster, a Johnson & Johnson company. The Niobe Magnetic Navigation System that drives the catheter was FDA-approved in 2004.

Cardiac radiofrequency ablation is a non-surgical procedure during which a catheter delivers energy to damaged heart tissue to restore normal heart rhythms.

The St. Louis-based Stereotaxis said its system incorporates Navistar RMT Thermocool Irrigated Tip Catheter and the Coolflow Pump from Biosense Webster, with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe Magnetic System and the Carto RMT System provides electrophysiologists with accurate 3D mapping, targeting and remote navigation, Stereotaxis said.