FDA Clears New Automated, Irrigated Tip RF Ablation System

January 22, 2008 – The FDA cleared 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 to improve control and versatility when performing ablations.

The system incorporates the 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 is intended to provide electrophysiologists with accurate 3D mapping, targeting and remote navigation.

For more information: www.biosensewebster.com