Device Dossier
ThermoCool SmartTouch Uni-Directional Navigation Catheter - Cardiac radio-frequency ablation system catheter
Device Dossier for ThermoCool SmartTouch Uni-Directional Navigation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency…
- GMDN category: Cardiac radio-frequency ablation system catheter
Intended purpose
Indicated for use in cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. The ThermoCool SmartTouch Uni-Directional Navigation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used in Carto 3 Navigation System.
Functional description
This is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. For ablation, the catehter is used with an RF generator and a dispersive pad. The catheter has force-sensing technology that provides a real-time measurement of contact force between the catheter tip and the heart wall.