Device Dossier
ThermoCool SmartTouch SF Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter
Device Dossier for ThermoCool SmartTouch SF Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation…
- 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. It provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO 3 Navigation System.
Functional description
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. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode). The catheter has force-sensing technology that provides a real-time measurement of contact force between the catheter tip and the heart wall.