Device Dossier

ThermoCool SmartTouch SF Bi-Directional Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for ThermoCool SmartTouch SF Bi-Directional Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation…

Intended purpose

Indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. The catheter 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

Steerable 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 conjuction wiht an RF 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.

TGA Public Summary