Device Dossier

ThermoCool Smart Touch Bi-Directional Navigation Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for ThermoCool Smart Touch Bi-Directional Navigation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency…

Intended purpose

ThermoCool Smart Touch Bi-Directional Navigation Catheter is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. This 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

The Catheter is a steerable multi-electrode, luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad. The catheter has a high torque shaft with a bi-directional deflectable tip section containing an array of electrodes. Compatible with Carto 3 Navigation system.

TGA Public Summary