Device Dossier

EZ STEER THERMOCOOL Bi-Directional Catheter (with Thermocouple) - Catheter, cardiac, electrophysiological mapping

Device Dossier for EZ STEER THERMOCOOL Bi-Directional Catheter (with Thermocouple) - Catheter, cardiac, electrophysiological mapping (Cardiac…

Intended purpose

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

Functional description

Multi-electrode 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 catheter is used in conjunction with a RF generator and a dispersive pad (indifferent electrode).

TGA Public Summary