Device Dossier

QDOT MICRO Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for QDOT MICRO Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system…

Intended purpose

Indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation. The QDOT Micro Uni-Directional Catheter provides a real-time measurement of temperature and contact force between the catheter tip and heart wall, as well as location information when used with the CARTO system.

Functional description

The catheter shaft measures 7.5F with 8F ring electrodes. For ablation, the catheter is used in conjunction with a compatible radiofrequency (RF) generator and a dispersive pad. All of the electrodes can be used for stimulation purposes but the tip electrode serves to deliver RF energy from the generator to the desired ablation site.

TGA Public Summary