Device Dossier

Advisor FL Circular Mapping Catheter with Bi-Directional Handle, Sensor Enabled - Electrophysiology cardiac catheter, single-use

Device Dossier for Advisor FL Circular Mapping Catheter with Bi-Directional Handle, Sensor Enabled - Electrophysiology cardiac catheter, single-use…

Intended purpose

The Advisor FL Circular Mapping Catheter, Sensor Enabled is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart. The catheter is compatible with Abbott Medical visualisation and navigation systems to enable real-time positioning and navigation.

Functional description

Advisor FL Circular Mapping Catheters, Sensor Enabled are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter’s proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction.

TGA Public Summary