Device Dossier

FlexAbility Ablation Catheter with Uni-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter

Device Dossier for FlexAbility Ablation Catheter with Uni-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter (Cardiac…

Intended purpose

The FlexAbility Ablation Catheter, Sensor Enabled is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of arrhythmias. Sensor Enabled™ Ablation Catheters are used with compatible magnetic tracking systems to enable catheter positioning and navigation. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.

Functional description

Catheter is made of thermoplastic elastomer material and noble metal electrodes, has a flexible tip electrode and magnetic sensor. A fluid lumen connects to open conduits at the flexible tip electrode for saline irrigation during the ablation procedure. The tip curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve of the distal tip on the uni-directional catheter, push or pull the thumb control located on the handle.

TGA Public Summary