Device Dossier

TactiFlex Ablation Catheter with Bi-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter

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

Intended purpose

The TactiFlex Ablation Catheter, Sensor Enabled is indicated for use in creating focal lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of arrhythmias. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.

Functional description

The catheter is made of thermoplastic elastomer material and noble metal electrodes, and has a force and magnetic sensor. It has a fluid lumen connected to a 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 bi-directional catheter, use the actuator to deflect the catheter in either direction.

TGA Public Summary