Device Dossier

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

Device Dossier for TactiCath Contact Force Ablation Catheter with Bi-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system…

Intended purpose

The TactiCath Contact Force Ablation Catheter, Sensor Enabled is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in right and left atrium, including atrial fibrillation.

Functional description

The Catheter is constructed of thermoplastic elastomer material and noble metal electrodes with a tri-axial optical force sensor to measure contact force at the tip. It facilitates electrophysiological mapping of the heart and transmits radiofrequency current to the tip electrode for intracardiac ablation. It has fluid lumen for saline irrigation during the ablation procedure. The tip curvature of the bi-directional catheter is manipulated by the control mechanism located on the handle.

TGA Public Summary