Device Dossier
TactiCath Contact Force Ablation Catheter with Uni-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system catheter
Device Dossier for TactiCath Contact Force Ablation Catheter with Uni-Directional Handle, Sensor Enabled - Cardiac radio-frequency ablation system…
- GMDN category: Cardiac radio-frequency ablation system catheter
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 uni-directional catheter is manipulated by the control mechanism located on the handle.