Device Dossier

FireMagicTM TrueForceTM Ablation Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for FireMagicTM TrueForceTM Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system…

Intended purpose

FireMagic™ TrueForce™ Ablation Catheter is indicated for use in cardiac electrophysiological mapping and, when used in conjunction with a radiofrequency generator, for cardiac ablation. FireMagic™ TrueForce™ Ablation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with Columbus™ 3D EP Navigation System.

Functional description

FireMagic™ TrueForce™ Ablation Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The diameter of the catheter shaft is 8F. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode).

TGA Public Summary