Device Dossier

FireMagic Cardiac RF Ablation Catheter, Strong Type - Cardiac radio-frequency ablation system catheter

Device Dossier for FireMagic Cardiac RF Ablation Catheter, Strong Type - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency…

Intended purpose

The FireMagic Cardiac RF Ablation Catheter is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording), and when used with radiofrequency generator, for the treatment of a trioventricular nodal reentrant tachycardia and a trioventricular reentrant tachycardia via catheter based radiofrequency ablation

Functional description

The device is a flexible, insulative, luminal catheter with a deflectable tip comprised of thermoplastic elastomer and several platinum electrodes. In the tip a thermocouple temperature sensor is embedded. The high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. All of the electrodes may be used for cardiac mapping and stimulation purposes; besides, the tip electrode may also be used for ablation.

TGA Public Summary