Device Dossier
FireMagic 3D Irrigated Ablation Catheter - Cardiac radio-frequency ablation system catheter
Device Dossier for FireMagic 3D Irrigated Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system…
- GMDN category: Cardiac radio-frequency ablation system catheter
Intended purpose
The FireMagic 3D Irrigated Ablation Catheter is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) in conjunction with a 3D EP navigation system, and when used with the RF generator, for the treatment of atrial fibrillation (AF) via catheter-based radiofrequency ablation in patients of 18 or older age. Indications include Drug refractory symptomatic paroxysmal atrial fibrillation and persistent atrial fibrillation.
Functional description
The FireMagic 3D Irrigated Ablation Catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes. All electrodes can be used for the purposes of cardiac electrophysiological mapping and stimulation, and the tip electrode can also be used for ablation. Tip deflection is controlled at the proximal end by a handle. It has an irrigated lumen and is integrated with a 3D location sensor