Device Dossier

IntellaNav MiFi XP Temperature Ablation Catheters - Cardiac radio-frequency ablation system catheter

Device Dossier for IntellaNav MiFi XP Temperature Ablation Catheters - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation…

Intended purpose

The device is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia – typically chronic, drug refractory atrial fibrillation.

Functional description

The device is designed to allow for therapeutic ablation, intracardiac diagnostic recordings, and pacing capabilities. Its electrode segment is comprised of a distal tip electrode with 3 embedded mini electrodes. RF energy is delivered for cardiac ablation through the distal tip electrode. The electrodes record EGM signals for mapping and deliver stimulus for pacing. The 3 mini electrodes are designed to provide additional localised electrogram information.

TGA Public Summary