Device Dossier

IntellaNav MiFi Open-Irrigated Ablation Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for IntellaNav MiFi Open-Irrigated Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation…

Intended purpose

The IntellaNav MiFi OI catheter is indicated for use in patients who require catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a RF generator, for cardiac ablation.

Functional description

The IntellaNav MiFi OI Ablation Catheter delivers RF energy to the catheter tip electrode for cardiac ablation. The electrode segment includes a tip electrode, three ring electrodes and three mini-electrodes. The mini-electrodes provide high resolution, precise, and localized electrograms. The ring electrodes record intracardiac electrocardiogram signals for mapping and deliver stimulus for pacing. The catheter features a magnetic sensor that is embedded in the distal tip for magnetic tracking.

TGA Public Summary