Device Dossier

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

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

Intended purpose

The device is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation.

Functional description

This device is a quadripolar, open-irrigated, RF ablation catheter that incorporates an open cooling design. This mechanism consists of a hybrid tip that is partitioned into two chambers which allows cooling of the proximal electrode and the tip-tissue interface. The electrode segment also incorporates a position sensor for magnetic tracking and navigation of the catheter on the cardiac electrophysiological mapping system (e.g. Rhythmia™ Mapping System).

TGA Public Summary