Device Dossier

IntellaNav StablePoint™ Ablation Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for IntellaNav StablePoint™ Ablation Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system…

Intended purpose

The IntellaNav™ StablePoint Ablation 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 StablePoint™ Ablation Catheter is an 8.5F compatible steerable, quadripolar open irrigated ablation catheter designed to deliver radiofrequency energy to the 4 mm catheter tip electrode for cardiac ablation. It also incorporates a position sensor for magnetic tracking and navigation when used with a compatible cardiac electrophysiological mapping system (e.g. Rhythmia™ Mapping System).

TGA Public Summary