Device Dossier

Khelix Loop Fixed Electrophysiology Catheter - Electrophysiology cardiac catheter, single-use

Device Dossier for Khelix Loop Fixed Electrophysiology Catheter - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac catheter,…

Intended purpose

The device is indicated for the electrical recording or stimulation of endocardial structures. In particular the catheter is used for obtaining and recording electrograms from the atrial region of the heart.

Functional description

The device is designed to facilitate electrophysiological mapping of the heart. It consists of a shaft with a distal loop containing an array of platinum-iridium electrodes for stimulation and recording. The device is available in a number of different electrode configurations and loop diameters. The loop diameter and curve shape of the catheter tip are fixed.

TGA Public Summary