Device Dossier

EasyLoop Circular Mapping Catheter - Electrophysiology cardiac catheter, single-use

Device Dossier for EasyLoop Circular Mapping Catheter - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac catheter, single-use,…

Intended purpose

The EasyLoop catheter is indicated for electrophysiological mapping the cardiac structures of the heart, for recording or stimulation. The catheter is designed to obtain electrograms in the atrial region of the heart. Indications include Paroxysmal Atrial fibrillation and Persistent Atrial fibrillation.

Functional description

The EasyLoop Circular Mapping Catheter is composed of a circular loop, a deflectable section, the main body and a control handle. Ten electrodes equally spaced on the distal tip of circular loop which is of a fixed diameter. All electrodes can be used for the purposes of cardiac electrophysiological mapping and stimulation. The deflectable section is controlled by the thumbknob on the handle. At the end of the handle, a connector for a connecting cable is provided.

TGA Public Summary