Device Dossier

OCTARAY Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use

Device Dossier for OCTARAY Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac…

Intended purpose

The OCTARAY Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart i.e. recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information only when used with compatible versions of CARTO 3 EP navigation system.

Functional description

Designed to facilitate electrophysiological mapping of the heart with the CARTO 3 EP Navigation System. The deployment in the heart chamber is through an 8.5F guiding sheath. The Catheter is deflectable in both a D and F curve configuration and consists of multiple 2F spines on its distal tip, each spine having multiple platinum electrodes that are used for recording and stimulation. The catheter also has a central electrode that can be used as an internal close unipolar reference electrode

TGA Public Summary