Device Dossier

PentaRay NAV eco High-density Mapping Catheter - Electrophysiology cardiac catheter; single-use

Device Dossier for PentaRay NAV eco High-density Mapping Catheter - Electrophysiology cardiac catheter; single-use (Electrophysiology cardiac catheter,…

Intended purpose

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. It provides location inforamtion when used with compatible CARTO 3 EP Navigation Systems. (This catheter is not compatible with CARTO 3 EP Navigation Systems prior to Version 3.x).

Functional description

This catheter is desinged for deployment in a heart chamber through a guiding sheath. It consists of multiple 3F spines on its distal tip which allows stimulation and recording. The catheters's tip has a magnetic location sensor and two electrodes which provide location and visualisation of the tip respectively when used with the CARTO 3 EP Navigation System. Pushing forward on the catheter thumbknob deflects the tip and pulling back straightens the tip.

TGA Public Summary