Device Dossier

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

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

Intended purpose

The POLARMAP is intended to obtain electrograms and provide pacing in cardiac structures in the atrial regions of the heart. The POLARMAP is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Functional description

Single-use, sterile, multi-electrode, diagnostic catheter designed to record intracardiac electrograms and provide pacing stimulation during electrophysiology procedures. It has a 20mm diameter with 8 evenly spaced radiopaque electrodes. Once deployed, the electrodes contact the endocardial surface. This allows for recording and interrogation of electrical conduction between the left atrium and the pulmonary veins. The POLARMAP allows for delivery of stimuli used in the interpretation of PVI.

TGA Public Summary