Device Dossier

Polaris X Diagnostic Catheter - Stimulator, electrical, cardiac, diagnostic

Device Dossier for Polaris X Diagnostic Catheter - Stimulator, electrical, cardiac, diagnostic (Stimulator, electrical, cardiac, diagnostic, Class III,…

Intended purpose

The catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Functional description

Polaris X is an uni-directional steerable catheter used to carry electrical signals for endocardial stimulation/pacing/recording. It is inserted via the vasculature percutaneously or by cut down to the desired intracardiac postition. The tip can be deflected to allow for curve changes by use of the thumb slide. A quick connect or lead tip pin of the connector is connected to appropriate electronic recording equipment. For pacing the catheter is connected to an external pulse stimulator.

TGA Public Summary