Device Dossier

IntellaMap Orion High Resolution Mapping Catheter - Electrophysiology cardiac catheter, single-use

Device Dossier for IntellaMap Orion High Resolution Mapping Catheter - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac…

Intended purpose

The IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Functional description

The IntellaMap Orion High Resolution Mapping Catheter iis a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that comprise the electrode array . The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls & deployment slider that activates the electrode array into a basket shape once inside the heart.

TGA Public Summary