Device Dossier

Agilis HisPro Steerable Catheter with Electrodes - Catheter, intravascular, guiding

Device Dossier for Agilis HisPro Steerable Catheter with Electrodes - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III,…

Intended purpose

The Agilis HisPro™ Steerable Catheter With Electrodes is intended for transvenous introduction of cardiovascular devices into the heart.

Functional description

The Agilis HisPro is a deflectable, slittable catheter with two distal tip electrodes. It is indicated to provide access (i.e. lead placement) to structures in the heart. The distal portion can be formed into a “U” shape, when fully deflected, to facilitate positioning of the tip at a desired location in the heart. The tip electrodes provide the ability to sense intracardiac EGM and pace when connected to the WorkMate Claris Recording System or the Merlin Pacing System Analyser.

TGA Public Summary