Device Dossier

Pressio® ICP & ICT monitoring kit, ventricular tunneling - Intracerebral sensor catheter

Device Dossier for Pressio® ICP & ICT monitoring kit, ventricular tunneling - Intracerebral sensor catheter (Intracerebral sensor catheter, Class III,…

Intended purpose

Catheter kit for implantation in to a patient for monitoring of Intracranial pressure and temperature to be displayed on a monitoring device

Functional description

The Pressio® ICP monitoring Kit, ventricular tunneling has a 3.1mm diameter catheter to be placed in a cerebral ventricle has three distinct lumina: —The first contains a 1m catheter with a diameter of 2.1Fr equipped with a 1.2mm diameter capsule at its end, enclosing a piezoresistive pressure sensor of the strain gauge type on silicone and a thermistor type temperature sensor. —The second contains the pre-inserted introduction stylet. —The third is for the drainage of the cerebrospinal fluid

TGA Public Summary