Device Dossier

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

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

Intended purpose

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

Functional description

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

TGA Public Summary