Device Dossier

NEUROVENT - RAUMEDIC® Precision pressure catheters – Parenchyma

Device Dossier for NEUROVENT - RAUMEDIC® Precision pressure catheters – Parenchyma (Intracerebral sensor catheter, Class III, sponsor Innovative Medcare…

Intended purpose

RAUMEDIC® precision pressure catheters for use in Neurosurgery are used to directly measure brain parameters (intracranial pressure (ICP). The Precision pressure catheters for use in Neurosurgery are divided according to their application sites (parenchyma, ventricle, dura), measurement site as well as their function. This group of catheters is for application site: parenchyma

Functional description

These invasive devices are in contact with cerebrospinal fluid. The devices are for short-term use, up to 29 days cumulative application. Single use, sterile device, without drainage function. The devices have similar specifications and properties for the measurement of intracranial pressure in the brain parenchyma.

TGA Public Summary