Device Dossier

NEUROVENT - RAUMEDIC® Precision pressure catheters - Measuring Site - Intracerebral sensor catheter

Device Dossier for NEUROVENT - RAUMEDIC® Precision pressure catheters - Measuring Site - Intracerebral sensor catheter (Intracerebral sensor catheter,…

Intended purpose

RAUMEDIC® precision pressure catheters for use in Neurosurgery are used to directly measure brain parameters (intracranial pressure (ICP), oxygen partial pressure (ptiO2) of the interstitial fluid and/or the brain temperature (TBr)). Depending on the version, up to three of the aforementioned functions can be measured with a catheter. Some versions also make liquor drainage possible at the same time. 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. The NEUROVENT-Sleeve Housing and NEUROVENT VP 16 measures ICP in the parenchyma while CSF is drained in the ventricle.

Functional description

RAUMEDIC® precision pressure catheters are invasive devices which are in contact with cerebrospinal fluid. The devices are for short-term use (up to 29 days cumulative application). Single use, sterile device, with drainage function. Measuring Site group: The RAUMEDIC NEUROVENT-Sleeve Housing and RAUMEDIC NEUROVENT VP 16 are applied in the ventricle and have similar drainage specifications, however, these devices measure ICP in the parenchyma of the brain.

TGA Public Summary