Device Dossier

NEUROVENT-PTO - RAUMEDIC® Precision pressure catheters – Parenchyma

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

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)). 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. They are invasive devices which are in contact with cerebrospinal fluid. This group of catheters is for application site: parenchyma.

Functional description

Invasive device in contact with cerebrospinal fluid for short-term use, up to 29 days cumulative application. Single use, sterile device, without drainage function. Measures ICP, temperature and oxygen partial pressure simultaneously in the parenchyma. It is designed for application using the single-lumen BOLT PTO. This catheter model has a mechanical stop in the front region of the catheter which serves to place the catheter tip at an ideal application depth via BOLT(DRILL) KIT PTO.

TGA Public Summary