Germany-based Raumedic has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its NEUROVENT-PTO device, a multimodal catheter for monitoring brain tissue oxygen partial pressure, intracranial pressure (ICP), and intracranial temperature (ICT).
The NEUROVENT-PTO does not require zeroing as it is pre-calibrated during manufacturing.
The device uses 'oxygen quenching' process, which does not consume oxygen when measuring available brain tissue oxygen and results in a rapid response to environment changes.
It has a sterility shelf life of two years and refrigeration storage is not required.
NEUROVENT-PTO can be implanted by using a tunneling sleeve or through a low-profile PEEK bolt.
Raumedic business unit director Robert Reichenberger noted the company's neuromonitoring products have been sold in countries all around the world for over a decade to the benefit of patients and medical personnel.
"We are very pleased that we now have received 510(k) clearance from the FDA and can continue our market entry in the United States with the unique NEUROVENT-PTO," Reichenberger added.
The NEUROVENT product line includes microchip ventricular catheters and parenchyma catheters.
Microchip ventricular catheters provide ICP and ICT monitoring with simultaneous CSF drainage, and parenchyma catheters provide ICP and ICT monitoring.
All ICP and ICT monitoring catheters can be connected directly to the patient's bedside monitor.