Neuromonitoring device company Raumedic has gained FDA 510(k) clearance to market Neurovent®-PTO. The company says this is the only marketed device that combines measurement of intracranial pressure (ICP), intracranial temperature (ICT) and oxygen partial pressure (pti02) in one Catheter.
Founded in 2004 with its headquarters located in Helmbrechts Germany, Raumedic’s stated mission in life is to provide critical care physicians with the most advanced diagnostic and therapeutic technology to enhance patient outcomes.
Raumedic’s line of Neurovent® products include microchip ventricular catheters which provide ICP and ICT monitoring with simultaneous CSF drainage and parenchyma catheters which provide ICP and ICT monitoring. All ICP and ICT monitoring catheters connect directly to the patient’s bedside monitor eliminating an additional monitor which saves both time and money to medical centers.
Cerebral ischemia is the leading cause of preventable death in cases of major trauma with severe traumatic brain injury (TBI). Measuring of oxygen partial pressure (pti02) shows the available oxygen in the brain tissue and allows for early detection of cerebral damage to help prevent secondary injury. This is where Neurovent-PTO steps in. It uses the process of ‘oxygen quenching’ which does not consume oxygen when measuring available brain tissue oxygen and results in a rapid response to environment changes. The catheter is pre-calibrated during manufacturing therefore does not require zeroing. It can be implanted via a low-profile PEEK BOLT or using a Tunneling Sleeve. Also it does not require refrigeration storage and has a sterility shelf life of 2 years.
“Our innovative 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,” says Robert Reichenberger, Raumedic’s Business Unit Director.
Source: Raumedic, PR Newswire