Raumedic Announces FDA Clearance Of Neurovent-PTO
RAUMEDIC Announces FDA Clearance of NEUROVENT®-PTO; a Multimodal Catheter for Monitoring of Brain Tissue pti02, ICP and ICT.
RAUMEDIC, developer and manufacture of innovative neuromonitoring devices is pleased to announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market NEUROVENT-PTO. NEUROVENT-PTO is the only marketed device that combines three parameters in one catheter to measure intracranial pressure (ICP), intracranial temperature (ICT) and oxygen partial pressure (pti02).
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. Cerebral ischemia is the leading cause of preventable death in cases of major trauma with severe traumatic brain injury (TBI).
NEUROVENT-PTO 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 NEUROVENT-PTO catheter is pre-calibrated during manufacturing therefore does not require zeroing. NEUROVENT-PTO can be implanted via a low-profile PEEK BOLT or using a Tunneling Sleeve. NEUROVENT-PTO 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, Business Unit Director from RAUMEDIC.
The addition of NEUROVENT-PTO puts RAUMEDIC in the forefront for offering advanced neuromonitoring devices for managing critical care patients. 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.
RAUMEDIC is a privately held corporation founded in 2004 with its headquarters located in Helmbrechts Germany. RAUMEDIC is dedicated to providing critical care physicians with the most advanced diagnostic and therapeutic technology to enhance patient outcomes. RAUMEDIC is also a leading worldwide OEM manufacturer of medical and pharmaceutical grade polymer components and systems.
Posted: November 2013