BOSTON, May 23, 2005 (PRIMEZONE) -- NeuroSystems, LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its NeuroSystems 1(tm) Multimodality Neurosurgical Critical Care Monitoring System.
The product of years of development by the company's team of NeuroMonitoring industry veterans and professionals from the fields of neurology, mathematics, real-time analytics and sensor technology, NeuroSystems 1 has been designed to accelerate the incorporation of multiple modalities into the neurotrauma and cerebrovascular disease monitoring regime.
Despite the introduction of many new sensor technologies which enable the monitoring of other important physical and chemical quantities, including cerebral blood flow (CBF), brain tissue oxygen, carbon dioxide, pH and various metabolites via microdialysis, invasive neurosurgical intensive care monitoring continues to be largely limited to intracranial pressure (ICP). Consequently, the applications of monitoring remain largely confined to the setting of traumatic brain injury.
Many of these emerging monitoring modalities have the potential to improve patient management and outcomes in both trauma and cerebrovascular disease, however their configuration as isolated single-parameter monitors presents a conundrum: It is very difficult, if not impossible, to determine the optimum level of, for example, brain tissue oxygen, for a particular patient without factoring in that patient's CBF, ICP and cerebral perfusion pressure, especially since these quantities are themselves changing from moment to moment. There simply may not ever be a "magic number" that is universally accepted by clinicians as being either "good" or "bad". The optimum value may vary from patient to patient, and even over time in a single patient.
NeuroSystems believes that this use of data in isolation is responsible for the continued lack of consensus among clinicians on the clinical significance or prognostic value of each measurable parameter, and hence the clinical utility of monitoring it. Simply put, the real clinical utility lies in the data relationships, not in the isolated parameters.
By intelligently blending various input parameters, NeuroSystems 1 provides neurosurgeons and other clinicians the ability to monitor clinically useful neurophysiologic functions including cerebral autoregulation, vasoreactivity and oxygen metabolic index, continuously and in real-time. The result is true multimodality monitoring.
"We are of course very pleased to have received 510(k) clearance to market NeuroSystems 1," said Rick Cataldo, NeuroSystems' President, "and we are grateful for this opportunity to contribute to the advancement of neurosurgical critical care. We are looking forward to making this multimodality monitoring system available to the neurosurgery community."
About NeuroSystems
NeuroSystems' mission is to develop and market innovative monitoring systems that enable improved management of traumatic brain injury and cerebrovascular disease. For additional information, please visit www.neurosystemsllc.com .