SAN FRANCISCO, Jan. 9, 2017 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative automated bedside monitoring for use in the intensive care unit (ICU), today announced that the OptiScanner® 6000 has received CE Mark certification for use in the European Union. The OptiScanner 6000 combines near-continuous glucose monitoring with the complementary ability to automatically and serially monitor levels of lactate using the same micro-sample of the patient's blood. CE Mark certifies that the OptiScanner 6000 has met all relevant EU consumer safety, health and environmental requirements, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA). OptiScan plans to initiate marketing of the OptiScanner 6000 in the EU later this year.
The OptiScanner 6000 is an automated bedside monitoring technology capable of providing near continuous tracking of glucose and lactate within a single patient micro-sample of blood. The system is designed to overcome the limitations of today's intermittent, manually operated monitoring devices and provide physicians with the tools and information they need to best manage patient glucose and lactate levels in the ICU.
With its glucose monitoring capabilities, the OptiScanner 6000 represents a significant advancement in the delivery of care to ICU patients by helping to prevent and combat both hyperglycemia and hypoglycemia through automated monitoring of patients' glucose in plasma, as opposed to whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 70 percent of ICU patients suffer from "stress hyperglycemia" or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain tight glycemic control.
The ability to serially measure patient lactate levels further expands the capability of the OptiScanner 6000 to optimize patient care in the ICU. Medical literature demonstrates that elevated lactate levels are common in patients with critical illnesses such as sepsis, burns and trauma, and are associated with adverse clinical outcomes. Recent sepsis definition changes suggest interventions for these conditions are considered effective if lactate is shown to decrease over a given time period, though verifying a reduction in lactate levels is very problematic with today's intermittent, manually based systems. Accordingly, the near continuous tracking of lactate levels represents an important advancement in monitoring and guiding interventions in critically ill patients.
