BOULDER, CO - Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation and respiratory care devices, today announced that its INVOS™ Cerebral/Somatic Oximeter can provide a simple, noninvasive way to help cardiac surgeons assess patients at risk for poor outcomes prior to surgery.

The new evidence, published in Anesthesiology, showed that INVOS System cerebral regional oxygen saturation (rSO2*) values, which reflect brain oxygenation, measured prior to cardiac surgery, were independent predictors of 30-day and one-year morbidity and mortality. This is the first adult study to link decreased preoperative cerebral rSO2 with postoperative morbidity and mortality.

"Our finding suggests that low, presurgical cerebral rSO2 might serve as a refined physiological marker for preoperative risk stratification in cardiac patients," said lead investigator Matthias Heringlake, M.D., Universitaet zu Luebeck, Germany. "This enhanced assessment may also enable physicians to proactively consider adding or tailoring care therapies per patient."
The study, published in the January 2011 issue of Anesthesiology, assessed cerebral rSO2 readings from the INVOS System in 1,178 adult patients about to undergo on-pump cardiac surgery. The analysis showed that baseline cerebral rSO2 values ≤[<2264>][<2264>]50% were independent predictors of 30-day and one-year morbidity and mortality.

The study also showed a statistically significant correlation between cerebral rSO2 values and traditional measures of cardiopulmonary function such as left ventricular ejection fraction, pro-B natriuretic peptide and kidney filtration rate, among others.

"Consistent with these new findings, earlier studies showed that rSO2 not only reflects cerebral oxygenation, but also a patient's overall cardiopulmonary function and systemic oxygen needs," added John M. Murkin, M.D., F.R.C.P.C., of the Schulich School of Medicine at the University of Western Ontario, whose earlier INVOS System trial showed a connection between adequate rSO2 and improved patient outcomes. "If non-cardiac researchers confirm similar benefits of cerebral rSO2 monitoring, then it could be employed as a simple, sensitive and noninvasive way to enhance the preoperative risk assessment of non-cardiac patients as well."

"This large clinical study further augments the clinical value of cerebral oximetry utilizing the INVOS System," said Scott Kelley, M.D., Vice President, Medical Affairs, Respiratory and Monitoring Solutions, Covidien. "To date, the INVOS System is backed by more than 600 peer-reviewed articles reporting a variety of clinical benefits that enhance decision-making, rapid response, patient safety and clinical outcomes."

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