Published Study Demonstrates the Absolute and Trend Accuracy of Masimo Noninvasive and Continuous Total Hemoglobin (SpHb) Monitoring in Intensive Care Unit Patients

IRVINE, Calif., Sept. 27, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that findings from a new study published in the Journal of Critical Care Medicine demonstrate that noninvasive and continuous hemoglobin (SpHb®) monitoring has absolute and trending accuracy similar to widely used invasive methods of hemoglobin measurement with additional advantages.  Study highlights that "the ability to measure hemoglobin noninvasively and continuously with SpHb has significant potential to facilitate hemoglobin monitoring, hasten the detection of acute anemia, and avoid the complications, expense, and discomfort associated with invasive blood draws."(1)  

Total hemoglobin measurement is one of the most frequently ordered laboratory tests.  But, traditional blood analysis has many drawbacks, including complexity, time-consuming turnaround times that can impact clinical decisions, and blood loss due to invasive blood draws that have been found to contribute substantially to the anemic conditions that commonly occur in critically ill patients.  Other studies suggest that blood loss from invasive blood draws induce iatrogenic anemia, with over 90% of intensive care unit (ICU) patients becoming anemic by the third day of ICU admission.(2)  In contrast, Masimo SpHb offers a completely noninvasive method of continuously measuring hemoglobin levels without removing a drop of blood. This study is the first to evaluate the performance and accuracy of SpHb against three invasive techniques commonly used in the ICU for measuring hemoglobin.  

In the study, conducted at the University Hospital in Poitiers, France, researchers compared SpHb measurements (obtained noninvasively using Radical-7 version 7.6.0.1 and Adult rainbow ReSposable Sensors R2-25, Rev. E) to invasive laboratory measurements analyzed by a satellite lab CO-Oximeter (Siemens RapidPoint 405), a HemoCue point-of-care device, and a laboratory hematology analyzer—considered the reference device (Sysmex XT-2000i) in 62 ICU patients.  Results showed bias and limits of agreement for SpHb were 0.0 + 1.0 g/dL, 0.3 + 1.3 g/dL for HemoCue, and 0.9 + 0.6 g/dL for the satellite lab CO-Oximeter compared to the reference device.  SpHb showed similar trend accuracy to the satellite lab CO-Oximeter, whereas the HemoCue point-of-care device did not appear to follow the trend of the laboratory analyzer or reference device.  As a result of these findings, researchers concluded that SpHb "has absolute accuracy and trending accuracy similar to widely used invasive methods of hemoglobin measurement at bedside" and has "the additional advantages of providing continuous measurements, noninvasively, which may facilitate hemoglobin monitoring in the intensive care unit."

The researchers commented that although invasive CO-Oximeters are an accepted laboratory standard for assessing hemoglobin and have high interdevice reproducibility, SpHb "had the best accuracy as evidenced by the highest concordance co-efficient correlation and the lowest Arms."

SpHb is available as part of Masimo rainbow SET® Pulse CO-Oximetry™—a breakthrough technology platform that noninvasively and continuously measures multiple blood constituents and physiological parameters that previously required invasive procedures, including: total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), perfusion index (PI), and acoustic respiration rate (RRa™), in addition to the 'gold standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), and pulse rate (PR).

To see a summary of all known clinical studies and abstracts on Masimo SpHb, please visit: http://www.masimo.com/cpub/clinicals.htm.

(1) Frasca D, Dahyot-Fizelier D, Catherine K, Levrat Q, Debaene B, Mimoz O.  "Accuracy of a Continuous Noninvasive Hemoglobin Monitor in Intensive Care Unit Patients."  Crit Care Med October 2011; Vol. 39, No. 10.  Available online here.  

(2) Rodriguez RM, Corwin HL, Gettinger A, et al.  "Nutritional Deficiencies and Blunted Erythropoietin Response as Causes of the Anemia of Critical Illness."  J Crit Care 2001; 16:36-41.  Available online here.  

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems.  In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI).  In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events.  In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices.  Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world.  Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to:  risks related to our assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo SpHb provides continuous monitoring of hemoglobin levels for all patients, and risks related to our assumptions that Masimo SpHb monitoring has the potential to decrease the frequency of invasive blood testing, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Dana Banks
Phone: (949) 297-7348
Email: [email protected]

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine  are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

SOURCE Masimo

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