New Clinical Study Finds Masimo Noninvasive Hemoglobin Accurate in Patients with Critically Low Hemoglobin Levels

IRVINE, Calif., Jan. 20, 2011 /PRNewswire/ -- Masimo (Nasdaq: MASI) announced today that a new study demonstrating the clinical accuracy and value of its noninvasive and continuous hemoglobin (SpHb®) monitoring technology breakthrough was presented this week at the Society of Critical Care Medicine (SCCM) Annual Critical Care Congress in San Diego. The largest multi-professional critical care event of the year, the SCCM Annual Congress reflects the latest in evidence-based research, clinical best practices, and medical developments that are shaping the future of critical care medicine.

The study, presented by researchers at Englewood Hospital and Medical Center (EHMC) in New Jersey, evaluated the accuracy of Masimo SpHb—a noninvasive measurement of hemoglobin blood levels obtained using a Masimo rainbow® ReSposable Sensor placed on the finger and continuously displayed on a Masimo Radical-7® Pulse CO-Oximeter™.  SpHb measurements obtained from nine intensive care unit (ICU) patients with critically low hemoglobin levels (ranging from 4.3-8.6g/dL for Hb lab values) were compared with invasive blood samples drawn simultaneously and analyzed by a central laboratory.  Results showed a mean bias and precision of 0.70 g/dL and 1.05 g/dL for SpHb, respectively, when compared to reference laboratory hemoglobin values—demonstrating "clinically acceptable agreement."  Researchers concluded that "the ability to measure hemoglobin noninvasively and continuously has the potential to facilitate the timely detection of changes in hemoglobin and thus improve patient blood management decisions in patients with critically low hemoglobin."(1)

According to lead researcher, Anna Juhl, RN, Clinical Research Director of Anesthesiology and Critical Care at EHMC, "Two important elements of Patient Blood Management (PBM) are: 1) managing post-op blood loss with any resulting anemia, and 2) only transfusing based on clinical and lab guided evidence.  The results of this study show that Masimo SpHb may help aid clinicians in achieving the goals of PBM in a timely fashion with less blood loss to the patient."

According to Dr. Michael O'Reilly, Chief Medical Officer at Masimo, "Successfully managing patients with very low hemoglobin levels is often a complex and risky undertaking that most physicians avoid by giving blood transfusions.  However, the growing significance of deleterious transfusion effects and complications are now forcing physicians to re-evaluate transfusion decisions in critically ill patients. This study showcases Masimo SpHb's importance and unique role in aiding the clinical management of patients with very low hemoglobin levels—providing clinicians with a new tool to monitor and manage very low hemoglobin levels more effectively."

SpHb is available as part of the Masimo rainbow® SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), and acoustic respiration rate (RRa™), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).

(1) Juhl A., Naqvi S., Aregbeyen O., Demir S., Shander A. "Accuracy of Noninvasive Hemoglobin Monitoring in Intensive Care Unit Patients with Very Low Hemoglobin." Englewood Hospital and Medical Center, Englewood, New Jersey. SCCM abstract #215 presented January 19, 2011.

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-OximetryTM technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOCTM), 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 MonitoringTM, 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 Outcomes 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, 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 forward-looking 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, Pulse CO-Oximetry, Pulse CO-Oximeter, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pronto-7, Pronto, Patient SafetyNet, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.

SOURCE Masimo Corporation