New Study Presented at European Society of Anaesthesia Validates Masimo Noninvasive and Continuous Hemoglobin Monitoring

Jun 16, 2010, 08:00 ET from Masimo Corporation

IRVINE, Calif., June 16 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new independent study demonstrating the clinical accuracy of Masimo noninvasive and continuous hemoglobin (SpHb) monitoring was presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Helsinki, Finland.  

In the study, titled "Comparison Between a New Noninvasive Continuous Technology of Spectrophotometry-based and RBC Count for Haemoglobin Monitoring During Surgery with Hemorrhagic Risk," Dr. Lionel Lamhaut and researchers from the Department of Anesthesiology and Intensive Care at Necker University Hospital in Paris, France, compared the accuracy of Masimo SpHb with hemoglobin measurements obtained invasively via laboratory blood analysis in 20 patients undergoing high blood-loss surgery. SpHb and invasive hemoglobin measurements were simultaneously recorded at the beginning and end of any clinical intervention and before and after blood transfusion. Results showed a strong agreement between the two (0.88), with a bias of 0.26 g/dL and standard deviation of 1.1 g/dL—leading researchers to conclude that this study, conducted under real-world clinical conditions, "confirms the first tests realized by the manufacturer." Affirming the clinical accuracy and utility of Masimo SpHb, researchers further noted that "the correlation is good, suggesting the possibility of a daily use of this technology."(1)

Masimo SpHb is available as part of Masimo Rainbow platform—the first-and-only platform 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), pulse rate (PR), and perfusion index (PI).  

(1) L. Lamhaut, R. Apriotesei, M. Lejay, B. Vivien, P. Carli. "Comparison Between a New Noninvasive Continuous Technology of Spectrophotometry-based and RBC Count for Haemoglobin Monitoring During Surgery with Hemorrhagic Risk" Eur J Anaesthesiol 2010; 27 (Suppl 47): 3AP7-1.

About Masimo

Masimo (NASDAQ: MASI) develops innovative 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 Masimo Rainbow SET® Pulse CO-Oximetry™, 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 PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). In 2009, Masimo introduced Masimo Rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of respiration rate with an easy to use acoustic adhesive sensor (RRa™). Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. 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, risks related to our belief that Masimo SpHb and PI will provide sufficient sensitivity and specificity to facilitate continuous measurement capabilities in all patients and deliver clinical improvement over alternative hemoglobin and perfusion assessment methods to allow for further adoption of the technology; and 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 Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, RRa, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.

Media Contacts:

Dana Banks

Masimo Corporation

(949) 297-7348

dbanks@masimo.com

SOURCE Masimo Corporation



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