New Clinical Study Shows Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Provides Accurate Noninvasive Measurements of Hemoglobin in Pediatric Patients
IRVINE, Calif., March 24 Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new clinical study presented this week at the IARS Annual Meeting in Honolulu, Hawaii, demonstrates that noninvasive and continuous hemoglobin (SpHb) from Masimo Rainbow SET Pulse CO-Oximetry provides comparable accuracy as point-of-care invasive measurements of total hemoglobin versus standard laboratory invasive measurements of total hemoglobin. The study confirms that SpHb is accurate, reliable, and a clinically-acceptable alternative for monitoring hemoglobin, and is the first SpHb study presented in pediatric patients.
Dr. Fay Jou and colleagues at the Cincinnati Children's Hospital Medical Center in Ohio compared SpHb and point-of-care (POC) hemoglobin measurements (Abbott iStat(TM)) to a standard laboratory hematology analyzer (Abbott Cell Dyn hematology analyzer) in 15 pediatric patients undergoing surgery. Compared to standard laboratory hemoglobin measurements, SpHb and iStat had a similar bias (-0.3 and 0.2 g/dL respectively) and standard deviation (1.1 and 0.5 g/dL, respectively). Researchers concluded that "SpHb offers clinically-acceptable absolute accuracy and very good trend accuracy" and that all significant directional changes in hemoglobin "were indicated by changes in SpHb." Additionally, researchers commented that "SpHb provided earlier indications of directional hemoglobin changes than intermittent tHb values."( )(1)
According to Dean Kurth, Anesthesiologist in Chief at Cincinnati Children's Hospital Medical Center, "These study results indicate that Masimo SpHb has the potential to replace the need for invasive blood draws in infants and children undergoing surgery."
SpHb is available as part of Masimo Rainbow SET Pulse CO-Oximetry--the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: total hemoglobin (SpHb®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and acoustic respiration rate (RRa(TM)), 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). Masimo SpHb and PVI have been shown in multiple clinical studies to provide accurate, reliable, real-time measurements that help clinicians to proactively monitor and manage hemoglobin and fluid volume levels more appropriately and optimally.
(1) F. Jou, C. Kurth, E. Beckman, G.K. Istaphanous. Department of Anesthesiology, Cincinnati Children's Hospital Medical Center. "Absolute and Trend Accuracy of Continuous and Noninvasive Hemoglobin in Pediatric Surgery Patients." Presentation S-401, Monday, March 22, 2010, 11 a.m. to 12:30 p.m.; International Anesthesia Research Society (IARS), Honolulu, Hawaii.
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(TM), allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). In 2009, Masimo introduced Masimo Rainbow SET® Acoustic Monitoring(TM), the first-ever noninvasive and continuous monitoring of acoustic respiration rate (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 belief that Masimo Rainbow SET Pulse CO-Oximetry technology will provide sufficient sensitivity and specificity to accurately measure SpHb, SpOC, PVI, SpCO, SpMet, RRa, SpO2, PI, and PR in real-time for all patients, 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 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 Contact: Dana Banks Masimo Corporation (949) 297-7348 firstname.lastname@example.org
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