New Clinical Research Presented at the European Society of Anaesthesiology Demonstrates the Accuracy and Utility of Masimo SpHb and PVI
IRVINE, Calif., June 16, 2011 /PRNewswire/ — Masimo Corporation (NASDAQ: MASI) announced today that multiple new clinical research studies presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Amsterdam add to the growing body of evidence that Masimo noninvasive and continuous total hemoglobin (SpHbÂ®) and Pleth Variability Index (PVIÂ®) are accurate and useful noninvasive and continuous measurements in a variety of patients.
Two studies, from researchers in Japan and Sweden, evaluated the accuracy and reliability of SpHb in both surgical and ED patients and found clinically acceptable correlations between noninvasive SpHb measurements and invasive lab values. Researchers at the Hamamatsu University School of Medicine in Japan analyzed 89 hemoglobin samples from 16 surgical patients and found a correlation coefficient between SpHb (obtained using the Masimo Radical-7 and R-125 rev C sensor) and invasive lab values of 0.8 with a bias of 0.65 g/dL and precision of 1.1 g/dL. Citing this as the first introduction of SpHb to Japanese patients, researchers concluded that “SpHb is reliable on Japanese patients.”(1) Similarly, researchers at the Karolinska Institute in Stockholm, Sweden, compared SpHb measurements (obtained using the Masimo Radical-7 software version 184.108.40.206 and adult ReSposable sensor rev E) to invasive venous blood sampling (tHb) in 30 patients admitted to the emergency room and found a very low bias of -0.2 and standard deviation of 1g/dL, with limits of agreement of -2.2 to 1.8 g/dL. Citing “fairly good agreement between tHb and SpHb values across the entire measurement range,” researchers concluded that “SpHb monitoring provides hemoglobin values with good agreement to laboratory analysis of blood.”(2)
Two other studies, conducted in France and Japan, analyzed finger, ear, and forehead sites for PVI measurement and found that sites on the head enable the best measurement. Previous studies have shown that PVI, as measured at the finger site, can help clinicians assess fluid responsiveness and improve fluid management to decrease patient risk. Results showed that Masimo ear and forehead sensors provide the best accuracy for PVI measurement. At the Louis Pradel Hospital in France, researchers evaluated PVI measurements obtained from the ear, forehead, and finger (using the Masimo Radical-7 and LNOP Adt sensor) in 16 patients during ongoing surgery and found that PVI correlations to pulse pressure variations (PPV) were r=0.72 at the ear, r=0.60 at the forehead, and r=0.43 at the finger (all p<0.001). PVI forehead >14% and PVI ear >15% predicted a PPV > 10% with 73% sensitivity and 72% specificity, while PVI finger > 13% predicted a PPV > 10% with a sensitivity of 78% and a specificity of 44% — leading researchers to conclude that “ear and forehead provide best accuracy for PVI.”(3) In Japan, researchers at Kagoshima University tested the effects of surgical stimuli on PVI measurements at the finger and forehead (obtained using the Masimo Radical-7 software version 7.3.11 and LNOP Adt sensor) in nine mechanically ventilated surgical patients and found that forehead PVI & perfusion index (PI) remained stable before and after skin incision while PVI captured at the finger site were more sensitive to vasomotor tone. Researchers concluded that “PVI obtained from the forehead may be a more reliable predictor of fluid responsiveness under conditions of varying vasomotor tone.”(4)
SpHb and PVI are available as part of Masimo rainbow SETÂ® platform — the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHbÂ®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCOÂ®), methemoglobin (SpMetÂ®), Pleth Variability Index (PVIÂ®), perfusion index (PI), and acoustic respiration rate (RRa(TM)), in addition to the ‘gold standard’ Measure-Through Motion and Low Perfusion performance of Masimo SETÂ® 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.
The ESA 2011 schedule of clinical abstracts presented can be accessed online here.
(1) Ishida C, Shiraishi Y., Mimuro S., Yu S., Katoh T., Sato S.. “Accuracy of a Noninvasive Measurement of Hemoglobin Via Pulse CO-Oximetry in Japanese Population.” Hamamatsu University School of Medicine, Department of Anesthesiology and Intensive Care, Hamamatsu, Japan.
(2) Svensen C.H., Rodhe P., Lundstrom N., Berglund E., Sjostrand F. “Use of a Noninvasive Hemoglobin Monitor for Volume Kinetic Analysis in an Emergency Room Setting.” Karolinska Institute,/Department of Clinical Science and Education, Department of Anesthesiology and Intensive Care, Stockholm, Sweden.
(3) Pavlakovitch I., Desebbe O., Cannesson M., Bastien O., Lehot J.J. “What is the Best Site for Measuring the Pleth Variability Index (PVI) During a Surgery Procedure?” Hospices Civils de Lyon Hopital L Pradel, Department of Anesthesiology and Intensive Care, Bron-Lyon, France.
(4) Matsunaga A., Kakihan Y., Kuniyoshi T., Kumemura M. Uchida Y., Kanmura Y. “Difference Between Pleth Variability Index Obtained from the Finger and Forehead.” Kagoshima University, Department of Anesthesiology, Kagoshima, Japan.
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 SETÂ®, 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 SETÂ® Pulse CO-Oximetry(TM) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHbÂ®), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCOÂ®), methemoglobin (SpMetÂ®), and Pleth Variability Index (PVIÂ®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet(TM), 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(TM), the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa(TM)). 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 SEDLineÂ®, 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 ApplicationsÂ®.” Additional information about Masimo and its products may be found at www.masimo.com.
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 of the repeatability of clinical results obtained using Masimo SpHb and PVI noninvasive measurements, 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.
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