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New Studies Show Clinical Advantages of Masimo Noninvasive Hemoglobin, PVI, and Perfusion Index in Critically-ill Patients
Date:3/24/2011

IRVINE, Calif., March 24, 2011 /PRNewswire/ -- Masimo (Nasdaq: MASI) announced today that three new studies presented at the International Symposium of Intensive Care and Emergency Medicine (ISICEM) Annual Meeting in Brussels, Belgium, demonstrate the accuracy, reliability, and clinical impact of Masimo noninvasive and continuous measurements—noninvasive hemoglobin (SpHb®), Pleth Variability Index (PVI®), and Perfusion Index (PI)—in Intensive Care Unit (ICU) patients.  

"Accuracy of a Continuous Noninvasive Hemoglobin Monitor in Intensive Care Unit"(1)

Researchers at the Centre Hospitalier Universitaire in Poitiers, France compared the absolute and trend accuracy of Masimo noninvasive hemoglobin (SpHb) to other invasive methods of hemoglobin assessment—including a point of care device (HemoCue301), a satellite lab CO-Oximeter (Siemens RapidPoint 450), and a 'gold-standard' laboratory hematology analyzer (Sysmex XT-2000i)—in 62 critically-ill ICU patients requiring 471 invasive blood samples.  Compared to the gold-standard Sysmex hematology analyzer, results showed a bias and limits of agreement for Masimo noninvasive SpHb of 0.0+/-1.0g/dL.  Compared to the gold-standard hematology analyzer, the invasive HemoCue301 and RapidPoint 450 had a bias and limits of agreement of 0.3+/-1.3 g/dL  and 0.9+/-0.6 g/dL, respectively. Citing "absolute and trending accuracy similar to widely used invasive methods," researchers concluded that Masimo SpHb has "the additional advantages of providing continuous measurements, noninvasively, which may facilitate hemoglobin monitoring in the ICU."

"Pleth Variability Index Predicts Fluid Responsiveness in Critically-ill Patients"(2)

To evaluate whether Masimo PVI, a noninvasive and continuous tool, can help clinicians predict fluid responsiveness in mechanically-ventilated patients with circulatory insufficiency, researchers at the Centre Hospitalier Universitaire in Poitiers, France measured PVI in 40 patients before and after planned volume expansion.  Fluid challenge consisted of either 500mL of 130/0.4 hydroxyethyl-starch (fluid) if respiratory variations in arterial pulse pressure  >/= 13%, or with passive leg raising (PLR) otherwise.  Results showed 21 patients (19 fluid, 2 PLR) were responders—defined as an increase in cardiac output of >/=15%.  A PVI threshold value of 17% allowed discrimination between responders and non-responders with a sensitivity of 95% (95% confidence interval, 74-100%) and a specificity of 91% (95% confidence interval, 70-99%), leading researchers to conclude that "PVI can predict fluid responsiveness noninvasively in ICU patients under mechanical ventilation."  Additionally, PVI at baseline correlated (r=0.72, p<.0001) with changes in cardiac output induced by fluid challenge—suggesting the higher PVI at baseline, the higher the percentage change in cardiac output after volume expansion.

"Perfusion Index as a Predictor for Central Hypovolemia in Humans"(3)

In this study—the first to evaluate the ability of Masimo PI to detect peripheral vasoconstriction due to neurohumoral response in central hypovolemia-induced by lower body negative pressure (LBNP)—researchers from Erasmus MC University Medical Centre in Rotterdam, Netherlands measured PI in 24 healthy volunteers during LBNP testing.  LBNP consisted of 5 min. baseline measurements in the supine position followed by stepwise increases of negative pressure from 0 to -20, -40, -60, -80, and o mmHg.  Results showed that PI decreased significantly by 40% (P=0.03) during first -20mmHg and stayed in this range during the remainder of the experiment while stroke volume (SV) decreased by 20% and heart rate (HR) increased by 15% at -40mmHg and were proportional to the level of negative pressure in the chamber.  Researchers concluded that PI is a "sensitive indicator of acute hemodynamic responses to LBNP-induced central hypovolemia" and could "detect hypovolemia earlier than 20% decrease in stroke volume."  

SpHb, PVI, and PI are available as part of 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®), 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). 1. Frasca D, Dahyot-Fizelier C, Karen C. Levrat Q, Soumagne-Vialle N, Boisson M, Debaene B, Mimoz O.  "Accuracy of a Continuous Noninvasive Hemoglobin Monitor in Intensive Care Unit."  CHU Poitiers, Anesthesie-Reanimation INSERM ERI 23, POITIERS, France. ISICEM Presentation A91.2. Nanadoumgar H, Loupec TL, Frasca DF, Petitpas FP, Laksiri LL, Baudouin DB, Mimoz OM. "Pleth Variability Index Predicts Fluid Responsiveness in Critically-ill Patients." CHU POITIERS, Reanimation Chirurgicale, Poitiers Cedex, France. ISICEM Presentation A532.3. Lima A, Van Genderen M, Klijn E, Bartels S, Van Bommel J, Bakker J. "Perfusion Index as a Predictor for Central Hypovolemia In Humans." Erasmus MC University Medical Centre Rotterdam, Intensive Care, Rotterdam, Netherlands. ISICEM Presentation A422.About MasimoMasimo (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 StatementsThis 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 assumptions that Masimo SpHb accurately tracks and trends Hb changes in all patients, Masimo PVI is accurately predicts fluid responsiveness in all mechanically-ventilated, and Masimo PI is capable of detecting acute LBNP-induced central hypovolemia earlier than stroke volume in all ICU patients, 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: dbanks@masimo.com

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, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.


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