New Clinical Study Shows Masimo PVI(TM) Accurately Predicts Fluid Responsiveness In The ICU

Main Category: Blood / Hematology
Also Included In: Medical Devices / Diagnostics;  IT / Internet / E-mail;  Clinical Trials / Drug Trials
Article Date: 01 Apr 2009 - 3:00 PDT

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Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that a new independent clinical study demonstrates Masimo PVI to be an "accurate index of fluid responsiveness" for critical care patients in the intensive care unit (ICU).(1) The study, presented at the 29th International Symposium on Intensive Care and Emergency Medicine on March 25, 2009, in Brussels, Belgium, is the first to show the potential value of Masimo PVI to predict fluid responsiveness beyond the operating room (OR) into the ICU.

Critically-ill patients are at great risk for volume depletion. Fluid administration is critical to optimizing oxygen delivery to organs and tissues, but giving too much fluid can induce life-threatening adverse effects. Therefore, parameters that aid clinicians in fluid management decisions may help improve patient outcomes. The most validated predictor of fluid responsiveness is pulse pressure variation (PP). However, this parameter requires an invasive arterial pressure catheter, which is not appropriate for all patients, or special software, which is not available in all monitoring systems. Masimo PVI is not only noninvasive, enabling easy application on almost any patient, but is also easily obtained from existing or field upgradable Masimo Rainbow SET(R) pulse oximeters and sensors that are already being used to monitor SpO2 and pulse rate.

In the study, Marc Feissel, MD, and colleagues at Le Centre Hospitalier Belfort-Montbeliard (CHBM) in Belfort, France, along with a team of researchers from Assistance Publique-Hopitaux de Paris (AP-HP) in Le Kremlin-Bicetre, France, conducted a two-step analysis of 43 mechanically-ventilated patients with septic shock to: 1) identify the optimal Masimo PVI threshold for distinguishing fluid responders from non-responders; and 2) test the accuracy of PVI at the optimal threshold to predict fluid responsiveness.

In the first step, researchers infused fluid (500 ml saline) in with pulse pressure variation (PPV) >/= 15% and performed passive leg raising in patients with PPV <15% while simultaneously recording Masimo PVI and PPV. A >15% increase in velocity-time-integral (VTI) from echocardiography was used to determine fluid responsiveness. After comparing all data for the 25 enrolled ICU patients in the first step, researchers found that a "threshold PVI value of 20 identified patients with PPV >15% with a sensitivity of 84% and specificity of 90%."

In the second step, researchers found that a PVI value of 20 was an effective threshold for discriminating fluid responders from non-responders among 18 additional ICU patients, with PVI >20 predicting all 8 fluid responders and PVI <20 predicting all non-responders. The researchers concluded that a PVI value of 20 "distinguished responders from non-responders with good sensitivity and specificity," and appeared to represent an "accurate index of fluid responsiveness" for critically-ill patients in the ICU.

Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "We are pleased to see the value and significance of Masimo PVI in the ICU, where clinicians are often faced with difficult decisions about whether to administer fluid. While traditional invasive measurements offer limited accuracy at predicting fluid responsiveness, this study showed that a PVI threshold of 20 was able to accurately predict both fluid responders and non-responders, underscoring the strong potential for PVI to aid clinicians in optimizing fluid management and improving patient outcomes."

1. M. Feissel, R. Kalakhy, J. Badie, G. Robles, J. Faller, JL. Teboul. "Plethysmography Variability Index: A New Fluid Responsiveness Parameter." Presented at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) Annual Meeting, March 25, 2009, Brussels, Belgium.

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(R), 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(R) Pulse CO-Oximetry(TM), a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. 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 http://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 PVI will prove to be an effective clinical indicator of patient hydration and the need for fluid loading, and will deliver a sufficient level of clinical improvement over alternative fluid assessment methods to allow for rapid adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended January 3, 2009, filed with the Securities and Exchange Commission ("SEC") on March 4, 2009, 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 Annual Report on Form 10-K for the fiscal year ended January 3, 2009, 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, 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. Other trademarks used herein are the property of their respective owners.

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http://www.masimo.com

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