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New Clinical Study Finds Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Accurate in the Noninvasive Monitoring of Fluid Status During Surgery

Posted on: Monday, 16 March 2009, 07:00 CDT

UCSF Researchers Presented Study Data Demonstrating the Unique Ability of Masimo PVI(TM) to Reflect Acute Changes in Intravascular Fluid Volume at the International Anesthesia Research Society 83rd Scientific Congress

IRVINE, Calif.,, March 16 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announce that a new clinical study, independently conducted by researchers from the University of California-San Francisco (UCSF), demonstrates that Masimo PVI accurately and reliably reflects acute changes in intravascular fluid volume (preload).(1) The study, presented at the International Anesthesia Research Society (IARS) 83rd Scientific Congress on March 14th in San Diego, Calif., affirms PVI as a highly predictive indicator of patient fluid status.

Assessing whether a patient needs fluid to increase their cardiac index (amount of blood the heart pumps each minute) is one of the biggest challenges anesthesiologists face during surgery. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality(2) and traditional invasive measurements are only 50 to 60% accurate at predicting improvement in cardiac index after volume administration.(3) PVI--a new method for noninvasive and automatic assessment of fluid responsiveness--has been shown in multiple studies to predict fluid responsiveness in mechanically ventilated patients, helping clinicians to optimize fluid administration and improve patient outcomes.(4-6)

In the study, Errol P. Lobo, M.D., PhD, at UCSF in San Francisco, Calif., and colleagues used Masimo Radical-7 Pulse CO-Oximeters to noninvasively measure and continuously track PVI, perfusion index (PI) and pulse rate (PR) data during 16 consecutive liver transplant operations. Researchers extracted and analyzed the noninvasive data at three critical points where preload changes occur rapidly: 1) immediately before clamping, 2) during clamping, and 3) immediately after clamping of the inferior vena cava (IVC), and found that PVI changed rapidly and significantly in response to known acute changes in preload (clamping and unclamping of IVC) in 100% of the cases.

The study results showed that PVI increased in response to IVC clamping (from 11.4, +/- 4.3, to 25.2, +/- 4.4; p<0.0001) and decreased after unclamping (from 25.2, +/- 4.4, to 8.9, +/- 3.8; p<0.0001) in all 16 transplant patients. Researchers concluded that this study data demonstrates that PVI may have "a role in monitoring intravascular volume in mechanically ventilated patients."

PVI is available as part of Masimo Rainbow SET Pulse CO-Oximetry--a revolutionary noninvasive patient monitoring platform that measures multiple blood constituents and helps to predict fluid responsiveness in patients previously requiring invasive procedures. The first-and-only upgradable noninvasive blood constituent monitoring technology platform capable of continuously and noninvasively measuring total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and pleth variability index (PVI(TM)), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), Masimo Rainbow SET has the potential to facilitate faster, easier and safer health decisions.

Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly, stated: "This UCSF study adds to the growing evidence base demonstrating PVI to be an accurate and reliable indicator of fluid status and responsiveness in mechanically-ventilated patients under general anesthesia. The ability to noninvasively and automatically assess fluid responsiveness in surgical patients has the potential to increase patient safety, improve the quality of care, and reduce the cost of care for hospitals and surgery centers."

1. E. Lobo, C. Niemann, P. Talke. Anesthesia and Perioperative Medicine, University of California-San Francisco, San Francisco, California. "Effect of Preload Changes on Pleth Variability Index During Liver Transplants." Available online at: http://www.abstractsonline.com/viewer/viewAbstractPrintFriendly.asp?CKey=&SKey=&MKey=&AKey=
2. Michard F, Teboul JL. "Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence." Chest. 2002 Jun;121(6):2000-8.
3. Joshi G. "Intraoperative Fluid Restriction Improves Outcome After Major Elective Gastrointestinal Surgery." Anesthesia Analgesia 2005; 101:601-5.
4. Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre." British Journal of Anaesthesia 2008; 0:aen133v1-7.
5. Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi, Aman Mahajan, M.D., Ph.D. Anestheiology, UCLA David Geffen School of Medicine, Los Angeles, California. "Ability of Pleth Variability Index to Detect Preload Changes in Orthotopic Liver Transplant Patients."
6. Olivier Desebbe, M.D., Bertrand Delannoy, R.A., Jean-Jacques Lehot, M.D., Ph.D., Olivier Bastien, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France. "Pleth Variability Index: A Noninvasive Device for Fluid Responsiveness Assessment during Anesthesia."

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 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; 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; and our belief that the applications of Masimo Rainbow SET measurements described in the foregoing statements will deliver a sufficient level of clinical improvement over alternative measurement capabilities to materially increase market share and/or revenues, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Contact: Dana Banks Masimo Corporation 949-297-7348

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.

SOURCE Masimo

Source: PR Newswire

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