Randomized Controlled Trial Shows Masimo Noninvasive and Continuous Hemoglobin Monitor Helps Clinicians Reduce Blood Transfusions During Surgery

IRVINE, Calif., Oct. 19 /PRNewswire/ -- Masimo (Nasdaq: MASI) announced today that a new randomized controlled trial shows that the Masimo noninvasive and continuous hemoglobin (SpHb®) monitor helped anesthesiologists reduce the frequency of blood transfusion by 86% in patients undergoing orthopedic surgery.(1)  Funded by the National Institutes of Health (NIH), the study was presented as part of the late breaking trial section at the American Society of Anesthesiologists (ASA) Annual Meeting in San Diego on October 18, 2010.

In the study, researchers at Massachusetts General Hospital, Harvard Medical School, and Vanderbilt University Medical Center examined the impact of SpHb monitoring upon transfusions in a total of 327 patients undergoing orthopedic surgery during a six-month period. Patients were randomized to either a Standard Care Group (157 patients guided by invasive laboratory hemoglobin measurements alone) or Masimo SpHb Group (170 patients guided by SpHb monitoring in addition to standard care).  SpHb measurements were obtained using a Masimo Radical-7® Pulse CO-Oximeter™ and rainbow® SpHb Adhesive ReSposable Sensor (R1 25). Of the 327 total surgical patients, eight received blood transfusions—seven in the Standard Care Group and only one in the SpHb Group.  As a result, the frequency of intraoperative transfusions was 86% lower in the SpHb Group compared to the Standard Care Group (0.6% vs. 4.5%, p=0.03). In addition, the average number of units of blood transfused was 90% lower in the SpHb Group compared to the Standard Care Group (0.01 vs. 0.10, p=0.0001).  The lack of blood transfusion in the SpHb Group did not subject those patients to added risk, as there were no differences in 30-day complication rates between groups.  Researchers concluded that the "use of SpHb monitoring resulted in fewer intraoperative blood transfusions."

Additionally, researchers presented a retrospective cohort analysis, which showed that in a case-by-case matched group of 327 patients (same age, gender, and surgical procedure as each patient in the active study) taken from the six-month period prior to the study, the transfusion rate without SpHb monitoring was 4.6%.  Consistent with the 4.5% transfusion rate of the Standard Care Group in the active control study, results from the cohort analysis demonstrate that SpHb monitoring made a key difference in reducing the transfusion rate.

According to lead researcher, Jesse M. Ehrenfeld, MD, MPH, recently appointed as Director, Center for Evidence Based Anesthesia at Vanderbilt University Medical Center, "Blood transfusions pose real risks to patients and are also a major contributor to the cost of surgical care.  Very few monitoring technologies are subjected to the rigor of a randomized controlled trial, and even fewer are able to show a significant impact on clinician behavior and ultimate patient outcome.  Our study has demonstrated that SpHb monitoring clearly changes clinician behavior and results in lower intraoperative blood transfusion rates and lower overall blood utilization.  These findings have important clinical implications for hospitals around the world who are seeking to reduce surgical patient risk and reduce costs."

There is a growing consensus that blood transfusions expose patients to significantly increased morbidity and mortality risk, with evidence that each unit of blood significantly increases the risk of infection, pneumonia, sepsis, and mortality after surgery and suggests that their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions.(2,3)  These two recent studies showed that blood transfusion increased the risk of 30-day mortality by up to 38% and morbidity by up to 40%.  

The ability to noninvasively and continuously trend a patient's hemoglobin level with the Masimo rainbow technology platform offers a breakthrough in blood management and patient safety.  Now, with the proven ability to reduce blood transfusions as evidenced by this study, SpHb monitoring allows clinicians to reduce patient risk and decrease blood utilization costs.

Ronald Miller, MD, MS, Anesthesiologist at University of California San Francisco and editor of "Miller's Anesthesia," stated, "These results show that SpHb monitoring enhances the decision-making process in transfusion medicine—helping to improve the basis and quality of transfusion decisions.  This study helps to verify the importance of continuous SpHb monitoring with regard to blood transfusion management."

"Since we introduced SpHb in 2008, clinicians around the world have shared their success stories about how SpHb monitoring has helped them to improve the care of their patients and reduce their costs," stated Joe Kiani, Founder and CEO of Masimo.  "With this new landmark study, we are happy to see Masimo SpHb become an evidence-based approach to help clinicians advance care and improve patient safety by minimizing unnecessary blood transfusions, which carry great risk and cost."

(1) Ehrenfeld J., Henneman J. "Impact of Continuous and Noninvasive Hemoglobin Monitoring on Intraoperative Blood Transfusions." American Society of Anesthesiologists, 2010 Annual Conference, October 18, 2010. Available online here.

(2) Bernard AC et al. "Intraoperative Transfusion of 1U to 2U of Packed Red Blood Cells is Associated with Increased 30-day Mortality, Surgical Site Infection, Pneumonia, and Sepsis in General Surgery Patients." Journal of the American College of Surgeons 2009;208:931-937.

(3) Surgenor SD et al, for the Northern New England Cardiovascular Disease Study Group. "The Association of Perioperative Red Blood Cell Transfusions and Decreased Long-Term Survival After Cardiac Surgery." Anesthesia & Analgesia 2009; 108:1741-1746.

About Masimo

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 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 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, risks related to our belief that using Masimo SpHb will help to reduce the frequency and quantity of blood transfusions, and risks related to our belief that Masimo SpHb provides accuracy and reliability comparable to invasive laboratory Hb measurements without its drawbacks, 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.

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SOURCE Masimo Corporation