Two Clinical Case Reports Demonstrate Trend Accuracy of Masimo Noninvasive and Continuous Hemoglobin and Illustrates Its Use as an Effective Tool for Blood Conservation

IRVINE, Calif., Sept. 28 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI) announced today that two new clinical case reports presented at the Society for the Advancement of Blood Management (SABM) Annual Meeting demonstrate that Masimo noninvasive and continuous hemoglobin (SpHb®) provides measurements as accurate as invasive laboratory blood tests, offering a "new and effective strategy to facilitate blood conservation efforts and minimize unnecessary transfusions in the intensive care unit (ICU)."  The case report also states that SpHb monitoring contains none of the drawbacks of traditional blood analysis that can impact clinical decisions.

According to Aryeh Shander, MD, Executive Medical Director at the Institute for Patient Blood Management & Bloodless Medicine Surgery and Chief of Anesthesiology and Critical Care Medicine at Englewood Hospital & Medical Center, "In continuing to recognize the negative impact of red blood cell (RBC) transfusion on the critically-ill, our threshold for transfusion is increasing.  Masimo noninvasive and continuous hemoglobin technology offers two significant advantages: the first is the ability to continuously monitor hemoglobin (especially at low levels) as we treat the patient with modalities other than transfusion and the second is the ability to avoid or reduce development of anemia in the ICU patients due to repeated blood draws that cause and aggravate anemia as noninvasive hemoglobin measurement eliminates the need for repeated blood draws in anemic patients."  

In the first case report presented, researchers at the Englewood Hospital and Medical Center (EHMC) in New Jersey and Mt. Sinai School of Medicine in New York tracked the performance of Masimo SpHb in a severely anemic patient over the course of four days in the ICU.  In comparing SpHb with invasive hemoglobin measurements (tHb), researchers found high correlation with a SpHb bias of 1.26 g/dL and standard deviation of 0.43 g/dL.  Researchers noted that SpHb measurements (ranging from 4.9 to 11.2 g/dL) "exhibited a consistent trend compared to the changes in laboratory hemoglobin measurements" (between 5.2 to 8.1g/dL) over the four-day period, concluding that "the ability to continuously monitor hemoglobin noninvasively may offer a new and effective strategy to facilitate blood conservation efforts and minimize unnecessary blood transfusions in the ICU."(1)  

In the second case report presented, researchers at Mayo Clinic in Jacksonville, Florida tracked the performance of Masimo SpHb in a patient undergoing high blood loss liver transplantation surgery.  Comparing SpHb with invasive hemoglobin measurements (tHb) led researchers to conclude that Masimo SpHb measurements compared "favorably with the laboratory measured values over a range of 6-12 g/dL." Researchers also noted the unique advantages of SpHb monitoring in that it provides "results faster and as an instantaneous readout" while the "stored data is easily retrievable enabling post-procedure processing."  Dr. Klaus Torp, lead researcher and Anesthesiologist at Mayo Clinic, recognizes the importance and impact of SpHb monitoring in surgical patients, offering that "During massive hemorrhage, having the ability to monitor hemoglobin levels in real-time may enable the anesthesiologist to assess and match transfusion needs fast—allowing one to rapidly optimize oxygen delivery, intravascular volume, and avoid over-transfusion."(2)

Traditional blood analysis has many drawbacks, including complexity, time-consuming turnaround times that can impact clinical decisions, and blood loss due to invasive blood draws that have been found to contribute substantially to the anemic conditions that commonly occur in critically-ill patients—thereby increasing transfusion rates.  Published studies have shown that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery.(3,4) These studies also suggest that transfusions and their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions. The ability to continuously and noninvasively trend a patient's hemoglobin level with Masimo SpHb offers a breakthrough in blood management with the potential to improve clinical decision-making, reduce patient exposure to unnecessary blood transfusions, and preserve precious resources.

"These two case reports clearly demonstrate that Masimo SpHb provides the best available opportunity for reducing and/or eliminating anemia and transfusion related risks in surgical patients in the easiest and quickest possible way," stated Dr. Shander.

SpHb is available as part of the 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®), and acoustic respiration rate (RRaTM), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).  

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®, 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® Pulse CO-Oximetry™, 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 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  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 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 assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo SpHb will facilitate early diagnosis and treatment of low hemoglobin/anemic conditions for all surgical and post-surgical 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 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.

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.

(1) Juhl A., Naqvi S., Aregbeyen O., Shander A.  "Noninvasive and Continuous Hemoglobin Monitoring in an Intensive Care Unit Patient with low Hemoglobin."  Society for the Advancement of Blood Management (SABM) Annual Meeting. September 24, 2010.

(2) Prith P, Torp K, et al. Real Time Hemoglobin Monitoring During Liver Transplantation. A Case Report. Society for the Advancement of Blood Management (SABM) Annual Meeting. September 24, 2010.

(3) 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.

(4) 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

SOURCE Masimo

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