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New Study of Masimo Noninvasive and Continuous Hemoglobin (SpHb(R)) Monitoring Evaluates Trending and Accuracy in Pediatric Patients

Companies mentioned in this article: Masimo

IRVINE, CA -- (Marketwired) -- 08/12/14 -- Masimo (NASDAQ: MASI) announced today that in a new study published in the journal Anesthesia and Analgesia, Masimo's noninvasive and continuous hemoglobin (SpHb®) technology showed a positive correlation for trending when compared with invasive lab measurements in pediatric patients undergoing surgeries with potential for substantial blood loss.(1)

In the study, Dr. Mario Patino, M.D., and colleagues from the Department of Anesthesiology at Cincinnati Children's Hospital, assessed the trending and point accuracy of SpHb (Revision E Disposable L Sensor R1-20/25L and ReSposable Sensor R2-20/25)) in pediatric patients versus arterial blood samples analyzed on a hematology analyzer (Cell-Dyn Sapphire). They also evaluated the impact of SpHb Invivo Adjustment on accuracy comparisons.

Researchers collected 158 SpHb and laboratory hemoglobin (Hb) data pairs and 105 delta pairs (ΔSpHb and ΔHb) from 46 patients aged 2 months to 17 years with Hb ranging from 16.7 g/dL to 7.9 g/dL. Patient selection was limited to those undergoing surgical procedures associated with substantial blood loss, such as cardiac surgery, liver/small bowel transplantation, and multilevel spine surgeries.

The primary goal of the study was to compare the magnitude and direction of change (trending) of SpHb versus that of the reference device. The authors found that the sensitivity of SpHb to correctly detect directional changes in Hb was 95% (95% CI = 0.83-0.99). The researchers calculated SpHb's correlation coefficient at r=0.76. Additionally, 95% of the individual data points were either in the upper right or in the lower left quadrant of the trending plots, showing changes in SpHb and Hb in the same direction.

Additionally, researchers found point accuracy bias and standard deviation of 0.4 +/- 1.3 g/dL and with Invivo Adjustment, 0.1 +/- 1.2 g/dL. The limits of agreement were -2.0 to 3.2 g/dL before Invivo Adjustment and -2.4 to 2.2 g/dL after Invivo Adjustment (P value = 0.04). Invivo Adjustment, a feature currently available in select European and other non-U.S. markets, allows clinicians to adjust the SpHb measurement to that of an initial blood sample analyzed with the clinician's invasive reference hemoglobin analyzer. This feature helps account for reference invasive instrument and individual patient variation.

The authors concluded that, "noninvasive, continuous Hb monitoring by Pulse CO-Oximetry (SpHb) displayed similar trending and absolute accuracy in pediatric patients undergoing a variety of surgical procedures associated with blood loss as has been found in adult surgical patients," adding that, "trending SpHb values has the potential to supplement detection of changes of Hb concentration by invasive blood draws."

SpHb is available with Masimo's rainbow® SET® monitoring platform, enabling the noninvasive assessment of multiple blood constituents and physiologic parameters that previously required invasive or complicated procedures, in addition to providing Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry. The rainbow® SET® platform -- including RRa®, SpCO® and SpMet® -- offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.

"This study adds to the growing body of clinical evidence supporting the value of SpHb's use with pediatric patients," said Dr. Stephen Barker, M.D., Ph.D., Chairman of the Scientific Advisory Board of Masimo. "As with adult patients, SpHb can help clinicians noninvasively assess hemoglobin levels and trending, which has been shown to lead to better clinical decisions and improved patient outcomes."

1 Patino M, Schultz L, Hossain M, Moeller J, Mahmoud M, Gunter J, Kurth C. "Trending and Accuracy of Noninvasive Hemoglobin Monitoring in Pediatric Perioperative Patients" Anesthesia and Analgesia, doi: 10.1213/ANE.0000000000000369. Available online here.

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 have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, 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). 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 Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.

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 are trademarks or registered trademarks of Masimo Corporation

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Contact:

Media Contact:
Mike Drummond
Masimo Corporation
Phone: (949) 297-7434
Email: mdrummond@masimo.com