2014

New Clinical Study Finds Pronto® Has Similar Accuracy to Commonly Used Point-of-Care Invasive Hemoglobin Analyzer

IRVINE, Calif., Oct. 24, 2012 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that a new study published in Postgraduate Medicine demonstrates noninvasive total hemoglobin (SpHb®) measurements from the Pronto have an accuracy similar to those of the most commonly used invasive point-of-care (POC) hematology analyzer (HemoCue® 201+, Quest Diagnostics) in outpatient settings.1

Total hemoglobin (Hb) is one of the most frequently ordered laboratory tests in hospitals, urgent care centers, physician offices, and public health clinics.2 Anemia, defined as low hemoglobin concentration, is among the most common blood disorders in the United States, afflicting an estimated 3.4 million Americans, according to the National Center for Health Statistics. Many people are at risk for anemia because of poor diet, intestinal disorders, chronic diseases, infections, and other conditions. The signs and symptoms of anemia can be easily overlooked, and many people do not realize they have anemia until it is identified by a blood test.

Yet conventional invasive POC testing is time-consuming and exposes the patient and clinician to potential contamination and exposure to blood-borne pathogens. Errors occurring during the pre-analytical phase – from the time the test is ordered by the physician until the sample is ready for analysis – can account for up to 93% of the errors currently encountered during the total diagnostic process.3 A review of multiple studies in 2002 showed similarly high levels of errors.

The study that appears in Postgraduate Medicine, by Marina Raikhel, M.D., of the Torrance Clinical Research Institute in Lomita, Calif., measured hemoglobin of 152 subjects (69% women) presenting at an outpatient research clinic with common conditions such as diabetes, asthma, high cholesterol and high blood pressure.

Compared to laboratory analysis of blood, the bias ± standard deviation were −0.5 ± 1.0 g/dL for SpHb and 0.3 ± 1.0 g/dL for HemoCue 201+.  Noninvasive SpHb testing had bias and standard deviation similar to those of HemoCue 201+, according to the study.

Device

Pronto

HemoCue

Sample Type

Noninvasive

Invasive

Methodology

Spectrophotometric

Photometric

Bias

-0.5 g/dL

0.3 g/dL

SD

1.0 g/dL

1.0 g/dL

Limit of agreement

-2.5 to 1.5 g/dL

- 1.7 to 2.3 g/dL

"Because SpHb mea­surement is noninvasive, it has the potential to confer the additional benefits of patient comfort, decreased complexity, and increased safety for health care providers who are not exposed to risks of needle-stick injury and blood-spill contaminations," the study concluded.

"As this study shows, the accuracy of the Pronto provides clinicians a powerful, yet painless, tool to test total hemoglobin without many of the risks associated with conventional, invasive testing," said Dr. Michael O'Reilly, Chief Medical Officer at Masimo. "The simplicity, safety and accuracy of the Pronto can help hospitals, clinics and physician offices improve processes and patient outcomes."

1 Raikhel M. "Accuracy of Noninvasive and Invasive Point-of-Care Total Blood Hemoglobin Measurement in an Outpatient Setting" Postgraduate Medicine, Volume 124, Issue 4, July 2012, ISSN – 0032-5481, e-ISSN – 1941-9260.
2 Steindel SJ, Rauch WJ, Simon MK, Handsfield J. National Inventory of Clinical Laboratory Testing Services (NICLTS). Development and test distribution for 1996. Arch Pathol Lab Med. 2000;124:1201-1208.
3 Preanalytical variability: the dark side of the moon in laboratory testing. G Lippi, GC Guidi, C Mattiuzzi, and M Plebani. Clin Chem Lab Med, Jan 2006; 44(4): 358-65.

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, 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.

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

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, Adaptive Threshold Alarm, and SEDLine  are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

SOURCE Masimo Corporation



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