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New Study Reports on Accuracy of Masimo’s Blue® Sensors at Saturations below 85% in Children with Cyanotic Congenital Heart Disease

03/17/16

IRVINE, Calif.--(BUSINESS WIRE)--Mar. 17, 2016-- Masimo (NASDAQ: MASI) announced today that a new study reported on the accuracy of Masimo’s Blue® sensors as compared to Nellcor and Masimo Standard sensors for cyanotic children with blood oxygen saturation less than 85%.1 Masimo’s Blue sensor was designed specifically for cyanotic infants and children with congenital heart disease.

The study was performed at the Lucile Packard Children’s Hospital at Stanford University with the aim of determining, in children with cyanotic congenital heart disease, which of three different pulse oximeter sensors is the most accurate at lower blood oxygen saturation levels, when compared to the “gold standard” of arterial blood gas analysis with CO-oximetry. The three sensors were Masimo SET® with LNCS® sensor (Masimo Standard), Masimo SET® with Blue sensor (Masimo Blue), and Nellcor™ N-600 with MAX-I sensor (Nellcor).

In the study, published in the journal Pediatric Critical Care Medicine, Dr. Harris and colleagues collected data from 50 infants and children weighing 3–20 kg with baseline saturations under 90% (measured by pulse oximetry at the time of clinical assessment) undergoing surgical or catheterization procedures. Following standard care monitoring, which included placement of the Masimo Standard sensor, the Masimo Blue and Nellcor MAX-I sensors were placed on a thumb or great toe, or alternatively on a finger. Up to four arterial blood samples were taken from each subject.

Compared to the CO-oximeter saturations (SaO2) over all measurements, the mean error ± standard deviation of the saturation values from pulse oximetry (SpO2) for the Masimo Blue, Nellcor, and Masimo Standard sensors were 1.7% ± 3.3%, 1.7% ± 5.4%, and 2.4% ± 4.9%, respectively.

The investigators concluded that “the Masimo Blue sensor has improved accuracy at saturations 75–85% versus the Nellcor and Masimo Standard sensors,” although the authors noted inaccuracies with all three sensors in this saturation range. The authors suggested there is a continued need for device manufacturers to calibrate and develop algorithms for pulse oximeters to have improved overall accuracy at saturations less than 85%. The authors further stated “clinical decisions at saturations below 85% should not be made by pulse oximetry alone; instead, co-oximetry and/or an arterial blood gas is warranted.”

Study limitations included small sample size, difficulty collecting steady-state samples from the operating room and catheterization lab, and placement of the Masimo Standard sensor in nonstandard locations.

The institution where this study was performed received a grant from Masimo to partially support the data collection for this study.

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1. Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatr Crit Care Med. 2016 Feb 24. [Epub ahead of print] PubMed PMID: 26914626.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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 more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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 include, among others, statements regarding the potential effectiveness of Masimo’s Blue® sensor. 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 Masimo’s Blue® sensor, 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.

Source: Masimo

Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com