NEUCHATEL, Switzerland–(BUSINESS WIRE<\/a>)–Masimo<\/a> (NASDAQ: MASI) today announced the findings of an observational, retrospective study published in Pediatrics International. <\/i>In the study, researchers at the Osaka Women\u2019s and Children\u2019s Hospital in Japan found the Masimo EMMA\u00ae <\/sup>Portable Capnograph \u201cuseful for assessment of the respiratory condition in children with tracheostomy.\u201d1<\/sup> EMMA\u00ae<\/sup> provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The device requires no routine calibration and minimal warm-up time, with accurate end-tidal carbon dioxide (EtCO2<\/sub>) and respiration rate measurements and continuous EtCO2<\/sub> waveforms displayed within 15 seconds.\n<\/p>\n This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20210315005185\/en\/<\/a><\/p>\n Masimo EMMA\u00ae Capnograph (Photo: Business Wire)<\/p>\n<\/div>\n \nNoting the potential value of a compact and portable way to monitor changes in respiratory status for patients in scenarios where typical inpatient hospital monitoring equipment is less likely to be available, Dr. Masashi Hotta and colleagues sought to evaluate the utility of the EMMA capnograph on children with tracheostomy by comparing EtCO2<\/sub> values from the EMMA device (which was connected to the distal side of the tracheostomy cannula) to invasively measured partial pressure of venous carbon dioxide (PvCO2<\/sub>). Although partial pressure of arterial carbon dioxide (PaCO2<\/sub>) is considered a gold standard for assessing respiratory condition, the researchers chose PvCO2<\/sub> because \u201ccollection of arterial samples is more invasive than collection of venous samples\u201d and noted that studies have shown a correlation between PaCO2<\/sub> and PvCO2<\/sub>.2,3<\/sup> They enrolled 9 infants (median age 8 months) and compared 43 paired EtCO2<\/sub>-PvCO2<\/sub> readings in total.\n<\/p>\n \nThe researchers found a correlation coefficient of 0.87 (95% confidence interval of 0.7 \u2013 0.93; p < 0.001) between EtCO2<\/sub> and PvCO2<\/sub> readings. Analysis of the data revealed that EtCO2<\/sub> readings were, on average, 10.0 mmHg lower than the corresponding paired PvCO2<\/sub> value (95% limits of agreement of 1.0 \u2013 19.1 mmHg). The researchers speculated that the tendency for EtCO2<\/sub> to be lower than PvCO2<\/sub> may be explained by \u201cgas mixing proximal to the tracheostomy cannula due to the presence of anatomic and physiologic dead space. Because almost all patients used a cannula without a cuff, some air leakage may have occurred. In addition, about two-thirds of the patients had [chronic lung disease or bronchopulmonary dysplasia],\u201d which they noted have been shown to cause lower CO2<\/sub> concentrations during exhalation, relative to the partial pressure of CO2<\/sub> in the blood.\n<\/p>\n \nThey also found that the median difference in values was significantly greater for readings collected while patients were on mechanical ventilation (28 of the 43 data pairs). With a ventilator, there was a median 11.2 mmHg (6.8 \u2013 14.3) difference; without a ventilator, there was a median 6.6 mmHg (4.1 \u2013 9.0) difference (p = 0.043). The researchers noted that use of a ventilator was significantly related to the difference in paired readings because patients on ventilators had respiratory or circulatory disease.\n<\/p>\n \nNoting that, \u201cWe demonstrated a strong positive relationship between PvCO2<\/sub> and EtCO2<\/sub> and revealed the availability and usefulness of this capnometer for children with tracheostomy,\u201d the researchers concluded, \u201cEMMA is useful for assessment of the respiratory condition in children with tracheostomy. EMMA can be used especially in home-care settings and outpatient departments for such children.\u201d They also noted, \u201cThe main strength of this study is that we used a portable capnometer to evaluate EtCO2<\/sub>.\u201d\n<\/p>\n @Masimo<\/a> | #Masimo\n<\/p>\n About Masimo<\/b><\/p>\n \nMasimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET\u00ae<\/sup> Measure-through Motion and Low Perfusion\u2122 pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.4<\/sup> Masimo SET\u00ae<\/sup> has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,5<\/sup> improve CCHD screening in newborns,6 <\/sup>and, when used for continuous monitoring with Masimo Patient SafetyNet\u2122 in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.7-10 <\/sup>Masimo SET\u00ae<\/sup> is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,11<\/sup> and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report<\/i> Best Hospitals Honor Roll.12<\/sup> Masimo continues to refine SET\u00ae<\/sup> and in 2018, announced that SpO2<\/sub> accuracy on RD SET\u00ae<\/sup> sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2<\/sub> values they rely on accurately reflect a patient\u2019s physiological status. In 2005, Masimo introduced rainbow\u00ae<\/sup> Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb\u00ae<\/sup>), oxygen content (SpOC\u2122), carboxyhemoglobin (SpCO\u00ae<\/sup>), methemoglobin (SpMet\u00ae<\/sup>), Pleth Variability Index (PVi\u00ae<\/sup>), RPVi\u2122 (rainbow\u00ae<\/sup> PVi), and Oxygen Reserve Index (ORi\u2122). In 2013, Masimo introduced the Root\u00ae<\/sup> Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine\u00ae<\/sup> Brain Function Monitoring, O3\u00ae<\/sup> Regional Oximetry, and ISA\u2122 Capnography with NomoLine\u00ae<\/sup> sampling lines. Masimo\u2019s family of continuous and spot-check monitoring Pulse CO-Oximeters\u00ae<\/sup> includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7\u00ae<\/sup> and Radius PPG\u2122, portable devices like Rad-67\u2122, fingertip pulse oximeters like MightySat\u00ae<\/sup> Rx, and devices available for use both in the hospital and at home, such as Rad-97\u00ae<\/sup>. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation\u2122 platform, and include Iris\u00ae<\/sup> Gateway, iSirona\u2122, Patient SafetyNet, Replica\u2122, Halo ION\u2122, UniView\u2122, UniView :60\u2122, and Masimo SafetyNet\u2122. Additional information about Masimo and its products may be found at www.masimo.com<\/a>. Published clinical studies on Masimo products can be found at www.masimo.com\/evidence\/featured-studies\/feature\/<\/a>.\n<\/p>\n \nORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.\n<\/p>\n References<\/b><\/p>\n Forward-Looking Statements <\/strong><\/p>\n \nThis 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 EMMA\u00ae<\/sup>. 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 EMMA, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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<\/a>. 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.\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210315005185\/en\/<\/a><\/span><\/p>\n Masimo KEYWORDS:<\/b> California Switzerland United States Japan North America Asia Pacific Europe<\/p>\n INDUSTRY KEYWORDS:<\/b> Medical Devices Surgery Medical Supplies Children Hospitals Baby\/Maternity Clinical Trials Biotechnology Consumer Health<\/p>\n![\"Masimo](\"https:\/\/mms.businesswire.com\/media\/20210315005185\/en\/865065\/4\/masimo-emma_handheld.jpg\")
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Evan Lamb
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949-396-3376
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elamb@masimo.com<\/a><\/p>\n
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