07/15/2019 | Press release | Distributed by Public on 07/15/2019 00:12
NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jul. 15, 2019-- Masimo (NASDAQ: MASI) announced today that in a study recently published in the Journal of Clinical Monitoring and Computing, researchers investigated the ability of Masimo ORi™ (Oxygen Reserve Index) to serve as a noninvasive indicator of the arterial partial pressure of oxygen (PaO2) during general anesthesia, to help avoid hyperoxia.1 ORi is an index of oxygenation in the moderate hyperoxic region (PaO2 range of 100 to 200 mmHg). As an 'index' with a scale between 0.0 and 1.0, ORi can be trended to notify clinicians of changes in a patient's oxygen reserve.
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Masimo Root® with Radical-7® and ORi™ (Photo: Business Wire)
Dr. Keisuke Yoshida and colleagues at the Fukushima Medical University School of Medicine in Japan sought to evaluate whether ORi could provide continuous, noninvasive insight into avoiding excessive hyperoxia by comparing the relationship between PaO2 and ORi during various oxygen administration conditions. They enrolled 20 patients scheduled for surgery requiring general anesthesia. ORi was measured using Masimo Root® with the Radical-7® Pulse CO-Oximeter® and rainbow® sensors. PaO2 was measured using the Siemens RAPIDLab® 1265 blood gas analyzer. For each patient, after inducing anesthesia, blood gas analysis to measure PaO2 was performed four times, with ORi values recorded each time blood was drawn, providing 80 data sets. Initial analysis was performed with inspired oxygen concentration (FiO2) set to 0.33, with the three subsequent analyses performed when ORi was around 0.5, 0.2, and 0, achieved by adjusting FiO2.
For analysis, the researchers chose an upper PaO2 threshold of 240 mmHg, based on a previous study that found a positive correlation between ORi and PaO2 when PaO2 < 240 mmHg.2 They defined hyperoxemia as PaO2 ≥ 150 mmHg. Using linear regression analysis, the researchers found a 'relatively strong' positive correlation (r2 = 0.706) between ORi and PaO2 when PaO2 was less than 240 mmHg. Using receiver operating characteristic (ROC) curve analysis, they calculated that the optimal cut-off ORi value to detect PaO2 ≥ 150 mmHg was 0.21 (sensitivity 0.950, specificity 0.755). Using four-quadrant plot analysis, they found that ORi trended PaO2 with a 100% concordance rate.
The researchers concluded that 'Hyperoxemia can be detected by observing ORi of patients under general anesthesia, and thus unnecessary administration of high concentration oxygen can possibly be avoided.' They also noted, 'ORi has unique characteristics reflecting the state of oxygenation in the hyperoxic range. The present study examined data under general anesthesia in the operating room, but ORi's unique features can provide benefits not only in the operating room, but also in the ICU and other fields. In the future, in order to make the most use of ORi, further clinical study is required.'
As study limitations, the researchers noted the small number of subjects in the study. In addition, they noted, 'It is plausible that a given patient's factors (e.g. age, physique, body temperature, finger perfusion, hemoglobin concentration) affect their ORi value. Therefore, ORi might not reflect all changes in PaO2.'
ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
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Masimo (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® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.3 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,4 improve CCHD screening in newborns,5 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.6-8 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.10 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET™ sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® 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® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo's family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius™ PPG, portable devices like Rad-67™, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97™. Masimo hospital automation and connectivity solutions are centered around the Iris® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.
ORi 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.
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 ORi™. 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 ORi, 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; 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.
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