Researchers Use Masimo ORi™, Oxygen Reserve Index, to Help Suppress Postoperative Hyperoxia in Patients Undergoing Breast Surgery

Rhea-AI Summary

Masimo (NASDAQ: MASI) revealed findings from a study presented at Euroanaesthesia 2020, led by Dr. Kumagai at Iwate Medical University. The research demonstrated that Masimo ORi™, or Oxygen Reserve Index, effectively limits postoperative hyperoxia, potentially preventing hypoxia. In a trial involving 50 breast surgery patients, those monitored with ORi had significantly lower arterial oxygen levels post-surgery compared to a control group. However, ORi is currently not available in the U.S. due to the lack of FDA 510(k) clearance.

Positive

• Masimo ORi demonstrated potential in reducing postoperative hyperoxia, thereby preventing hypoxia.
• Significantly lower arterial oxygen levels in the ORi group indicate effective monitoring.

Negative

• Masimo ORi has not received FDA 510(k) clearance and is unavailable in the U.S.

Masimo (NASDAQ: MASI) announced today the findings of an abstract recently presented at Euroanaesthesia 2020 in which Dr. Kumagai and colleagues at Iwate Medical University Hospital in Yahaba-cho, Japan investigated whether Masimo ORi™, Oxygen Reserve Index, could be used to limit the extent of postoperative hyperoxia.¹ The researchers concluded that ORi helped “suppress hyperoxia, preventing hypoxia.”

Masimo Root® with ORi™ (Photo: Business Wire)

ORi, available outside the U.S., is a noninvasive and continuous parameter intended to provide insight into a patient’s oxygen status during moderate hyperoxia. Enabled by the multi-wavelength rainbow^® Pulse CO-Oximetry platform, ORi is provided alongside oxygen saturation (SpO₂), a clinically proven Masimo SET^® pulse oximetry measurement.

Noting that postoperative hyperoxia is associated with various adverse outcomes—including “acute lung injury, increased hospital mortality, and worse outcomes in patients with ischemic stroke”—the researchers sought to determine whether a noninvasive, continuous parameter could help clinicians assess the appropriate amount of supplemental oxygen to administer to surgical patients, so as to limit hyperoxia post-surgery. They divided 50 patients scheduled for breast surgery into a group receiving ORi-based oxygen treatment (group O) and a control group that received conventional postoperative oxygen treatment (group C). In group C, after extubation, oxygen was administered at a fixed rate (4 L/min); in group O, oxygen was administered at 4 L/min but decreased by 0.5 L/min if ORi > 0.00, until ORi was 0.00 for 30 minutes continuously. Blood gas analysis was performed at various intervals. Hyperoxia was defined as partial pressure of arterial oxygen (PaO₂) > 120 mmHg, and hypoxia as oxygen saturation (SpO₂) ≤ 94% for more than 1 minute.

The researchers found that PaO₂ was significantly lower in the ORi group both before patients left the PACU (mean 117.3 mmHg [one standard deviation 26.8 mmHg] in group O vs. 170.0 mmHg [42.8 mmHg] in group C) and the morning after surgery (107.5 mmHg [16.5 mmHg] in group O vs. 157.1 mmHg [28.4 mmHg] in group C); p < 0.01. No patients had hypoxia.

The researchers concluded, “Determining postoperative supplemental oxygen amount using ORi can noninvasively suppress hyperoxia, preventing hypoxia.”

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

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About Masimo

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.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs^5-8 Masimo SET^® is estimated to be used on more than 200 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 according to the 2020-21 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 Masimo Hospital Automation™ platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. 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.

References

1. Kumagai M, Koishi W, Kurihara H, Eizuka A, Suzuki K. Contribution of the novel pulse oximeter-based index in determining the amount of postoperative supplemental oxygen needed. Proceedings from the Euroanaesthesia 2020 Annual Meeting. #4339.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 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; 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. 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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FAQ

What are the findings from Masimo's recent study at Euroanaesthesia 2020?

The study found that Masimo ORi™ could effectively limit postoperative hyperoxia and prevent hypoxia.

What does Masimo ORi measure?

Masimo ORi measures the Oxygen Reserve Index to provide insights into a patient's oxygen status during moderate hyperoxia.

Why is Masimo ORi not available in the U.S.?

Masimo ORi has not yet received FDA 510(k) clearance, making it unavailable for sale in the United States.

How did the ORi group perform compared to the control group in the study?

Patients in the ORi group had significantly lower arterial oxygen levels compared to those in the control group after surgery.

What is the significance of the study's findings for postoperative care?

The findings suggest that using Masimo ORi can help clinicians better manage supplemental oxygen, improving postoperative outcomes.