Business Wire

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

Share

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.”

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201213005053/en/

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

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.

@Masimo | #Masimo

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 costs5-8 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.

Contact information

Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Takeda Named Global Top Employer for Fourth Consecutive Year25.1.2021 03:00:00 EETPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it is one of only 16 companies to achieve global Top Employer® certification for 2021. In addition to receiving the global certification for the fourth consecutive year, Takeda was also certified as a Top Employer in four regions and 38 countries. This underscores the company’s commitment to creating an exceptional people experience for its global workforce. For more than 30 years, Top Employers Institute has given annual award certification to companies with outstanding culture, work environments, benefits and opportunities for their people. The Institute certifies organizations based on the results of its HR Best Practices Survey. The survey covers 20 people-centric topic areas, including Career Development, Culture, Diversity & Inclusion, Learning, Sustainability, Values, Well-being and Work Environment. “We are very proud of the global, regional and country recognition we’ve received from Top

GPD Companies, Inc. to Acquire Distrupol22.1.2021 16:33:00 EETPress release

GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0

Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 14:50:00 EETPress release

Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Dec. 31, 2020 Sept. 30, 2020 Dec. 31, 2019 Sequential Year-on-year Revenue $5,532 $5,258 $8,228 5% -33% Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4% Net income (loss) - GAAP basis $374 $(82) $333 n/m 12% Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33% Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bps Pretax segment operating income* $654 $575 $1,006 14% -35% Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bps Net income, excluding charges & credits* $309 $228 $545 35% -43% Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26% North America 1,167 1,034 2,339 13% -50% Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -

JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 09:00:00 EETPress release

JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment22.1.2021 01:12:00 EETPress release

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV H

Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)22.1.2021 00:30:00 EETPress release

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde

Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 19:45:00 EETPress release

Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom