MORIOKA, Japan--(BUSINESS WIRE)--Jul. 1, 2018--
Masimo (NASDAQ:
MASI) announced today the findings of a study in which researchers
evaluated the ability of Masimo ORi™ (Oxygen Reserve Index) to detect
declining blood oxygenation prior to standard oxygen saturation (SpO2)
monitoring in patients undergoing elective thoracic surgery requiring
one-lung ventilation (OLV).1
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Masimo Root® with Radical-7® and ORi™ (Photo: Business Wire)
ORi is a noninvasive, relative indicator of a patient’s oxygen reserve
in the moderate hyperoxic region (partial pressure of oxygen in arterial
blood [PaO2] in the range of 100 to 200 mmHg). As an “index”
parameter with a unit-less scale between 0 and 1, ORi can be trended and
has optional alarms to notify clinicians of changes in a patient’s
oxygen reserve.
In the study, Dr. Koishi and colleagues at Iwate Medical University in
Morioka, Japan sought to evaluate whether ORi could serve as an early
warning of desaturation in patients undergoing OLV, as such patients are
often prone to hypoxemia. To this end, they assessed whether ORi
decreased earlier than SpO2 during OLV, and evaluated how
well ORi correlated with an invasive PaO2 measurement. ORi
and SpO2 were measured every 2 seconds using a Masimo Root®
with Radical-7® Pulse CO-Oximeter® and rainbow®
sensors (revision L). The anesthesiologist was blinded to the ORi
values. For data analysis, the researchers defined the start of the
decrease in ORi as when its value fell below 0.05 less than its highest
value after OLV began, and the start of the decrease in SpO2
as when it was 1% less than the maximum SpO2 value. PaO2
was calculated as part of blood gas analysis and performed every 3
minutes during OLV, resulting in 101 pairs of measurements.
The researchers found that from the start of OLV, ORi started decreasing
significantly sooner than SpO2, a mean of 171 seconds vs. a
mean of 372 seconds, p<0.01 (standard deviation of 102 and 231 seconds,
respectively). They also found “a significant, strong correlation”
between ORi and PaO2: r2=0.671, p<0.01.
The researchers concluded, “ORi decreased significantly earlier than SpO2
during OLV, suggesting that monitoring ORi might allow earlier detection
of a deterioration of blood oxygenation than monitoring SpO2
alone, contributing to a reduction in the patient’s risk of exposure to
complications from OLV. However, further studies in different clinical
and experimental settings are needed to evaluate the superiority of the
ORi over SpO2.”
ORi has not received FDA 510(k) clearance and is not yet available for
sale in the United States.
@MasimoInnovates |
#Masimo
Reference
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1.
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Koishi W, Kumagai M, Ogawa S, Hongo S, and Suzuki K. Monitoring
the Oxygen Reserve Index can contribute to the early detection of
deterioration in blood oxygenation during one-lung ventilation. Minerva
Anestesiologica. 14 May 2018. DOI:
10.23736/S0375-9393.18.12622-8.
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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. 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. Masimo SET® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 and is the primary pulse oximetry at 17 of the top 20
hospitals listed in the 2017-18 U.S. News and World Report Best
Hospitals Honor Roll.7 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®), and more
recently, Oxygen Reserve Index (ORi™), in addition to SpO2,
pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®,
an intuitive patient monitoring and connectivity platform with the
Masimo Open Connect® (MOC-9®) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in mHealth
with products such as the Radius-7® wearable patient monitor,
iSpO2® pulse oximeter for smartphones, and the
MightySat™ fingertip pulse oximeter. Additional information about Masimo
and its products may be found at www.masimo.com.
Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale
in the United States.
*The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
References
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1.
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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.
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2.
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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.
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3.
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Taenzer AH 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.
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4.
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Taenzer AH et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
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5.
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McGrath SP 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.
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6.
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Estimate: Masimo data on file.
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7.
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http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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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; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180701005059/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com