Masimo (NASDAQ: MASI) announced today the findings of a
study, recently published in Anaesthesia and Intensive Care, in
which researchers at Austin Hospital in Melbourne, Australia sought
to measure cerebral oxygenation in a large cohort of healthy
volunteers, using Masimo O3® Regional Oximetry, to establish a
normal range of values and investigate the relationship between
cerebral oxygenation and other physical and hemodynamic
characteristics.1 O3 uses near-infrared spectroscopy (NIRS) to
monitor cerebral oxygenation in situations in which peripheral
pulse oximetry alone may not be fully indicative of the oxygen in
the brain.
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Masimo Root® with O3® Regional Oximetry
and Next Generation SedLine® Brain Function Monitoring (Graphic:
Business Wire)
Noting that “normative values for clinical devices are essential
to allow for definition of abnormality during clinical use” and
that available regional cerebral tissue oxygen saturation (SctO2)
reference values have limitations, including not taking into
account variables such as brain hemisphere, sex, skin type, height,
weight, and others, Dr. Christopher Eyeington and colleagues used
Masimo O3 to assess for differences in SctO2 between hemispheres,
sex, and comorbidity and smoking status, and for associations
between SctO2 and key physical and hemodynamic characteristics, in
healthy adults. They enrolled 98 volunteers, 22-60 years old,
including 41 males, 22 with one or more co-morbidities, 13 current
or former smokers, and with a variety of skin types. Each volunteer
was monitored continuously for five minutes using O3 on the Masimo
Root® Patient Monitoring and Connectivity Hub, with SctO2
measurements recorded every two seconds.
The researchers recorded 32,130 SctO2 observations. Mean left,
right, and combined average SctO2 values were 67.3%, 67.9%, and
67.6%, respectively, with a “narrow” combined average 95%
confidence interval of 66.8% to 68.6%. (None of the 95% confidence
intervals was lower than 66.5% or greater than 69.1%.) The
researchers found “statistically significant yet quantitatively
small differences” in SctO2 values according to hemisphere (p <
0.001). They also found that increasing mean arterial pressure
(MAP) (p = 0.001) and cardiac index (CI) (p ≤ 0.001) were
associated with increased SctO2: each 10 mmHg increase in MAP and 1
L/min/m2 increase in CI was associated with 0.01% and 0.1%
increases in SctO2, respectively.
The researchers noted, “Our study implies that in healthy adults
the mean SctO2 measured with modern technology is close to 68% with
narrow confidence intervals of 1%, and with no difference between
hemispheres. Moreover, given a lowest mean combined bi-hemispheric
SctO2 value of 56%, it implies that an SctO2 value below 56% should
be considered ‘abnormally low.’ In addition, the very few SctO2
values below 60% seen in our study imply that persistent
measurements below such a threshold should be viewed with concern.
Finally, our observation that SctO2 values were not affected in any
clinically significant amount by hemispheres, sex, skin type,
comorbidity or smoking status, age or any haemodynamic parameter
implies that in healthy adults, cerebral tissue oxygen saturation
is unaffected by these factors.” They concluded that “These
findings have significant implications regarding the clinical
interpretation of SctO2 and the application of this information to
individual patients.”
Study co-author Dr. Rinaldo Bellomo commented, “The estimation
of cerebral oxygenation by near infrared spectroscopy (NIRS) during
anesthesia or in critical illness is becoming increasingly
recognized as a desirable form of monitoring. Thus, it is vital for
clinicians to understand normal values and to have confidence in
the technology behind such measurements. The recent study by my
colleagues and myself used >30,000 observations in close to 100
normal subjects and found that the mean normal value for cerebral
oxygen estimation using modern Masimo NIRS technology was 67.6%,
and, more importantly, that the 95% confidence interval for such
value was narrow, between 66.8% and 68.6%. Such findings provide a
reference value for patient assessment and give a degree of
confidence to clinicians in relation to the validity and robustness
of this technology.”
@MasimoInnovates | #Masimo
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 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
activations and costs.5-7 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,8 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.9 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
- Eyeington C, Ancona P, Osawa E, Cutuli
S, Eastwood G and Bellomo R. Modern technology-derived normative
values for cerebral tissue oxygen saturation in adults. Anaesthesia
and Intensive are. 2019. DOI: 10.117.7/0310057X18811962.
- 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.
- 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.
- 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.
- 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.
- Taenzer A et al. Postoperative
Monitoring – The Dartmouth Experience. Anesthesia Patient Safety
Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
-
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 O3®. 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 O3, 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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MasimoEvan Lamb949-396-3376elamb@masimo.com
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