NEUCHATEL, Switzerland--(BUSINESS WIRE)--Feb. 25, 2019--
Masimo (NASDAQ:
MASI) announced today the findings of a series of four clinical cases,
recently published in the Canadian Journal of Anesthesiology, in
which researchers at the University of Montreal found that combined use
of Masimo SedLine® brain function monitoring and O3®
regional oximetry assisted their understanding and management of
cerebral desaturations during cardiac surgery.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20190224005089/en/
Masimo Root® with SedLine® and O3® (Photo: Business Wire)
Drs. Etienne Couture, Alain Deschamps, and André Denault hypothesized
that the addition of processed electroencephalography (pEEG) using
Masimo SedLine’s processed EEG parameter, the Patient State Index (PSi),
to a previously developed clinical management algorithm based on Masimo
O3 near-infrared spectroscopy (NIRS), could help guide the management of
cerebral desaturation episodes. In this series of case studies, they
describe the impact of combining the modalities on the clinical
management of four patients undergoing cardiac surgery. The researchers
then outline a series of scenarios that enumerate possible causes of
desaturation based on various combinations of changes in NIRS and pEEG,
as well as changes in related monitoring data available via SedLine,
such as the density spectral array (DSA) and spectral edge frequency
(SEF). Possible causes include a change in cerebral blood flow, cerebral
hypoperfusion, cardiogenic shock, hypoxemia, a change in the anesthetic
state, hyperthermia, and seizure. In the four cases, more insight into
the likely cause of a desaturation episode helped guide how clinicians
responded during surgery.
The researchers concluded, “Combining both NIRS and pEEG allows for a
much more nuanced understanding of the etiology of cerebral
desaturation. Future studies are needed to investigate if the
combination of both modalities is more prognostic than each alone. Every
cerebral oxygen desaturation is not equal.”
Dr. Denault commented, “By combining NIRS and pEEG we were able to have
a better appreciation of the significance of brain desaturation, and
using Masimo O3 and SedLine in particular to obtain those measurements
provided a number of advantages. The additional brain monitoring
parameters available through Masimo SedLine, such as the DSA and SEF,
play an important role in our protocol, helping to provide additional
insight. And, perhaps most significantly, both SedLine and O3 can be
used simultaneously on the same Masimo Root® monitoring hub,
making it easier to view and interpret the combined data and thus
streamlining our use of the desaturation protocol and workflow during
surgery.”
Masimo O3 is not currently indicated for somatic use.
@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
|
|
|
|
1.
|
|
|
Couture EJ, Deschamps A, and Denault AY. Patient management
algorithm combining processed electroencephalographic monitoring
with cerebral and somatic near-infrared spectroscopy: a case series.
Can J Anesth. 2019. https://doi.org/10.1007/s12630-019-01305-y.
|
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 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.
|
6.
|
|
|
Taenzer A et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
|
7.
|
|
|
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.
|
8.
|
|
|
Estimate: Masimo data on file.
|
9.
|
|
|
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 SedLine® and 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 SedLine and 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190224005089/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com