Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring
March 04 2019 - 3:14AM
Business Wire
Next Generation SedLine Now Available for Use
on Patients 1-18 Years Old in CE Mark Countries
Masimo (NASDAQ: MASI) announced today the CE marking of
Next Generation SedLine® brain function monitoring for pediatric
patients (1-18 years of age). With this clearance, the benefits of
Next Generation SedLine are available for all patients one year old
and above in CE mark countries. SedLine helps clinicians monitor
the state of the brain under anesthesia with bilateral data
acquisition and processing of four leads of electroencephalogram
(EEG) signals.
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Masimo Root® with Next Generation
SedLine® (Photo: Business Wire)
SedLine uses a pediatric-specific signal processing engine to
improve performance of Masimo’s processed EEG parameter, the
Patient State Index (PSi), when monitoring pediatric patients one
year old and above. The use and monitoring of anesthesia on
pediatric patients can differ from its use on adults.1-2
Maintaining an appropriate level of anesthesia is key to preventing
anesthesia-related events and enabling faster recovery.3 The PSi in
SedLine, driven by its pediatric-specific engine, is uniquely
suited to helping clinicians interpret the EEGs of this challenging
population.
In addition to the newly announced pediatric-specific signal
processing when used on pediatric patients, Next Generation SedLine
offers significant improvements over original SedLine,
including:
- A PSi with less susceptibility to
electromyography (EMG) interference.
- A Multitaper Density Spectral Array
(DSA), which may enhance visibility of EEG features.
Joe Kiani, Founder and CEO of Masimo, said, “Next Generation
SedLine is doing for brain function monitoring what Masimo SET® did
for pulse oximetry. We believe Next Generation SedLine is the best
and most advanced way to monitor depth of sedation, crucial to
helping ensure patients with even the most challenging brains are
appropriately anesthetized. We are gratified that its benefits are
now available to those younger patients whose brains are
particularly delicate and to whose wellbeing Masimo has always been
so committed.”
Next Generation SedLine has received FDA clearance for adults
but is not currently indicated for pediatric patients in the
USA.
@MasimoInnovates | #Masimo
About MasimoMasimo (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.4 Masimo SET® has also been shown to help
clinicians reduce severe retinopathy of prematurity in neonates,5
improve CCHD screening in newborns,6 and, when used for continuous
monitoring with Masimo Patient SafetyNet™ in post-surgical wards,
reduce rapid response activations and costs.7-9 Masimo SET® is
estimated to be used on more than 100 million patients in leading
hospitals and other healthcare settings around the world,10 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.11
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
- Davidson et. Current Anesthesiology
Reports 3. 1 (2013): 57-63.).
- Cornelissen L et al. Elife 4 (2015):
e06513.
- Musialowicz et al. Current
Anesthesiology Reports 4. 3 (2014): 251-260.
- 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 StatementsThis 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 Next Generation SedLine. 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
Next Generation SedLine, 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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