NEUCHATEL, Switzerland--(BUSINESS WIRE)--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.
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.
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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 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 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
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.
