Masimo (NASDAQ: MASI) today announced that in a study recently
published in the Journal of Tropical Pediatrics, researchers
evaluating Masimo SpHb® (noninvasive, continuous hemoglobin
monitoring) on neonatal patients concluded that the technology
“offers reliable Hb [hemoglobin] values, which are comparable with
the more traditional tHb [invasive venous blood sampling].”1
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Masimo Root® with SpHb® (Photo: Business
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Noting that “iatrogenic anemia caused by diagnostic blood
sampling is a common problem in intensive care units,” especially
in neonatal intensive care units (NICUs), and that diagnostic blood
sampling also has implications for infection control and health
care costs, Drs. Halil Kazanasmaz and Mahmut Demir at Harran
University in Sanliurfa, Turkey sought to assess the efficacy of
noninvasive, continuous hemoglobin monitoring with SpHb on neonates
by comparing it to conventional tHb. To investigate this, they
studied 310 neonatal patients in a level III NICU in Turkey.
Immediately after patients had blood drawn for tHb analysis using a
hematological laboratory analyzer, their SpHb values (alongside
other noninvasive measurements) were recorded using a Masimo
Radical-7® Pulse CO-Oximeter® with rainbow® sensors placed on the
neonate’s left foot.
Using Bland-Altman analysis, the researchers found a mean bias
of 0.05 g/dL between tHb and SpHb, with limits of agreement of
-1.85 and 1.96 g/dL. Based on the study results, they concluded,
“In this study, it was found that the SpHb measurement method could
yield reliable results similar to tHb measurement method in the
newborns. It is thought that the SpHb method may have a
complementary role in reducing unnecessary blood sampling and
therefore iatrogenic anemia, especially in the newborns with
anemia. Further clinical studies are needed to define the
effectiveness of this measurement method in critically ill patients
with circulatory disorders.”
In a similar study published earlier this year in the Journal of
Clinical Neonatology, Drs. Ahmed Jamal and Biju John at Armed
Forces Medical College in Pune, India, compared conventional
laboratory hemoglobin to SpHb in 100 hemodynamically stable
neonatal patients at a tertiary hospital in southern India.2 To
measure SpHb, they similarly used Radical-7 devices with rainbow®
sensors, but the sensors were placed on the babies’ wrists instead
of the foot. Analyzing the paired Lab-Hb and SpHb data with
Bland-Altman analysis, the researchers found “a good visual
agreement between the Lab-Hb and SpHb values,” and calculated bias
± precision of 0.763 ± 1.349 g/dL. Drs. Jamal and John similarly
concluded that SpHb is “an efficacious method of assessing Hb trend
among neonates.”
In clinical studies with adult patients, continuous monitoring
with SpHb as part of blood management programs has been shown to
improve outcomes, such as reducing the percentage of patients
receiving transfusions,3 reducing the units of red blood cells
transfused per patient,4-5 reducing the time to transfusion,6
reducing costs,7 and even reducing mortality 30 and 90 days after
surgery by 33% and 29%, respectively.8 Today, SpHb technology
supports clinicians in over 75 countries around the world.9
SpHb is not intended to replace laboratory blood testing.
Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering, among other factors,
patient condition, continuous SpHb monitoring, and laboratory
diagnostic tests using blood samples.
Noninvasive, continuous SpHb for neonatal patients received CE
marking in August 2019, and SpHb is now available for patients of
all ages in CE marked countries. Noninvasive, continuous SpHb has
received FDA clearance for patients > 3 kg but is not currently
indicated for patients < 3 kg in the U.S.
@MasimoInnovates | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.10 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,11 improve CCHD screening in newborns,12 and, when used
for continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.13-16 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,17 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.18 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET®
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. 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®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius PPG™, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97®. Masimo hospital
automation and connectivity solutions are centered around the
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and
Masimo SafetyNet™. Additional information about Masimo and its
products may be found at www.masimo.com. Published clinical studies
on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Kazanasmaz H, Demir M. The Comparison of Hemoglobin Values
Measured by Blood and Continuous Non-Invasive Monitoring (SpHb) in
Newborn Infants. J Trop. Pediatrics. 2020,0,1o-6. DOI:
10.1093/tropej/fmaa050.
- Jamal A, John B. Efficacy of Noninvasive Hemoglobin Measurement
by Pulse CO-Oximetry in Neonates. J Clin Neonatol.
2020;9:57-62.
- Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin
Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood
Disorders Transf. 2014. 5:9. 2.
- Awada WN et al. Continuous and noninvasive hemoglobin
monitoring reduces red blood cell transfusion during neurosurgery:
a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
- Imaizumi et al. Continuous and noninvasive hemoglobin
monitoring may reduce excessive intraoperative RBC transfusion.
Proceedings from the 16th World Congress of Anaesthesiologists,
Hong Kong. Abstract #PR607.
- Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin
Monitoring in Intraoperative Blood Transfusion Practice During
Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
- Ribed-Sánchez B et al. Economic Analysis of the Reduction of
Blood Transfusions during Surgical Procedures While Continuous
Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367;
doi:10.3390/s18051367.
- Cros J et al. Continuous hemoglobin and plethysmography
variability index monitoring can modify blood transfusion practice
and is associated with lower mortality. J Clin Monit Comp. 3 Aug
2019. https://doi.org/10.1007/s10877-019-00367-z.
- Masimo data on file.
- 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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 SpHb®. 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 SpHb, 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; risks related to
COVID-19; 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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