New Neonatal Study Adds to Body of Clinical
Evidence Demonstrating Masimo SET® Pulse Oximetry’s Unique Ability
to Improve Care
Masimo (NASDAQ: MASI) provides a variety of innovative
monitoring solutions designed to improve maternal and newborn
safety during childbirth and the critical first minutes of life.
Masimo SET® pulse oximetry’s ability to measure during motion and
low perfusion has helped newborns, neonates, and pediatric patients
like no other pulse oximetry. Not only has Masimo SET® helped
clinicians reduce retinopathy of prematurity (ROP)1 and improve
screening for critical congenital heart disease (CCHD),2-10 but it
has helped push the standard of care for babies to new heights—the
evidence from CCHD studies with SET®, for example, has been used in
the establishment of screening guidelines used around the
world.11
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Masimo Newborn Sensor (Photo: Masimo)
Today, on International Women’s Day, it is especially important
to recognize that, as UNICEF reports, “newborns and mothers are
still dying in appalling numbers.” Every day, approximately 7,000
babies in the first month of life die, and approximately 810 women
die, from preventable complications related to childbirth or
pregnancy.12 Similarly, according to the WHO, “Although important
progress has been made in the last two decades, about 295,000 women
died during and following pregnancy and childbirth in 2017. The
most common direct causes of maternal injury and death are
excessive blood loss, infection, high blood pressure, unsafe
abortion, and obstructed labor, as well as indirect causes such as
anemia, malaria, and heart disease.”13
Masimo’s first and ongoing focus has been helping
neonatologists, pediatricians, OB-GYNs, and midwives around the
world provide the best care possible for newborns and their
mothers. The Masimo Newborn Sensor, the first and still the only
sensor of its kind, was introduced in 2004 and is designed to
provide accurate arterial oxygen saturation (SpO2) and pulse rate
(PR) measurements in the fastest time possible during hectic
neonatal resuscitation scenarios. Alongside Newborn Sensors,
Pathway™, introduced in 2019 for the Root® platform, helps
clinicians visualize their preferred SpO2 and PR protocol during
neonatal resuscitation. Eve™, a software application introduced in
2014, simplifies and automates the CCHD screening process, which
Masimo SET® enabled. The Blue® Sensor, introduced in 2004, provides
accurate monitoring in cyanotic children at low SpO2 levels to help
clinicians care for them and was validated specifically on infants
with cyanotic disease.14 rainbow® SpHb®, noninvasive hemoglobin
monitoring, introduced in 2008, can measure hemoglobin levels
during pregnancy and alert clinicians to the possibility of
excessive blood loss during delivery.
Adding to the significant body of clinical evidence
demonstrating the utility of SET® pulse oximetry and other Masimo
newborn and maternal solutions, a new study published in the
Journal of Clinical Neonatology investigated the use of comparing
Masimo perfusion index (Pi) pre- and post-ductal values on pre-term
infants to aid clinicians in diagnosing hemodynamically significant
patent ductus arteriosus (hsPDA).15 Dr. Melek Büyükeren and
colleagues at Hacettepe University in Ankara, Turkey found that the
difference in right-hand and right-leg Pi values obtained using
Masimo SET® pulse oximetry was significantly higher in pre-term
infants with hsPDA, leading them to conclude that the difference in
Pi “has diagnostic value in hsPDA and can assist diagnosis when
echocardiography is not available.”
Marcelo Cardetti, MD, said, “As Head of the Neonatology Service
of the Clinic and Maternity of the Center for Endocrinology and
Human Reproduction (CERHU) in San Luis, Argentina, we have been
using Masimo pulse oximetry monitors with SET® for approximately 8
years in all high-risk newborns and also for newborn resuscitation.
In addition, we use Masimo SET® monitors for the detection of CHD
and hypoxemia in all newborns in the mother-infant unit.
Furthermore, our neonatal department is engaged in a research
protocol on regional cerebral oxygenation (O3®) with neonatal
sensors for Masimo Root - to know what happens with cerebral
oxygenation during routine clinical procedures in the NICU. This
monitoring, in addition to SpO2 and perfusion index (Pi), perfectly
shows us what is happening with oxygenation of seriously ill
newborns in real-time and in a noninvasive way. Masimo SET®’s
innovative technology far overcomes the limitations of conventional
oximetry and the Pi is an important clinical tool in the care of
sick neonates. This monitor and the special neonatal RD sensors
have been of great value for the prevention of ROP and for
successful and quick, accurate, and reliable steps needed in
resuscitation in the delivery room.”
Hernando Baquero, MD, commented, “I am a pediatrician,
neonatologist, clinician, educator and researcher in a major
university in Colombia, with several publications on noninvasive
neonatal SpO2 monitoring and oxygenation. The introduction in the
Latin American market of Masimo SET® technology dramatically
improved neonatal care in our countries. In contexts with serious
resource limitations, as is the case in most neonatal units in our
countries, it was vital to be able to provide quality care to the
most vulnerable population due to their health conditions (e.g.
hypoperfusion) or their biological characteristics (e.g.
prematurity). Having reliable, fast, and stable readings as
provided by SET® and its neonatal sensors improved the chances of
many of our newborns.”
Anne de-Wahl Granelli, PhD, Biomedical Scientist, RDCS(PE),
Medical Centre Manager, Sweden, said, “The integration of pulse
oximetry into the CCHD screening process has made a significant
impact on the detection of congenital heart disease and neonatal
health. In clinical studies, the use of pulse oximetry screening
with SET® technology significantly improved the detection of duct
dependent heart disease before hospital discharge. In 2011, the
U.S. Department of Health and Human Services added pulse oximetry
screening of newborns for CCHD to the Recommended Uniform Screening
Panel. Today pulse oximetry has become a global standard of care
when screening newborns for CHD.”
Sergio Golombek, MD, MPH, FAAP, Member of the Board and Past
President of the Ibero-American Society of Neonatology (SIBEN),
said, “I have authored and published several scientific studies in
relation to newborn oxygenation and screening for CCHD. Masimo SET®
and new innovations and sensor development like RD sensors for
noninvasive monitoring represent excellent technology that we can
trust, that work promptly and accurately when we need it the most,
and are designed specifically with ill newborn babies in the NICU
in mind. SET® technology allows us also to do the pulse oximetry
test or CCHD screening on newborn babies in our units, knowing well
that we can fully trust the results. The technology is very easy to
use and understand, and makes us deliver better clinical care.”
Katsuyuki Miyasaka, MD, PhD, Executive Advisor, Wayo Women’s
University Graduate School, Tokyo and Professor Emeritus, St.
Luke’s International University, Tokyo, said, “As a critical care
pediatric anesthesiologist, reliable and accurate pulse oximetry is
paramount to optimal patient outcomes. Some suggest pulse oximetry
is the fifth vital sign. Clinicians can rely on the sensitivity and
specificity provided by Masimo’s measure-through-motion technology
in the management of children in the PICU. The use of pulse
oximetry can lead to fewer adverse events in the recovery room by
capturing accurate readings even during movement such as shivering
in critically ill or unstable patients.”
Mark Ansermino, MBBCh, MMed, Director of the Center for
International Child Health and Professor, Department of
Anesthesiology, Pharmacology & Therapeutics at the University
of British Columbia, Canada, said, “Anemia is a significant public
health problem that especially affects the quality of life, health
status, and survival of mothers and children around the world.
Having access to continuous hemoglobin monitoring technology can
help provide visibility to hemoglobin levels. The noninvasive
nature of the SpHb solution makes it comfortable for the mother and
child and makes monitoring during childbirth feasible even in
low-resource settings.”
Asrat Dibaba Tolossa, MD, MPH, is Chief of Party for the Global
Affairs Canada ENRICH (Enhancing Nutrition Services to Improve
Maternal and Child Health) Program, a multi-year, multi-country
initiative designed to improve the health and nutrition of mothers,
newborns, and children. As part of the program, ENRICH has been
conducting a study in central Tanzania, where maternal and child
care services are often overburdened, using the Masimo Rad-67®
Pulse CO-Oximeter®, which provides spot-check SpHb measurements.
Dr. Tolossa commented, “In our field experimentation with the
Rad-67, we found out that the device can be used easily by
lower-level health workers in the communities for screening and
referral of patients to health facilities for further assessment
and treatment. There was also a high acceptance rate by community
members as the method is noninvasive.”
Joe Kiani, Founder and CEO of Masimo, said, “From our inception,
we have been committed to improving outcomes for the youngest and
most fragile patients. Our foundational SET® pulse oximetry was
designed with newborns in mind. With rainbow® Pulse CO-Oximetry, we
have made the noninvasive monitoring of child and mother clinically
more meaningful. While we stand behind the fact that we have the
best pulse oximetry for all patients, especially the most fragile
patients, we continue to seek new ways to help clinicians provide
newborns and their mothers with the best care possible. On this
International Women’s Day, we thank the caregivers who have
dedicated themselves to the health of newborns and their mothers,
as well as women everywhere, for their achievements, their
sacrifices, and for nurturing us all.”
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 has CE clearance for all patients
and in the U.S. has received FDA clearance for patients >3 kg
but is not currently indicated for patients <3 kg. As part of
its U.S. FDA 510(k) clearance, spot-check SpHb on Rad-67 is
contraindicated for use on pregnant patients and not indicated for
use on pediatric patients or patients with renal disease. Eve has
not obtained FDA clearance and is not available in the United
States.
@Masimo | #Masimo
*ARMS accuracy is a statistical calculation of the difference
between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell within +/-
ARMS of the reference measurements in a controlled study.
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.16 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,4 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.17-20 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,21 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.22 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,
iSirona™, 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
- 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.
- Slitine N, et al. Pulse Oximetry and Congenital Heart Disease
Screening: Results of the First Pilot Study in Morocco. Int J
Neonatal Screen 6(53). 30 June 2020.
- Zhao et al. Pulse oximetry with clinical assessment to screen
for congenital heart disease in neonates in China: a prospective
study. Lancet. 2014 Aug 30;384(9945):747-54.
- 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.
- Ewer AK et al. Pulse Oximetry Screening for Congenital Heart
Defects in Newborn Infants (Pulseox): A Test Accuracy Study.
Lancet. 2011 Aug 27;378(9793):785-94.
- de-Wahl Granelli A et al. Noninvasive Peripheral Perfusion
Index as a Possible Tool for Screening for Critical Left Heart
Obstruction. Acta Paediatr 2007; 96(10): 1455-9.
- Meberg A et al. First Day of Life Pulse Oximetry Screening to
Detect Congenital Heart Defects. J Pediatr 2008; 152:761-5.
- Schena F et al. Perfusion Index and Pulse Oximetry Screening
for Congenital Heart Defects. J Pediatr. 2017 Apr;183:74-79.
- Hamilçıkan S, Can E. Critical Congenital Heart Disease
Screening With a Pulse Oximetry in Neonates. J Perinat Med. 2018
Feb 23;46(2):203-207.
- Jawin V et al. Beyond Critical Congenital Heart Disease:
Newborn Screening Using Pulse Oximetry for Neonatal Sepsis and
Respiratory Diseases in a Middle-Income Country. PLoS One. 2015;
10(9): e0137580.
- Kemper et al. Strategies for implementing screening for
critical congenital heart disease. Pediatrics. 2011
Nov;128(5):e1259-67. doi: 10.1542/peds.2011-1317.
- https://www.unicef.org/health/maternal-and-newborn-health
-
https://www.who.int/health-topics/maternal-health#tab=tab_1
- Harris B et al. Ped Crit Care Med. 2016 Apr;17(4):315-20.
- Büyükeren M, Yiğit S, Aykan HH, Karag�z T, Çelik HT, Yurdak�k
M. Comparison of perfusion index and echocardiographic parameters
in preterm infants with hemodynamically significant patent ductus
arteriosus. J Clin Neonatol 2021;10:11-8.
- 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.
- 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 SET®, Newborn Sensors,
Pathway™, Eve™, Blue®, rainbow®, and 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 SET®, Newborn
Sensors, Pathway, Eve, Blue, rainbow®, and 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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