IRVINE, Calif.--(BUSINESS WIRE)--Feb. 21, 2017--
Masimo (NASDAQ:
MASI) announced today the findings of a recent study conducted on
children admitted to a Ugandan hospital with fever and malaria, in which
Masimo’s noninvasive measurement SpMet® was used to monitor
methemoglobin (MetHb) levels. One group of children with severe malaria
was selected to receive inhaled nitric oxide (iNO) treatment as an
adjunct to intravenous therapy while a placebo group received room air.
Both of these groups were monitored with SpMet.1
Red blood cells containing hemoglobin can become oxidized in the
presence of certain drugs and compounds, including nitric oxide,
changing it to methemoglobin (MetHb), which impairs the oxygen-carrying
capacity of blood. When MetHb levels rise, headache, respiratory
distress, cyanosis, and finally death may occur. A 2004 study conducted
at Johns Hopkins Hospital reported that 20% of the patients tested, from
neonates to geriatrics, had elevated MetHB caused by the side effects of
40 drugs given to patients in hospitals, including nitric oxide. Three
patients nearly died and one patient died from elevated MetHb during the
study period.2
An estimated 1.2 million people die from malaria annually worldwide,
with a mortality rate of 8-20% in children with severe malaria.3
In the Ugandan study, Dr. Andrea Conroy and colleagues at Jinja Regional
Referral Hospital assessed an adjunctive therapy for malarial patients:
the administration of inhaled nitric oxide (iNO) – but as iNO is
absorbed by the body, it “induces MetHb in a dose-dependent manner.”
Noting that “[t]here are no reliable estimates of methemoglobinemia in
low resource clinical settings,” but seeking to “evaluate whether iNO
could improve clinical recovery…in a cohort of children with severe
malaria,” the investigators chose to monitor MetHb levels during
treatment with a Masimo Rad-57® Pulse CO-Oximeter®
with noninvasive SpMet monitoring.
The investigators in Uganda selected 180 children admitted to the
hospital with severe malaria between 2011 and 2013 to receive either iNO
(n=88) or a placebo, room air (n=92), in conjunction with standard
anti-malarial treatment. MetHb levels were measured on a four-hourly
basis following gas initiation, using Masimo SpMet. Between gas
initiation and the first check with SpMet, MetHb levels rose from an
average of 1.8% to 4.1% for the iNO group but stayed the same (1.7% to
1.8%) in the placebo group. MetHb levels typically plateaued within
12-24 hours of receiving iNO. Gas was withdrawn for 31 children
(placebo: 12; iNO: 19; p=0.13).
The researchers stated that “we were able to evaluate the variability in
MetHb responses within subjects and the frequency of methemoglobinemia
prompting study gas discontinuation. Despite the high doses of iNO
administered, study gas was temporarily discontinued only five times for
MetHb >10% (all children in the iNO group). We were able to re-start
study gas for all children that had a MHb measurement that exceeded 10%
once the MetHb returned to <7 % without having the MetHb exceed 10%
again. It was not necessary to wean children off iNO, in contrast to
studies administering iNO to neonates with hypoxic respiratory failure,
as we did not observe any rebound effects (e.g. worsening oxygenation)
following discontinuation of study gas.”
The authors concluded that, “Hospitalized children with evidence of
impaired oxygen delivery, metabolic acidosis, anemia, or malaria were at
risk of methemoglobinemia. However, we demonstrated high-dose iNO could
be safely administered to critically ill children with severe malaria
with appropriate MHb monitoring.”
Joe Kiani, Founder and CEO of Masimo, stated, “It’s great to see that
our invention of continuous methemoglobin monitoring has allowed these
clinicians to study the outcomes of administering iNO treatment. We hope
to continue developing monitoring technologies that help to address such
public health crises.”
SpMet monitoring is not intended to be used as the sole basis for making
diagnosis or treatment decisions. It is intended to be used in
conjunction with other clinical tools, including signs and symptoms and
laboratory blood tests.
@MasimoInnovates |
#Masimo
References
-
Conroy et al. Methemoglobin and nitric oxide therapy in Ugandan
children hospitalized for febrile illness: results from a prospective
cohort study and randomized double-blind placebo-controlled trial. BMC
Pediatrics. (2016) 16:177. DOI 10.1186/s12887-016-0719-2.
-
Ash-Bernal et al. Acquired methemoglobinemia: A retrospective series
of 138 cases at 2 teaching hospitals. Medicine. October
2004;83(5)265-73. DOI 10.1097/01.md.000141096.00377.3f.
-
Murray et al. Global malaria mortality between 1980 and 2010: a
systematic analysis. Lancet. 2012;379(9814):413-31.
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 by taking noninvasive monitoring to new sites
and applications. In 1995, the company debuted Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, which has been
shown in multiple studies to significantly reduce false alarms and
accurately monitor for true alarms. Masimo SET® has also been
shown to helps clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring in post-surgical wards, reduce
rapid response activations and costs.3,4,5 Masimo SET®
is estimated to be used on more than 100 million patients in leading
hospitals and other healthcare settings around the world. 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®), and more
recently, Pleth Variability Index (PVi®) and Oxygen Reserve
Index (ORi™), in addition to SpO2, pulse rate, and perfusion
index (PI). Studies with SpHb have shown reductions in unnecessary blood
transfusion*,6,7 and when used with PVi, reductions in length
of hospital stay8 and 30- and 90-day mortality.9
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/cpub/clinical-evidence.htm.
*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.
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.
-
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;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 AH 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.
-
Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring
during Orthopedia 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.
-
Thiele RH et al. Standardization of Care: Impact of an Enhanced
Recovery Protocol on Length of Stay, Complications, and Direct Costs
after Colorectal Surgery. JACS (2015). doi:
10.1016/j.jamcollsurg.2014.12.042.
-
Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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 SpMet®. 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 SpMet, contribute to positive clinical
outcomes and patient safety; 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: http://www.businesswire.com/news/home/20170221005629/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com