IRVINE, Calif.--(BUSINESS WIRE)--Feb. 22, 2018--
Masimo (NASDAQ:
MASI) announced today the findings of a recently published study in
which researchers at Michigan State University evaluated the performance
of noninvasive hemodynamic monitoring (NIHM) using Masimo noninvasive
and continuous hemoglobin (SpHb®), as compared to invasive
laboratory hemoglobin (LabHb) monitoring, in clinically stable pediatric
trauma patients with solid organ injury.1
This press release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20180222005495/en/
Masimo Radical-7® with SpHb® (Photo: Business Wire)
In the study, Dr. Welker and colleagues utilized data from 21 patients
under 18 years of age who had experienced blunt trauma, with a mean
injury severity score of 16.6. Their hemodynamic status was assessed
using physical examination and vital signs in conjunction with periodic
LabHb monitoring per normal institutional pediatric trauma guidelines.
In addition, NIHM using Masimo SpHb was measured continuously using a
Masimo Radical-7® Pulse CO-Oximeter®, and SpHb
values were recorded at multiple times to correspond with LabHb blood
draws.
Using Bland-Altman analysis, the researchers calculated an average bias
of 0.80 g/dL between SpHb and LabHb, with a 95% confidence interval of
+3.94 g/dL to -2.33 g/dL. They noted that, “Measurement trends were
highly correlated in patients with stable hemoglobin levels and those
requiring blood transfusion.”
The investigators concluded that, “NIHM demonstrated clinically
acceptable accuracy when following hemoglobin trends in the defined
pediatric trend patient population. Slight variances between NIHM and
LabHb values were occasionally noted, but did not affect clinical
management. Continuous NIHM represents a potentially valuable adjunct to
traditional laboratory hemoglobin monitoring.”
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.
@MasimoInnovates |
#Masimo
Reference
-
Welker E, Novak J, Jelsma L, Koehler T, Davis A, DeCou J, and Durkin
E. Continuous hemoglobin monitoring in pediatric trauma patients with
solid organ injury. J Pediatr Surg. 2018. https://doi.org/10.1016/j.jpedsurg.2017.12.015.
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 multiple studies to significantly reduce false alarms and
accurately monitor for true alarms. Masimo SET® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
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,6 and is the primary pulse oximetry at 17 of the top 20
hospitals listed in the 2017-18 U.S. News and World Report Best
Hospitals Honor Roll.7 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/cpub/clinical-evidence.htm.
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
-
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 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.
-
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; 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/20180222005495/en/
Source: Masimo
Media Contact:
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com