IRVINE, Calif.--(BUSINESS WIRE)--Jul. 14, 2016--
Masimo
(NASDAQ: MASI) announced today that in a new study using the 1st
Generation Masimo Pronto® Pulse CO-Oximeter®,
which noninvasively measures total hemoglobin (SpHb®),
researchers found that noninvasive and invasive measurements correlated
well and that “[g]iven the rapid availability of results and the lack of
requirement of venipuncture, noninvasive hemoglobin monitoring may be a
valuable adjunct in the initial evaluation and monitoring of pediatric
trauma patients.”1
Pronto features rainbow SET™ technology, allowing for the noninvasive
spot checking of SpHb, oxygen saturation (SpO2), pulse rate
(PR), and perfusion index (PI).
In the study, published online in the Journal of Trauma and Acute
Care Surgery and conducted at the University of Tennessee Health
Science Center, Le Bonheur Children’s Hospital, Dr. Mark Ryan and
colleagues evaluated noninvasive SpHb measurement accuracy relative to
current invasive and point-of-care testing in pediatric trauma patients.
They performed a prospective observational trial involving 114 patients
under age 17, measuring hemoglobin levels with a point-of-care device
(i-STAT) and a lab analyzer (Sysmex XN Series). Noninvasive hemoglobin
measurement, using 1st Generation Pronto, was performed
within 15 minutes of phlebotomy.
Of the 114 patients, SpHb was successfully measured 89% of the time.
Mean lab hemoglobin was 12.6 ± 1.9 and mean SpHb was 12.3 ± 1.6 (mean
point-of-care hemoglobin was 12.2 ± 2.0). Bland-Altman analysis showed
the limits of agreement between lab hemoglobin and non-invasive SpHb to
be -2.9 and 1.9, with a mean difference of -0.49.
The researchers concluded that they were able to demonstrate “low bias
and strong correlation between hemoglobin measurements using a
noninvasive monitor, a point-of-care testing device, and laboratory
co-oximeter in pediatric trauma patients.” They noted that noninvasive
SpHb testing “may be most effective in determining when invasive testing
of hemoglobin is warranted.”
Key limitations to the study include: the majority of the hemoglobin
values measured were within normal limits; limited data on injury
severity, morbidity, and mortality to understand their effects on device
accuracy and precision; data is based on a convenience sample depending
on availability of certified personnel; and no assessment on the effects
of pre-hospital administration of intravenous fluids.
The researchers noted that “[f]urther study is required to determine the
clinical utility of the [Pronto] device during the initial assessment
and its accuracy in evaluating hemoglobin levels in hemodynamically
unstable patients.” They stated that SpHb measurements should not be
relied upon alone to determine active hemorrhage or the need for
transfusion, and suggested the following reasons a noninvasive
measurement could not be taken in 11% of the study’s participants:
severe anemia; patients who were normotensive but tachycardic; patients
unreadable due to the presence of nail polish; and cold extremities or
low signal IQ without hemodynamic instability or anemia.
The University of Tennessee Health Science Center received equipment
from Masimo to support the data collection for this study.
@MasimoInnovates
| #Masimo
References
-
Ryan, Maxwell, Manning, Jacobs, Bachier-Rodriguez, Felizm, and
Williams. “Noninvasive hemoglobin measurement in pediatric trauma
patients.” Journal of Trauma and Acute Care Surgery. DOI:
10.1097/TA.0000000000001160. E-published ahead of print.
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® 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). In 2014, Masimo
introduced Root®, an intuitive patient monitoring and
connectivity platform with the Masimo Open Connect™ (MOC-9™) interface.
Masimo is also taking an active leadership role in mHealth with products
such as the Radius-7™ wearable patient monitor and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and its
products may be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 Pronto® Pulse CO-Oximeter with 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 Pronto Pulse CO-Oximeter with
SpHb, contribute to positive clinical outcomes and patient safety; risks
related to our belief that Masimo noninvasive medical breakthroughs
provide cost-effective solutions with comparable accuracy and unique
advantages, including: immediate and continuous results that enable
earlier treatment without causing invasive trauma in all patients and in
every clinical situation; 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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Source: Masimo
Masimo
Irene Paigah, 858-859-7001
[email protected]