New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in
Evaluating Pediatric Trauma Patients
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.
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com
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