NEUCHATEL, Switzerland--(BUSINESS WIRE)--Feb. 4, 2016--
Masimo
(NASDAQ: MASI) announced today that in a new clinical study, Masimo’s
Oxygen Reserve Index (ORI™), the first noninvasive and continuous
parameter to provide insight into patients’ oxygen reserve when they are
receiving supplemental oxygen, helped clinicians in the early
identification of impending desaturation in pediatric patients during
induction of anesthesia.1
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Masimo Root® with ORI™ (Photo: Business Wire)
Oxygen saturation (SpO2) using pulse oximetry provides
noninvasive, continuous visibility to arterial blood oxygenation in
hypoxia (lower than normal oxygenation) and normoxia (normal
oxygenation). For procedures such as induction of anesthesia and
intubation, clinicians will usually build an “oxygen reserve” in the
patient by providing supplemental oxygen or “pre-oxygenation,” creating
a transitional state of hyperoxia (higher than normal oxygenation). The
extent of hyperoxia can be determined by the measured partial pressure
of oxygen in the blood (PaO2), which requires invasive
arterial blood sampling and laboratory analysis. When patients have low
oxygen reserve prior to intubation of the trachea, they are susceptible
to sudden hypoxia, depending upon the time taken to perform the
intubation.
ORI, Masimo’s 11th rainbow® parameter2, is a relative index
of the partial pressure of oxygen in arterial blood (PaO2)
within the range of 100 to 200 mmHg that can provide insight into
significant changes in oxygen reserve. ORI is intended to supplement,
not replace, SpO2 monitoring and PaO2 measurements.
In a prospective study published in Anesthesiology and conducted
at Children’s Medical Center in Dallas, Texas, Dr. Peter Szmuk and
colleagues evaluated whether ORI could provide a clinically important
warning of impending desaturation in pediatric patients with induced
apnea after pre-oxygenation. The investigators enrolled 33 patients in
this study. Eight of these resumed spontaneous ventilation during the
study period, leaving 25 apneic patients to evaluate, with an average
age of 7.6 years. Data were recorded continuously by the Masimo
Radical-7® Pulse CO-Oximeter®, connected to the patient through an R1
25L rainbow® sensor. ORI was retrospectively calculated and was not
visible to investigators.
After pre-oxygenation with supplemental oxygen, anesthesia induction,
and endotracheal intubation, the anesthesia circuit was disconnected and
SpO2 was allowed to decrease to 90% before ventilation
recommenced. During the period of apnea, the ORI progressively decreased
from a mean of 0.73±0.2 at the beginning of apnea to 0.37±0.1. The SpO2
remained at 100% during this initial period. After decreases in ORI that
would trigger the ORI alarm if monitored in real time, there was a
median elapsed time of 31.5 seconds before the SpO2 decreased
to 98%. After reinstitution of ventilation, SpO2 values
declined further to 88%, before recovering to 98%, 34 seconds later. The
researchers concluded that “In this pilot study, we found that during
prolonged apnea in healthy anesthetized children, the ORI detected
impending desaturation in median of 31.5 seconds (IQR, 19 to 34.3
seconds) before noticeable changes in SpO2 occurred. Knowing
even roughly how much time remains before the rapid desaturation phase
begins seems likely to guide proper decisions.”
Radical-7® with Root® has a CE Mark with the ORI parameter. ORI is not
FDA cleared and is not available for sale in the United States.
@MasimoInnovates
| #Masimo
1. Szmuk P, Steiner JW, Olomu, PN, Ploski, RP, Sessler, DI, Ezri, T.
Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A
Pilot Study. Anesthesiology 2016; 124:00-00.
doi:10.1097/ALN.0000000000001009.
2. 11 parameters include: 1) Oxygen saturation (SpO2); 2)
Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI®);
5) Respiration Rate from the pleth (RRp®); 6) Total hemoglobin (SpHb®);
7) Oxygen Content (SpOC™); 8) Carboxyhemoglobin (SpCO®); 9)
Methemoglobin (SpMet®); 10) Fractional oxygen saturation (SpfO2®); 11)
Oxygen Reserve Index (ORI™)
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. The benefits of Masimo SET® have
been proven in more than 100 independent and objective studies and it 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 open architecture patient monitoring and connectivity
platform designed to speed the pace of innovation and reduce the cost of
care. 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.
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’s Oxygen Reserve Index (ORI™). 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 ORI™, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160204005527/en/
Source: Masimo
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com