NEUCHATEL, Switzerland--(BUSINESS WIRE)--Mar. 31, 2016--
Masimo
(NASDAQ: MASI) announced today that a new retrospective study reports
the relationship between Masimo’s Oxygen Reserve Index (ORI™) and
arterial partial pressure of oxygen (PaO2) during surgery.
The study suggests that ORI may provide an advanced indication of
impending desaturation in adults undergoing surgery based on trends in
the relationship between ORI and PaO2.1
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Masimo Root with ORI (Photo: Business Wire)
ORI, Masimo’s 11th rainbow® parameter2,which
is available outside of the United States, is a relative index of the PaO2
operating in the range of 100 to 200 mm Hg. ORI can provide a calculated
oxygen reserve index that may add to information from pulse oximetry
when oxygen saturation (SpO2) is >98%. ORI is intended to
supplement, not replace, SpO2 monitoring and PaO2
measurements.
In the study, published in the journal Anesthesia & Analgesia and
conducted at Loma Linda University, Dr. Applegate and colleagues studied
106 patients in which arterial catheterization and intraoperative
arterial blood gas analysis were planned during surgery. Multiwavelength
Pulse CO-oximetry data from multiple sensors on each patient were
continuously collected (Masimo Radical-7® with Root®).
A retrospective analysis was then conducted to evaluate the ORI to PaO2
relationship.
Regression analysis showed a positive ORI to PaO2
relationship for PaO2 values up to 240 mm Hg (r2 =
0.536), but not for PaO2 over 240 mm Hg (r2 =
0.0016). Measured PaO2 was ≥100 mm Hg for all ORI values over
0.24, and when ORI was higher than 0.55, the measured PaO2
was ≥150 mm Hg in 96.6% of samples.
The investigators concluded, “This study suggests that intraoperative
ORI can distinguish PaO2 between 100 and 150 mm Hg when SpO2
is >98%. Decreases in ORI to near 0.24 may provide advance indication of
falling PaO2 when SpO2 is still >98% and above the
PaO2 level at which SaO2 [arterial oxygen
saturation] declines rapidly. Usefulness of ORI >0.24 to distinguish PaO2
≥100 mm Hg and ORI >0.55 to distinguish PaO2 ≥150 mm Hg
should be tested prospectively in a range of clinical settings.”
Additionally, the investigators noted that “the clinical utility of
interventions based on continuous ORI monitoring should also be studied
prospectively,” and that other clinical or feasibility limitations may
not have been identified. The authors also noted that the study was
limited by a small number of subjects and samples with PaO2
values <100 mm Hg, and that the study results did not apply to intensive
care settings.
The Loma Linda University School of Medicine, Department of
Anesthesiology received a grant from Masimo to support the data
collection for this study.
Radical-7 with Root has a CE Mark with the ORI parameter. ORI has not
received FDA 510(k) clearance and is not available for sale in the
United States.
@MasimoInnovates
| #Masimo
1. Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The
Relationship Between Oxygen Reserve Index and Arterial Partial Pressure
of Oxygen During Surgery. Anesth Analg. 2016 Mar 22. [Epub ahead
of print] PubMed PMID: 27007078.
2. The 11 rainbow® 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. 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’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 Masimo’s Oxygen Reserve Index
(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/20160331005405/en/
Source: Masimo
Masimo
Irene Paigah
858-859-7001
irenep@masimo.com