ORi to Be Launched in the U.S. at
ANESTHESIOLOGY 2023 This Weekend
Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive,
continuous parameter designed to provide additional insight into a
patient’s oxygen status in the moderate hyperoxic range under
supplemental oxygen, has been granted a De Novo by the FDA. Enabled
by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform,
ORi is designed for use in conjunction with oxygen saturation
(SpO2) to provide increased resolution of changes in oxygenation
under supplemental oxygen. With the De Novo, ORi becomes the
first-of-its-kind parameter cleared by the FDA to help clinicians
manage oxygen of adults undergoing surgery in perioperative
hospital environments.
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Masimo ORi™ (Photo: Business Wire)
Without ORi, there is no noninvasive way to monitor oxygenation
under supplemental oxygen to manage hyperoxia, or higher than
normal oxygenation of arterial blood. There is growing evidence
that hyperoxia is harmful and can lead to oxygen toxicity, causing
oxygen poisoning or pulmonary tissue damage.1 Currently, clinicians
take blood draws that are analyzed to determine PaO2 levels, the
partial pressure of oxygen measured by arterial blood gas devices.
However, arterial blood analyses are both intermittent and delayed
– leaving clinicians blind to the changes in oxygenation occurring
between blood draw results.
Masimo ORi addresses these shortcomings by providing continuous
insight into the oxygenation of hemoglobin in the moderate
hyperoxic range (PaO2 > 100 and ≤ 250 mmHg). ORi is trended
continuously with SpO2 as a unit-less index between 0.00 and 1.00
to extend the visibility of the oxygenation of patients beyond SpO2
under supplemental oxygen. By convention, SpO2 is limited to an
upper limit of 100%, but oxygenation can rise into hyperoxia when
supplemental oxygen is administered. ORi provides clinicians with
additional visibility, as a complement to Masimo SET® pulse
oximetry, into when oxygenation is increased into, or decreased out
of, moderate hyperoxia, in real time.
Numerous studies have demonstrated ORi’s utility. For example,
in a study published in Anesthesia & Analgesia of 106 adult
patients undergoing scheduled surgery, researchers found decreases
in ORi “may provide advance indication of falling PaO2 when SpO2 is
still > 98%.”2 In another study published in Intensive Care
Medicine, researchers found that the use of ORi monitoring to
titrate oxygen rates “allowed an important reduction of the time
spent with hyperoxia compared with the use of SpO2 alone,” in a
group of 150 mechanically ventilated adult patients randomized to
an ORi or a control group.3
Joe Kiani, Founder and CEO of Masimo, said, “Since ORi’s
availability and success outside the U.S., perioperative clinicians
in the U.S. have been waiting for a way to noninvasively monitor
patients under supplemental oxygen beyond the limits of SpO2. We
are thrilled that U.S. clinicians can now integrate ORi monitoring
– available now on our rainbow SET® platform – into their
oxygenation monitoring practices, alongside Masimo SET® Measure
through Motion and Low Perfusion™ pulse oximetry, and experience
their combined benefits.”
With the De Novo, Masimo is introducing a new sensor line to the
market, RD rainbow™ 4λ sensors, expanding the RD family of pulse
CO-oximetry sensors, which are now available in four levels of
capabilities:
- RD SET®, which utilizes two wavelengths (2 LEDs) and features
SET® pulse oximetry.
- RD rainbow 4λ, which utilizes four wavelengths (4 LEDs) and
adds the ability to measure ORi.
- RD rainbow 8λ, which utilizes eight wavelengths (8 LEDs) and
enables SpHb® (total hemoglobin) monitoring alongside ORi and other
measurements.
- RD rainbow 12λ*, which utilizes twelve wavelengths (12 LEDs)
and offers 12 total parameters, including SpHb, ORi and fractional
oxygen saturation (SpfO2™) for visibility of the impact of
dyshemoglobins, SpCO® and SpMet®, on the patient’s
oxygenation.
Jesse M. Ehrenfeld, MD, President of the American Medical
Association and advisor to Masimo, commented, “I can envision a
number of scenarios I encounter in my daily clinical practice as an
anesthesiologist where ORi would be invaluable. During patient
pre-oxygenation, I often find myself unsure of the adequacy of
pre-oxygenation, especially in a patient with a significant
cardiopulmonary comorbidity or a patient with diminished oxygen
reserve capacity. ORi would solve this problem by giving an
easy-to-understand parameter that provides visibility to how
oxygenation is changing during the pre-oxygenation process.
Additionally, I often find that during the management of a
difficult airway, it is never quite clear when to stop,
re-establish mask ventilation, and allow the patient to recover.
Again, ORi would be very helpful in addressing this issue as it can
track the trajectory of the patient’s oxygenation status. I am
delighted to see ORi receive FDA clearance. It is not often that
new parameters are developed which can actually make a real impact
in clinical practice.”
Richard L. Applegate II, MD, Chair of Anesthesiology at Loma
Linda University Health, California, stated, “Our studies show that
ORi provides advanced detection of low SpO2 events. This additional
time may allow modification of airway management, earlier calls for
help, or assistance from other providers. Advanced detection of
worsening oxygenation is valuable in operative and critical care
settings and ORi use has the potential to provide continuous
monitoring to detect changes in pulmonary function.”
Ken B. Johnson, MD, Professor of Anesthesiology, University of
Utah, commented, “I have been eager for the ORi parameter to be
available in the U.S. for a long time as it is a unique innovation
with the potential to significantly improve patient care. Observing
the ORi trend may help clinicians anticipate hemoglobin oxygen
desaturations before they occur. Clinical scenarios where this
technology may be useful include airway management that takes
longer than expected, prompting rescue breaths before desaturation
occurs, and procedural sedation with unanticipated prolonged
periods of apnea that can trigger rescue maneuvers before the onset
of unwanted desaturation. This index in combination with pulse
oximetry shows promise in better managing adverse events related to
poor oxygenation and improved patient outcomes.”
ORi is granted a De Novo by the US FDA to be used in patients
undergoing surgery as an adjunct to SpO2 for increased monitoring
resolution of elevated hemoglobin oxygen saturation levels (e.g.,
due to administration of supplemental oxygen).
The ORi feature is indicated for the monitoring of hemoglobin
oxygen saturation levels in patients 18 years and older (adults and
transitional adolescents) on supplemental oxygen during no-motion
conditions perioperatively in hospital environments.
*SpfO2 and RD rainbow 12λ sensors have obtained CE Marking. Not
available in the U.S.
@Masimo | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. In addition, Masimo Consumer Audio is home to eight
legendary audio brands, including Bowers & Wilkins, Denon,
Marantz, and Polk Audio. Our mission is to improve life, improve
patient outcomes, and reduce the cost of care. Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry,
introduced in 1995, has been shown in over 100 independent and
objective studies to outperform other pulse oximetry technologies.4
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,5 improve CCHD screening in
newborns6 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
team activations, ICU transfers, and costs.7-10 Masimo SET® is
estimated to be used on more than 200 million patients in leading
hospitals and other healthcare settings around the world,11 and is
the primary pulse oximetry at 9 of the top 10 hospitals as ranked
in the 2022-23 U.S. News and World Report Best Hospitals Honor
Roll.12 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®), RPVi™ (rainbow® PVi), and Oxygen Reserve
Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7®,
Radius PPG®, and Radius VSM™, portable devices like Rad-67®,
fingertip pulse oximeters like MightySat® Rx, and devices available
for use both in the hospital and at home, such as Rad-97®. Masimo
hospital and home automation and connectivity solutions are
centered around the Masimo Hospital Automation™ platform, and
include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo
ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing
portfolio of health and wellness solutions includes Radius Tº®,
Masimo W1™, and Masimo Stork™. Additional information about Masimo
and its products may be found at www.masimo.com. Published clinical
studies on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
RPVi 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
- Mach WJ, et al. Consequences of hyperoxia and the toxicity of
oxygen in the lung. Nurs Res Pract. 2011; 2011: 260482.
- Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM.
Anesth Analg. 2016 Mar 22. [Epub ahead of print] PubMed PMID:
27007078.
- Lasocki S, Brochant A, Leger M, Gaillard T, Lemarié P, Gergaud
S, Dupré P. Intensive Care Med. 2019 Aug 13.
doi:10.1007/s00134-019-05732-9.
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- 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 A 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 A et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
- McGrath S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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 ORi™ and RD
rainbow™ sensors. 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 ORi and RD rainbow sensors,
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; risks
related to COVID-19; 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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