NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jan. 2, 2018--
Masimo (NASDAQ:
MASI) announced today the CE marking and release of RD rainbow Lite SET™
sensors, which enable the monitoring of Masimo Oxygen Reserve Index™
(ORi™) and RPVi™, an improved PVi® that allows clinicians to
assess fluid responsiveness noninvasively and continuously1
at a fraction of the cost of invasive methods, and at a fraction of the
cost of rainbow® sensors. rainbow Lite sensors utilize twice
as many wavelengths of light as SET® sensors, allowing
rainbow Lite sensors to provide ORi and RPVi along with Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry.
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Masimo RD rainbow Lite SET™ Sensor (Photo: Business Wire)
ORi is the first noninvasive and continuous parameter to provide insight
into a patient’s oxygen reserve in the moderate hyperoxic range. In
conjunction with SET® pulse oximetry, ORi may provide
advanced warning of impending desaturation, which may allow clinicians
to intervene sooner. For example, in a study of 25 pediatric patients
undergoing general anesthesia with orotracheal intubation, researchers
found that ORi helped clinicians identify impending desaturation a
median of 31.5 seconds before noticeable changes in oxygen saturation
(SpO2) occurred.2 In another recent study of 106
adult patients scheduled for surgery with arterial catheterization and
intraoperative blood gases analyses, researchers found a significant
relationship between change in PaO2 and change in ORi.3
In addition, ORi may provide insight into oxygen reserve when titrating
patients who are receiving supplemental oxygen.4
Joe Kiani, Founder and CEO of Masimo, said, “rainbow Lite sensors allow
clinicians, who depend on powerful SET® pulse oximetry
technology, to augment their patient monitoring with ORi and newly
introduced RPVi. Given the positive reception of ORi in available
markets, and feedback from clinicians who see great value in the
benefits of ORi monitoring, we are excited to make ORi and RPVi
accessible via the cost-effective solution represented by RD rainbow
Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay
only nominally more per sensor than for SET®.”
Masimo RPVi is a multi-wavelength version of Pleth Variability Index
(PVi). RPVi is designed to provide enhanced assessment of changes in
fluid volume compared to PVi5, which has been shown in over
90 independent clinical studies to be as effective as invasive
monitoring methods.6
With the addition of RD rainbow Lite SET, the RD family of sensors is
now available in three levels of capability: RD SET, utilizing two
wavelengths (2 LED) and featuring SET® pulse oximetry; RD
rainbow Lite SET, which utilizes four wavelengths (4 LED) and adds the
ability to measure ORi and RPVi; and RD rainbow SET, which utilizes over
seven wavelengths (7+ LED) and enables the measurement of additional
advanced noninvasive parameters such as SpHb® (total
hemoglobin), SpCO® (carboxyhemoglobin), SpMet®
(methemoglobin), and SpOC™ (oxygen content).
Like RD SET sensors, RD rainbow Lite SET sensors are designed to
maximize patient comfort and optimize clinician workflow. The sensors
are lightweight and have a flat, soft cable with smooth edges, so that
they lie comfortably on a patient’s hand or foot. The sensors feature an
intuitive sensor-to-cable connection, with tactile and audible feedback
to ensure a proper connection, and have graphics printed on both sides
to assist with application.
Devices with ORi and RPVi measurements and RD rainbow Lite SET sensors
have not received FDA 510(k) clearance and are not available for sale in
the United States.
@MasimoInnovates |
#Masimo
References
-
Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on
the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate
Levels and Improves Fluid Management. Anesth Analg. 2010 Oct;
111(4):910-4.
-
Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, and Ezri T.
Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A
Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784.
doi:10.1097/ALN.0000000000001009.
-
Applegate R, Dorotta I, Wells B, Juma D, and Applegate P. The
Relationship Between Oxygen Reserve Index and Arterial Partial
Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep;
123(3); 626-633.
-
Scheeren TWL, Belda FJ and Perel A. The oxygen reserve index (ORi): a
new tool to monitor oxygen therapy. J Clin Monit Comput. 2017.
doi:10.1007/s10877-017-0049-4.
- Masimo data on file.
-
Published clinical studies on PVi can be found at http://www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.
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. 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® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 and is the primary pulse oximetry at 17 of the top 20
hospitals listed in the 2017-18 U.S. News and World Report Best
Hospitals Honor Roll.7 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®), and more
recently, 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, enabling other companies to
augment Root with new features and measurement capabilities. Masimo is
also taking an active leadership role in mHealth with products such as
the Radius-7™ wearable patient monitor, iSpO2®
pulse oximeter for smartphones, and the MightySat™ fingertip pulse
oximeter. Additional information about Masimo and its products may be
found at www.masimo.com.
Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
ORi 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
-
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;338.
-
Taenzer AH 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 AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
Patient Safety Foundation Newsletter. Spring-Summer 2012.
-
McGrath SP 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.
-
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 RD rainbow Lite SET™ sensors, ORi™, RPVi™, and
PVi®. 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 RD rainbow Lite SET sensors, ORi, RPVi, and PVi,
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; 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/20180101005082/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com