Masimo Super Sensor is the First Ever to Measure Arterial Oxygen
Saturation (SpO2), Hemoglobin (SpHb®),
Carboxyhemoglobin (SpCO®), Methemoglobin (SpMet®),
Pleth Variability Index (PVi®), Index of
Perfusion (Pi), and Pulse Rate (PR), All Noninvasively
NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jul. 10, 2017--
Masimo
(NASDAQ: MASI) announced today the CE marking of the rainbow®
Super DCI®-mini sensor, a reusable spot-check sensor that
features Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry and rainbow SET™ technology with multiple
physiologic measurements – including, for the first time, the ability to
measure total hemoblogin (SpHb®), carboxyhemoglobin (SpCO®),
methemoglobin (SpMet®), and arterial oxygen saturation (SpO2)
using the same noninvasive reusable sensor.
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Masimo Rad-67™ Pulse CO-Oximeter® with rainbow® Super DCI®-mini Sensor (Photo: Business Wire)
In 2016, Masimo introduced the rainbow® DCI-mini sensor,
enabling spot-check measurement of Next Generation SpHb and other
parameters. Now, with the rainbow® Super DCI-mini sensor, an
expanded set of parameters can be measured using a single sensor: SpO2,
pulse rate (PR), perfusion index (Pi), pleth variability index (PVi®),
SpHb, SpCO, and SpMet.
The rainbow® Super DCI-mini sensor can be used to spot-check
all patients weighing 3 kg or more, further reducing the need for
multiple sensor types; the sensor can be applied to an adult finger, a
pediatric finger, or an infant finger, thumb, or great toe. The sensor
is small and lightweight, with a flexible cable to provide sensor
stability and patient comfort during monitoring.
Next Generation SpHb technology offers motion tolerance and a faster
time to display SpHb results (in as few as 30 seconds). In addition,
field performance has been enhanced in lower hemoglobin ranges. Next
Generation SpHb is enabled when the Rad-67™ Pulse CO-Oximeter®
and the DCI-mini or Super DCI-mini sensor are used together.
SpCO monitoring may lead to the identification of elevated carbon
monoxide levels that might otherwise go undetected in front-line
settings, such as triage and emergency care. SpMet helps clinicians
monitor for methemoglobin in care areas where the drugs that cause
methemoglobinemia are most common, such as procedure labs and the
operating room.
Joe Kiani, Founder and CEO of Masimo, said, “This is an exciting day for
us and hopefully a great opportunity to improve patient care. Since the
invention of rainbow® technology, we have been wanting our
customers to be able to measure SpCO, SpMet, SpHb and SpO2
simultaneously. Now they can! In addition, we have been pursuing a
spot-check sensor that fits all patients across the age spectrum. We
believe the rainbow® Super DCI-mini sensor will be especially
valuable for use in triage and emergency care situations. We plan to
introduce a continuous measurement version of the Super Sensor in the
near future.”
The rainbow® Super DCI-mini sensor, Next Generation SpHb, and
Rad-67 have not received FDA 510(k) clearance and are not available for
sale in the United States.
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SpCO is intended to be used to monitor CO levels in the blood and is not
intended to be used as the sole basis for making diagnosis or treatment
decisions related to carbon monoxide poisoning. SpMet is not to be used
as the sole basis for making diagnosis or treatment decisions related to
methemoglobinemia. SpHb, SpCO, and SpMet monitoring are not intended to
replace laboratory blood testing; blood samples should be analyzed by
laboratory instruments prior to clinical decision making.
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 16 of the top 20
hospitals listed in the 2016-17 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®), 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, 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 rainbow® Super DCI®-mini
sensor.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 rainbow® Super DCI-mini sensor, contribute
to positive clinical outcomes and patient safety; 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/20170709005051/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com