New Study Evaluates Ability of Masimo SpHb® (Noninvasive Hemoglobin) to Estimate Timing for Invasive Measurement to Detect Anemia During Surgery

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) announced today the results of a study published in BMC
Anesthesiology in which clinicians at Peking Union Medical College
in Beijing evaluated the ability of noninvasive and continuous
hemoglobin monitoring with Masimo SpHb^® to help clincians
estimate when to conduct invasive hemoglobin measurement to detect
possible anemia in patients undergoing spine or cytoreductive surgery.¹

Noting that because of the “invasive, time-consuming and intermittent”
nature of invasive blood sampling, clincians often forgo these
“objective indications” when making transfusion decisions during
surgery, Dr. Tang and colleagues sought to determine whether
noninvasive, continuous hemoglobin monitoring could aid clinicians in
estimating when it might be appropriate to perform an invasive
measurement. They enrolled 69 adult patients scheduled for spine surgery
or cytoreductive surgery for whom estimated blood loss was more than 15%
of total blood volume. The patients were randomly divided into an SpHb
group (32 patients) and a standard care group (37 patients). In the SpHb
group, diagnostic blood samples were drawn when a patient’s SpHb,
measured using a Masimo Radical-7^® Pulse CO-Oximeter^®,
decreased by 1 g/dL. In the standard care group, they were drawn at the
clinicians’ discretion. Blood gas analysis was performed using a
Radiometer ABL800. The researchers determined the positive predictive
value (PPV) of SpHb for the SpHb group and clinician perception in the
standard care group in detecting a decrease in lab hemoglobin of more
than 1 g/dL or lab hemoglobin of less than 10 g/dL.

The researchers found that the incidence of unnecessary hemoglobin
measurement was lower in the SpHb group than the standard care group.
For a decrease of greater than 1 g/dL in lab hemoglobin, SpHb had a PPV
of 93.3%, compared to 54.5% for clinical perception (p = 0.002). For
hemoglobin lower than 10 g/dL, SpHb had a PPV of 86.7%, compared to
50.0% for clinical perception (p = 0.015). In the SpHb group, lab
hemoglobin was never less than 7 g/dL. In addition, using Bland-Altman
analysis, the researchers calculated that, compared to lab hemoglobin,
SpHb had bias and precision of -0.29 +/- 1.03 g/dL, with limits of
agreement of -2.30 and 1.72 g/dL. No difference was observed in
transfusion units or postoperative hemoglobin concentrations between the
two groups.

The researchers concluded, “The SpHb trend tracked changes in hemoglobin
satisfactorily during surgery and more accurately estimated the
appropriate timing for invasive hemoglobin measurements than the
clinicians.” They also noted that “This study was the first diagnostic
randomized controlled trial to explore the triage role of Pulse
CO-Oximetry in the intraoperative detection of anemia. We found that the
trend in SpHb could detect a decrease in Hb in dynamic situations and
indicate the appropriate timing for further Hb measurements.”

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SpHb monitoring is not intended to replace laboratory blood testing.
Clinical decisions regarding red blood cell transfusions should be based
on the clinician’s judgment considering, among other factors: patient
condition, continuous SpHb monitoring, and laboratory diagnostic tests
using blood samples.

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. Our mission is to
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.² Masimo SET^®
has also been shown to help clinicians reduce severe retinopathy of
prematurity in neonates,³ improve CCHD screening in newborns,⁴
and, when used for continuous monitoring with Masimo Patient SafetyNet™
in post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.^5-7 Masimo SET^® is estimated
to be used on more than 100 million patients in leading hospitals and
other healthcare settings around the world,⁸ and is the
primary pulse oximetry at 9 of the top 10 hospitals listed in the
2018-19 U.S. News and World Report Best Hospitals Honor Roll.⁹
Masimo continues to refine SET^® and in 2018, announced that
SpO₂ accuracy on RD SET™ sensors during conditions of motion
has been significantly improved, providing clinicians with even greater
confidence that the SpO₂ values they rely on accurately
reflect a patient’s physiological status. 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^®, 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 automation and connectivity solutions are
centered around the Iris^® platform, and include Iris
Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and
Doctella™. 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/.

ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.

References

1. Tang Bo, Yu X, Xu L, Zhu A, Zhang Y, and Huang Y. Continuous
   noninvasive hemoglobin monitoring estimates timing for detecting
   anemia better than clinicians: a randomized controlled trial. BMC
   Anesthesiology. 17 May 2019. https://doi.org/10.1186/s12871-019-0755-1
2. 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.
3. 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.
4. 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.
5. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
   Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. Estimate: Masimo data on file.
9. 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 SpHb^®. 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 SpHb^®, 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.

Contacts

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com