International Consensus Statement on Postoperative Anemia Management Recommends Noninvasive Hemoglobin Measurement Including ...
November 12 2018 - 2:00AM
Business Wire
Masimo (NASDAQ: MASI) announced today that a new consensus
statement on postoperative anemia management was published in
Anaesthesia by an international panel of clinicians specializing in
patient blood management, which includes clear guidance on the use
and benefits of noninvasive hemoglobin measurement.1 The statement,
which discusses both spot-check and continuous measurement,
references the Masimo Rad-67™ Pulse CO-Oximeter®, a spot-check
device that measures noninvasive hemoglobin using Masimo SpHb®, as
the example of noninvasive measurement.
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Masimo Rad-67™ with SpHb® (Photo:
Business Wire)
The statement notes in part that “The use of non-invasive
continuous haemoglobin monitoring devices instead of phlebotomy may
reduce blood loss, pain and discomfort for the patient, but
concerns about precision limit routine clinical use. Although the
debate focuses on accuracy of a single check, the reliability of
non-invasive haemoglobin monitoring devices for dynamic changes
over time may permit detection of occult bleeding and response to
therapy.”
In addition to this newest consensus statement, SpHb has
recently received positive recognition from two other reputable
institutions in the European anesthesiology community. Both the
2017 European Society of Anaesthesiology’s (ESA) Guidelines for the
Management of Severe Perioperative Bleeding2 and the 2017 Italian
Ministry of Health’s Blood Management Program Guidelines3 included
noninvasive and continuous SpHb as a recommended tool for
monitoring hemoglobin. Specifically, the ESA guidelines provided a
strong recommendation that “continuous haemoglobin monitoring can
be used as a trend monitor.”
SpHb is available on a variety of Masimo noninvasive spot-check
and continuous monitoring devices, both portable and bedside, as
well as through licensed third-party devices. For continuous
monitoring, these include Masimo’s Rad-97™, Radical-7®, and
Radius-7®. Noninvasive and continuous hemoglobin (SpHb) monitoring
helps automate the patient’s hemoglobin status and provides
real-time visibility to changes – or lack of changes – in
hemoglobin between invasive blood samples. For spot-check SpHb
measurement, Masimo Pronto® is available in addition to Rad-67.
Next Generation SpHb, available on these devices outside the U.S.,
significantly advances noninvasive hemoglobin spot-checking with
improved motion tolerance, faster time to display SpHb results, and
enhanced field performance in low hemoglobin ranges.
Joe Kiani, Founder and CEO of Masimo, said, “We are happy to see
growing recognition, from some of the world’s most renowned
clinicians, institutions, and advisory bodies, of the utility and
benefits of our noninvasive hemoglobin measurement technology.
Studies on three continents have shown that continuous SpHb
monitoring optimizes blood transfusion4-6 and in a trial with over
3,000 patients, continuous SpHb and PVi® were shown to reduce
mortality 30 and 90 days after surgery.7 Never content, we continue
to refine and improve SpHb and PVi, and look forward to bringing
the advantages of Next Generation SpHb to additional markets and
devices soon.”
Rad-67 with Next Generation SpHb has not received FDA clearance
and is not available in the U.S.
@MasimoInnovates | #Masimo
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 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,8 improve CCHD screening in
newborns,9 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
activations and costs.10-12 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,13 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.14 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/evidence/featured-studies/feature/.
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
- Munoz M, Acheson AG, Bisbe E, Butcher
A, Gomez-Ramirez S, Khalafallah AA, Kehlet H, Kietaibl S, Liumbruno
GM, Meybohm P, Rao Baikady R, Shander A, So-Osman C, Spahn DR, and
Klein AA. An international consensus statement on the management of
postoperative anaemia after major surgical procedures. Anaesthesia
2018. Doi:10.1111/anae.14358.
- Kozek-Langenecker SA, et al. Management
of severe perioperative bleeding: guidelines from the European
Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol.
2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.
- Vaglio S, et al. The Italian Regulatory
Guidelines for the implementation of Patient Blood Management.
Blood Transfus. 2017 Jul;15(4):325-328. doi:
10.2450/2017.0060-17.
- Imaizumi et al. Continuous and
noninvasive hemoglobin monitoring may reduce excessive
intraoperative RBC transfusion. Proceedings from the 16th World
Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
- Ehrenfeld JM et al. Continuous
Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A
Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
- Awada WN et al. Continuous and
noninvasive hemoglobin monitoring reduces red blood cell
transfusion during neurosurgery: a prospective cohort study. J Clin
Monit Comput. 2015 Feb 4.
- Nathan N et al. Impact of Continuous
Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual
Meeting, Chicago. Abstract #A1103.
- 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 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 A 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 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.
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MasimoEvan Lamb, 949-396-3376elamb@masimo.com
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