NEUCHATEL, Switzerland-Wednesday 14 November 2018 [ AETOS Wire ]
(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.
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181111005053/en/
Contacts
Masimo
Evan Lamb, +1-949-396-3376
elamb@masimo.com
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