IRVINE, Calif.--(BUSINESS WIRE)--Sep. 15, 2016--
Masimo (NASDAQ:
MASI) announced today the findings of a study recently presented at the
World Congress of Anesthesiologists (WCA) in Hong Kong. In the study,
researchers at Cairo University in Egypt investigated the clinical
utility of a Masimo SET® noninvasive, continuous
measurement, PVI®.
In the prospective study of 60 adult patients undergoing major abdominal
surgery, Drs. Hafez and Helmy of Cairo University evaluated the
performance of Masimo PVI as a non-invasive guide to fluid optimization,
as compared to transesophageal doppler. Patients were divided into fluid
responders and non-responders, based upon the change in stroke volume
due to a bolus response. The baseline value of PVI was significantly
higher (p < 0.05) in responders compared to non-responders. The authors
also noted that a baseline PVI cutoff value of 11 had 96.67% sensitivity
and 33.33% specificity for predicting >10% stroke volume increase. They
concluded that PVI is “an efficient predictor of fluid responsiveness…in
patients undergoing elective major abdominal surgery.”1
PVI is a measure of the dynamic changes in perfusion index (PI) that
occur during the respiratory cycle. In clinical studies, PVI has been
shown to help clinicians assess fluid responsiveness in mechanically
ventilated patients under general anesthesia during surgery,2,3,4,5
in the ICU in both adults and children,6,7 and in septic
patients in the early stages of shock in the emergency department.8
Another study used PVI as part of goal-directed therapy for patients in
an enhanced recovery after surgery (ERAS) program who underwent
colorectal surgery; the program led to significant reductions in lengths
of stay, costs, surgical site infections, fluid administered, as well as
improvement in patient satisfaction.9
@MasimoInnovates |
#Masimo
References
1. Hafez, Helmy. Evaluation of Plethysmographic variation indices for
assessing fluid responsiveness in major operations using Masimo
Radical-7 Pulse CO-Oximeter. Proceedings from the 16th World Congress of
Anaesthesiologists, Hong Kong. Abstract #PR371.
2. Cannesson M. et al. Br J Anaesth. 2008;101(2):200-6.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf
B.M., Wiesenack C. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q., Mi W.D., Zhang H. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L.,
Reuter D.A. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T. et al. Crit Care Med. 2011;39(2):294-299.
7. Byon H et al. BJA 2012 December; DOI 10.1093/bja/aes467
8. Feissel M et al. J Crit Care. 2013 May 14
9. Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, Goudreau
BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of
Care: Impact of an Enhanced Recovery Protocol on Length of Stay,
Complications, and Direct Costs after Colorectal Surgery. Journal of the
American College of Surgeons (2015). doi:
10.1016/j.jamcollsurg.2014.12.042.
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 by taking noninvasive monitoring to new sites
and applications. 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® is estimated
to be used on more than 100 million patients in leading hospitals and
other healthcare settings around the world. 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.
Masimo is also taking an active leadership role in mHealth with products
such as the Radius-7™ wearable patient monitor and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and its
products may be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 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 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.
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Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com