NEUCHATEL, Switzerland--(BUSINESS WIRE)--Oct. 8, 2015--
Masimo
(NASDAQ: MASI) announced today that an 18-study meta-analysis of 665
subjects reported that Masimo’s Pleth Variability Index (PVI®),
available with Masimo’s SET® and rainbow® SET®
monitoring platforms, may help clinicians assess fluid responsiveness in
mechanically ventilated patients in normal sinus rhythm in the operating
room and intensive care unit.1
Clinicians commonly use intravenous fluid administration in the
operating room and intensive care unit to attempt to improve blood flow,
or cardiac output.2 Administering either too little fluid or
too much fluid can increase patient risk. 2 However,
traditional “static” monitoring parameters such as central venous
pressure (CVP) are considered unreliable to assess fluid responsiveness.
2 Therefore, experts recommend the use of “dynamic” parameters
that measure physiologic variation over the respiratory cycle.3
Multiple dynamic parameters have been shown to help clinicians assess
fluid responsiveness, but most dynamic parameters require invasive,
complex, and/or costly methods. PVI is a measure of the dynamic changes
in the Perfusion Index (PI) that occur during one or more complete
respiratory cycles, and may show changes that reflect physiologic
factors such as vascular tone, circulating blood volume, and
intrathoracic pressure excursions. In contrast to other dynamic
parameters, PVI is noninvasive, easily obtained with any Masimo SET®
or rainbow® sensor, and has no incremental procedural cost.
The meta-analysis, published in the Journal of Clinical
Monitoring and Computing by Dr. Chu and colleagues from The
First Hospital of China Medical University, Shenyang, China, combined
the findings from 18 independent studies evaluating the ability of PVI
to help clinicians assess fluid responsiveness. The authors reported
that the pooled area under the curve (AUC) for PVI to correctly
determine fluid responsiveness was 0.88 (95% confidence interval 0.84 to
0.91). The pooled sensitivity of PVI, or its ability to determine
whether cardiac output would increase upon fluid administration, was
0.73 (95% confidence interval 0.68 to 0.78). The pooled specificity of
PVI, or its ability to determine whether cardiac output would not
increase upon fluid administration, was 0.82 (95% confidence interval
0.77 to 0.86). The authors noted that the sensitivity of PVI was greater
in the operating room than in the intensive care unit (0.84 vs. 0.56,
p=0.00004). The authors also noted that “the applicability of PVI may be
limited by potential interference from several factors such as
spontaneous breathing activity, arrhythmia, and low peripheral
perfusion.” Technical factors that may affect PVI include probe
malposition and patient motion.
For more information on PVI, go to www.masimo.com.
@MasimoInnovates
| #Masimo
1 Chu (et al.). Accuracy of pleth variability index to predict fluid
responsiveness in mechanically ventilated patients: a systematic review
and meta-analysis: J Clin Monit Comput. 2015, 8:5.
2 Navarro (et al.). Perioperative fluid therapy: a statement from the
international Fluid Optimization Group. Perioperative Medicine.
2015, 4:3.
3 Vallet B (et al). Strategy for perioperative vascular filling -
Guidelines for perioperative haemodynamic optimization. Experts'
Formalized Recommendations, French Society of Anaesthesia and Intensive
Care (SFAR), Validation by the administrative council of SFAR on 19
October 2012.
About Masimo
Masimo (NASDAQ: MASI) is the 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. The benefits of Masimo
SET® have been proven in more than 100 independent and objective studies
and it 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 Pleth Variability Index (PVI®), in addition
to SpO2, pulse rate, and perfusion index (PI). Additional information
about Masimo and its products may be found at www.masimo.com.
For the U.S. market, PVI is a measure of dynamic changes in the
perfusion index (PI) that occur during the respiratory cycle. The PVI
calculation is accomplished by measuring changes in PI over a time
interval where one or more complete respiratory cycles have occurred.
PVI is displayed as a percent (0-100%). PVI may show changes that
reflect physiologic factors such as vascular tone, circulating blood
volume and intrathoracic pressure excursions. The utility of PVI is
unknown at this time and requires further clinical studies. Technical
factors that may affect PVI include probe malposition and patient motion.
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 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: total hemoglobin (SpHb®) contribute to positive
clinical outcomes and patient safety; risks related to our belief that
Masimo noninvasive medical breakthroughs provide cost-effective
solutions with comparable accuracy and unique advantages, including:
immediate and continuous results that enable earlier treatment without
causing invasive trauma in all patients and in every clinical situation;
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
Irene Paigah, 858-859-7001
irenep@masimo.com