NEUCHATEL, Switzerland--(BUSINESS WIRE)--Feb. 27, 2017--
Masimo (NASDAQ:
MASI) announced today the findings of a recent study conducted on
low-risk patients undergoing colorectal surgery, in which researchers
assessed the utility of noninvasive and continuous Masimo PVi®
(Pleth Variability Index) monitoring to guide fluid management, as
compared to esophageal Doppler, an invasive method. The researchers
found no significant difference between the two technologies in mean
total fluid administered and concluded that “PVi offers an entirely
noninvasive alternative for goal-directed therapy in this group of
patients.”1
In the study, Dr. Warnakulasuriya and colleagues at York Teaching
Hospital in York, United Kingdom, evaluated the performance of Masimo
PVi monitoring in guiding fluid management, as compared to that of an
established technology, esophageal Doppler. Forty low-risk patients
undergoing elective colorectal surgery were enrolled in the study. The
patients were randomly assigned to two groups, with each group having
fluid therapy directed by one of the two technologies. The researchers
measured the absolute volume of fluid given intraoperatively and fluid
volume at 24 hours. The researchers found “no significant difference
between PVi and esophageal Doppler groups in mean total fluid
administered (1286 vs 1520 ml, p=.300) or mean intraoperative fluid
balance (+839 v + 1145 mL, p=.150).”
The researchers concluded that “amongst fit patients undergoing major
colorectal surgery there was no significant difference in the volume of
fluid administered when targeted by noninvasive PVi technology compared
to a stroke volume maximization technique using esophageal Doppler.
There was no significant difference in postoperative outcomes between
the groups. Therefore, PVi offers a noninvasive, consumable free
alternative for intraoperative fluid optimization in fit patients
undergoing major colorectal surgery, where intraoperative goal-directed
therapy is deemed a standard of care but there is no requirement for
arterial cannulation.”
PVi is a measure of the dynamic changes in perfusion index (PI) that
occur during the respiratory cycle. In other clinical studies, PVi has
been shown to provide benefits in the monitoring of
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 In a study in which PVi
was used in conjunction with Masimo SpHb® (noninvasive
hemoglobin measurement), the technologies were shown to reduce mortality
at 30 and 90 days.10
“Clinical evidence for the utility of Masimo PVi continues to amass,”
said Joe Kiani, Founder and CEO of Masimo. “Dr. Warnakulasuriya’s study
provides additional information about the benefits of PVi. We are
grateful for the opportunity we have to continue to improve patient
outcomes and reduce cost of care with our innovative noninvasive
monitoring.”
@MasimoInnovates |
#Masimo
References
1. Warnakulasuriya S et al. Comparison of esophageal Doppler and
plethysmographic variability index to guide intraoperative fluid therapy
for low-risk patients undergoing colorectal surgery. Journal of
Clinical Anesthesia. (2016)34,600-608.
2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory
Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and
Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth.
2008;101(2):200-6.
3. Zimmermann M et al. Accuracy of Stroke Volume Variation
Compared with Pleth Variability Index to Predict Fluid Responsiveness in
Mechanically Ventilated Patients Undergoing Major Surgery. Eur J
Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to
Predict Fluid Responsiveness During Resection of Primary Retroperitoneal
Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S et al. Prediction of Volume Responsiveness using Pleth
Variability Index in Patients Undergoing Cardiac Surgery after
Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T et al. Pleth Variability Index Predicts Fluid Responsiveness
in Critically Ill Patients. Crit Care Med. 2011;39(2):294-299.
7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically
Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013
Apr;110(4):586-91.
8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid
Responsiveness in Ventilated Patients in the Early Phase of Septic Shock
in the Emergency Department: A Pilot Study. J Crit Care. 2013 May
14:634-639.
9. Thiele et al. 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.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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® has also been
shown to helps clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring in post-surgical wards, reduce
rapid response activations and costs.3,4,5 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). Studies with SpHb have shown reductions in unnecessary blood
transfusion*,6,7 and when used with PVi, reductions in length
of hospital stay8 and 30- and 90-day mortality.9
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/cpub/clinical-evidence.htm.
*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.
References
1. 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.
2. 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;338.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
5. 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.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring
during Orthopedia Surgery: A Randomized Trial. J Blood Disorders
Transf. 2014. 5:9. 2.
7. 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.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced
Recovery Protocol on Length of Stay, Complications, and Direct Costs
after Colorectal Surgery. JACS (2015). doi:
10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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; 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