Masimo (NASDAQ: MASI) today announced that PVi® has received FDA
clearance as a continuous, noninvasive, dynamic indicator of fluid
responsiveness in select populations of mechanically ventilated
adult patients. PVi, or pleth variability index, is a measure of
the dynamic changes in perfusion index that occur during the
respiratory cycle.
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Masimo Root® with PVi® and SpHb® (Photo:
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William C. Wilson, MD, MA, Chief Medical Officer at UCI Health,
said, “Anesthesiologists and critical care physicians have long
recognized the importance of dynamic measures of intravascular
volume and fluid responsiveness. Previously this data could only be
acquired using an invasive arterial line, and/or additional
sophisticated devices. With the Masimo pleth variability index
(PVi), one can now obtain this essential data using the pulse
oximeter probe and following the continuous readout on the monitor.
The PVi technology has undergone rigorous peer-reviewed evaluation,
and demonstrated efficacy in determining adequacy of intravascular
volume for guiding goal-directed therapy. The recent clearance of
the Masimo PVi system will serve as another major breakthrough in
promoting patient safety.”
Available alongside Masimo SET® pulse oximetry and rainbow®
Pulse CO-Oximetry on a variety of 2-LED, 4-LED, and 8-LED Masimo
sensors, PVi is an index between 0 and 100 that is calculated using
a proprietary algorithm based upon the relative variability of the
pleth waveform.
Hospital protocols such as Enhanced Recovery After Surgery
(ERAS) and Goal-directed Therapy (GDT) recommend fluid management
as part of larger initiatives designed to improve patient care and
safety. Fluid management protocols look to balance fluids by
identifying when patients may be fluid responsive. The utility of
PVi as a fluid responsiveness indicator has been demonstrated in
more than 100 independent, published studies, including in ERAS and
GDT protocols.1 For example:
- ERAS: In a study of 109 patients undergoing colorectal
surgery, researchers found that the implementation of an ERAS
protocol which included PVi led to substantial reductions in
lengths of stay (from a median of 5 days to 3 days), complication
rates (from 30.1% to 14.7%), and costs per patient (from mean cost
at 30 days of $20,435 to $13,306 per patient)—in addition to
improved patient satisfaction.2
- GDT: In a study of 82 patients undergoing major
abdominal surgery, researchers found that GDT with fluid management
using PVi reduced the volume of intraoperative fluid infused and
reduced intraoperative and postoperative lactate levels.3
In addition, PVi has been used in combination with Masimo’s
noninvasive, continuous hemoglobin monitoring technology (SpHb®).
In a study published last year involving 18,716 surgical patients
at a hospital in Limoges, France, researchers investigated the
effects of implementing a hospital-wide protocol for fluid
management and blood administration using PVi and SpHb. The
researchers found that use of an integrated GDT algorithm using
both PVi and SpHb led to earlier transfusion and fewer units of
blood transfused, as well as a 33% lower mortality rate 30 days
after surgery and a 29% lower mortality rate 90 days after surgery.
A year after the study ended, when the hospital did not use PVi and
SpHb technology, the mortality rate returned to levels similar to
those found before implementation of the GDT protocol.4
Stephen Weston, MD, Health Sciences Associate Clinical Professor
and Medical Director, Operating Room Support Services, Department
of Anesthesia and Perioperative Care at the University of
California, San Francisco, said, “At UCSF we display PVi on all of
our Masimo pulse oximeters. PVi is a great tool for helping to
assess the patient’s fluid status. Having a fluid responsiveness
monitor incorporated into something as ubiquitous as pulse oximetry
allows us to monitor fluid responsiveness universally. I integrate
PVi into my routine sweeps of the hemodynamic data in the operating
room, and we’ve rolled out this functionality to the intensive care
units as well. Without PVi, I feel that I’m flying a little bit
blind.”
Joe Kiani, Founder and CEO of Masimo, said, “We are thrilled
that at long last we are able to offer clinicians and patients in
the U.S. the full benefits of PVi monitoring. Multiple studies have
shown how this breakthrough noninvasive indicator of fluid
responsiveness can help improve outcomes and reduce costs on
mechanically ventilated patients – with no more equipment needed
than a software upgrade with most existing Masimo SET® and rainbow®
platforms and the existing Masimo SET® sensors that so many top
hospitals around the world already use for pulse oximetry.”
@MasimoInnovates | #Masimo
The accuracy of PVi in predicting fluid responsiveness is
variable and influenced by numerous patient, procedure, and
device-related factors. PVi measures the variation in the
plethysmography amplitude but does not provide measurements of
stroke volume or cardiac output. Fluid management decisions should
be based on a complete assessment of the patient’s condition and
should not be based solely on PVi.
SpHb 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.
The GDT and ERAS studies summarized above were conducted on
patients undergoing specific types of procedures and following
specific fluid management protocols. The results may not be
reflective of all cases and the described GDT and ERAS protocols
may not be appropriate for all types of patients and
procedures.
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.5 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,6 improve CCHD screening in newborns,7 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.8-11 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,12 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.13 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET®
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. 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®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius PPG™, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97®. Masimo hospital
automation and connectivity solutions are centered around the
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and
Masimo SafetyNet™. Additional information about Masimo and its
products may be found at www.masimo.com. Published clinical studies
on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Published clinical studies on PVi, with varying results and
outcomes, can be found on our website at
http://www.masimo.com/evidence/pulse-oximetry/pvi. Studies include
independent and objective studies which are comprised of abstracts
presented at scientific meetings and peer-reviewed journal
articles.
- Thiele RH et al. Standardization of care: impact of an enhanced
recovery protocol on length of stay, complications, and direct
costs after colorectal surgery. J Am Coll Surg. 2015
Apr;220(4):430-43.
- Forget P et al. Goal-directed fluid management based on the
pulse oximeter-derived pleth variability index reduces lactate
levels and improves fluid management. Anesth Analg. 2010
Oct;111(4):910-4.
- Cros J et al. Continuous hemoglobin and plethysmography
variability index monitoring can modify blood transfusion practice
and is associated with lower mortality. J Clin Monit Comp. 3 Aug
2019. https://doi.org/10.1007/s10877-019-00367-z.
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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 PVi® and 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 PVi and 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; risks related to
COVID-19; 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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