NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jul. 20, 2017--
Masimo
(NASDAQ: MASI) announced today the CE marking of RPVi™, a noninvasive
and continuous measurement of the dynamic changes in perfusion index
(Pi) that occur during one or more respiratory cycles. RPVi is designed
to show changes that reflect physiologic factors such as vascular tone,
circulating blood volume, and intrathoracic pressure excursions.
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Masimo Radical-7® Pulse CO-Oximeter® with RPVi™ (Photo: Business Wire)
RPVi, powered by Masimo rainbow® technology, is a
multi-wavelength version of the currently available Pleth Variability
Index (PVi®). RPVi is designed to provide enhanced
specificity to changes in fluid volume compared to PVi.1
Several peer-reviewed clinical studies have evaluated the utility of the
currently available measurement PVi as an indicator of fluid
responsiveness in mechanically ventilated patients. For example:
-
In a study of 82 patients undergoing major abdominal surgery,
researchers found that PVi-based goal-directed fluid management
reduced the volume of intraoperative fluid infused and reduced
intraoperative and postoperative lactate levels.2
-
In a study of 109 patients undergoing colorectal surgery, researchers
found that the implementation of an enhanced recovery protocol which
included PVi led to improved patient satisfaction and substantial
reduction in lengths of stay, complication rates, and costs for
patients undergoing both open and laparoscopic colorectal surgery.3
Joe Kiani, Founder and CEO of Masimo, said, “Masimo rainbow®
technology, first announced in 2005, continues to drive innovative new
measurements and improvements to existing ones. We are proud to
introduce RPVi, and hope that it will be useful to clinicians around the
world in helping to improve patient care.”
RPVi is not available for sale in the United States.
@MasimoInnovates |
#Masimo
References
- Masimo data on file.
-
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; 111(4):910-4.
-
Thiele RH 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.
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,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
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,6 and is the primary pulse oximetry at 16 of the top 20
hospitals listed in the 2016-17 U.S. News and World Report Best
Hospitals Honor Roll.7 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/cpub/clinical-evidence.htm.
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
-
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;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 AH 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 RPVi™ and 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 RPVi and 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170719006462/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com