Findings show detection rate for CHD improved from 78% to 100% with Masimo's PI measurement
IRVINE, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI),
the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion
pulse oximetry, reported that a new independent and objective clinical study
demonstrates the ability of Masimo SET Perfusion Index (PI) to improve
detection of congenital heart defects (CHD) in newborns with duct-dependent
systemic circulation. Even when routine neonatal physical examinations and
saturation screenings fail, PI may help to accurately detect CHD-enabling
life-saving early detection and critical intervention before discharge from
the hospital. It has been documented that up to 30% of all deaths from CHD in
the first year of life are due to unrecognized cases being discharged to the
home.
PI is a measurement featured in the Masimo Rainbow SET technology platform
that reflects the real-time changes in peripheral blood flow at the monitored
site and the strength of the plethysmographic signal displayed on the pulse
oximeter. In addition to improving the detection of CHD in infants, the
ability to noninvasively and continuously measure PI could enable faster
identification of clinically significant changes in a patient's physiologic
status, including potentially hypothermia, hypovolemia, shock and/or sepsis.
In the study, entitled "Noninvasive Peripheral Perfusion Index as a
Possible Tool for Screening for Critical Left Heart Obstruction," conducted at
the Institute of Clinical Sciences, Gothenburg University, Sweden, A de-Wahl
Granelli and I Ostman-Smith observed whether PI was a dependable indicator in
critically-ill newborns to enable its use for congenital heart disease
screening purposes. The researchers indicated that several studies have
reported that babies with congenital heart disease are not detected by routine
neonatal physical examinations and that neonatal screening fails mainly in
children with duct-dependent systemic circulation.
Granelli and Ostman-Smith conducted single pre- and postductal
measurements of PI using the Masimo Radical SET Pulse Oximeter in a total of
10,000 healthy newborns (ranging in age from 1 hour to five days) and
established PI reference values of healthy babies. In establishing reference
values that validate possible PI indices for normal vs. disease state in
newborns, researchers were able to show that low PI values may correspond to
illness.
Study results showed that combined neonatal examination and oxygen
saturation screening detected only 78% of the newborns with LHOD, but when PI
was added, 100% of all newborns with LHOD showed abnormalities -- indicating
that PI may reflect abnormal blood flow from the heart in CHD newborns. All
LHOD newborns had either pre- or postductal PI values below the interquartile
cut-off value of 1.18 and five had values below a potential cut-off of 0.70,
leading researchers to conclude that "PI values lower than 0.70 may indicate
illness and a value less than 0.50 indicates definite underperfusion."
Study findings suggest that a combination of saturation screening cut-offs
with PI value cut-offs may help improve the early detection of congenital
heart defects that have duct-dependent systemic circulation. As a result,
researchers concluded that PI is a "promising tool for improving the detection
of critical congenital heart disease with duct-dependent systemic
circulation."(1)
Joe E. Kiani, Chairman and CEO of Masimo stated, "When we introduced
Masimo SET ten years ago, we knew that the improved accuracy and fidelity
would allow clinicians to more tightly control the arterial oxygen levels of
their patients, but it is truly remarkable to see research like this where our
technology is being used to improve screening for congenital heart defects. We
are all indebted to clinicians like these from Gothenburg University who are
constantly looking for ways to utilize the latest technological advancements
to deliver better care."
About Masimo
Masimo (Nasdaq: MASI) develops innovative monitoring technologies that
significantly improve patient care -- helping solve "unsolvable" problems. In
1995, the company debuted Read-Through Motion and Low Perfusion pulse
oximetry, known as Masimo SET, and with it virtually eliminated false alarms
and increased pulse oximetry's ability to detect life-threatening events. More
than 100 independent and objective studies have confirmed that Masimo SET
technology allows clinicians to accurately monitor blood oxygen saturation in
critical care situations. Our Masimo SET platform has significantly addressed
many of the previous technology limitations, has substantially contributed to
improved patient outcomes and has been referred to by several industry sources
as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo
Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively
monitors the level of carbon monoxide and methemoglobin in the blood, allowing
early detection and treatment of potentially life-threatening conditions.
Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and
Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and
Applications." Additional information about Masimo and its products may be
found at http://www.masimo.com.
Forward Looking Statements
This press release may include forward-looking statements. These
forward-looking statements are based on current expectations about future
events affecting us and are subject to uncertainties and factors, all of which
are difficult to predict and many of which are beyond our control, including:
risks related to our assumption that the results of the PI study will be
duplicated in future clinical studies and risks related to our assumptions
regarding the correlation between PI and abnormal blood flow from the heart in
CHD newborns, as well as changes in a patient's physiologic status, and other
factors discussed in the "Risk Factors" section of our quarterly report on
Form 10-Q for the quarter ended September 29, 2007, filed with the Securities
and Exchange Commission on November 1, 2007. Although we believe that the
expectations reflected in our forward-looking statements are reasonable, we do
not know whether our expectations will prove correct. You are cautioned not to
place undue reliance on these forward-looking statements, which speak only as
of the date hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements or the risk factors contained in our
quarterly report on Form 10-Q for the quarter ended September 29, 2007,
whether as a result of new information, future events or otherwise, except as
may be required under the federal securities laws.
(1) Granelli A, Ostman-Smith I. Noninvasive Peripheral Perfusion Index as
a Possible Tool for Screening for Critical Left Heart Obstruction.
Acta Paediatrica 2007;96:1455-1459.
Contact:
Tom McCall
Masimo Corporation
949-297-7075
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad-57,
APOD, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive
Monitoring to New Sites and Applications, Rainbow, SpCO, SpMet, and Pulse
CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
SOURCE Masimo Corporation