Study Presented at the American Thoracic Society by Researchers at The
Children's Hospital of Philadelphia Confirms Accuracy and Clinical Value of
Noninvasive SpCO(R) and SpMet(R)
IRVINE, Calif., May 19 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI),
the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and
Low-Perfusion pulse oximetry, announced today that a new independent clinical
study, funded by the National Institutes of Health (NIH) and presented at the
American Thoracic Society in San Diego, CA, shows that the noninvasive
measurement of carboxyhemoglobin (SpCO) and methemoglobin (SpMet) with Masimo
Rainbow SET Pulse CO-Oximetry is accurate and may help clinicians better
detect hypoxemia-a potentially life-threatening lack of oxygen in the blood-in
children with sickle cell disease.
Sickle cell disease is an inherited blood disorder characterized by
abnormally-shaped red blood cells that compromise vital blood and oxygen
supply to the tissues and organs, causing life-threatening complications. The
presence of carboxyhemoglobin and methemoglobin in a sickle cell patient's
blood reduces oxygen supply further because these dyshemoglobins that take the
place of normal oxyhemoglobin lack the ability to carry any oxygen. However,
conventional two-wavelength pulse oximeters are incapable of measuring
carboxyhemoglobin and methemoglobin levels and as a result cannot provide
clinicians with an accurate picture of their patients' true oxygenation status
in the presence of dyshemoglobins.
Masimo Rainbow SET-the first-and-only technology that noninvasively and
continuously measures SpCO and SpMet, in addition to total hemoglobin
(SpHb(TM)), oxygen content (SpOC(TM)), PVI, oxyhemoglobin (SpO2), pulse rate,
and PI--allows for faster and more accurate assessment of the patient's true
oxygenation, which may help to advance the care and management of patients
with sickle cell disease.
In the study presented, Dr. Caboot and colleagues at Children's Hospital
of Philadelphia simultaneously compared SpCO and SpMet measurements obtained
noninvasively using the Masimo Radical-7 Pulse CO-Oximeter with invasive blood
draws and laboratory analysis of carboxyhemoglobin and methemoglobin in 38
asymptomatic children (2-18 years of age) with sickle cell disease. The
researchers found SpCO (with a bias of 0.1% and precision of +/- 2.2%) and
SpMet (with a bias of -0.19% and precision of +/- 0.39%) to be closely
comparable to invasive laboratory measurements. Researchers concluded that
the Masimo Radical-7 Pulse CO-Oximeter "is useful in measuring
carboxyhemoglobin and methemoglobin levels in pediatric patients with sickle
cell disease."
Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly,
stated, "This research not only reinforces the clinical accuracy of SpCO and
SpMet in assessing the true oxygenation of patients, but also highlights the
importance of measuring these dyshemoglobins while managing and treating
pediatric patients with sickle cell disease."
Caboot, J.B., Jawad, A.F., McDonough, J.M., Bowdre, C.Y., Ohene-Frempong,
K., Smith-Whitley, K., Allen, J.L. "Non-Invasive Measurements of
Carboxyhemoglobin and Methemoglobin in Pediatric Patients with Sickle Cell
Disease." Am. J. Respir. Crit. Care Med., Apr 2009; 179: A4788. Presented at
the American Thoracic Society (ATS) Annual Meeting, May 19, 2009, San Diego,
California. http://www.abstracts2view.com/ats09/view.php?nu=ATS09L_2057
About Masimo
Masimo (NASDAQ: MASI) develops innovative monitoring technologies that
significantly improve patient care-helping solve "unsolvable" problems. In
1995, the company debuted Measure-Through Motion and Low-Perfusion pulse
oximetry, known as Masimo SET(R), which virtually eliminated false alarms and
increased pulse oximetry's ability to detect life-threatening events. More
than 100 independent and objective studies demonstrate Masimo SET provides the
most reliable SpO2 and pulse rate measurements even under the most challenging
clinical conditions, including patient motion and low peripheral perfusion.
In 2005, Masimo introduced Masimo Rainbow SET(R) Pulse CO-Oximetry(TM), a
breakthrough noninvasive blood constituent monitoring platform that can
measure many blood constituents that previously required invasive procedures.
Masimo Rainbow SET continuously and noninvasively measures total hemoglobin
(SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)),
methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2),
pulse rate (PR), and perfusion index (PI), 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 www.masimo.com.
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 and our belief
that SpCO and SpMet will improve clinical assessments and the identification
of hypoxemia in patients with sickle cell disease, as well as other factors
discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q
for the fiscal quarter year ended April 4, 2009, filed with the Securities and
Exchange Commission ("SEC") on May 6, 2009, 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
forward-looking statements or the "Risk Factors" contained in our Quarterly
Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a
result of new information, future events or otherwise, except as may be
required under the applicable securities laws.
Media Contact:
Dana Banks,
Masimo Corporation
949-297-7348
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing
Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications,
Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8,
Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered
trademarks of Masimo Corporation.
SOURCE Masimo
05/19/2009
Editor's Note: The study abstract available online depicts study data
and results at the time of the "call for abstracts" submission deadline,
although the study was on-going and continued beyond the submission date. The
data and results captured in this press release represent the updated, final
study data and results presented at the ATS International Conference on May
19, 2009.
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web Site: http://www.masimo.com
(MASI)