Masimo's Commercial Exhibit Draws More Than 2,500 Conference Attendees
IRVINE, Calif., Oct. 23 /PRNewswire-FirstCall/ -- Masimo, the inventor of
Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse
oximetry, announced today that 13 new independent and objective clinical
studies presented at the American Society of Anesthesiology (ASA) Annual
Meeting in Orlando, Fla., October 19-21, 2008, found Masimo SET(R) and Masimo
Rainbow SET(R) technologies to be crucial in providing clinicians with an
early indication of their patients' deteriorating health status in numerous
clinical settings, which may allow earlier intervention and prevention of
adverse clinical outcomes.
In addition, Masimo's commercial exhibit attracted over 2,500
anesthesiologists from the U.S. and around the world. Anesthesiologists
visiting the commercial exhibit marveled at Masimo noninvasive hemoglobin
(SpHb(TM)), the first-and-only technology capable of continuously monitoring
hemoglobin status. Continuous monitoring of anemic status with Masimo SpHb
may allow clinicians to make earlier and better treatment decisions, such as
detecting blood loss earlier to initiate more timely transfusions in some
patients and avoiding unnecessary blood transfusions in others.
Select Clinical Study Highlights
Continuous Pulse Ox Impacts Early Detection of Physiological Abnormalities
in Post-Surgical Patients(1), a clinical evaluation led by Dr. George Blike at
Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, compared
clinical data, patient outcomes and nursing satisfaction before and after
implementation of Masimo Patient SafetyNet(TM) -- a remote monitoring and
wireless clinician notification system -- on a 36-bed post-surgical care unit.
Findings during the three-month evaluation -- covering 2,587 total patient
days -- showed an 80 percent decrease in distress codes and rescue
activations, and a 50 percent decrease in ICU transfers for Masimo Patient
SafetyNet system-monitored patients. Researchers concluded that, "the system
supported the early identification of patients with sedation or
analgesia-induced respiratory depression," as well as the "early recognition
of other patterns of deterioration, including: poor heart rate control, acute
bradycardia needing atropine, new onset A-fib, unrecognized obstructive
patterns of respiration like sleep apnea, and pulmonary complications such as
fat emboli syndrome, pulmonary embolus and edema." In addition, researchers
also noted that the system rated high for up-time at 99.9995% and nursing
satisfaction, as identified by 'desire to keep vs. remove the system', at 5.5
on a 6 point scale.
Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with Blood Gas
CO-Oximetry in Neonates?(2), a clinical study led by Dr. Mitchell R. Goldstein
at Loma Linda Children's Hospital in Loma Linda, California, evaluated whether
methemoglobin saturation (SpMet(TM)) could be successfully measured in
neonates without compromise in oxygen saturation (SpO2) accuracy. Researchers
compared noninvasive SpMet and SpO2 measurements obtained from neonates using
the Masimo Radical-7 Pulse CO-Oximeter and Rainbow R25-L disposable sensor
with MetHb and SaO2 measurements obtained from blood gas analysis using a
laboratory CO-oximeter and found that the accuracy of SpMet (with a Bias of
0.17, Standard Deviation of 0.92, and Average Root Mean Square of 0.93) and
SpO2 (with a Bias of 1.4, Standard Deviation of 2.46, and Average Root Mean
Square of 2.86) was maintained and correlated with blood gas measurements.
Researchers concluded that Masimo's multi-wavelength Pulse CO-Oximeter "can
simultaneously measure SpMet and SpO2 in neonates," and that "continuous
monitoring of MetHb allows better assessment of toxicity and helps identify
the need for ongoing treatment."
Ability of Pleth Variability Index to Non Invasively Predict the
Hemodynamic Effects of PEEP(3) -- led by Dr. Olivier Desebbe at Louis Pradel
Hospital in Lyon-Bron, France, studied the ability of PVI to predict the
effects of positive end-expiratory pressure (PEEP) on cardiac index (CI) in 21
mechanically-ventilated patients following cardiac surgery. The clinical team
recorded mean arterial pressure (MAP), central venous pressure (CVP), cardiac
index (measured using pulmonary artery catheter), and PVI at three successive
tidal volume settings (6, 8, and 10 ml/kg) under zero end-expiratory pressure
and following adjunction of a PEEP, and found that successive zero
end-expiratory pressure induced significant changes in PVI, but not CVP or
MAP. Findings also showed that "PVI was able to predict the hemodynamic effect
of PEEP with 73% sensibility and 80% specificity." Researchers concluded that
PVI could allow clinicians to "optimize fluid loading noninvasively before
adding PEEP for pulmonary reasons."
Pulse Oximeter Perfusion Index as a Predictor for the Effect of
llio-Inguinal Block(4), a prospective clinical study led by Dr. AKI Uemura at
the Tsukuba University Hospital in Ibaraki, Japan, examined whether changes in
Perfusion Index (PI) reflect the effect of llio-inguinal block in 18 children
(mean age 32 months) during inguinal herniorrhaphy. Patients receiving
llio-inguinal blocks were divided into two groups according to the
concentration of Ropivacaine received (0.25% or 0.5%), and monitored using
electrocardiography, noninvasive blood pressure, and two Masimo SET Radical
pulse oximeters placed on both the left and right side limb. The clinical
team recorded PI, blood pressure, heart rate, end-tidal CO2, end-tidal Sevo%,
and respiratory rate for all patients and found that PI on the block side was
significantly elevated when compared to the non-block side. Researchers
concluded that "PI value is a useful, objective, and noninvasive method to
evaluate the effect of llio-inguinal block in pediatric patients."
In addition, there were nine other clinical studies(5-13) presented
validating the accuracy, reliability, and clinical value of Masimo SET Pulse
Oximetry and Rainbow SET Pulse CO-Oximetry -- the first-and-only technology
platform to noninvasively measure blood constituents and fluid responsiveness
that previously required invasive procedures, including: noninvasive &
continuous total hemoglobin (SpHb), oxygen content (SpOC(TM)),
carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)) and Pleth Variability
Index (PVI), in addition to the 'Gold Standard'
measure-through-motion-and-low-perfusion performance of Masimo SET Oxygen
Saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI).
Michael O'Reilly, MD, Masimo Executive Vice President of Medical Affairs,
stated; "The 13 new studies presented at ASA this year add to the growing body
of evidence showing that the use of Masimo SET pulse oximetry and Masimo
Rainbow SET Pulse CO-Oximetry improves patient safety and outcomes."
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, 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, 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 http://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
belief that the applications of Masimo Rainbow SET technologies described in
the foregoing clinical studies will deliver a sufficient level of clinical
improvement over alternative measurement capabilities to allow for rapid
adoption of the technology, and risks related to our assumptions regarding the
repeatability of clinical results at other hospitals and healthcare settings,
and risks related to our assumptions regarding timing or commercial
availability of SpHb, as well as other factors discussed in the "Risk Factors"
section of our Quarterly Report on Form 10-Q for the fiscal quarter ended June
28, 2008, filed with the Securities and Exchange Commission ("SEC") on August
5, 2008, which may be obtained for free at the SEC's website at
http://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 June 28, 2008, whether as a result of new
information, future events or otherwise, except as may be required under the
applicable securities laws.
(1) Continuous Pulse Ox Impacts Early Detection of Physiological
Abnormalities in Post-Surgical Patients. George Blike, M.D., Jean Avery, R.N.,
Melanie Mastanduno, R.N., Klaus Christoffersen, Ph.D., Susan McGrath, Ph.D.
Quality & Patient Safety, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
(2) Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with Blood
Gas CO-Oximetry in Neonates. Mitchell R. Goldstein, M.D., Daniel Saesim, M.D.,
Mark Macknet, M.D., Martin Allard, M.D., Ricardo Peverini, M.D. Neonatal
Medicine, Loma Linda University Children's Hospital, Loma Linda, California.
(3) Ability of Pleth Variability Index to Non Invasively Predict the
Hemodynamic Effects of PEEP. Olivier Desebbe, M.D., Cecile Boucau, R.D.,
Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D., Ph.D., Maxime Cannesson, M.D.
Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(4) Pulse Oximeter Perfusion Index as a Predictor for the Effect of
llio-Inguinal Block. Aki Uemura, M.D., Ph.D., Masahiro Yagihara, M.D.,
Masayuki Miyabe, M.D., Ph.D. Anestheiology, Tsukuba University, Ibaraki,
Japan.
(5) Ability of PVI to detect preload changes in ortho liver transplant.
Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi,
Aman Mahajan, M.D., Ph.D. Anesthesiology, David Geffen School of Medicine,
UCLA, Los Angeles, California.
(6) PVI A non invasive device for fluid responsiveness. Olivier Desebbe,
M.D., Cecile Boucau, R.D., Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D.,
Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel
Hospital, Lyon-Bron, France.
(7) Impact of PEEP on PI and PVI. Nitin K. Shah, M.D., Darin V. Allred,
M.D., Laverne Estanol, M.S., Fine Brian, B.S., Ghandi Vipal, B.S.
Anesthesiology, Long Beach VAHS, Long Beach, California.
(8) Impact of lower extreminity nerve blockade on PI and PVI. Darin V.
Allred, M.D., Nitin K. Shah, M.D., Laverne Estanol, M.S. Anesthesiology,
University of California Irvine, Orange, California.
(9) Perfusion Index via finger and toe. Hiroyuki Sumikura, M.D., Ph.D.,
Yayoi Ohashi, M.D., Ph.D., Yasuyuki Suzuki, M.D., Youichi Kondo, M.D.,
Hirokazu Sakai, M.D. Obstetric Anesthesia, National Center for Child Health
and Development, Tokyo, Japan.
(10) Effect of Servoflurane on peripherial PI. Anne Laffargue, M.D.,
Bruno Marciniak, M.D., Anne Hebrard, M.D., Caroline Petyt, M.D., Renee
Krivosic-Horber, M.D. Pole de'Anethesie Reanimation, Jeanne de Flandre, CHRU,
Lille, France.
(11) Prolocaine induced Methemoglobinemia. Peter Soeding, M.D., Matthias
Deppe, Hartmut Gehring, M.D., Ph.D. Anesthesiology, University of Luebeck,
Lubeck, Schleswig-Holstein, Germany.
(12) Second hand smoke in children. Branden E. Yee, B.A., Iqbal M. Ahmed,
M.D., Raghu Idupuganti, D.O., Douglas Brugge, Ph.D., M.S., Roman Schumann,
M.D. Anesthesia, Tufts Medical Center, Boston, MA.
(13) Estimation of respiration dependent PaO2 Oscillations. Marc
Bodenstein, M.D., Stephan Boehme, John Graybeal, M.D., Hemei Wang, Ph.D.,
Klaus Markstaller, M.D., Ph.D. Department of Anesthesiology, Johannes
Gutenber-University, Mainz, Rhineland-Palatinate, Germany.
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 Corporation