ORLANDO, Fla., Dec. 3 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the
inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse
oximetry, reported that multiple independent and objective clinical studies
and case studies presented this week at the 2007 American Association of
Respiratory Care (AARC) Annual Congress in Orlando, Florida, focused on the
unique capabilities of Masimo's noninvasive patient monitoring technologies in
the diagnosis, treatment and recovery of several disease states, including
pulmonary effusion, methemoglobinemia, carboxyhemoglobin and hypoxemia-helping
clinicians provide more rapid, improved patient care.
These new studies add to the more than 100 independent and objective
studies demonstrating the superiority of Masimo SET pulse oximetry, as well as
adding to the growing body of research proving the efficacy of Masimo Rainbow
SET in providing accurate, reliable physiological measurements of multiple
blood constituents that previously required invasive procedures. Built on the
"gold-standard" of Masimo SET Read-Through Motion and Low Perfusion
technology, Masimo Rainbow SET is the first and only upgradeable technology
platform capable of continuously and noninvasively measuring carboxyhemoglobin
(SpCO), methemoglobin (SpMet) and pleth variability index (PVI), in addition
to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate. Highlights of
key study findings include:
New Masimo Rainbow SET SpMet Measurement Enables Rapid Diagnosis and
Tracking of Benzocaine-induced Methemoglobinemia
In the case study entitled "Benzocaine Induced Methemoglobinemia After
TEE," a team of Anesthesiologists headed by Dr. Mark R. Macknet at Loma Linda
University in Loma Linda, California, documented the accuracy of the Masimo
Rad-57 Pulse CO-Oximeter in the diagnosis and continuous monitoring of SpMet
levels during a case of benzocaine-induced methemoglobinemia after
transesophageal echocardiography and subsequent treatment with methylene blue.
Researchers observed, 40 minutes following the benzocaine administration, a
drop in the patient's oxygen saturation to 88% along with SpMet readings, as
reported by the rad-57, greater than 50%. When an arterial blood sample was
analyzed by laboratory CO-Oximeter, the results reported SpMet "value over
calibration limits" of the invasive laboratory CO-Oximeter. Researchers
treated the patient with methylene blue using the Masimo Rad-57 Pulse
CO-Oximeter "to guide the therapy" and concluded that the new Masimo Rainbow
SET Pulse CO-Oximeter "has documented SpMet accuracy" enabling them to
"rapidly confirm the diagnosis and continuously monitor the levels of
methemoglobin."(1)
Masimo Rainbow SET Pulse CO-Oximetry Shown Effective in the Rapid
Recognition and Continuous Measurement of Carboxyhemoglobin (SpCO)
In a report entitled "Detection of CO-Poisoning Through Pulse CO-Oximetric
Measurement" by Dr. Frank Marx, Rettungsdienst, Berufsfeuerwehr Duisburg Fire
Department and Emergency Service, Duisburg, Germany, the researcher used the
Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to quickly and accurately diagnose
and triage two patients with acute CO-poisoning requiring immediate
transportation to a Center of HBO (hyperbaric oxygen therapy) for treatment.
Both patients had SpCO values greater than 20%, yet recovered completely
following the success of immediate HBO treatment. The results of these case
reports illustrate that suspected CO-poisoning "can be proven with the Masimo
Rad-57 Pulse CO-Oximeter" enabling responsive "triage decisions in the field
so that special treatment in an HBO facility can be arranged." Additionally,
researchers concluded, "the Rad-57 Pulse CO-Oximeter provides rapid
noninvasive assessment of victims and provides information that directly
impacts triage and treatment decisions at the emergency scene."(2)
In another study entitled "Carboxyhemoglobin Levels in Smokers vs.
Non-Smokers in a Smoking Environment," researchers from Ozarks Technical
Community College in Springfield, Ohio, headed by Aaron Light, used the Masimo
Rainbow SET Rad-57 Pulse CO-Oximeter to observe how non-smokers exposed to
cigarette smoke are affected by CO-poisoning. Aided by SpCO measurements
obtained from the Masimo Rad-57 Pulse CO-Oximeter, researchers tested 33
smokers (avg. SpCO of 5.04%) and 27 non-smokers (avg. SpCO of 2.49%) in an
establishment where cigarette smoke was very noticeable against a control
group of 50 non-smokers (avg. SpCO of 1%) in a well-ventilated non-smoking
environment and found that the average SpCO level for the non-smokers in a
smoking environment was nearly two and one half times higher than the control
group indicating that "non-smokers are not exempt from the effects of
cigarette smoke in the atmosphere."(3)
New Masimo Rainbow SET PVI Measurement May Provide Significant Value in
the Detection and Treatment of Processes that Produce Increased Intrathoracic
Pressure
In a study entitled "The Use of Pleth Variability Index (PVI) to Detect
Changes in Intrathoracic Pressure," a team of Neonatologists headed by Dr.
Mitchell Goldstein at the Loma Linda University Children's Hospital in Loma
Linda, California, observed the correlation between Masimo PVI during pre-tap
and post-tap epochs in a 6-week-old newborn with pulmonary effusion and found
that PVI was significantly increased post-drainage. Study findings showed that
PVI consistently increased-from 17.6 pre-tap to 21.8 post-tap in the first
tap, 25.2 to 33.8 in the second, 17.6 to 20.0 in the third and 19.9 to 25.1 in
the fourth-indicating that "an increase in the PVI dynamic could be correlated
to the release of intrathoracic pressure." Researchers concluded, "PVI may
have significant value in the diagnosis and treatment of processes that
produce increased intrathoracic pressure, such as pneumothorax, chylothorax,
and in this case pulmonary effusion."(4)
Masimo SET Read-Through Motion and Low Perfusion Pulse Oximetry More
Reliable and Accurate During Air Transport
In a separate study entitled "Rad-5 and MRL SpO2 Comparison Trial: "A
Prospective Analysis of Pulse Oximetry During Air Transport," Jason A. Elliott
of REACH, Mediplane Inc., in Santa Rosa, California, conducted a three-month
prospective review of the Masimo SET Read-Through Motion and Low Perfusion
Rad-5 pulse oximeter and the Welch Allyn MRL with Nellcor pulse oximetry on a
total of 158 helicopter air ambulance missions and found that the Masimo Rad-5
provided more reliable and accurate SpO2 measurements during air transport and
detected more real hypoxic events than the Nellcor pulse oximeter. Researchers
concluded that the Nellcor pulse oximeter inside the Welch Allan MRL had "more
than two-fold increase in failure rate over the Masimo Rad-5 pulse
oximeter."(5)
Other studies presented at AARC showed promising results for Masimo
engineering prototype technologies, the Acoustic Respiration Monitoring
technology (ARM) and noninvasive and continuous hemoglobin measurement
(SpHb).(6,7)
Joe E. Kiani, Chairman and CEO of Masimo, stated, "These studies not only
showcase the ability of Masimo Rainbow SET to rapidly and accurately diagnose
a disease state, but to also track the progression of and recovery from that
state-enabling critical real-time assessments that show whether a patient is
improving or declining with intervention. This tracking and trending
capability provides clinicians with the useful clinical data they need to
ensure prompt administration of the most appropriate life-saving treatment. We
are happy that the technologies we have developed are helping clinicians
improve patient care and safety."
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.
Masimo SET is the most accurate and reliable pulse oximetry technology,
clinically proven in more than 100 independent and objective studies to
provide the most trustworthy SpO2 and pulse rate measurements even under the
most difficult 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.
Rainbow SET continuously and noninvasively measures carboxyhemoglobin (SpCO)
and methemoglobin (SpMet), pleth variability index (PVI), in addition to
oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate, 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.
(1) Benzocaine Induced Methemoglobinemia After TEE. Mark R. Macknet, Penny
L. Kimball-Jones, Richard L. Applegate, Robert D. Martin, Martin W.
Allard. Anesthesiology, Loma Linda University, Loma Linda, CA.
(2) Detection of CO-Poisoning Through Pulse CO-Oximetric Measurement.
Frank Marx. Rettungsdienst, Berufsfeuerwehr, Duisburg, Germany.
(3) Carboxyhemoglobin Levels in Smokers vs. Non-Smokers in a Smoking
Environment. Aaron Light, Casie Grass, Doug Pursley, Julie Krause.
Ozarks Technical Community College, Springfield, MO.
(4) The Use of Pleth Variability Index (PVI) to Detect Changes in
Intrathoracic Pressure. Mithcell Goldstein, Merrick Lopez, Daniel
Saesim, Richard Peverini. Neonatology, Loma Linda University
Children's Hospital, Loma Linda, CA.
(5) Rad-5 and MRL SpO2 Comparison Trial: A Perspective Analysis of Pulse
Oximetry During Air Transport. Jason A. Elliot. REACH, Santa Rosa, CA.
(6) Accuracy of a Novel Bioacoustic Sensor in Postoperative Patients. Mark
R. Macknet, Penny L. Kimball-Jones, Richard L. Applegate, Robert D.
Martin, Martin W. Allard. Anesthesiology, Loma Linda University, Loma
Linda, CA.
(7) Continuous Noninvasive Measurement of Hemoglobin Via Pulse CO-Oximetry
During Major Surgery. Mark R. Macknet, Penny L. Kimball-Jones, Richard
L. Applegate, Robert D. Martin, Martin W. Allard. Anesthesiology, Loma
Linda University, Loma Linda, CA.
Contact:
Tom McCall
Masimo Corporation
949-297-7075
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing
Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications,
Rainbow, SpCO, SpMet, PVI, SpHb, ARM, and Pulse CO-Oximeter are trademarks or
registered trademarks of Masimo Corporation.
SOURCE Masimo