World's First Device Capable of Noninvasively Measuring
Carboxyhemoglobin, Methemoglobin and Oxyhemoglobin saturation levels in the blood
Irvine, California - March 27, 2006 - Masimo, the inventor of Pulse
CO-Oximetry™ and Read-Through Motion & Low Perfusion Pulse
Oximetry, announced today the FDA clearance of the Masimo Rainbow SET
Rad-57cm Pulse CO-Oximeter™. The Masimo Rad-57cm is a handheld,
continuous monitor that analyzes data from a sophisticated yet
simple-to-apply, 8-wavelength finger sensor to accurately measure
arterial oxygen saturation, carbon monoxide, methemoglobin and pulse
rate. Building on the success of the Rad-57 launched in 2005, the
Rad-57cm adds the ability to measure methemoglobin, another silent
killer like carbon monoxide.
Methemoglobinemia compromises the blood's ability to carry oxygen
and can be life-threatening in many areas of the hospital, as well as
in many settings outside of the hospital. The Institute for Safe
Medical Practice (ISMP) states that "methemoglobinemia is unlikely to
be a rare occurrence" while authors from The 2004 Johns Hopkins
University School of Medicine studyi entitled "Acquired Methemglobenemia", concluded "drugs that cause acquired
methemoglobinemia are ubiquitous in both the hospital and the outpatient setting."
The Johns Hopkins study had several key findings:
- Acquired methemoglobenemia is ubiquitous in hospitals,
from OR to the General Ward and is independent of patient's age, from 4 days of age to 86 year of age.
- Over 25 drugs that are used frequently in hospitals cause
acquired methemoglobenemia, including 'caine' anesthetics such as
Benzocaine and Lidocaine, nitroglycerin which is commonly used on
cardiac patients, EMLA cream for infants and neonates, inhaled nitric
oxide used on premature infants and sometimes cardiac patients, and
Dapsone, a powerful anti-infective which is commonly used on organ
transplant, AIDS, and dermatoses patients.
- Methemoglobinemia can cause serious injury and
even death, but can be treated if detected. During the study time, there were 3 near deaths and one death.
- 20% of patients tested had elevated methemoglobin levels and 25% of the cases were
found accidentally.
- The cost of doing invasive testing of methemoglobin is $35
each time and during the 28-month period it would have cost the
hospital $9 Million.
- Despite the cost, the authors recommended the measurement of
methemoglobin every time blood was drawn for arterial blood gas testing
and serial testing during treatment.
Methylene blue, a common dye used in imaging procedures, is the
standard treatment for methemoglobinemia. Blood transfusion can
also be used to save a patient that has very high levels of
methemoglobin.
In another studyii by Osaka City University Medical
School Researchers entitled "Elevated Methemoglobin in Patients with
Sepsis", the authors showed that methemoglobin rises in patients before
they go into septic shock. Detecting the onset of septic shock
has been one of the most sought after findings in modern
medicine. If patients developing sepsis can be diagnosed early
enough, they can be treated more effectively, enhancing their chances
of surviving this potentially fatal condition.
Meanwhile, in the outpatient setting, many common agents can cause
methemoglobinemia such as: inhalation of industrial fumes from
automobile exhaust or the burning of plastics and wood; herbicides and
pesticides; industrial chemicals such as petrol octane booster;
nitrobenzene; nitroethane which is found in nail polish; resins and
rubber adhesives; and drugs of abuse.
Joe E. Kiani, Chairman and CEO of Masimo, stated, "We are proud to
once again develop a life saving product that was never available
before. Monitoring methemoglobin noninvasively should help save
hundreds of thousands of lives around the world. The Johns
Hopkins study showed that 20% of the patients tested had elevated
methemoglobin. These patient ranged from 4 days old to 86 years
old and were found all over the hospital, including the OR, NICU, ICU,
and General Ward. During their study, they also reported 3 near
deaths and one death. More alarming is that 25% of the cases were
found accidentally. We believe that noninvasive monitoring of
methemoglobin is essential to reducing the number of injuries and
deaths."
"Methemoglobinemia is much more common than the healthcare community
realizes" said Maribeth Sayre, MD, Director of Medical Affairs of
Masimo. "Historically, methemoglobinemia has often been missed
because clinical suspicion was necessary and then a blood test using an
expensive laboratory co-oximeter was required for confirmation.
Only about 50% of US hospitals have a laboratory co-oximeter, so
diagnosing elevated and potentially dangerous levels of methemoglobin
has been a practical challenge. We believe that Rad 57cm with Masimo
Rainbow SET represents a major advance in patient monitoring."
About Masimo
Masimo 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 SET, and
with it virtually eliminated false alarms and increased pulse
oximetry's ability to detect life-threatening events. Over 70
independent clinical studies have confirmed that Masimo SET technology
allows clinicians to accurately monitor blood oxygen saturation in
critical care situations. In 2005 Masimo introduced Rainbow SET
and with it, Pulse CO-Oximetry, which, for the first time,
noninvasively monitors the level of carbon monoxide and methemoglobin
in the blood, as well as oxygen saturation, pulse rate and perfusion
index, allowing early detection and treatment of potentially
life-threatening conditions.
Masimo, founded in 1989, has the mission of "Improving Patient
Outcome 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
Masimo,
Signal Extraction Technology, SET and LNOP are registered trademarks of
Masimo Corporation. Signal Extraction and Rad-57 are trademarks of
Masimo Corporation. Rainbow, Pulse CO-Oximetry, SpMet and SpCO
are trademarks of Masimo Laboratories.
Contact:
Brad Langdale
949-297-7009
blangdale@masimo.com
i Ash-Bernal R, Wise
R, Wright SM. Acquired Methemoglobinemia. A Retrospective Series
of 138 Cases at 2 Teaching Hospitals. Medicine 2004; 83: 265-272.
ii Ohashi K, Yukioka
H, Hayashi M, Asada A. Elevated Methemoglobin in Patients with
Sepsis. Acta Anaesthesiol. Scand. 1998; 42:713-716.