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Masimo Announces the FDA Clearance of Masimo Rainbow SET Rad-57cm

03/27/06
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:
  1. 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.  
  2. 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.
  3. 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.
  4. 20% of patients tested had elevated methemoglobin levels and 25% of the cases were found accidentally.
  5. 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.
  6. 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.