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Breaking Studies at AARC Congress Show Masimo SET and Masimo Rainbow SET to be Accurate, Effective and Uniquely Beneficial in Detecting and Tracking Disease States

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

(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.


Tom McCall

Masimo Corporation


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.

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