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Breaking Studies - Masimo's Technologies the Focus of Multiple Clinical Studies at Last Week's American Society of Anesthesiologists' Annual Meeting
Date:10/25/2007

New studies show Masimo provides unique benefits in pulse oximetry, as well as

noninvasive blood constituent and functional hemodynamic monitoring

IRVINE, Calif., Oct. 25 /PRNewswire-FirstCall/ Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that multiple independent and objective clinical studies and a case study were presented last week at the 2007 American Society of Anesthesiology (ASA) Annual Meeting in San Francisco focused on the unique benefits of Masimo's noninvasive patient monitoring technologies in helping clinicians provide 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:

Masimo SET and Blue Sensor more accurate and more reliable in cyanotic children

In a study entitled "New Generation and Old Generation Pulse Oximeters in Children with Cyanotic Congenital Heart Disease" a team of anesthesiologists headed by Dr. Maxime Cannesson at the Louis Pradel Hospital in Lyon, France, found that in a study of 10 children ages seven days to 53 months following palliative cardiac surgery, Masimo obtained readings 100% of the time and "Nellcor failed to obtain readings 15% of the time." Additionally, findings showed a "significant difference between the Nellcor SpO2 reading and the blood gas readings," but no significant difference between the Masimo and blood gas readings when compared to laboratory CO-Oximetry. For the 116 arterial samples, the accuracy of the Masimo Radical pulse oximeter was two times better than that of the Nellcor N-395 pulse oximeter, leading researchers to conclude that "new generation pulse oximeters provide more accurate information and are more reliable than old generation pulse oximeters." (1)

A separate study, entitled "New Pulse Oximetry Sensors with Low Saturation Accuracy Claims -- A Clinical Evaluation" performed by Dr. Peter Cox at the Hospital for Sick Children in Toronto, Canada, compared the accuracy of the Masimo Radical with Blue Sensor, the Nellcor N-600 (with Lo-Sat) and Max-I sensor, and the Radical with LNOP sensor to laboratory CO-Oximetry readings on 12 patients with congenital cyanotic cardiac lesions (CCCL) and concluded that "despite advances in technology, only the Masimo Blue sensor demonstrates acceptable accuracy." (2) Findings showed that, although the Nellcor N-600 with LoSat is advertised to work in CCCL patients, the accuracy demonstrated in this study was not within Nellcor's published accuracy specifications; whereas the Masimo Radical with Blue Sensor had significantly better accuracy and was within Masimo specifications.

Masimo Rainbow SET provides a noninvasive tool to greatly facilitate the clinical diagnosis and treatment for carbon monoxide poisoning and Benzocaine-induced methemoglobinemia

In a report entitled "Rad-57 Rainbow CO-Oximeter in Detecting Methemoglobin during Upper GI Endoscopy -- A Case Report" by Dr. Udaya B. Padakandla at Baylor University Medical Center in Dallas, Texas, the researcher described how four minutes after the Benzocaine application, the patient exhibited a rise in methemoglobin levels above 40% along with a decrease in SpO2 (to 90%), both measured continuously with the Masimo Rainbow SET Rad-57 and confirmed via arterial blood gas analysis. The patient was treated for methemoglobinemia with methylene blue and the SpO2 and methemoglobin levels returned to normal. This case report documents the induction of methemoglobinemia in a GI patient from Benzocaine spray used as a topical anesthetic prior to endoscopy and shows the accuracy and effectiveness of Masimo Rainbow SET to continually and noninvasively measure methemoglobin levels during the entire procedure as confirmed by blood gas with CO-oximetry. This case illustrates the importance of continuous monitoring of SpMet when Benzocaine spray is used. (3)

In another study entitled "Clinical Analyses of 429 Cases of Acute CO Poisoning," researchers from the Hyperbaric Oxygen Department of Beijing Chaoyang Hospital in Beijing, China, headed by Dr. Zhou Li, used the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter and found that 98 of the 429 acute carbon monoxide (CO) poisoning patients had methemoglobin (MetHb) greater than 1.2 percent at the first measurement with significant positive correlation between CO and MetHb levels, suggesting that "MetHb may be involved in the physiopathological process of hypoxia of acute CO poisoning patients." The application of Masimo Rainbow SET technology in the noninvasive measurement of carbon monoxide and methemoglobin concentration levels in the blood lead researchers to conclude that this technology "provides a noninvasive tool to greatly facilitate the clinical diagnosis and treatment for CO poisoning patients." (4)

In a study entitled "A Comparison of Finger, Ear and Forehead SpO2 on Detecting Oxygen Desaturation in Healthy Volunteers," by Dr. Kentaro Tokuda and researchers from the Kyushu University Hospital in Fukuoka City, Japan, researchers compared the time for desaturations and resaturations to be detected by Nellcor forehead (MaxFast), Masimo ear (TC-I) and finger (LNOP) SpO2 sensors when patients were in heads-down, supine and heads-up positions. The study found Masimo's ear sensor to be as fast, or slightly faster, than the Nellcor forehead sensor in detecting desaturations and resaturations. The researchers concluded "sensors on the head (forehead and ear), especially Masimo ear sensor, can detect hypoxia as soon as or even sooner than finger," adding that "sensors on the head (forehead and ear) can also sense recovery state from hypoxia sooner than finger." (5)

In addition, a study entitled "New Algorithm for Automatic Estimation of the Respiratory Variations in the Pulse Oximeter Waveform" conducted at the Louis Pradel Hospital in Lyon, France by a team headed by Dr. Maxime Cannesson demonstrated the ability of Pleth Variability Index (PVI) to accurately and noninvasively detect changes in patient fluid volume. Researchers noted that PVI "has potential clinical applications for noninvasive hypovolemia detection and fluid responsiveness monitoring." (6)

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. More than 100 independent and objective studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations. Our Masimo SET platform has significantly addressed many of the previous technology limitations, has substantially contributed to improved patient outcomes and has been referred to by several industry sources as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, 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.

Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. ARM, Acoustic Respiratory Monitoring, BiFi, Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.

(1) New Generation and Old Generation Pulse Oxymeters in Children with Cyanotic Congenital Heart Disease. Maxime Cannesson, M.D., Jean Neidecker, M.D., Dominique Bompard, M.D., Catherine Vedrinne, M.D., Ph.D., Jean-Jacques Lehot, M.D. Anesthesiology, Hospices Civils de Lyon, Louis Pradel Hospital, Lyon, France.

(2) New Pulse Oximetry Sensors with Low Saturation Accuracy Claims -- A Clinical Evaluation. Peter N. Cox, M.D., F.R.C.P.C. Department of Critical Care Medicine, Hospital for Sick Children, Toronto, Ontario, Canada.

(3) Rad-57 Rainbow CO-Oximeter in Detecting Methemoglobin during Upper GI Endoscopy -- A Case Report. Udaya B. Padakandla, M.B.B.S., F.F.A.R.C.S.I. Anesthesiology, Baylor University Medical Center, Dallas, Texas.

(4) Clinical Analyses of 429 Cases of Acute CO Poisoning. Zhou Li, M.M.S., Chunjin Gao, B.S.M.E., Xiang Huang, M.M.S., Gang Wang, M.D., Huan Ge, B.S.M.E. Hyperbaric Oxygen Department, Beijing Chaoyang Hospital Affiliate of Capital University of Medical Sciences, Beijing, China.

(5) A Comparison of Finger, Ear and Forehead SpO2 on Detecting Oxygen Desaturation in Healthy Volunteers. Kentaro Tokuda, M.D., Kengo Hayamizu, M.D., Kei Ogawa, M.D., Takeshi Hirai, M.D., Kazuo Irita, M.D., Ph.D. Anesthesiology and Critical Care Medicine, Kyushu University Hospital, Fukuoka City, Japan.

(6) New Algorithm for Automatic Estimation of the Respiratory Variations in the Pulse Oximeter Waveform. Maxime Cannesson, M.D., Bertrand Delannoy, M.D., Antoine Morand, M.D., Olivier Bastien, M.D., Ph.D., Jean-Jacques Lehot, M.D., Ph.D. Anesthesiology, Hospices Civils de Lyon, from Louis Pradel Hospital, Lyon, France.

Contact:

Tom McCall

Masimo Corporation

949-297-7075


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