Healthcare Industry News:  Pulse Oximetry 

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 News Release - March 6, 2007

Breaking Study: Masimo Blue Sensor Shown to Be Most Accurate in Monitoring Cyanotic Infants

Study presented at the Society for Critical Care Medicine's 2007 annual meeting concludes Masimo Blue sensor superior in continuous and accurate Pulse Oximetry monitoring of cyanotic infants with congenital heart disease

IRVINE, Calif., March 6 (HSMN NewsFeed) -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion Pulse Oximetry, reported that an independent study presented at the 2007 Society for Critical Care Medicine (SCCM) Annual Meeting in Orlando clearly demonstrated the superiority of Masimo LNOP Blue Sensors in providing accurate, reliable and continuous Pulse Oximetry readings in cyanotic infants with congenital heart disease. In the study, the Masimo LNOP Blue sensor -- which was specifically designed for use in pediatric patients with low oxygen saturation -- was compared to a Nellcor OxiMax sensor and to a standard Masimo LNOP sensor not designed for cyanotic patients, and was shown to have a "significantly higher correlation to arterial blood gas in comparison to the two other sensors studied."(1)

The study was performed by a team of researchers from the Department of Clinical Engineering and Anesthesiology at St. Mary's Hospital in Fukuoka, Japan, who stated that it is extremely difficult to measure low saturation values (<70%) with accuracy with a conventional pulse oximeter. They explained that infants with congenital heart disease (CHD) are often kept at low oxygen saturation levels in order to maintain cardiac output and perfusion and that because of this, it is especially important for clinicians to be able to accurately measure their oxygen saturation by pulse oximeter.

To determine the accuracy of the Masimo Blue sensor with this difficult patient population, researchers analyzed 45 arterial blood gas samples received from six cyanotic infants undergoing pulmonary artery banding procedures and compared Pulse Oximetry data with arterial blood samples analyzed by CO-Oximetry. The results clearly showed the Masimo LNOP Blue sensor delivered more accurate and reliable readings, with a bias (indicating 95% limit agreement) and precision of 0.83 and 2.16 respectively, compared to 8.24 and 4.23 for the Nellcor OxiMax and 7.83 and 4.57 for the standard LNOP. The root-mean-square -- a method of analyzing bias and precision -- of these results shows that the Masimo LNOP Blue sensor is four times more accurate than the other sensors.

The researchers reported, "The LNOP Blue Sensor indicated significantly higher correlation to arterial blood gas in comparison to other two sensors studied. Therefore, LNOP Blue sensor can be a solution for monitoring accurately low saturation levels. Accurate non-invasive monitoring can reduce the number of arterial blood gas draws and can also reduce the risk of infection related to blood draws. The LNOP Blue Sensor provides for the accurate measurement of Pulse Oximetry" when used on cyanotic infants with congenital heart disease.

Joe E. Kiani, Chairman and CEO of Masimo stated, "We are happy to see that researchers all around the world are recognizing and validating the effectiveness of our LNOP Blue sensor with Masimo SET technology in providing accurate, reliable and continuous Pulse Oximetry readings in infants with congenital heart disease, enabling clinicians to more effectively care for one of the most vulnerable patient populations. With this study, there have now been a total of five independent studies on the LNOP Blue sensor conducted in the United States, Japan and Canada -- all with similar results. At Masimo, we take very seriously our legacy of developing technologies that enable more advanced and comprehensive care for those patients who are most at risk. We will continue to expand and deepen our technology portfolio to provide a broad spectrum of noninvasive monitoring parameters that help caring clinicians make better diagnostic and treatment decisions across a wide range of patient populations."

(1) Clinical evaluation of Accuracy of Masimo LNOP Blue sensor in cyanotic infants: Yoshimitsu Tsutsumi, Masakazu Nakashima, Takeshi Ifuku, Hiroshi Yasunaga M.D., Fumiya Nakao M.D., Jun Takamatsu M.D. Department of Clinical Engineering and Anesthesiology, St. Mary's Hospita, Fukuoka, Japan

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. More than 100 independent clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations -- establishing the technology as the "gold standard" Pulse Oximetry and substantially contributing to improved patient outcomes. 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. 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.

Contact:
Tom McCall, Masimo Corporation
Phone: 949-297-7075
Email: tmccall@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. Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corp.


Source: Masimo

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