New Clinical Study Presented At The Society For Critical Care Medicine Shows Value Of Pulse CO-Oximetry(TM) To Identify Acquired Methemoglobinemia

February 7, 2009 at 8:00 am Leave a comment


Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that a new study presented at the Society for Critical Care Medicine 38th Critical Care Congress suggests providers should consider routine screening with Masimo Rainbow SET Pulse CO-Oximetry for the immediate and noninvasive detection of potentially life-threatening acquired methemoglobinemia in patients receiving Dapsone therapy. Results showed that “Dapsone therapy is associated with a clinically significant elevation of methemoglobin levels” in 1 out of 7 HIV+ patients.



In the study, Hollis R. O’Neal, M.D., and colleagues at the Vanderbilt University School of Medicine in Nashville, TN, found that 32% of HIV positive patients receiving chronic Dapsone therapy, a commonly used antimicrobial agent for the treatment of prophylaxis of pneumocystis jirovecii pneumonia (PCP), had elevated methemoglobin blood levels (>2%) and 15% had dangerously high methemoglobin blood levels (>3%) when compared to a control group of HIV positive patients not receiving Dapsone.(1) Dapsone has been shown to cause potentially deadly levels of methemoglobin — a damaged form of hemoglobin that cannot bind to oxygen — to accumulate in the blood. Elevated methemoglobin concentration reduces oxygen delivery to vital organs and tissues, which can lead to brain and organ damage, or even death.(2) The researchers concluded: “As noninvasive Pulse CO-Oximetry is now available, providers should consider the routine screening of persons receiving Dapsone for methemoglobinemia.”



Masimo Executive Vice President of Medical Affairs, Dr. Michael O’Reilly, stated: “Previous studies have shown that methemoglobinemia can occur in any patient type in any care area of the hospital. This study reinforces the need for clinicians to quickly, easily and conveniently screen all patients receiving Dapsone therapy using Masimo Rainbow SET Pulse CO-Oximetry as the first line of defense and prevention against acquired methemoglobinemia.”



(1)Hollis R. O’Neal, John H. Newman, Catherine McGowan, Stephen P. Raffanti, Timothy Sterling, Vanderbilt University School of Medicine, Nashville, TN. “The Prevalence of Methemoglobinemia in HIV-Infected Patients on Chronic Dapsone Therapy for Prophylaxis of Pneumocystis Jirovecci Infection.” Society of Critical Care Medicine, February 2, 2009. (2)Ash-Bernal, R., Wise, R., Wright, SM. “The Johns Hopkins Study: Acquired Methemoglobinemia.” Medicine (Baltimore). 2004 Sep;83(5):265-73.



About Masimo



Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care — helping solve “unsolvable” problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET(R), which virtually eliminated false alarms and increased pulse oximetry’s ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET(R) Pulse CO-OximetryTM, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHbTM), oxygen content (SpOCTM), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVITM, in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), 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.



Forward Looking Statements



This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our belief that the positive results and clinical outcomes achieved in this study will be repeated in other studies, and risks related to our assumption that Masimo Rainbow SET Pulse CO-Oximetry technology and devices will deliver a sufficient level of sensitivity for improved methemoglobinemia detection over alternative methods to allow for rapid adoption of the technology, as well as other factors discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, filed with the Securities and Exchange Commission (“SEC”) on October 29, 2008, which may be obtained for free at the SEC’s website at http://www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the “Risk Factors” contained in our Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.



Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.



Masimo

http://www.masimo.com

[Via http://www.medicalnewstoday.com]

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