Healthcare Industry News: Pulse CO-Oximetry
News Release - May 13, 2009
New Study Funded By the National Institutes of Health (NIH) Finds Masimo SpCO(R) May Provide a Noninvasive Measure of Acute Asthma Severity in ChildrenStudy Presented at the Pediatric Academic Societies Annual Meeting by Vanderbilt University Researchers Shows a Statistically-Significant Association between SpCO and Measures of Lung Function
IRVINE, Calif., May 13 (Healthcare Sales & Marketing Network) -- Masimo (Nasdaq: MASI ), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new clinical study conducted in the Emergency Department at Vanderbilt Children's Hospital shows that the noninvasive measurement of carbon monoxide in the blood with Masimo Rainbow SET® Pulse CO-Oximetry (SpCO) may help clinicians better assess acute asthma severity during and after treatment. The study was funded by the National Institutes of Health (NIH) and presented at the Pediatric Academic Societies (PAS) Annual Meeting on May 5, 2009.(1)
Asthma is a life-threatening inflammatory disease of the airways that affects more than 6 million children in the U.S., leading to more pediatric hospitalizations than any other cause.(2) However, a common challenge for children with asthma is the requirement of a forced expiratory test called spirometry. In contrast to spirometry, SpCO--a noninvasive measurement easily obtained from Masimo Rainbow SET Pulse CO-Oximeters and sensors already used in many hospitals--does not require patient instruction or breathing effort. As a result, SpCO may help to improve the assessment of asthma severity and response to treatment in young children and patients who are unconscious, heavily sedated, unable to understand and follow instructions, or have limitations that would interfere with vigorous respiratory efforts.
"We have limited measures to assess severity of acute asthma exacerbations and the finding of an association between carboxyhemoglobin (SpCO) by multi-wavelength Pulse CO-Oximeter may have clinical importance," stated Donald H. Arnold, MD, MPH, Associate Professor of Emergency Medicine and Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee. "Our preliminary results suggest that SpCO is a measure of oxidative stress and inflammation in pediatric patients with acute asthma exacerbations."
Dr. Arnold and colleagues at Vanderbilt used the Masimo Radical-7 Pulse CO-Oximeter to measure SpCO in 139 children (5-10 years of age) during acute asthma exacerbations and 2-hours after initiation of corticosteroid and bronchodilator treatment. Comparing SpCO measurements to conventional measures of airway obstruction and inflammation, researchers found a significant association between SpCO and percent predicted Forced Expiratory Volume in 1 Second (%FEV1, p = 0.001) and airway resistance (p = 0.04), as well as a trend with exhaled nitric oxide (eNO, p = 0.1). Study findings showed that for every 6% increase in SpCO, there was an associated 79% proportionate decrease in lung function (%FEV1, p=0.015) and a trend indicating SpCO may predict lung function after 2-hours of treatment, as measured by the change in %FEV1 (p = 0.06). Researchers concluded that SpCO may "represent a noninvasive, effort-independent measure of acute asthma disease severity as assessed by physiologic measures."
Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly, stated, "This study adds new evidence that expands the value of Masimo's Pulse CO-Oximetry SpCO measurement. The researchers at Vanderbilt Children's Hospital have shown that the ability to easily and quickly perform SpCO measurements on almost any patient without cooperation or risk has the potential to enable more immediate, accurate, and reliable asthma severity assessment."
Editor's Note: The study abstract available online via the PAS website depicts study data and results at the time of the "call for abstracts" and submission deadline (late 2008), although the study was on-going and continued beyond the submission deadline. The data and results captured in this press release represent the actual study data and results presented at the PAS Annual Meeting on May 5, 2009.
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®, 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® Pulse CO-Oximetry(TM), 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 (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI(TM), 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 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 assumptions regarding the repeatability of clinical results, and our belief that noninvasive SpCO measurements will prove to be an effective clinical indicator of lung function and acute asthma severity in children or other patients such that SpCO measurement can effectively substitute for spirometry, as well as other factors discussed in the "Risk Factors" section of our Annual Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, which may be obtained for free at the SEC's website at 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 April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
(1) D. H. Arnold, T. Gebretsadik, D. Resha, T. V. Hartert. "Association of Carboxyhemoglobin Levels with Clinical Measures of Acute Asthma Severity." Presented at the Pediatric Academic Societies (PAS) Annual Meeting, May 5, 2009, Baltimore, Maryland. http://www.abstracts2view.com/pas/view.php?nu=PAS09L1_3201
(2) Centers for Disease Control and Prevention. "Current Asthma Prevalence" 2005. http://www.cdc.gov/nchs/products/pubs/pubd/hestats/ashtma03-05/asthma03-05.htm
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.
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