IRVINE, Calif., April 28, 2011 /PRNewswire/ -- Masimo Corporation (NASDAQ: MASI) announced today the availability of new, enhanced versions of its reusable, noninvasive carboxyhemoglobin (SpCO) sensors—with improved accuracy and reliability performance for patients with low oxygen saturation (SpO2) between 90% and 95% and elevated methemoglobin (SpMet®) between 0% and 2%.
Low SpO2 and elevated SpMet states are known physiological factors that compromise SpCO accuracy and contribute to erroneous measurements. Although this limitation still applies, the new sensors will provide enhanced SpCO performance when a patient's functional SpO2 is > 90%, as well as when their SpMet is < 2%. All previous SpCO sensor versions still meet or exceed their accuracy specification of + 3% at one standard deviation compared to laboratory COHb values when properly applied per the manufacturer's directions for use (DFU). The published accuracy specifications of SpCO-equipped monitors do not change as a result of this new enhancement.
Carbon monoxide (CO) poisoning is a major cause of morbidity and mortality. At least 20,000 known exposures(1) and 439 deaths(2) a year are attributed to non-fire-related, unintentional CO poisoning cases in the U.S. However, large registry trials show the prevalence of CO poisoning is far greater with approximately 50,000 ED visits per year.(3) Because the symptoms of CO poisoning are nonspecific—ranging from mild headache, nausea, confusion, and dizziness to end-organ injury, such as myocardial infarction, stroke, and death—diagnosis is difficult and has historically relied on clinical suspicion and confirmation by invasive blood gas analysis. Unfortunately, it has been estimated that up to half of U.S. hospitals do not have invasive COHb testing ability—increasing the potential that many victims of CO poisoning could be overlooked and misdiagnosed.(4) Masimo SpCO allows immediate and noninvasive assessment of toxic CO levels—enabling early detection of CO poisoning that facilitates prompt, potentially life-saving treatment.
SpCO is part of the Masimo rainbow® SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVI®), and acoustic respiration rate (RRa™), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR). Available in handheld (Masimo Rad-57™) and bedside devices (Masimo Radical-7™, Masimo Rad-87™), SpCO provides clinicians and emergency first responders with a way to quickly, noninvasively evaluate and address the significant health and safety risks associated with CO poisoning—helping to save and sustain lives, minimize suffering, and enhance safety. The new, enhanced versions of the Masimo rainbow Reusable Direct Connect SpCO and DCI® SpCO sensors (previous part numbers 2201, 2407, 2202, 2069, 2640, 2070, 2696, 2697) will now be identified as ID code H. Customers who would like to purchase the enhanced ID code H sensors should call (800) 257-3810 in the U.S., +41 32 720 1111 internationally, or their local sales representative.
(1) Centers for Disease Control and Prevention. "Nonfatal, unintentional, non–fire-related carbon monoxide exposures—United States, 2004-2006." MMWR Morb Mortal Wkly Rep. 2008;57:896-899.
(2) Centers for Disease Control and Prevention. "Carbon monoxide–related deaths—United States, 1999-2004." MMWR Morb Mortal Wkly Rep. 2007;56:1309-1312.
(3) Keles A, Demircan A, Kurtoglu G. "Carbon monoxide poisoning: how many patients do we miss?" Eur J Emerg Med. 2008;15:154-157.
(4) Hampson NB, Scott KL, Zmaeff JL. "Carboxyhemoglobin measurement by hospitals: implications for the diagnosis of carbon monoxide poisoning." J Emerg Med. 2006;31:13-16.
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive 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 rainbow® SET Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Non-invasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.
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, risks related to our belief that Masimo SpCO will provide an accurate and effective method of screening for CO poisoning in large numbers of at-risk populations, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), 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 statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
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