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
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