New Study Shows Masimo rainbow® Pulse CO-Oximetry™ Speeds Evaluation & Treatment of Carbon Monoxide Poisoning
IRVINE, Calif., June 21, 2012 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today a new study in The American Journal of Emergency Medicine demonstrates for the first time that compared to invasive carboxyhemoglobin (COHb) measurement with laboratory CO-oximetry, noninvasive carboxyhemoglobin (SpCO®) measurement with Masimo rainbow® Pulse CO-Oximetry™ leads to more rapid diagnosis of carbon monoxide (CO) poisoning and a shorter time to the initiation of treatment with hyperbaric oxygen.(1)
Historically, CO levels in the blood have been measured using a laboratory CO-oximeter, requiring a patient or a patient's blood sample be transported to a hospital with laboratory CO-oximetry capability. In one region of the country, it was demonstrated that only one-half of acute care hospitals had laboratory CO-oximetry capabilities.(2) Additional delays occur if a patient needs hyperbaric oxygen therapy, which often requires transfer to yet another medical center with hyperbaric capability.
In the study, based on three years of U.S. data from the Undersea Hyperbaric Medicine Society's CO poisoning surveillance system (supported by the Centers for Disease Control), researchers analyzed 1,711 cases of CO poisoning treated with hyperbaric oxygen. Of those, 1,606 had their initial carboxyhemoglobin (COHb) level measured by laboratory CO-oximetry; 105 with a Masimo Rad-57™ rainbow® Pulse CO-Oximeter. Of the 1,606 cases, 105 were selected to match the Pulse CO-Oximetry group on the basis of age, sex, race/ethnicity, intent of poisoning, and occurrence of loss of consciousness to compare the time it took to obtain a CO measurement, as well as the time from the end of CO exposure to treatment.
Patients who were initially measured using Pulse CO-Oximetry had a significantly shorter time to measurement of CO (1.1 vs. 1.7 hours, p<0.01), higher COHb levels, and a shorter period of time from the end of CO exposure to treatment (4.4 vs. 5.3 hours, p<0.01). Three hours after exposure, 45% of patients evaluated by Pulse CO-Oximetry had started treatment vs. just 25% of patients evaluated by laboratory CO-oximetry had started treatment (P< 0.01).
While previous studies have examined the accuracy of SpCO as well as the clinical utility of the Rad-57 for rapid mass screenings and detection of unsuspected CO poisoning, this is the first study Masimo is aware of to examine whether Pulse CO-Oximetry can help clinicians decrease the time patients are diagnosed and treated for CO poisoning.
Researchers concluded: "Patients evaluated with Pulse CO-Oximetry had significantly shorter times from CO exposure to COHb determination and hyperbaric oxygen treatment," adding, "it seems reasonable to consider further study of this simple and inexpensive technology for its potential benefit and to hope that even more time delay to treatment can be saved through increased use and adoption of standardized patient management algorithms."
1 Hampson N. "Noninvasive pulse CO-oximetry expedites evaluation and management of patients with carbon monoxide poisoning." The American Journal of Emergency Medicine 2012 (10.1016/j.ajem.2012.03.026) Available online here
2 Hampson NB, Scott KL, Zmaeff JL. Carboxyhemoglobin measurement by hospitals: Implications for the diagnosis of carbon monoxide poisoning. J Emerg Med 2006;31(1):13-6.
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, the company introduced Masimo 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 also be 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 Noninvasive 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 of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, 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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