IRVINE, Calif., April 11, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that a new study published in this month's issue of the European peer-reviewed journal Acta Paediatrica demonstrates that pulse oximetry makes a critical difference in neonatal resuscitation both in terms of reliability and speed of measurements. In comparing the measurement response times of three different pulse oximetry technologies, researchers found that the Masimo Radical-7™ pulse oximeter with Masimo SET® Measure-Through Motion and Low Perfusion technology displayed reliable oxygen saturation (SpO2) measurements three to four times faster than competing pulse oximeters.(1)
Despite numerous advances to improve newborn care, oxygen is still used liberally during newborn resuscitation—unnecessarily exposing many newborns to potentially damaging hyperoxia. Although pulse oximetry is an important clinical tool for evaluating a patient's oxygenation status and guiding resuscitation, measurement failure rates due to motion artifact and low perfusion can be high -- leading to inaccurate readings, failure to report readings, or freezing of displayed values. As a result, the time to obtain a reliable oxygen saturation reading during newborn resuscitation in the delivery room and during NICU care is a critically important consideration when choosing a pulse oximetry technology. This is the first prospective observational study to compare pulse oximetry technology performance in detail during newborn resuscitation under unstable critical conditions.
The study was conducted at two health care centers in Barranquilla, Colombia (Clinica del Mar and Medicina Alta Complejidad S.A.) on 32 newborns (median gestational age of 32 weeks) receiving resuscitation as standard of care either in the delivery room or in the Neonatal Intensive Care Unit (NICU). Using the Masimo LNOP® sensor with the Radical-7, the E630 sensor with the Ohmeda Biox 3700, and the OxiMax Max-N sensor for the Nellcor N395, the time to a reliable SpO2 measurement was recorded post-ductally (one sensor placed on each foot) once an adequate pulse rate signal was displayed. Results showed that "the pulse oximeter with Masimo SET provided the fastest response time." In the first comparison of 17 infants, the median response time to obtain a reliable measurement for the Masimo Radical-7 was 20.2+6 (with a range of 18-26 seconds) versus 74.2+12 (with a range of 38-98 seconds) for the Ohmeda Biox 3700. In the second comparison of 15 infants, the median response time for the Masimo Radical-7 was 20.9+4 (with a range of 19-28 seconds) versus 67.3+21 (with a range of 40-90 seconds) for the Nellcor N-395.
Finding that "there are significant differences in the response of pulse oximeters during neonatal resuscitation," researchers concluded that "the speed and reliability of the Masimo SET technology can be of help for clinicians to more accurately adjust the fraction of inspired oxygen during newborn resuscitations, thus preventing or minimizing damage secondary to unnecessary exposure of oxygen and hyperoxemia and to wide fluctuations in oxygen levels."
The 'gold standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® has been shown in over 100 independent clinical studies to provide the most accurate and trustworthy measurements -- even under the most challenging clinical conditions, including patient motion and low perfusion.
(1) Baquero H, Alviz R, Castillo A, Neira F, Sola A. "Avoiding Hyperoxemia During Neonatal Resuscitation: Time To Response Of Different SpO2 Monitors." Acta Paed April 2011 Vol. 100, Issue 4, pp 515-518. Published online here
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 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 regarding the repeatability of clinical results, risks related to our belief that Masimo SET delivers more reliable measurements significantly faster than other pulse oximetry technologies and the use of Masimo SET enables better adjustments during neonatal resuscitation situations, which may aiding in the prevention of damage caused by unnecessary exposure to high or low oxygen, 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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