Healthcare Industry News: Patient SafetyNet
News Release - October 8, 2014
Masimo Announces CE Mark of the 11th Rainbow(R) Parameter - ORI(TM), Oxygen Reserve Index(TM)First Noninvasive & Continuous Parameter to Provide Insight Into Oxygen Reserve in Patients Receiving Supplemental Oxygen
NEUCHATEL, SWITZERLAND--(Healthcare Sales & Marketing Network) - Masimo (NASDAQ: MASI) today announced CE Mark and limited market release of Oxygen Reserve Index (ORI™), the first noninvasive and continuous parameter of its kind to provide insight into a patient's oxygen reserve when they are receiving supplemental oxygen. With ORI, Masimo's rainbow SET® Pulse CO-Oximeters with the latest MX-5 circuit board can now measure an unprecedented 11 parameters1 through its noninvasive optical rainbow® sensor technology.
Pulse oximetry (SpO2) provides noninvasive and continuous visibility to arterial blood oxygenation in hypoxia (less than normal oxygenation) and normoxia (normal oxygenation). During supplemental oxygen administration, clinicians often use the partial pressure of oxygen (PaO2), which is intermittent and delayed, to monitor levels of hyperoxia (higher than normal oxygenation). Between invasive sampling, changes in PaO2 cannot be assessed and therefore unexpected hypoxia or unintended hyperoxia can occur.
ORI provides real-time visibility to oxygenation status in moderate hyperoxic range (PaO2 of approximately 100 to 200mmHg). ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements. As an "index" parameter with a unit-less scale between 0.0 and 1.0, ORI can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen reserve.
In patients receiving supplemental oxygen such as those in surgery, conscious sedation, or the intensive care unit, ORI may provide an advance warning of an impending hypoxic state, or an indication of an unintended hyperoxic state. In this way, ORI may enable proactive interventions to avoid hypoxia and unintended hyperoxia.
"ORI is another example of Masimo's commitment to take noninvasive patient monitoring to new sites and applications," said Masimo founder and CEO Joe Kiani. "We believe ORI will have significant applications during surgical procedures, intubation and procedural sedation, among others, and can help clinicians improve patient outcomes by keeping patients in the optimal oxygenation zone to help reduce risk for both hypoxia and hyperoxia."
ORI is available in Europe, but is not available in the United States.
1. 11 parameters include: 1) oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI); 5) Respiration Rate from the pleth (RRp); 6) Total hemoglobin (SpHb); 7) Oxygen Content (SpOC); 8) Carboxyhemoglobin (SpCO); 9) Methemoglobin (SpMet); 10) Fractional oxygen saturation (SpfO2); 11) Oxygen Reserve Index (ORI)
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 help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. 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 commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can 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 risks related to our assumptions regarding the repeatability of clinical results, risks related to our assumptions that Masimo ORI offers noninvasive, continuous patient monitoring enabling full-time visibility to dissolved arterial oxygen status that may enable proactive interventions in 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.
Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation
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