New Clinical Studies Presented at the International Anesthesia Research Society Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb®, RRa™, and SedLine®
IRVINE, Calif., May 13, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that three new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented before the world's leading anesthesia educators and investigators at the International Anesthesia Research Society (IARS) Annual Meeting in San Diego. The following studies highlight the positive clinical outcomes and patient safety impact of Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), acoustic respiration rate (RRa™), and SedLine® brain function monitoring.
Noninvasive Total Hemoglobin (SpHb)
Researchers at the Resuscitation Research Laboratory at the University of Texas Medical Branch measured SpHb continuously with a Masimo Radical-7 Pulse CO-Oximeter®, and compared measurements with total hemoglobin (tHb) by arterial blood sampling in volunteer patients under general anesthesia. Researchers said, "SpHb lends itself to effective trend analysis and accurate assessment of changes in tHb during periods of significant hemodilution. Trending was highly reliable in terms of concordance and trending ability."1
rainbow® Acoustic Monitoring for RRa and SedLine
Researchers at Loma Linda University School of Medicine used standard monitoring of patients during procedural sedation, which included pulse oximetry (SpO2) and noninvasive blood pressure, in addition to rainbow® acoustic monitoring (RRa, Rad-87 Pulse CO-Oximeter®), and depth of sedation monitoring using Patient State Index (PSI™) and SedLine. They found, "Respiratory depression, apnea and deep sedation were common in our cohort of patients receiving procedural sedation. These events may not be detected by standard care monitoring of SpO2 and blood pressure. We found concurrent excess sedation or respiratory depression with SpO2 ≤92% in some patients. Our results indicate that advanced respiration rate and brain function monitoring should be considered for patients undergoing procedural sedation."2
In another study, researchers David R. Drover, M.D., and Pedro Tanaka, M.D., at Stanford University School of Medicine, evaluated results of patients who underwent total knee arthoplasty and were provided monitored anesthesia care (MAC) – a combination of sedation and/or analgesic drugs common for less invasive procedures, with the benefit of fewer side effects such as respiratory depression and apnea. Patients received routine ASA monitoring as well as measurement of respiration rate by rainbow® acoustic monitoring (RRa, Rad-87) and depth of sedation measured by PSI and SedLine. Researchers concluded: "Both apnea and excessive sedation occur in patients undergoing MAC but do not occur at the same time. This is consistent with our knowledge of the anatomy of the upper airway and risks of airway obstruction. This suggests that both respiration rate monitoring for the detection of hypoventilation and brain function monitoring for depth of sedation are indicated for patients being provided sedation."3
1 Marques N, Kramer G, Salter M, Voigt R, Kinsky M. "Trending, Accuracy and Precision of Noninvasive Hemoglobin Monitoring During Hemodilution." Proceedings of the International Anesthesia Research Society, May 7, 2013. San Diego. S-386
2 Applegate R, Macknet M, Qoshlli S, Mehdizadeh A, Jacobson P, Neumann M, Allard M. "Incidence of Deep Sedation and Respiratory Compromise During Procedural Sedation" Proceedings of the International Anesthesia Research Society, May 7, 2013. San Diego. S-298
3 Drover D, Tanaka P. "Depth of Sedation Does Not Predict Episodes of Apnea." Proceedings of the International Anesthesia Research Society, May 7, 2013. San Diego. S-302
*To see a summary of all known clinical studies and abstracts on Masimo technologies and noninvasive measurements, please visit: http://www.masimo.com/cpub/clinicals.htm.
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, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), acoustic respiration rate (RRa™), and SedLine® contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation, 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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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, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.
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