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New Clinical Study Evaluates Masimo RAM(TM) Technology for Tracking Changes in Respiratory Rate in Anesthetized Patients

Companies mentioned in this article: Masimo

IRVINE, CA -- (Marketwired) -- 08/22/14 -- Masimo (NASDAQ: MASI) announced today that a new study published in the journal Anesthesia & Analgesia demonstrates that Masimo's rainbow® Acoustic Monitoring (RAM™) technology for Acoustic Respiration Rate (RRa®) rapidly detects changes in respiration rate during general anesthesia with a laryngeal mask airway and spontaneous ventilation, and is helpful in the early identification of patients at risk for adverse outcomes.(1)

In the study, Dr. Joshua Atkins, M.D., and colleagues from the Department of Anesthesiology and Critical Care, Perelman School of Medicine at the University of Pennsylvania in Philadelphia, obtained complete data sets from 50 patients undergoing elective urological surgical procedures in the operating room. 1269 minutes of simultaneous data from the pneumotachograph signals and RRa were compared using a Bland-Altman analysis that showed the 95% limits of agreement were -2.1 to 2.2 breaths per minute with a mean error of 0.05 bpm (Bias/Precision of 0.1/1.1 bpm).

The authors report that while accurate monitoring of respiration rate may be useful for the early detection of patient deterioration, "Monitors such as capnometry and thoracic impedance pneumography have significant drawbacks." Known clinical drawbacks of capnometry include patient intolerance and high false alarm rates(2); limitations of thoracic impedance pneumography include susceptibility to artifact, potential inaccuracy, and inability to detect apnea.(3)

"Under conditions of spontaneous ventilation during general anesthesia, RRa provides accurate estimates of respiratory rate changes over a wide range of respiratory rates," the researchers said, and noted that, "RRa is able to track changes in respiratory rate with minimal delay."

The authors concluded: "To the extent that immediate knowledge of changes in respiratory rate is beneficial in early identification of patients at risk for adverse outcomes, RRa may be a useful clinical monitoring indicator."

Masimo's RAM technology provides a method of continuous, noninvasive monitoring of respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck. Using acoustic signal processing that leverages Masimo's patented breakthrough Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa) -- enabling earlier detection of respiratory compromise and patient distress. Several studies have shown RAM is responsive to changes in respiration rate, has similar accuracy to capnography, is superior to capnography in detecting respiratory pause, and has greater patient tolerance than capnography in various patient populations.(1,2,4,5)

(1) Atkins J, Mandel J. Performance of Masimo Rainbow Acoustic Monitoring for Tracking Changing Respiratory Rates Under Laryngeal Mask Airway General Anesthesia for Surgical Procedures in the Operating Room: A Prospective Observational Study. Anesthia-Analgesia Epub July 2014.
(2) Ramsay M, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. "The Accuracy, Precision and Reliability of Measuring Ventilatory Rate and Detecting Ventilatory Pause by rainbow Acoustic Monitoring and Capnometry." Anesth Analg; April 30, 2013 ANE.0b013e318290c798. Available online here.
(3) Goudra BG, Penugonda LC, Speck RM, Sinha AC. Comparison of acoustic respiration rate, impedance pneumography and capnometry monitors for respiration rate accuracy and apnea detection during GI endoscopy anesthesia. Open J Anesthesiol 2013;3:74-9
(4) Mimoz et al. Accuracy of Respiratory Rate Monitoring using a Non-Invasive Acoustic Method after General Anaesthesia. Br J Anaesth. 2012 May;108(5):872-5.
(5) Patino et al. Accuracy of Acoustic Respiration Rate Monitoring in Pediatric Patients. Paediatr Anaesth. 2013 Sep 3.

About Masimo

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 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 could only be measured invasively, 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). Additional information about Masimo and its products may be found at www.masimo.com.

Forward Looking Statements
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 and performance of Masimo rainbow Acoustic Monitoring; our belief that the breakthrough acoustic respiration rate (RRa) capabilities of Masimo's proprietary rainbow acoustic monitoring technology will provide more accurate, precise, and reliable results over capnography in all patients and monitoring conditions -- enabling clinicians to detect and treat respiratory compromise and patient distress earlier; and 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 forward-looking 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.

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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Contact:

Media Contact:
Mike Drummond
Masimo Corporation
Phone: (949) 297-7434
Email: mdrummond@masimo.com