New Clinical Study Presented at the NYPGA Meeting Shows Respiration Rate Monitoring -- Considered the Fourth Primary Vital Sign -- Has Been Revolutionized With Masimo rainbow Acoustic Monitoring Technology

December 13, 2011

IRVINE, Calif., Dec. 13, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that a new clinical study evaluating Masimo Acoustic Respiration Rate (RRa™) was presented at the New York State Society of Anesthesiologists (NYSSA) Annual Post Graduate Assembly (PGA) Meeting in New York City.

The new study, presented at the 2011 NYPGA, highlights the positive clinical outcomes and patient safety impact of Masimo's unique Acoustic Respiration Rate (RRa™) measurement.  Researchers Michael Ramsay, M.D., Elaine Lagow, R.N., and Mohammed Usman, Ph.D., at Baylor University Medical Center in Dallas, Texas, evaluated the accuracy and sensitivity of Masimo RRa and capnography and found that Masimo RRa had higher sensitivity for detecting respiratory pause events compared to capnography.  The study, conducted in 34 post-surgical patients in the post-anesthesia care unit (PACU) each monitored for an average of 109 minutes, concluded that RRa provided "acceptable respiration rate accuracy" when compared to capnography, but only RRa had the additional advantage of providing "superior sensitivity for detecting respiratory-pause events" defined as no inspiration or expiration activity for > 30 seconds.(1)

Performance Characteristics of Masimo RRa and Capnography (Compared to Reference Method) (1)


Method

Bias (bpm)

Standard
deviation (bpm)

Sensitivity

= TP/(TP+FN)

Specificity

= TN/(TN+FP)

Capnometry

-0.6

2.6

62%

98%

RRa

-0.1

2.4

81%

99%


Table Reference: 2011 NYPGA Study Abstract #P-9137 presented December 11, 2011 @ 2 p.m.



Respiration rate is defined as the frequency of breathing expressed as the number of breaths per minute and is considered the fourth primary vital sign for assessing the physiological status of hospitalized patients; however, current methods for respiration rate monitoring are limited by reliability or patient tolerance. In contrast, Masimo rainbow Acoustic Monitoring technology is a breakthrough in respiration rate monitoring that is completely noninvasive, reliable, and virtually unnoticeable to the patient—enabling clinicians to continuously measure patient breathing acoustically to facilitate earlier detection of respiratory compromise and patient distress.

Featuring an innovative adhesive sensor with an integrated acoustic transducer that is applied to the patient's neck to detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle, Masimo rainbow Acoustic Monitoring uses patented acoustic signal processing that leverages Masimo's revolutionary Signal Extraction Technology (Masimo SET) to separate and process the respiratory signal and display continuous RRa measurements on the Radical-7 Pulse CO-Oximeter.  RRa is part of Masimo rainbow® SET, a noninvasive patient monitoring platform enabling the measurement of multiple blood constituents, such as oxygen saturation, hemoglobin level, fluid responsiveness, respiration rate, and other physiological parameters that previously required invasive blood sampling and time-consuming laboratory analysis.  

According to Dr. Ramsay, Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center, "The increasing number of surgical patients with OSA and morbid obesity has increased our need for accurate surveillance. Our study findings showed that Masimo RRa was more accurate, sensitive, and specific to respiration rate changes than capnography. The improved accuracy offered by RRa translates to less false respiratory alarms, earlier detection of respiratory compromise and, ultimately, better patient care."

*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.

(1) Ramsay MA, Lagow E, Usman M. Accuracy of Respiration Rate and Detection of Respiratory Pause by Acoustic Respiratory Monitoring in the PACU.  NYPGA 2011 Abstract #P-9137; presented December 11, 2011 @ 2 p.m.

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 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.

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; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), PVI®, 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.

Media Contacts:
Dana Banks
Phone: (949) 297-7348
Email: dbanks@masimo.com

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.

SOURCE Masimo Corporation