New Clinical Study Presented at the American Association of Respiratory Care Finds Masimo Rainbow Acoustic Monitoring Accurate for Respiration Rate Assessment

IRVINE, Calif., Dec. 13, 2010 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI) announced today that a new clinical study demonstrating the accuracy of its latest medical technology breakthrough—Rainbow Acoustic Monitoring™—was presented last week at the American Association of Respiratory Care's (AARC) 56th Annual International Respiratory Congress in Las Vegas. The largest gathering of respiratory care clinicians in the world, the AARC Annual Meeting provides an important platform for previewing the latest in medical developments and clinical research to respiratory care thought-leaders.

The study presented by Jim Kumpula, RRT, System-wide Manager of Respiratory Care Services at Swedish Medical Center, evaluated the accuracy of acoustic respiration rate (RRa) measurements, obtained noninvasively with Masimo's Rainbow Acoustic Sensor and continuously displayed on the Radical-7 Pulse CO-Oximeter, in 25 patients on an acute nursing unit in comparison to manual estimates of respiration rate obtained via clinical auscultation (listening to breathing sounds with a stethoscope) and visual observations of patient breathing. After analyzing 187 respiratory rate data pairs collected (7.4 +/- 4.6 data pairs per patient) with bias and precision of 0.8 and 3.4 bpm respectively, Kumpula concluded that Rainbow Acoustic Monitoring was a "simple and automatic method of measuring respiration rate at the bedside, with clinically acceptable accuracy" that could be of "significant value in a wide range of clinical settings including the general care floor, PACU, OR, sleep laboratories, and any care area utilizing conscious sedation."(1)  

Respiration rate is an important vital sign and is especially important for post-surgical patients receiving patient-controlled analgesia (PCA) for pain management as sedation can induce respiratory depression and place patients at considerable risk of serious injury or death.(2-5) Although the Anesthesia Patient Safety Foundation (APSF) recommends continuous oxygenation and ventilation monitoring in all patients receiving opioids,(6-7) current methods for respiration rate monitoring are limited by reliability or patient tolerance.  Early this year Swedish Medical Center became a limited market release site for Masimo's Rainbow Acoustic Monitoring technology, which according to Kumpula has been beneficial.

According to Dr. Michael O'Reilly, Chief Medical Officer at Masimo, "Rainbow Acoustic Monitoring technology provides a new cost-effective solution to address the longstanding and growing need to more accurately and easily monitor patient breathing. This study, from the Swedish Medical Center, underscores the value and impact of this new medical technology tool for significantly improving patient safety and decreasing the cost of care."

Additionally, underscoring the Company's commitment, dedication, and industry leadership in providing best-in-breed, innovative patient care solutions, Masimo received its third consecutive Zenith Award.  As the AARC's top industry honor for quality and service excellence, more than 400 companies were eligible for one of five Zenith Award honors. Award winners are chosen by the association's membership—more than 44,000 respiratory care professionals—based upon the quality of the company's equipment and/or supplies, responsiveness, service record, truth in advertising, accessibility and helpfulness of sales personnel, and overall support of the respiratory care profession.

Joe Kiani, Founder and CEO of Masimo, stated, "Confronted with the challenges of delayed lab results, patient tolerance/compliance issues, and time-consuming invasive procedures, respiratory clinicians must provide vital, life-sustaining care for the critically-ill in the face of enormous clinical uncertainty. It is gratifying to see, through studies like this one from Swedish Medical Center, that our noninvasive products and innovative technologies are providing respiratory care clinicians with the immediate access to critical physiological measurements, detailed clinical data, and, in turn, earlier detection of adverse respiratory conditions they need to improve clinical care and patient outcomes.  And, we are honored by the appreciation of so many AARC members who have once again recognized us with the Zenith Award for the superior quality and performance of our products and the service, commitment, and integrity excellence of our company."

(1) Kumpula, J., Harrison, R. "Accuracy of Acoustic Respiration Rate Monitoring in an Acute Nursing Unit." Swedish Medical Center, Seattle, Washington. AARC abstract 811730 presented December 9, 2010, (Open Forum #15—Monitoring/Equipment Part II 9:30-11:25am).

(2) Joint Commission on Accreditation of Healthcare Organizations. "Sentinel Event Alert: Patient Controlled Analgesia By Proxy." Chicago: JCAHO, 2004

(3) Institute for Safe Medication Practice. "Safety Issues with Patient-Controlled Analgesia: Part 1-How Errors Occur." Huntingdon Valley: ISMP, 2003

(4) Institute for Safe Medication Practices. "Safety Issues with Patient-Controlled Analgesia: Part II – How to Prevent Errors." Huntingdon: ISMP, 2003

(5) Bird M. "Acute Pain Management: a New Area of Liability for Anesthesiologists." ASA Newsletter. Park Ridge: American Society of Anesthesiologists, 2007

(6) Weinger MB. "Dangers of Postoperative Opioids: APSF Workshop and Whitepaper Address Prevention of Postoperative Respiratory Complications." APSF Newsletter, 2006;21:61–7.  Available online here.

(7) Stoelting RK, Weinger MB. "Dangers of Postoperative Opioids—Is There a Cure?" APSF Newsletter, 2009;24:25-26. Available online here.

(8) Macknet, M., Allard, M., Kimball-Jones, P., Rook, J., Applegate, R. "Accuracy of Respiratory Rate Using an Acoustic Respiration Monitor." Loma Linda University, Loma Linda, California.

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 Outcomes 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, 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 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, Pulse CO-Oximetry, Pulse CO-Oximeter, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pronto-7, Pronto, Patient SafetyNet, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.

SOURCE Masimo Corporation