FDA Clears Masimo rainbow® Acoustic Monitoring Sensor for Use on Pediatric Patients

May 6, 2013
Acoustic Respiration Rate (RRa™) Now Offers Accuracy, Ease of Use and Enhanced Tolerance for Pediatric Patients

IRVINE, Calif., May 6, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that its rainbow® Acoustic Monitoring™ sensor, RAS-125c Acoustic Respiration Cloth Sensor has received U.S. FDA 510(k) clearance for continuous, noninvasive monitoring of acoustic respiration rate (RRa™) in pediatric patients. Previously FDA-cleared for adult use, clinicians can now use the RAS-125c Acoustic Respiration Cloth Sensor to noninvasively and continuously assess breathing acoustically in both adult and pediatric patients.

Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia (PCA) for pain management as the sedation can induce respiratory depression and place patients at considerable risk of serious injury or death.1-4 Last year The Joint Commission issued a Sentinel Event Alert on opioid-induced respiratory depression and recommended continuous monitoring of oxygenation and ventilation of post-surgical patients.5 Similarly, Anaesthesia Patient Safety Foundation (APSF) guidelines include oxygenation and ventilation monitoring in all patients receiving opioids.6 Historically, traditional methods for respiration rate monitoring—nasal cannula capnography—can be limited by reliability and patient tolerance.7

Masimo rainbow® Acoustic Monitoring noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck. Now indicated for use in pediatric patients, the accuracy of the RAS-125c Acoustic Respiration Rate Sensor remains the same (as the adult version) at ±1 over the range of 4 to 70 breaths per minute.

"It's going to be a home run," Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas, said of RRa. "Kids don't tolerate capnography," which entails a nasal cannula for monitoring respiratory rate and end-tidal CO2. Ramsay recently finished a study on the efficacy of RRa that will soon be published in Anesthesia & Analgesia.8

"We have been eager to offer this patient-friendly respiration rate monitoring solution to pediatric patients in the United States," said Masimo Founder and CEO Joe Kiani. "We believe that noninvasive, continuous monitoring of acoustic respiration rate is better suited for younger patients than traditional capnography technologies that we also offer. And because the RAS-125c Acoustic Respiration Rate Sensor is more comfortable and tolerable for patients, it will help clinicians improve patient outcomes."

1 Joint Commission on Accreditation of Healthcare Organizations. Sentinel event alert: patient controlled analgesia by proxy; JCAHO. 2004.
2 Institute for Safe Medication Practices. Safety issues with patient-controlled analgesia: Part I – How errors occur; ISMP. 2003.
3 Institute for Safe Medication Practices. Safety issues with patient-controlled analgesia: Part II – How to prevent errors; ISMP. 2003.
4 Bird M. Acute pain management: a new area of liability for anesthesiologists; ASA Newsletter. 2007; 71:8.
5 The Joint Commission. Sentinel event alert: Safe use of opioids in hospitals; 2012
6 Weinger MB et al. APSF Newsletter. 2011; 26(2):21-40.
7 Macknet MR, et al. Accuracy and tolerance of a novel bioacoustic respiratory sensor in pediatric patients; Anesthesiology. 2007; A84.
8 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 ahead of print online here.

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 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.

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 monitoring capabilities of Masimo's proprietary RRa technology will provide sufficient sensitivity and specificity to measure respiratory rate in a variety of patients and monitoring conditions--enabling clinicians to detect and treat respiratory compromise and patient distress earlier; as well as assumptions regarding full commercialization timing and worldwide market availability of the technology; 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.

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