FDA Clears Masimo Rainbow® Acoustic Monitoring(TM) Sensor for Use on Pediatric Patients


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



IRVINE, Calif. - 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 CO(2). 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 SpO(2), 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.



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.



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Masimo



Web Site: http://www.masimo.com




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