Masimo Receives FDA Clearance for Masimo Rainbow SET(R) Acoustic Respiration Rate Monitoring
IRVINE, Calif., Dec. 1 Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA clearance of its latest innovation -- Masimo Rainbow SET Acoustic Monitoring(TM)( -- )providing noninvasive and continuous respiration rate (RRa(TM)) that is accurate, easy-to-use, and enhances patient compliance. Masimo Rainbow SET Acoustic Monitoring may enable earlier detection of respiratory compromise and patient distress -- offering a breakthrough in patient safety for post-surgical patients on the general floor. The limited market release, which will begin in December, will allow select hospitals to be the first to benefit from the new technology.
Respiration rate is defined as the number of breaths per minute and is considered a critical vital sign in assessing the physiological status of hospitalized patients. Continuous monitoring of respiration rate 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.(1-4) Although the Anesthesia Patient Safety Foundation (APSF) recommends continuous oxygenation and ventilation monitoring in all patients receiving opioids,(5,6) current methods for respiration rate monitoring are limited by accuracy and patient compliance.
Masimo Rainbow SET Acoustic Monitoring features an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck to detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle. Using patented acoustic signal processing that leverages Masimo's revolutionary Signal Extraction Technology (SET), the respiratory signal is separated and processed to display continuous respiration rate.
When Masimo Rainbow SET Acoustic Monitoring is used in conjunction with Masimo Rainbow SET Pulse CO-Oximetry and the Masimo Patient SafetyNet(TM) Remote Monitoring and Clinician Notification System, clinicians can follow key indicators of oxygenation with Masimo gold standard SpO2, ventilation with the breakthrough RRa, circulation with Masimo measure through motion pulse rate (PR), and bleeding with Masimo noninvasive and continuous hemoglobin (SpHb(TM)) - enabling them to monitor more patients, more safely, than ever before.
According to Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas, Texas, "Breathing adequately is what matters most. Masimo acoustic respiration rate provides clinicians with the ability to automatically and continuously monitor the breathing status of post-surgical patients in general care or post-anesthesia settings -- alerting them to the first sign of an abnormal or compromised breathing pattern that may be indicative of airway obstruction or respiratory distress." After using the new technology, Dr. Ramsay also stated "The Masimo Acoustic Sensor is virtually unnoticeable when worn - making it extremely patient-friendly."
Masimo Founder and CEO, Joe E. Kiani, stated, "Solving 'unsolvable' problems that have plagued patient monitoring is key to advancing medicine and improving patient care. Masimo Rainbow SET Acoustic Monitoring addresses a longstanding and growing need to accurately and easily monitor patient breathing, which is expected to improve patient safety and decrease the cost of care in hospitals. It also adds another compelling reason for hospitals to choose the Masimo Rainbow SET upgradeable platform for pulse oximetry, Pulse CO-Oximetry, and now -- Acoustic Monitoring."
Live demonstrations of Masimo Rainbow SET Acoustic Monitoring will be featured at the Masimo exhibit at the American Association of Respiratory Care December 5-7, 2009 in San Antonio, Texas.
(1) Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert: Patient controlled analgesia by proxy. Chicago: JCAHO, 2004
(2) Institute for Safe Medication Practice. Safety issues with patient-controlled analgesia: Part 1-How errors occur. Huntingdon Valley: ISMP, 2003
(3) Institute for Safe Medication Practices. Safety issues with patient-controlled analgesia: Part II - How to prevent errors Huntingdon: ISMP, 2003
(4) Bird M. Acute pain management: a new area of liability for anesthesiologists ASA Newsletter. Park Ridge: American Society of Anesthesiologists, 2007
(5) Weinger MB. Dangers of Postoperative Opioids: APSF Workshop and White paper address prevention of postoperative respiratory complications. APSF Newsletter, 2006;21:61-7. http://www.apsf.org/assets/Documents/winter2007.pdf
(6) Stoelting RK, Weinger MB. Dangers of Postoperative Opioids -- Is There a Cure? APSF Newsletter, 2009;24:25-26. http://www.apsf.org/assets/Documents/summer2009.pdf
Masimo (NASDAQ: MASI) develops innovative 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 SETŪ, 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 Masimo Rainbow SETŪ Pulse CO-Oximetry(TM), a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCOŪ), methemoglobin (SpMetŪ), PVI(TM), and acoustic respiration rate (RRa), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. 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 and performance of Masimo Rainbow SET Acoustic Monitoring, risks related to our belief that the breakthrough respiration rate monitoring capabilities of Masimo Rainbow SET Acoustic Monitoring technology will allow clinicians to detect and treat respiratory compromise and patient distress earlier, risks related to our belief that Masimo Rainbow SET Acoustic Monitoring technology will provide sufficient sensitivity and specificity to measure respiratory rate in a variety of patients and monitoring conditions, risks related to our assumptions regarding the commercial timing and availability of the technology, 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 Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, RRa, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
Media Contacts:Dana BanksMasimo Corporation+1 (949) 297-7348
SOURCE Masimo Corporation
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