IRVINE, Calif., Oct. 13, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance and CE Mark of its new Radical-7® with rainbow® Acoustic Monitoring capability for continuous display of the acoustic respiration rate (RRa™) waveform and measurements. Also new to the Radical-7 is an In Vivo Adjustment™ (pending FDA 510(k) clearance in the U.S.) that allows clinicians to, for the first time, adjust the noninvasive measurements to the specific patient and laboratory reference device they use for invasive blood testing.
rainbow® Acoustic Monitoring
The new Radical-7 provides clinicians with the option to measure RRa and display the acoustic waveform directly on the monitor screen with the pleth waveform overlayed—allowing them to observe changes in breathing upon inhalation and exhalation. With this new display capability, clinicians may be able to more readily detect respiratory pause events where there is an absence of breathing, high ambient noise that can degrade the acoustic signal, and improper sensor placement.
Respiration rate is defined as the frequency of breathing expressed as the number of breaths per minute and is considered a critical vital sign in 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 is completely noninvasive and virtually unnoticeable to the patient—featuring 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 RRa measurements.
In Vivo Adjustment Allows Users to Account for Individual Patient Bias from Laboratory Reference Device
The measurement of blood components such as oxygen saturation, methemoglobin, carboxyhemoglobin, and total hemoglobin have inherent and expected variability within and between noninvasive and invasive measurement techniques and from patient to patient. For example, all of the noninvasive measurements use a technique coined 'patient calibration' which takes the noninvasive monitor's detected light that is transmitted or reflected from the patient at different values and matches them to empirically gathered invasive blood measurements from a small number of volunteers and in some cases patients. However, individuals may vary from the pool of patients used in the 'patient calibration' and hence provide a bias for the particular patient. In addition, many clinicians are unaware that laboratory reference devices that measure oxygen saturation or hemoglobin can have great variability from each other. In fact, hemoglobin can vary 2 g/dL or more from one manufacturer's product to another. And, physiologic factors such as the blood source (venous or arterial), site and time of blood draws, blood draw technique, and patient body position are recognized in the clinical literature to add variability to hemoglobin levels. As a result, noninvasive and invasive measurements can vary in the same patient depending on the methods and invasive equipment used.
The In Vivo Adjustment feature available in the new Radical-7 now provides the option to adjust the noninvasive oxygen saturation (SpO2), total hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), and methemoglobin (SpMet®) values displayed on the monitor to the laboratory reference value used at the site by patient. With this new feature, clinicians can adjust the noninvasive value at the beginning of a monitoring period to account for individual patient variation and the laboratory reference value and continuously trend the noninvasive value to the patient and reference laboratory value until the next blood sample and laboratory analysis.
"With the addition of the new In Vivo Adjustment feature, Masimo refines its solution for three major limitations that have always plagued pulse oximetry: 1) the inability to measure-through motion and low perfusion (virtually eliminated by Masimo SET); 2) the inaccuracy of SpO2 in the presence of dyshemoglobins (they can now be monitored with SpCO and SpMet); and 3) the inability of one calibration curve to fit all patients (an individual patient's SpO2 can be adjusted to a reference arterial blood gas measurement)," stated Steven Barker, PhD, MD, Chairman of Masimo's Scientific Advisory Board.
Juan Soliveres, M.D., University Hospital in Valencia, Spain, stated, "There are many invasive devices that measure Hb and the results they report may be different from one device to the next. Even laboratory co-oximeters will report different Hb values when the same blood sample is run through different machines of the same make and model. When comparing invasive Hb measurements with noninvasive SpHb measurements, an In Vivo Adjustment feature—to remove measurement bias and calibrate SpHb measurement relative to the lab device—is an important enhancement that should contribute to improved Hb correlations between these measurements."
In addition, the new Radical-7 now features a larger number display with pulse oximetry measurements that are 40% larger than before to improve visibility. And for added safety, the device now includes an optional Alarms All Mute feature that allows the customer to enable or disable the ability for users to mute (silence) alarms on the monitor and adds an additional layer of protection that password-protects this feature—enabling only qualified clinicians to turn-on the Alarms All Mute feature. This feature safeguards against indiscriminate and accidental silencing of monitor alarms that can place patients at increased risk of unrecognized distress and deterioration, while enabling qualified clinicians (through password access) the ability to focus their attention on immediate patient care, interventions, and intensive care resuscitations in sensitive care situations without the audible distractions of monitor alarms.
Masimo Founder and CEO, Joe Kiani, stated, "With the latest Radical-7, we have once again expanded what clinicians can expect from a pulse oximeter; this time by adding the ability to monitor comfortably and reliably a patient's respiration rate. And, with In-Vivo Adjustment, clinicians can, when they need to, get very accurate measurements that are not only patient focused, but adjusted to their laboratory reference devices."
According to Michael O'Reilly, MD, Chief Medical Officer at Masimo, "On hospital general care floors around the world, the problems associated with aggressive post-operative pain management with patient-controlled analgesia (PCA) pumps, rising patient co-morbidities, and decreasing nurse-to-patient ratios have led to dramatic increases in adverse events and avoidable patients deaths. As a result, leading patient safety organizations have been calling for continuous monitoring of oxygenation and ventilation on post-surgical general care floor patients. Today, thanks to Masimo innovations, the need for a reliable SpO2 and respiration rate monitor for patients on general care floors is finally realized—and patients can be safer than ever before."
*The new Radical-7 Pulse CO-Oximeter has FDA 510(k) and CE Mark clearances for rainbow® Acoustic Monitoring and CE Mark clearance for In-Vivo Adjustment. In-Vivo Adjustment is pending FDA 510(k) clearance.
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(TM) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC(TM)), 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(TM), 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.
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 the new Radical-7 offers clinicians expanded functionality and new features that improve patient monitoring; risks related to our belief that the new RRa waveform overlayed with the pleth waveform will allow clinicians to more readily detect respiratory pause events where there is an absence of breathing, high ambient noise that can degrade the acoustic signal, and improper sensor placement; and risks related to our belief that the new In Vivo Adjustment feature will enable clinicians to calibrate noninvasive measurements directly to their specific invasive blood sampling reference device for improved device-to-device comparisons; 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.
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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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