IRVINE, Calif., June 2, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today FDA 510(k) Clearance, CE Mark, and limited market release of the industry's first single-patient-use ear sensor. Compared to digit sensors, the Masimo E1™ enables faster detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, including sedative or medication-induced vasoconstriction.(1,2,3) Compared to reusable ear sensors, it also avoids cross-contamination risks for patients and reduces the complexity of sensor management for clinicians, including cleaning, storage, and transport. In the limited market release, select clinicians around the world will have the opportunity to use and evaluate the performance and benefits of the E1 sensor.
Due to the signal processing limitations of conventional pulse oximetry during challenging conditions, clinicians often seek alternative monitoring sites on the head. In spite of the established need, available single-patient-use sensors for the head have suffered from unreliability. While Masimo SET Measure-through Motion and Low Perfusion pulse oximetry overcomes the limitations of conventional pulse oximetry and offers reliable true alarm detection and false alarm prevention during challenging conditions, there are still some advantages to monitoring on the head such as faster response to oxygenation changes during low perfusion and the use of an alternative site when the digit is unavailable.
As a single-patient-use ear sensor that is placed securely in the cavum conchae (the deep hollow near the ear canal opening), the E1 allows clinicians to combine Masimo SET performance with a reliable alternative monitoring site while minimizing cross-contamination. This site frees up the patient's hands and is easy-to-access for clinicians. Made of durable soft silicone, it has no moving parts that can entangle in the hair or irritate the skin. In addition to its advantages for faster detection of saturation changes during low perfusion, it also offers an alternative site when other monitoring sites are unavailable due to emergency transport or use by another type of head sensor such as those used for Masimo's SEDLine® brain function monitoring. In addition, by using the cavum conchae as the monitoring site, the E1 avoids the challenges associated with forehead sensors, including known limitations in the presence of venous pulsations and when patients are in a supine or trendelenburg position. When compared to the traditional ear lobe site, the cavum conchae site also offers better perfusion and superior signal quality—enabling improved monitoring performance in a sensor that stays in place more securely.
According to Dr. Daniel Davis, a contributor on the design of the E1 ear sensor, Professor of Clinical Emergency Medicine, and Director of the UCSD Center for Resuscitation Science in San Diego, California, "The Masimo E1 ear sensor is an ideal monitoring site solution for multiple clinical applications. With it, signal detection is optimized in low perfusion states (sepsis, hemorrhage, hypothermia) and in the presence of peripheral vascular disease. In my experience, the E1 ear sensor detected hypoxemia up to 2-3 minutes sooner, which is critically important during airway management, resuscitation, and inpatient apnea/hypopnea episodes. Additionally, the ear site is more accessible and offers distinct advantages when traditional peripheral monitoring sites are unavailable due to trauma or injury, are swollen and do not easily fit into a digital sensor, or are inaccessible due to drapes, bandages, and dressings. The E1 also eliminates the need for excess cords making it ideal for ambulatory and general care floor patients because it frees up their hands for better mobility, physical therapy, or exercise."
To locate a Masimo representative or distributor in your area and evaluate the E1 sensor, call 1-800-257-3810 or visit www.masimo.com.
(1) Tokuda K, Hayamizu K, Ogawa K, Hirai T, Irita K. "A Comparison of Finger, Ear and Forehead SpO2 on Detecting Oxygen Desaturation in Healthy Volunteers." Anesthesiology 2007; 107: A1544.
(2) Redford D, Lichtenthal P, Barker SJ. "Evaluation of Masimo SET Ear and Forehead Pulse Oximetry and Nellcor MAX-FAST Forehead Pulse Oximetry." Anesthesiology 2004; 101: A593 and A579.
(3) Whitman RA, Garrison ME, Oestreich TJ, Musumbi MS. "Evaluation of a New Reflectance Forehead Sensor in Detecting Oxygen Desaturation in Patients Undergoing Polysomnography." Anesthesiology 2003; 99: A553.
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 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 that the Masimo E1 disposable ear sensor provides faster response times and rapid detection of oxygen saturation, risks related to our assumptions that the E1 sensor offers improved performance for patients in extremely low perfusion states, and risks related to our belief that the design of the E1 sensor does not put excessive pressure on the site and eliminates cross contamination risks, 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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