Two New Clinical Studies Using Masimo Technologies Presented at the American Society of Anesthesiologists Annual Meeting
29.10.2015 12:03 | Business Wire
Masimo (NASDAQ: MASI) announced today that two new studies using Masimo technologies were presented at the American Society of Anesthesiologists (ASA) annual meeting in San Diego, California, October 24-28. The conference is the largest gathering of anesthesiologists in the world.
Study Evaluating the EMMA Portable Capnometer in Children Under General Anesthesia
Carbon dioxide levels in the blood reflect the degree of gas exchange occurring in the lungs and provide a critical indictor of cardio-respiratory function that aids in the assessment of the adequacy of ventilation. In a study of 13 children (average age 18 months) undergoing surgery, Dr. Yuko Nawa and colleagues from the Hokkaido Medical Center for Child Health and Rehabilitation in Sapporo, Japan, compared the end tidal carbon dioxide values (EtCO2) from the Masimo EMMA portable capnometer and traditional sidestream capnography (GE Patient Monitor).¹ Compared to sidestream capnography, the EMMA had 95% limits of agreement of -1.3 to 2.5 mm Hg, leading the investigators to conclude that the EMMA has “good correlation with sidestream type capnometer in children” and “may be useful for general anesthesia in out-of-operating room or in case of cardiopulmonary resuscitation, bedside respiratory care and patient transportation.”
Study Evaluating Pleth Variability Index in Spontaneously Breathing Adults During Regional Anesthesia
Dexmedetomidine is an intravenous drug used to sedate patients during surgery which can also cause hypertension or hypotension that may increase patient risk. In a study of 42 spontaneously breathing patients under regional anesthesia,2 Dr. Makoto Sato and colleagues from Asahikawa Medical University in Hoikkado, Japan evaluated the association of baseline pleth variability index (PVI) from Masimo SET® pulse oximetry and dexmedetomidine-induced changes in blood pressure. A baseline PVI≤15 had a 94% sensitivity, 85% specificity, and area under the curve (AUC) of 0.93 (p=0.00002) for resulting hypertension. A baseline PVI≥16 had an 83% sensitivity, 64% specificity, and area under the curve (AUC) of 0.79 (p=0.0008) for resulting hypotension. The investigators concluded, “PVI can predict dexmedetomidine-induced changes in blood pressure in spontaneously breathing patients.”
For more information on the Masimo technology, go to www.masimo.com.
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1. Nawa Y, Chaki T, Tamashiro K, Sato M, Mizuno E, Yamakage M. Accuracy of Portable Capnometer in Children. Proceedings of the American Society of Anesthesiologists, Oct. 27, 2015, San Diego, A4049, Room Upper 10.
2. Sato M, Kunisawa T, Kurosawa A, Sasakawa T, Iwasaki H. Pulse oximeter-derived pleth variability index can predict dexmedetomidine-induced changes in blood pressure in spontaneously breathing patients. Proceedings of the American Society of Anesthesiologists, Oct. 26, 2015, San Diego, A3153, Hall B2, Area B.
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, 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). For the U.S. market, PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The PVI calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percent (0-100%). PVI may show changes that reflect physiologic factors such as vascular tone, circulating blood volume and intrathoracic pressure excursions. The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion. The indications for EMMA include the following: 1) The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 2) The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 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 Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.
Irene Paigah, 858-859-7001
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