Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Corporation Noninvasive Patient Monitoring Technologies: SpHb, PVI, RRa, and SEDLine
Published: Oct 19, 2012
IRVINE, Calif., Oct. 18, 2012 /PRNewswire/ --Masimo (NASDAQ: MASI) announced today that eight significant new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented at the largest gathering of anesthesiologists in the world, the American Society of Anesthesiologists (ASA) Annual Meeting in Washington, D.C. The following studies highlight the positive clinical outcomes and patient safety impact of Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), PVI®, acoustic respiration rate (RRa), and SEDLine® brain function monitoring.
Noninvasive Total Hemoglobin (SpHb®)
At Fujisawa Municipal Hospital, in Fujisawa, Japan, researchers found that "continuous monitoring of SpHb by pulse oximetry enabled us to evaluate relative change in blood volume and adjust ultrafiltration rate to plasma refilling rate," and concluded: "The results of this study indicate that SpHb monitoring contributes to effective ultrafiltration and stable blood purification."1
At the Seoul National University Hospital, in Seoul, Korea, researchers found that the change in bias and precision of SpHb when compared to invasive laboratory hemoglobin was not significantly different before vs. after intravenous volume loading in children during neurosurgery. The study concluded: "The Radical-7 Pulse CO-Oximeter® can be useful as a trend monitor in children during operation even immediately after volume expanders are administered."2
In another study, researchers Nitin Shah, M.D., and Deval Modi, M.B.,B.S., at the VA Long Beach Healthcare System in Long Beach, Calif., conducted noninvasive hemoglobin testing in patients undergoing cataract surgery in South Africa and with health fair participants in Southern California and showed that Masimo's Pronto-7® noninvasive spot-check hemoglobin device performs "with acceptable reliability" in populations with darker skin pigmentation and "was able to obtain SpHb readings in the vast majority of subjects of both light and dark skin pigmentation."3
Pleth Variability Index (PVI®)
A study at the University of Bordeaux, in Bordeaux, France, by researchers Thakoor Bhismadev, M.D., Tarik Riahi, M.D., Olivier Bernard, M.D., Musa Sesay, M.D., Pierre Maurette, M.D., and Karine Nouette-Gaulain, M.D., , found that "PVI can reliably predict fluid responsiveness in neurosurgical patients in the ICU."4
rainbow® Acoustic Monitoring for RRa
In a multi-center study at Cincinnati Children's Hospital Medical Center, University of Arizona Medical Center, and Children's Medical Center at Dallas, by researchers Mario Patino, M.D., Mohamed Mahmoud, M.D., Dean Kurth, M.D., Daniel Redford, M.D., Thomas Quigley, M.D., and Peter Szmuk, M.D., found that RRa "showed a bias, precision and accuracy root mean square (Arms) of -0.02, 3.25 and 3.25 breaths per minute (bpm) compared to the reference method, whereas capnography showed a bias, precision and Arms of 0.23, 3.29 and 3.30 bpm." They concluded: "This multicenter study showed that respiratory rate measured from noninvasive, acoustic monitoring had similar accuracy and precision as nasal capnography, the current standard of care when used in pediatric patients."5
A study at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, by Jeff Mandel, M.D., M.S., and Joshua Atkins, M.D.,Ph.D., found that RRa compared favorably to capnography and respiratory inductance plethysmography (RIP), concluding that RRa "displayed good accuracy and precision compared to capnography, demonstrating a good alternative for patients not tolerating capnography." Researchers noted that in comparing RRa to RIP, RIP produced a larger bias and precision, possibly due to noise of RIP recordings during patient transport from OR to PACU, showing RRa utility under such interfering conditions for RIP."6
A separate study at Stanford University School of Medicine, by Pedro Tanaka, M.D., David Drover, M.D., and Maria Tanaka, M.D., evaluated the accuracy of respiration rate monitored by CapnoStream (RRetCO2) and RRa in anesthetized patients under sedation and concluded: "The use of RRa could be a good alternative for the perioperative period as most patients will have received sedation during surgery and need to be monitored in PACU and later on the patient wards."7
Results from a study conducted at the University of California San Francisco by researchers Susana Vacas, M.D., Erin McInrue, M.P.H., Mervyn Maze, M.D., and Jacqueline Leung, M.D.,Ph.D., using the SEDLine 4-channel brain function monitor "confirmed the utility of a portable monitor to measure different sleep stages." Researchers concluded: "Having the ability to continuously monitor sleep in the ICU setting will facilitate clinical trials with goal-directed interventions that rectify sleep disruption. Targeting modifiable risk factors such as sleep disruption may ultimately decrease delirium and associated adverse events in the critically ill patients."8
1 Yamada H, Minako S, Sakamoto S, Junko I, Saitoh M, Minoguchi K, Kawada K, Higurashi A, Takahashi S, Takeda K. "Measurement of Relative Change in Blood Volume and Plasma Refilling Rate During Hemodialysis by Noninvasive Continuous Hemoglobin Monitoring Using Pulse Oximetry" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. 8A811.
2 Park Y, Kim J-T, Byon H, Kim H-S. "The Accuracy of Noninvasive Hemoglobin Monitoring Using Radical-7 Pulse CO-Oximeter in Children Undergoing Neurosurgery" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A421.
3 Shah N, Modi D. "Performance of Pronto-7 Noninvasive Hemoglobin Pulse CO-Oximeter in a Dark Skinned Population" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A573.
4 Bhismadev T, Riahi T, Bernard O, Sesay M, Maurette P, Nouette-Gaulain K. "Comparison Between Pleth Variability Index and Arterial Pulse Pressure Variation in the Neurosurgical Intensive Care Unit (ICU)" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A908.
5 Patino M, Mahmoud M, Kurth D, Redford D, Quigley T, Szmuk P. "Accuracy of Acoustic Respiration Rate Monitoring in Pediatric Patients" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. JS10.
6 Mandel J, Atkins J. "Reliability of Masimo Rainbow Acoustic Monitoring in Patients Undergoing Elective Procedures Under General Anesthesia" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A093.
7 Tanaka P, Drover D, Tanaka M. "Correlation Between RRetCO2 and Masimo RRA in Patients Under Deep Sedation: A Pilot Assessment" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A571.
8 Vacas S, McInrue E, Maze M, Leung J. "Sleep Disruption in the Intensive Care Unit" Proceedings of the American Society of Anesthesiologists, October 13, 2012. Washington DC. A396.
*To see a summary of all known clinical studies and abstracts on Masimo technologies and noninvasive measurements, please visit: http://www.masimo.com/cpub/clinicals.htm.
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient carehelping 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 regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), PVI®, acoustic respiration rate (RRa), and SEDLine® 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.
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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.