IRVINE, Calif., Oct. 27 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI) announced today that over 20 new clinical studies showcasing Masimo noninvasive patient monitoring technologies were presented last week at the American Society of Anesthesiologists (ASA) Annual Meeting in San Diego, California. The largest gathering of anesthesiologists in the world, the ASA Annual Meeting provides an important platform for previewing the latest in medical developments and clinical research to industry thought-leaders.
Noninvasive and Continuous Hemoglobin (SpHb®)
This year, 10 new clinical studies examining the accuracy and clinical utility of SpHb monitoring in a variety of patient populations were conducted and presented by a variety of researchers from leading institutions around the world. Dr. Jesse Ehrenfeld, in an NIH-funded randomized controlled trial, showed SpHb monitoring reduced the frequency of intraoperative transfusions by 86% (0.6% vs. 4.5%)(1) while Dr. Ronald Miller, from the University of California-San Francisco, confirmed its value in transfusion medicine, concluding that SpHb may "facilitate the decision as to whether blood should be administered"(2) and Dr. Lionel Lamhaut, after evaluating patients undergoing urologic surgery using SpHb monitoring in a study conducted at Necker University Hospital in Paris, France, suggested "daily use of this technology."(3)
Several studies highlighted the accuracy of SpHb monitoring, including Dr. Chunyuan Qui from Kaiser Permanente who, in the first multi-center study of SpHb in a large integrated healthcare delivery network, evaluated its accuracy "over a wide range of hemoglobin values" and concluded SpHb "has the significant potential to facilitate real time decisions and to avoid the complications, expense and discomfort associated with invasive blood draws."(4) Dr. Juan Soliveres, from University Hospital in Valencia, Spain, monitored surgical patients and concluded that SpHb demonstrated "clinically-acceptable accuracy and precision"(5) and Dr. Kathleen Richard, at Dartmouth Hitchcock Medical Center, showed SpHb guided "early goal-directed therapy with an appropriate patient-centered algorithm in patient populations that lack more invasive access for such monitoring."(6) In a separate study, Dr. Richard demonstrated SpHb's value in trending patients with significant co-morbidities during high-risk surgical procedures, noting that SpHb may "reduce serial and invasive hemoglobin measurements and tests" in the operative environment and may also "add value to care and reduce laboratory costs in many other clinical locations and scenarios (ICU, PACU, Jehovah's Witness patients, pediatrics, etc.)"(7)
The final three studies presented on SpHb examined its application and benefit across patient populations and procedures. At the University of Texas Medical Branch, Dr. Michael Kinsky presented his findings on two case reports demonstrating SpHb to be an "effective noninvasive indicator of vascular volume expansion" and suggested that it could "help guide fluid resuscitation during hemorrhage."(8) Dr. Aubrey Yao, in a study conducted at the University of California-Davis, found SpHb to be "a feasible alternative to invasive hemoglobin monitoring" in cardiac surgery patients(9) while Dr. Jochen Renner, at the University Hospital in Schleswig-Holstein, Germany, studied its accuracy in infants undergoing major surgery and concluded that SpHb showed "clinical acceptable agreement with standard laboratory hemoglobin measurement."(10)
Rainbow Acoustic Monitoring™
Two studies presented on Masimo's newest rainbow measurement—acoustic respiration rate (RRa™)—underscored its accuracy and applicability across hospital care areas. Dr. Jim Kumpula, at Swedish Medical Center, found RRa to be an accurate, easy, automatic method of measuring respiration rate at the bedside that could be of "significant value in a wide range of clinical settings including the general care floor, PACU, OR, sleep laboratories, and any care area utilizing conscious sedation."(11) And at Loma Linda Medical Center, Dr. Mark Macknet found RAM was "better tolerated by patients and easier to use for clinical staff than capnography as some patients do not tolerate the presence of the nasal cannula needed for this technology."(12)
Dr. Andreas Taenzer, in a study conducted on two post-surgical units at Dartmouth-Hitchcock Medical Center, found that Masimo Patient SafetyNet significantly reduced ICU transfers by 30% and rescue events in both a high-risk (vascular and cardiothoracic) and low-risk general care floor post-surgical unit.(13)
Two studies demonstrated comparable accuracy between Masimo PVI for noninvasive fluid responsiveness assessments and invasive methods. Dr. Jochen Renner, at University Hospital in Schleswig-Holstein, Germany, found that PVI >14.5% "reliably predicted fluid responsiveness in infants and neonates undergoing congenital heart surgery with 80% sensitivity and specificity," but invasive CVP did not(14) and Dr. Koff, at Dartmouth-Hitchcock Medical Center, showed that while Masimo PVI had "consistent agreement" with invasive methods of assessing fluid responsiveness (71%), other more manual calculation measures (PPV and SPV) were less accurate at 62%.(15)
Other studies presented on Masimo technologies included a study led by Dr. Soehnke Boye, at the University Medical Center in Schleswig Holstein, Germany, who "strongly recommended" Masimo SpMet monitoring for patients undergoing liposuction due to the high methemoglobinemia toxicity risks associated with use of local tumescent anesthesia, including lidocaine and prilocaine.(16) Two case reports from Dr. Patrick Olomu, at the University of Texas Southwestern Medical Center at Dallas, demonstrated the "emerging utility of noninvasive technology in clinical anesthetic practice," concluding that Masimo PI is a "useful tool in assessing the efficacy of therapeutic interventions in the management of low perfusion states associated with traumatic vascular or soft tissue injury."(17) And, in a study conducted at Loma Linda University, Dr. Martin Allard concluded that Masimo's brain function monitoring technology (SEDLine PSA4000) "adequately and consistently reports burst suppression events as compared to the standard EEG," allowing SEDLine to be used "in selected settings in place of standard EEG."(18)
According to Dr. Michael O'Reilly, Chief Medical Officer of Masimo, "The growing volume of independent clinical studies with Masimo technologies confirms noninvasive, continuous monitoring is taking center stage within the minds and research agendas of the world's leading clinical authorities. While it is inspiring to see such an explosion of research interest and excitement generated by our innovations, the true value of any medical technology is in what you can do clinically to benefit patients. The impact our monitoring technologies are having on both clinical practice and patient care, as evidenced by the results of the randomized control trial on SpHb, is most satisfying because it gets to the heart of our mission of 'Improving patient outcomes and reducing the cost of care by taking noninvasive monitoring to new sites and applications.'"
(1) Ehrenfeld J., Henneman J. "Impact of Continuous and Noninvasive Hemoglobin Monitoring on Intraoperative Blood Transfusions." Massachusetts General Hospital, Harvard University Medical School. Available online here.
(2) Miller, R., Ward, T. "Changes in Noninvasive Versus Co-Oximeter Hemoglobin Values During Intraoperative Blood Loss." University of California San Francisco.
(3) Lamhaut, L., Apriotesei, R., Lejay, M., Vivien, B., Carli, P. "Comparison between a Technology of Spectrophotometry-Based and RBC Count for Haemoglobin Monitoring." Necker University Hospital- Assistance Publique Hopitaux de Paris, Paris, France.
(4) Qiu, C., LaPlace, D., Smith, M., Friedman, M., Etrata, R. "Perioperative Use of Non-Invasive Hemoglobin Monitoring: A Multi-Center Study in a Large HMO." Kaiser Permanente (Baldwin Park, San Diego, Los Angeles).
(5) Soliveres, J., Balaguer, J., Estruch, M., Sanchez, A., Sanchez, J. "Validation of Continuous and Noninvasive Hemoglobin Monitoring from Pulse CO-Oximetry during Surgery." University Hospital Dr Peset, Valencia, Spain.
(6) Richard, K., Novak, M., Dodds, T., Loftus, R., Koff, M. "Non-Invasive Measurement of Oxygen Delivery Index: Is This the Future of Goal Directed Therapy?" Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.
(7) Richard, K., Quill, T., Surgenor, S., Trummel, J., Koff, M. "Evaluation of Non-Invasive Hemoglobin Measurements on High Risk Surgical Patients." Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.
(8) Kinsky, M., Salter, M., Daneshvari, S., Indrikovs, A., George, K. "Continuous Noninvasive Hemoglobin: Impact of Hemorrhage on Volume Expansion of Crystalloid in Humans." University of Texas Medical Branch, Galveston, Texas.
(9) Yao, A., Dastrange, M., Fleming, N. "Continuous Noninvasive Hemoglobin Measurement in Cardiac Surgical Patients." University of California at Davis Medical Center, Sacramento, California.
(10) Renner, J., Broch, O., Scheewe, J., Gruenewald, M., Bein, B. "Non-Invasive Estimation of Hemoglobin by Pulse-CO-Oximetry in Infants Undergoing Major Surgery." University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, Germany.
(11) Kumpula, J., Harrison, R. "Accuracy of Acoustic Respiration Rate Monitoring in an Acute Nursing Unit." Swedish Medical Center, Seattle, Washington.
(12) Macknet, M., Allard, M., Kimball-Jones, P., Rook, J., Applegate, R. "Accuracy of Respiratory Rate Using an Acoustic Respiration Monitor." Loma Linda University, Loma Linda, California.
(13) Taenzer, A., McGrath, S., Pyke, J., Avery, J., Dodds, T. "Patient Surveillance: Transfers and Rescues on a Two Surgical Unit at Dartmouth." Dartmouth Medical School, Hanover, New Hampshire; Thayer School of Engineering, Thayer School of Engineering, Hanover, New Hampshire.
(14) Renner, J., Broch, O., Scheewe, J., Gruenewald, M., Bein, B. "Non-Invasive Prediction of Fluid Responsiveness in Infants Using Pleth Variability Index." University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, Germany.
(15) Koff, M., Novak, M., Richard, K., Loftus, R., Cannesson, M. "Crossing the Threshold To Give a Fluid Bolus; Do We All Agree?" Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire; Anesthesiology, University of California, Orange, California.
(16) Boye, S., Opp, A., Eng., M., Klose, A., Schmeller, W., Gehring, H. "Pulse Oximeter Methemoglobin Measurements in Patients with Tumescent Anaesthesia and Prilocaine." University Medical Center Schleswig Holstein, Luebeck, Germany; Institute of Biomedical Engineering, University of Luebeck, Luebeck, Germany; Hanse-Klinik Luebeck, Luebeck, Germany.
(17) Olomu, P., Romero, A., Steiner, J., Szmuk, P. "Perfusion Index – A Useful Tool To Assess Changes in Extremity Perfusion Following Major Trauma." UT Southwestern and Children's Medical Center Dallas, Dallas, Texas; Outcomes Research Consortium, The Cleveland Clinic, Cleveland, Ohio.
(18) Allard, M., Macknet, M., Hsu, F., Applegate, R. "Feasibility Study: PSA Array Burst Suppression Monitoring Compared to Standard EEG in Craniotomy." Loma Linda University, Loma Linda, California; Neurosurgery, Loma Linda University, Loma Linda, California.
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 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, 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.
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