New Clinical Studies Presented at the American Society of Anesthesiology (ASA) Annual Meeting Show Masimo Technologies Provide Advanced Clinical Intelligence
IRVINE, Calif., Oct. 23 /PRNewswire-FirstCall/ — Masimo, the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that 13 new independent and objective clinical studies presented at the American Society of Anesthesiology (ASA) Annual Meeting in Orlando, Fla., October 19-21, 2008, found Masimo SET(R) and Masimo Rainbow SET(R) technologies to be crucial in providing clinicians with an early indication of their patients’ deteriorating health status in numerous clinical settings, which may allow earlier intervention and prevention of adverse clinical outcomes.
In addition, Masimo’s commercial exhibit attracted over 2,500 anesthesiologists from the U.S. and around the world. Anesthesiologists visiting the commercial exhibit marveled at Masimo noninvasive hemoglobin (SpHb(TM)), the first-and-only technology capable of continuously monitoring hemoglobin status. Continuous monitoring of anemic status with Masimo SpHb may allow clinicians to make earlier and better treatment decisions, such as detecting blood loss earlier to initiate more timely transfusions in some patients and avoiding unnecessary blood transfusions in others.
Select Clinical Study Highlights
Continuous Pulse Ox Impacts Early Detection of Physiological Abnormalities in Post-Surgical Patients(1), a clinical evaluation led by Dr. George Blike at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, compared clinical data, patient outcomes and nursing satisfaction before and after implementation of Masimo Patient SafetyNet(TM) — a remote monitoring and wireless clinician notification system — on a 36-bed post-surgical care unit. Findings during the three-month evaluation — covering 2,587 total patient days — showed an 80 percent decrease in distress codes and rescue activations, and a 50 percent decrease in ICU transfers for Masimo Patient SafetyNet system-monitored patients. Researchers concluded that, “the system supported the early identification of patients with sedation or analgesia-induced respiratory depression,” as well as the “early recognition of other patterns of deterioration, including: poor heart rate control, acute bradycardia needing atropine, new onset A-fib, unrecognized obstructive patterns of respiration like sleep apnea, and pulmonary complications such as fat emboli syndrome, pulmonary embolus and edema.” In addition, researchers also noted that the system rated high for up-time at 99.9995% and nursing satisfaction, as identified by ‘desire to keep vs. remove the system’, at 5.5 on a 6 point scale.
Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with Blood Gas CO-Oximetry in Neonates?(2), a clinical study led by Dr. Mitchell R. Goldstein at Loma Linda Children’s Hospital in Loma Linda, California, evaluated whether methemoglobin saturation (SpMet(TM)) could be successfully measured in neonates without compromise in oxygen saturation (SpO2) accuracy. Researchers compared noninvasive SpMet and SpO2 measurements obtained from neonates using the Masimo Radical-7 Pulse CO-Oximeter and Rainbow R25-L disposable sensor with MetHb and SaO2 measurements obtained from blood gas analysis using a laboratory CO-oximeter and found that the accuracy of SpMet (with a Bias of 0.17, Standard Deviation of 0.92, and Average Root Mean Square of 0.93) and SpO2 (with a Bias of 1.4, Standard Deviation of 2.46, and Average Root Mean Square of 2.86) was maintained and correlated with blood gas measurements. Researchers concluded that Masimo’s multi-wavelength Pulse CO-Oximeter “can simultaneously measure SpMet and SpO2 in neonates,” and that “continuous monitoring of MetHb allows better assessment of toxicity and helps identify the need for ongoing treatment.”
Ability of Pleth Variability Index to Non Invasively Predict the Hemodynamic Effects of PEEP(3) — led by Dr. Olivier Desebbe at Louis Pradel Hospital in Lyon-Bron, France, studied the ability of PVI to predict the effects of positive end-expiratory pressure (PEEP) on cardiac index (CI) in 21 mechanically-ventilated patients following cardiac surgery. The clinical team recorded mean arterial pressure (MAP), central venous pressure (CVP), cardiac index (measured using pulmonary artery catheter), and PVI at three successive tidal volume settings (6, 8, and 10 ml/kg) under zero end-expiratory pressure and following adjunction of a PEEP, and found that successive zero end-expiratory pressure induced significant changes in PVI, but not CVP or MAP. Findings also showed that “PVI was able to predict the hemodynamic effect of PEEP with 73% sensibility and 80% specificity.” Researchers concluded that PVI could allow clinicians to “optimize fluid loading noninvasively before adding PEEP for pulmonary reasons.”
Pulse Oximeter Perfusion Index as a Predictor for the Effect of llio-Inguinal Block(4), a prospective clinical study led by Dr. AKI Uemura at the Tsukuba University Hospital in Ibaraki, Japan, examined whether changes in Perfusion Index (PI) reflect the effect of llio-inguinal block in 18 children (mean age 32 months) during inguinal herniorrhaphy. Patients receiving llio-inguinal blocks were divided into two groups according to the concentration of Ropivacaine received (0.25% or 0.5%), and monitored using electrocardiography, noninvasive blood pressure, and two Masimo SET Radical pulse oximeters placed on both the left and right side limb. The clinical team recorded PI, blood pressure, heart rate, end-tidal CO2, end-tidal Sevo%, and respiratory rate for all patients and found that PI on the block side was significantly elevated when compared to the non-block side. Researchers concluded that “PI value is a useful, objective, and noninvasive method to evaluate the effect of llio-inguinal block in pediatric patients.”
In addition, there were nine other clinical studies(5-13) presented validating the accuracy, reliability, and clinical value of Masimo SET Pulse Oximetry and Rainbow SET Pulse CO-Oximetry — the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: noninvasive & continuous total hemoglobin (SpHb), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)) and Pleth Variability Index (PVI), in addition to the ‘Gold Standard’ measure-through-motion-and-low-perfusion performance of Masimo SET Oxygen Saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI).
Michael O’Reilly, MD, Masimo Executive Vice President of Medical Affairs, stated; “The 13 new studies presented at ASA this year add to the growing body of evidence showing that the use of Masimo SET pulse oximetry and Masimo Rainbow SET Pulse CO-Oximetry improves patient safety and outcomes.”
Masimo develops innovative 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 Masimo Rainbow SET, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. 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 http://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 belief that the applications of Masimo Rainbow SET technologies described in the foregoing clinical studies will deliver a sufficient level of clinical improvement over alternative measurement capabilities to allow for rapid adoption of the technology, and risks related to our assumptions regarding the repeatability of clinical results at other hospitals and healthcare settings, and risks related to our assumptions regarding timing or commercial availability of SpHb, as well as other factors discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2008, filed with the Securities and Exchange Commission (“SEC”) on August 5, 2008, which may be obtained for free at the SEC’s website at http://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 Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
(1) Continuous Pulse Ox Impacts Early Detection of Physiological Abnormalities in Post-Surgical Patients. George Blike, M.D., Jean Avery, R.N., Melanie Mastanduno, R.N., Klaus Christoffersen, Ph.D., Susan McGrath, Ph.D. Quality & Patient Safety, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
(2) Do Pulse CO-Oximeter Measures of SpMet and SpO2 Correlate with Blood Gas CO-Oximetry in Neonates. Mitchell R. Goldstein, M.D., Daniel Saesim, M.D., Mark Macknet, M.D., Martin Allard, M.D., Ricardo Peverini, M.D. Neonatal Medicine, Loma Linda University Children’s Hospital, Loma Linda, California.
(3) Ability of Pleth Variability Index to Non Invasively Predict the Hemodynamic Effects of PEEP. Olivier Desebbe, M.D., Cecile Boucau, R.D., Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(4) Pulse Oximeter Perfusion Index as a Predictor for the Effect of llio-Inguinal Block. Aki Uemura, M.D., Ph.D., Masahiro Yagihara, M.D., Masayuki Miyabe, M.D., Ph.D. Anestheiology, Tsukuba University, Ibaraki, Japan.
(5) Ability of PVI to detect preload changes in ortho liver transplant. Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi, Aman Mahajan, M.D., Ph.D. Anesthesiology, David Geffen School of Medicine, UCLA, Los Angeles, California.
(6) PVI A non invasive device for fluid responsiveness. Olivier Desebbe, M.D., Cecile Boucau, R.D., Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(7) Impact of PEEP on PI and PVI. Nitin K. Shah, M.D., Darin V. Allred, M.D., Laverne Estanol, M.S., Fine Brian, B.S., Ghandi Vipal, B.S. Anesthesiology, Long Beach VAHS, Long Beach, California.
(8) Impact of lower extreminity nerve blockade on PI and PVI. Darin V. Allred, M.D., Nitin K. Shah, M.D., Laverne Estanol, M.S. Anesthesiology, University of California Irvine, Orange, California.
(9) Perfusion Index via finger and toe. Hiroyuki Sumikura, M.D., Ph.D., Yayoi Ohashi, M.D., Ph.D., Yasuyuki Suzuki, M.D., Youichi Kondo, M.D., Hirokazu Sakai, M.D. Obstetric Anesthesia, National Center for Child Health and Development, Tokyo, Japan.
(10) Effect of Servoflurane on peripherial PI. Anne Laffargue, M.D., Bruno Marciniak, M.D., Anne Hebrard, M.D., Caroline Petyt, M.D., Renee Krivosic-Horber, M.D. Pole de’Anethesie Reanimation, Jeanne de Flandre, CHRU, Lille, France.
(11) Prolocaine induced Methemoglobinemia. Peter Soeding, M.D., Matthias Deppe, Hartmut Gehring, M.D., Ph.D. Anesthesiology, University of Luebeck, Lubeck, Schleswig-Holstein, Germany.
(12) Second hand smoke in children. Branden E. Yee, B.A., Iqbal M. Ahmed, M.D., Raghu Idupuganti, D.O., Douglas Brugge, Ph.D., M.S., Roman Schumann, M.D. Anesthesia, Tufts Medical Center, Boston, MA.
(13) Estimation of respiration dependent PaO2 Oscillations. Marc Bodenstein, M.D., Stephan Boehme, John Graybeal, M.D., Hemei Wang, Ph.D., Klaus Markstaller, M.D., Ph.D. Department of Anesthesiology, Johannes Gutenber-University, Mainz, Rhineland-Palatinate, Germany.
Contact: Dana Banks Masimo Corporation 949-297-7348
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web site: http://www.masimo.com/