IRVINE, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that new clinical studies presented this week at the American Society of Anesthesiology (ASA) Annual Meeting in New Orleans, Louisiana, show Masimo noninvasive and continuous hemoglobin (SpHb(TM)) technology is reliable and accurate compared to invasive blood tests for both healthy subjects and hospitalized patients. Another study presented found Masimo PVI to be an accurate, reliable automatic noninvasive indicator of a patient's ability to respond to fluid.
Clinical Study Highlights
Accuracy of Noninvasive Hemoglobin Measurements by Pulse CO-Oximetry in Hemodilution Subjects (A184)(1), a clinical study led by Dr. Martin W. Allard at Loma Linda University in Loma Linda, California, compared SpHb measurements to 165 invasive laboratory measurements in 20 healthy adult patients undergoing hemodilution. All 20 patients had one unit of blood drawn through an arterial line while isolyte intravenous fluid was given (to compensate for the decrease in intravascular volume) until they reached a 30% reduction in hemoglobin or a maximum of 30 ml/kg of fluid. Blood samples were drawn after each 500 ml of fluid administered and analyzed for total hemoglobin by laboratory CO-Oximeter. Masimo SpHb had a bias of 0.15 g/dL and precision of 0.92 g/dL, leading researchers to conclude that SpHb "measurement accuracy was unaffected by perfusion index levels" and offers an "acceptable alternative to invasive hemoglobin tests in many clinical scenarios."
Validation of a New Noninvasive Hemoglobin Algorithm in Patients Undergoing Liver Transplantation (A751)(2), a clinical study led by Dr. Klaus D. Torp at the Mayo Clinic in Jacksonville, Florida, compared SpHb measurements to 55 invasive laboratory measurements in five patients undergoing liver transplantation and found significant agreement between the two methods. The study showed that SpHb--using the new Masimo ReSposable(TM) Sensor that helps to reduce medical waste and costs----had a bias of 0.2 g/dL and precision of 0.8 g/dL. Researchers concluded that "the accuracy of noninvasive SpHb measurements obtained by the Pulse CO-Oximeter with new ReSposable sensors was high."
Additionally, two studies presented at the ASA highlight the importance of understanding the variation in invasive arterial and venous hemoglobin measurements. A study (A937) of 471 paired invasive hemoglobin measurements from 33 patients on two different invasive laboratory devices (Beckman Coulter® hematology analyzer and Nova Biomedical® CO-Oximeter) showed a bias of -0.97 g/dL and a precision of 0.58 g/dL. The authors noted that "different devices using different principles of operation can produce consistent differences in the absolute value of measurement."(3) Another study (A1294) comparing hemoglobin measurements in 107 subjects from time-matched arterial and venous blood samples on the same invasive laboratory device found average differences as high as 0.5 g/dL and noted that "arterial and venous hemoglobin values from the same individual are not interchangeable."(4)
Influence of Site of Measurement to Predict Automatically and Noninvasively Fluid Responsiveness (A477)(5), a clinical study led by Dr. Olivier Desebbe at the Hospices Civils de Lyon in Lyon, France, studied the finger, forehead, and ear as measurement sites for PVI and found that all three sites allowed discrimination between fluid responders and non-responders. Researchers measured hemodynamic data in 12 patients under general anesthesia using pulmonary artery catheter and Masimo PVI (obtained via noninvasive sensors attached to the forehead using a Masimo TF-I, ear using a Masimo TC-I, and finger using a Masimo LNOP Adt) before and after volume expansion of 500 ml of hetastarch 6%. Fluid responders were defined as patients presenting >15% increase in cardiac index (CI) following VE. Study results showed that a PVI >17% for the forehead and ear, and a PVI >13% for the finger before volume expansion "allowed discrimination between responders and non-responders with a sensitivity and specificity of 100 and 83% for the forehead, 83 and 100% for the ear, and 100 and 67% for the finger"--demonstrating that PVI is an accurate and reliable automatic noninvasive indicator of a patient's ability to respond to fluid and that clinicians should take site measurement into account when utilizing PVI to predict fluid responsiveness.
Dr. Michael O'Reilly, Executive Vice President of Medical Affairs for Masimo, stated: "We appreciate the work of these clinical researchers for not only validating the value of SpHb and PVI, but for also showing that invasive hemoglobin spot check measurements--considered to be the gold standard--have similar bias and precision as our noninvasive, continuous hemoglobin measurements. These new Masimo Rainbow SET studies reinforce the importance of monitoring changes in hemoglobin--facilitated by Masimo's continuous SpHb monitoring technology as opposed to a single measurement of hemoglobin--when caring for patients at risk for significant blood loss."
(1) Allard, M., Macknet, M., Kherzi, S., Rook, J. "Accuracy of Noninvasive Hemoglobin Measurements by Pulse CO-Oximetry in Hemodilution Subjects." ASA 2009 Annual Meeting: A184. Anesthesiology, Loma Linda University, Loma Linda, California.
(2) Torp, K., Aniskevich, S., Shine, T., Shapiro, D., Peiris, P. "Validation of a New Noninvasive Hemoglobin Algorithm in Patients Undergoing Liver Transplantation." ASA 2009 Annual Meeting: A751. Anesthesiology, Mayo Clinic Florida, Jacksonville, Florida.
(3) Torp, K., Shine, T., Aniskevich, S., Peiris, P., Shapiro, D. "Comparison of Coulter Counter and Co-Oximeter (pHOx) Measurements for Hemoglobin." ASA 2009 Annual Meeting: A937. Anesthesiology, Mayo Clinic Florida, Jacksonville, Florida.
(4) Rook, J., Khezri, S., Bertolizio, G., Allard, M. "Arterio-Venous Hemoglobin Differences in Healthy Subjects During Rapid Volume Expansion." ASA 2009 Annual Meeting: A1294. Department of Anesthesiology, Loma Linda University Medical Center, Loma Linda, California.
(5) Desebbe, O., Robin, J., Lehot, J., Cannesson, M. "Influence of Site of Measurement to Predict Automatically and Noninvasively Fluid Responsiveness." ASA 2009 Annual Meeting: A477. Anesthesiology and Intensive Care, Hospices Civils de Lyon, Lyon Bron, France.
Masimo (NASDAQ: MASI) 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 SpO(2) 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® Pulse CO-Oximetry(TM), 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®), methemoglobin (SpMet®), and PVI(TM), in addition to oxyhemoglobin (SpO(2)), 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 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, risks related to our belief that Masimo Rainbow SET and Masimo PVI provide unique clinical advantages that facilitate earlier intervention and prevention of adverse patient outcomes, risks related to our assumptions that Masimo SpHb is an accurate, reliable and acceptable clinical alternative to invasive blood tests for hospitalized patients and healthy patients in outpatient settings, and risks related to our assumptions that Masimo PVI is an accurate, reliable and acceptable clinical alternative to invasive methods of predicting fluid responsiveness, 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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