Healthcare Industry News: Edwards Lifesciences
News Release - January 14, 2010
New Published Study Finds Masimo PVI(R) Predicts Fluid Responsiveness as Accurately as Invasive Stroke Volume Variation in Mechanically-Ventilated PatientsMasimo PVI Accuracy Shown to Be Superior to Invasive Central Venous Pressure
IRVINE, Calif., Jan. 14 (Healthcare Sales & Marketing Network) -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, today announced that a new study published in the January 2010 issue of the European Journal of Anaesthesiology found that Masimo PVI predicts fluid responsiveness as accurately as invasive stroke volume variation (SVV) and more accurately than invasive central venous pressure (CVP) in mechanically-ventilated patients undergoing major surgery.(1)
Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality. Traditional invasive measurements such as CVP are not reliable to predict whether a patient will benefit from fluid administration, and newer more accurate methods to predict fluid responsiveness, such as SVV, are invasive and costly. Because SVV has been shown in multiple studies to be an accurate method to predict fluid responsiveness and optimize fluid management in surgical and intensive care patients, the similar accuracy shown with noninvasive PVI indicates that PVI-guided fluid optimization may also help guide fluid management to minimize patient risk and improve outcomes.
In the study, Dr. Zimmermann and colleagues at University Hospital Regensburg in Germany simultaneously measured PVI (obtained noninvasively using the Masimo Radical-7 Pulse CO-Oximeter), arterial pressure-based SVV (obtained invasively via radial arterial line using the Edwards Lifesciences FloTrac/Vigileo system), and CVP (obtained invasively via central venous catheter), in 20 patients immediately after induction of anesthesia and again after volume administration (6% hydroxyl-ethyl starch). Patients were classified as responders if stroke volume index (SVI), the amount of blood the heart pumps in each heartbeat, increased by 15% or more, and as non-responders if SVI did not increase 15%.
Results showed that a PVI value greater than 9.5% predicted fluid responsiveness with 93% sensitivity and 100% specificity, an SVV value greater than 11% predicted fluid responsiveness with 100% sensitivity and 80% specificity, while a CVP value greater than 10.5 mm Hg predicted fluid responsiveness with 66% sensitivity and 40% specificity.
The researchers concluded that both PVI and SVV "can serve as valid indicators of fluid responsiveness in mechanically-ventilated patients undergoing major surgery," but only PVI "seems to provide a simple alternative for accurate, noninvasive, and continuous preload monitoring."
Masimo Executive Vice President of Medical Affairs Dr. Michael O'Reilly stated, "Unnecessary fluid administration can increase the risk of serious injury or death, making fluid responsiveness monitoring a growing requirement to advance patient safety. The researchers at the University Hospital Regensburg have further demonstrated that accurate fluid responsiveness does not require invasive procedures, demonstrating that Masimo PVI is a safe, reliable, and noninvasive alternative to guide fluid management to minimize patient risk and improve outcomes."
(1) Markus Zimmermann, Thomas Feibicke, Cornelius Keyl, Christopher Prasser, Stefan Moritz, Bernhard M. Graf, and Christoph Wiesenack. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery." European Journal of Anaesthesiology 2010; Vol 27, No 00.
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 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® Pulse CO-Oximetry™, 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™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and acoustic respiration rate (RRa™), 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 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 PI provides unique clinical advantages as an automatic noninvasive measurement of low SVC and intraventricular hemorrhage in very low birth weight, preterm infants, risks related to our assumptions that Masimo PI is a useful noninvasive indicator of perfusion, an early predictor of high illness severity in neonates, and an early detection tool for left heart obstruction, and risks related to our assumptions that Masimo PI represents a more rapid, reliable and cost-effective clinical alternative for assessing perfusion and circulatory status, 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.
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, RRa, 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.
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