IRVINE, CA--(Marketwired - Jul 11, 2013) - Masimo (NASDAQ: MASI) announced today that the French Society for Anaesthesia and Intensive Care (SFAR) has added Masimo PVI® -- a noninvasive and continuous parameter to help clinicians assess fluid responsiveness and improve fluid management -- to guidelines for optimal hemodynamic management during surgery.1
During surgery, the optimal administration of fluid has been shown to reduce post-operative mortality, length of hospital stay, and the recovery period of patients who have undergone gastrointestinal surgery. However, SFAR noted some traditional management approaches to guide fluid administration are unreliable, and that central venous pressure (CVP) monitoring -- a common invasive parameter -- "constitutes a notoriously invasive and insufficient approach." SFAR added, "Particularly in high risk surgery, the classic monitoring of hemodynamic variables does not ensure adequate systemic perfusion (risk of occult 'hypovolemia') and may lead to inadequate treatment decisions."
Instead of so-called "static" parameters such as CVP, SFAR recommends the use of "dynamic" parameters that measure variations over the respiratory cycle. Multiple dynamic parameters have been shown to help clinicians predict fluid responsiveness and improve fluid management. However, most dynamic parameters require invasive and/or complex methods. In contrast, PVI is noninvasive and easily obtained with any Masimo SET® or rainbow® sensor. In recommending the use of dynamic parameters, SFAR noted, "PVI, whose reliability has been proven,2,3 is available today, and could allow the spread of preload dependence monitoring for patients under general anaesthesia and controlled ventilation in minor and moderate surgery."
SFAR said dynamic indices such as PVI contribute "to the detection of the 'low probability of response to filling' as long as the value remains low ( < 9%), eliminating the need to test the response to filling in a regular systemic manner," and that compared to traditional "empirical administration of fluids," which can either be insufficient or excessive, a dynamic indicator such as PVI "allows an improvement in the patient's prognosis."
SFAR also observed that, "If the main effect of the vascular filling (VF) is to increase venous return and thus cardiac output, it is surprising that cardiac output is only rarely monitored in current practice by anaesthetists." In alluding to PVI, SFAR stated: "Only rapid implementation, surgeon-independent strategies which are either noninvasive or minimally invasive and of low cost will be able to spread in practice."
The new SFAR Formalized Experts' Recommendations add to the growing catalog of clinical evidence in support of Masimo's breakthrough, noninvasive and continuous monitoring technologies, such as PVI. Just last year, the United Kingdom's National Health Service included PVI in its Intra Operative Fluid Management pack, which serves as a guide for hospitals wishing to implement fluid responsiveness monitoring to improve patient outcomes.4
"In our randomized clinical trial,5 we found that Masimo PVI-based goal-directed fluid management helps to improve perioperative vascular filling, saving unnecessary fluids and reducing intraoperative and postoperative lactate levels," said Patrice Forget, MD, anesthesiologist, Department of Anesthesiology at St-Luc University Hospital in Brussels, Belgium.
Joe Kiani, Founder and CEO of Masimo, stated: "We are delighted that PVI has proven so useful and that leading international medical bodies such as SFAR and NHS offer powerful validations of PVI. Our mission has been and continues to be to 'improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications.' PVI has certainly been shown to do just that. We are honored that some of the world's leading medical authorities are making PVI the standard of care."
1 Vallet B., Blanloeil Y., Cholley B., Orliaguet G., Pierre S., Tavernier B. "Strategy for perioperative vascular filling - Guidelines for perioperative haemodynamic optimization." Experts' Formalized Recommendations, French Society of Anaesthesia and Intensive Care (SFAR), Validation by the administrative council of SFAR on 19 October 2012. Available here.
2 Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth 2008;101:200-6
3 Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol 2010;27:555-61
5 Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg 2010;111(4):910-4
*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 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 help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. 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 commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be 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 PVI, 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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