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Masimo PVI® Evaluated in 18-Study Meta-Analysis for Ability to Help Clinicians Assess Fluid Responsiveness

Del

Masimo (NASDAQ: MASI) announced today that an 18-study meta-analysis of 665 subjects reported that Masimo’s Pleth Variability Index (PVI ® ), available with Masimo’s SET® and rainbow® SET® monitoring platforms, may help clinicians assess fluid responsiveness in mechanically ventilated patients in normal sinus rhythm in the operating room and intensive care unit.1

Clinicians commonly use intravenous fluid administration in the operating room and intensive care unit to attempt to improve blood flow, or cardiac output.2 Administering either too little fluid or too much fluid can increase patient risk. 2 However, traditional “static” monitoring parameters such as central venous pressure (CVP) are considered unreliable to assess fluid responsiveness. 2 Therefore, experts recommend the use of “dynamic” parameters that measure physiologic variation over the respiratory cycle.3 Multiple dynamic parameters have been shown to help clinicians assess fluid responsiveness, but most dynamic parameters require invasive, complex, and/or costly methods. PVI is a measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles, and may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. In contrast to other dynamic parameters, PVI is noninvasive, easily obtained with any Masimo SET® or rainbow® sensor, and has no incremental procedural cost.

The meta-analysis, published in the Journal of Clinical Monitoring and Computing by Dr. Chu and colleagues from The First Hospital of China Medical University, Shenyang, China, combined the findings from 18 independent studies evaluating the ability of PVI to help clinicians assess fluid responsiveness. The authors reported that the pooled area under the curve (AUC) for PVI to correctly determine fluid responsiveness was 0.88 (95% confidence interval 0.84 to 0.91). The pooled sensitivity of PVI, or its ability to determine whether cardiac output would increase upon fluid administration, was 0.73 (95% confidence interval 0.68 to 0.78). The pooled specificity of PVI, or its ability to determine whether cardiac output would not increase upon fluid administration, was 0.82 (95% confidence interval 0.77 to 0.86). The authors noted that the sensitivity of PVI was greater in the operating room than in the intensive care unit (0.84 vs. 0.56, p=0.00004). The authors also noted that “the applicability of PVI may be limited by potential interference from several factors such as spontaneous breathing activity, arrhythmia, and low peripheral perfusion.” Technical factors that may affect PVI include probe malposition and patient motion.

For more information on PVI, go to www.masimo.com.

@MasimoInnovates | #Masimo

1 Chu (et al.). Accuracy of pleth variability index to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis: J Clin Monit Comput. 2015, 8:5.

2 Navarro (et al.). Perioperative fluid therapy: a statement from the international Fluid Optimization Group. Perioperative Medicine. 2015, 4:3.

3 Vallet B (et al). 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.

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, 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). Additional information about Masimo and its products may be found at www.masimo.com. For the U.S. market, PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The PVI calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percent (0-100%). PVI may show changes that reflect physiologic factors such as vascular tone, circulating blood volume and intrathoracic pressure excursions. The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.

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's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) 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.

Contact information

Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com

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