Study On Abdominal Surgical Patients Investigates Clinical Utility Of Masimo PVI

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the findings of a study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong. In the study, researchers at Cairo University in Egypt investigated the clinical utility of a Masimo SET^® noninvasive, continuous measurement, PVI^®.

“an efficient predictor of fluid responsiveness…in patients undergoing elective major abdominal surgery.”

In the prospective study of 60 adult patients undergoing major abdominal surgery, Drs. Hafez and Helmy of Cairo University evaluated the performance of Masimo PVI as a non-invasive guide to fluid optimization, as compared to transesophageal doppler. Patients were divided into fluid responders and non-responders, based upon the change in stroke volume due to a bolus response. The baseline value of PVI was significantly higher (p < 0.05) in responders compared to non-responders. The authors also noted that a baseline PVI cutoff value of 11 had 96.67% sensitivity and 33.33% specificity for predicting >10% stroke volume increase. They concluded that PVI is “an efficient predictor of fluid responsiveness…in patients undergoing elective major abdominal surgery.”¹

PVI is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In clinical studies, PVI has been shown to help clinicians assess fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery,^2,3,4,5 in the ICU in both adults and children,^6,7 and in septic patients in the early stages of shock in the emergency department.⁸ Another study used PVI as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.⁹

@MasimoInnovates | #Masimo

References

1. Hafez, Helmy. Evaluation of Plethysmographic variation indices for assessing fluid responsiveness in major operations using Masimo Radical-7 Pulse CO-Oximeter. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR371.

2. Cannesson M. et al. Br J Anaesth. 2008;101(2):200-6.

3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.

4. Fu Q., Mi W.D., Zhang H. Biosci Trends. 2012 Feb;6(1):38-43.

5. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J Anesth. 2012 Oct;26(5):696-701.

6. Loupec T. et al. Crit Care Med. 2011;39(2):294-299.

7. Byon H et al. BJA 2012 December; DOI 10.1093/bja/aes467

8. Feissel M et al. J Crit Care. 2013 May 14

9. Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.

About Masimo

Masimo (NASDAQ: MASI) is a 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. Masimo SET^® 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 more recently, Pleth Variability Index (PVI^®) and Oxygen Reserve Index (ORI™), in addition to SpO₂, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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 include, among others, statements regarding the potential effectiveness of Masimo PVI^® . 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 Masimo PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; 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.