Masimo Corporation Release: Two Randomized Trials Presented At The Euroanaesthesia 2014 Congress Show Similar Fluid Administration And Risk Profile With PVI As With Invasive Or Complicated Procedures

IRVINE, CA--(Marketwired - June 06, 2014) -

Masimo (NASDAQ: MASI) announced today that four new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented at the European Society of Anaesthesiology‘s (ESA) Euroanaesthesia 2014 Congress in Stockholm, Sweden.

PVI Studies
At University Hospital Linköping, in Linköping, Sweden, researchers evaluated whether fluid volume optimization using PVI would lead to similar fluid management and patient risk compared to Stroke Volume Optimization using Esophageal Doppler (ED) -- an established method to optimize preload during abdominal surgery. Researchers noted the ED technique “is costly and sensitive to interference, requires training and is not possible in prone position or at limited access to the head.” The investigators reported that there were no differences in colloid administration, total volume of fluids given during surgery, or lactate levels at the end of surgery. Higher lactate levels are strongly associated with greater patient risk. The investigators concluded: “Fluid optimization during open abdominal surgery guided by PVI seems to result in equal amounts of fluid administered compared to guidance using ED technique."(1)

At CHU Brugmann (Brugmann University Hospital) in Bruxelles, Belgium, researchers compared conventional pulse pressure variation induced by mechanical ventilation (PPV) with noninvasive PVI to predict intraoperative fluid management in patients undergoing elective abdominal (laparoscopic) surgery. Seventy-two patients were randomized according to the monitoring used to guide intraoperative fluid therapy (PPV group: N=36, PVI group: N=36). Basal balanced crystalloid infusion rate was set at 2 ml/kg/h and boluses of 250 ml of 3% modified fluid gelatin were administered if the PPV was > 13% or the PVI > 15% in the respective groups for more than five minutes. Researchers concluded: “The type of monitoring does not influence significantly the volume of fluid administered in the intraoperative period."(2)

SpHb Studies
At Città di Roma Hospital in Rome, Italy, researchers compared noninvasive SpHb with values from an invasive central laboratory device (Horiba Pentra DX 120) in laboring mothers to evaluate whether SpHb (rainbow® ReSposable R2-25 Revision K sensor; Radical-7 Pulse CO-Oximeter®) could detect changes in hemoglobin to enable earlier detection of postpartum hemorrhage. The investigators reported: “SpHb demonstrated bias and precision of 0.10 +/- 0.71 g/dL compared to the central laboratory device with limits of agreement of 1.51 and -1.31 g/dL. More importantly, SpHb was able to trend changes detected by laboratory readings.” They concluded that in this study: “SpHb was able to detect changes in hemoglobin concentration during and after delivery and therefore may provide a means for the early detection of bleeding and postpartum hemorrhage."(3)

At Tokyo Dental College Ichikawa General Hospital in Chiba-ken, Japan, researchers evaluated the accuracy of SpHb compared with laboratory CO-Oximetry measurements of total hemoglobin (tHb) during prolonged oral surgery. The investigators reported that 73 tHb values were compared to SpHb. Bias and precision were 0.86 g/dL and 1.17 g/dL, respectively. Bland-Altman analysis showed limits of agreement of -1.43 to 3.15 g/dl. They concluded: “The accuracy of SpHb monitoring during prolonged surgery was clinically acceptable, as shown by the low bias, precision and moderate limits of agreement when compared to laboratory values, although percent error exceeded normal range slightly."(4)

The Masimo rainbow® SET platform enables the assessment of multiple blood constituents and physiologic parameters that previously could only be measured invasively or with complicated procedures, in addition to providing Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry including SpO2, pulse rate, perfusion index, and PVI. Multiple noninvasive and continuous measurements -- including SpHb, RRa®, SpCO® and SpMet® -- offer an advancement in patient safety by helping clinicians better assess patients.

(1) Bahlmann H., Hahn R., Nilsson L. “Pleth variability index as a tool for volume optimization during open abdominal surgery” Proceedings of the European Society of Anaesthesiology’s (ESA) Euroanaesthesia 2014 Congress, June 2, 2014. Stockholm. 3AP5-5
(2) Delaporte A., Ghoundiwal D., Bidgoli J., Foulon P., Vanderlinden P. “Goal directed fluid management” based on pleth variability index or pulse pressure variations during abdominal surgery Proceedings of the European Society of Anaesthesiology’s (ESA) Euroanaesthesia 2014 Congress, June 2, 2014. Stockholm. 4AP3-9
(3) Tola G,Capogna G. “Noninvasive and continuous trending of hemoglobin during labor and in the post-partum period” Proceedings of the European Society of Anaesthesiology’s (ESA) Euroanaesthesia 2014 Congress, June 2, 2014. Stockholm. 11AP3-1
(4) Sazuka S., Koshika K., Watanabe Y., Ouchi T., Serita R., Koitabashi T. “Accuracy of continuous and noninvasive hemoglobin monitoring during prolonged surgery” Proceedings of the European Society of Anaesthesiology’s (ESA) Euroanaesthesia 2014 Congress, June 2, 2014. Stockholm. 3AP4-3

About Masimo
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 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 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.

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®) and 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation