New Case Series Investigates the Combined Use of Masimo SedLine® Brain Function Monitoring and O3® Regional Oximetry During Cardiac Surgery

Masimo (NASDAQ: MASI) announced today the findings of a series of four clinical cases, recently published in the Canadian Journal of Anesthesiology, in which researchers at the University of Montreal found that combined use of Masimo SedLine^® brain function monitoring and O3^® regional oximetry assisted their understanding and management of cerebral desaturations during cardiac surgery.

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Drs. Etienne Couture, Alain Deschamps, and André Denault hypothesized that the addition of processed electroencephalography (pEEG) using Masimo SedLine’s processed EEG parameter, the Patient State Index (PSi), to a previously developed clinical management algorithm based on Masimo O3 near-infrared spectroscopy (NIRS), could help guide the management of cerebral desaturation episodes. In this series of case studies, they describe the impact of combining the modalities on the clinical management of four patients undergoing cardiac surgery. The researchers then outline a series of scenarios that enumerate possible causes of desaturation based on various combinations of changes in NIRS and pEEG, as well as changes in related monitoring data available via SedLine, such as the density spectral array (DSA) and spectral edge frequency (SEF). Possible causes include a change in cerebral blood flow, cerebral hypoperfusion, cardiogenic shock, hypoxemia, a change in the anesthetic state, hyperthermia, and seizure. In the four cases, more insight into the likely cause of a desaturation episode helped guide how clinicians responded during surgery.

The researchers concluded, “Combining both NIRS and pEEG allows for a much more nuanced understanding of the etiology of cerebral desaturation. Future studies are needed to investigate if the combination of both modalities is more prognostic than each alone. Every cerebral oxygen desaturation is not equal.”

Dr. Denault commented, “By combining NIRS and pEEG we were able to have a better appreciation of the significance of brain desaturation, and using Masimo O3 and SedLine in particular to obtain those measurements provided a number of advantages. The additional brain monitoring parameters available through Masimo SedLine, such as the DSA and SEF, play an important role in our protocol, helping to provide additional insight. And, perhaps most significantly, both SedLine and O3 can be used simultaneously on the same Masimo Root^® monitoring hub, making it easier to view and interpret the combined data and thus streamlining our use of the desaturation protocol and workflow during surgery.”

Masimo O3 is not currently indicated for somatic use.

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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. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.^5-7 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.⁹ 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^®), Pleth Variability Index (PVi^®), and more recently, 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, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7^® wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1.			Couture EJ, Deschamps A, and Denault AY. Patient management algorithm combining processed electroencephalographic monitoring with cerebral and somatic near-infrared spectroscopy: a case series. Can J Anesth. 2019. https://doi.org/10.1007/s12630-019-01305-y.
2.			Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles
3.			Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4.			de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
5.			Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6.			Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.			McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8.			Estimate: Masimo data on file.
9.			http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 SedLine^® and O3^®. 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 SedLine and O3, 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.

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Contact information

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com