New Prospective Study Finds That Masimo SpHb® Noninvasive and Continuous Hemoglobin Monitoring Can Help Provide Effective Blood Management in Patients Undergoing Major Surgery

(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the findings of a prospective, double-blinded, randomized, controlled trial published in the Journal of the College of Physicians and Surgeons Pakistan. In the study, Dr. Sukriye Akdag and colleagues at Marmara University in Istanbul, Turkey assessed the impact of noninvasive and continuous hemoglobin monitoring with Masimo SpHb^® on blood transfusion management for adult patients undergoing elective major surgery with anticipated blood loss of 20% or more. The researchers found that the postoperative red blood cell (RBC) transfusion rate was lower, and the hemoglobin level of ICU patients higher, when monitored with SpHb in the operating room. They concluded, “SpHb can provide effective patient blood management in cases of major surgery.”¹

Noting that delayed or unnecessary blood transfusions have been associated with increased mortality and morbidity, the researchers sought to evaluate the impact of continuous hemoglobin monitoring with Masimo SpHb, which offers continuous trending of hemoglobin levels, provided noninvasively and in real time. The researchers enrolled 120 patients aged 18-85 (ASA score I-III) scheduled for major surgery, divided randomly into an SpHb group (n=60) and a control group (n=60). There were no significant differences in the demographics or mean arterial pressure, heart rate, or arterial blood gas analysis between the groups. In the control group, patients’ hemoglobin was measured using conventional, intermittent blood sampling, analyzed with an ABL800Flex Radiometer, at the beginning, the second hour, the fourth hour, and the end of the operation. In the SpHb group, in addition to conventional blood sampling, patients’ SpHb values, pleth variability index (Masimo PVi^®) and perfusion index (Pi) were noninvasively and continuously monitored with Masimo Radical-7^® Pulse CO-Oximeters^®; in the case of a sudden decrease in hemoglobin value, an additional blood gas analysis was performed. In both groups, transfusion was carried out when hemoglobin levels fell below 9 g/dL (per standard European Society of Anaesthesia recommendations) by blood gas analysis.

The researchers found that, comparing overall postoperative measurements, there were no significant differences between the groups in hemoglobin, platelet, or creatinine levels; nor in the amount of fresh frozen plasma, or platelet suspension transfused intraoperatively and postoperatively; nor in the amount of RBC units transfused intraoperatively. However, the postoperative RBC transfusion rate in the SpHb group was significantly lower (SpHb group: median 0 international units (IUs); control group: median 2 IUs; p=0.020).* Postoperative hemoglobin levels in SpHb group patients in the ICU were also statistically significantly higher (SpHb group: 8.41 g/dL ± 1.08 g/dL; control group: 7.75 g/dL ± 1.19 g/dL; p=0.033).

The investigators concluded, “SpHb measurement in major surgical cases can accompany conventional Hb measurement methods, allowing effective patient blood management practice. … Since this may decrease mortality and morbidity by reducing postoperative blood transfusion, the use of such an advanced monitoring method in major surgeries may increase patient safety.”

This study adds additional evidence to the growing literature on the value of continuous hemoglobin monitoring with SpHb. SpHb, as part of patient blood management programs, has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,^2,3 reducing the units of red blood cells transfused per patient,^4-6 reducing the time to transfusion,⁷ reducing costs,⁸ and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi^®).⁹ This evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.^1-9 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

*The transfusion rate data were provided by the authors after study publication and are included here with their permission.

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹⁰ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹¹ improve CCHD screening in newborns,¹² and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^13-16 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁷ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁸ 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^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

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

References

1. Akdag S, Zengin SU, Cakmak G, Umuroglu T, Aykac ZZ, Saracoglu A. Targeted Bleeding Management Guided by Non-Invasive Haemoglobin Measurement in Surgical Patients. J Coll Physicians Surg Pak 2022; 32(10):1242-1248.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Nakamori E et al. Geriatr Orthop Surg Rehabil. 2021 Nov 19;12:21514593211060575.
4. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
5. Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
6. Saracoglu A, Abdullayez R, Sakar M, Sacak B, Incekoy F, Aykac Z. Continuous hemoglobin measurement during frontal advancement operations can improve patient outcomes. J Clin Mon Comp. 7 Mar 2022. https://doi.org/10.1007/s10877-022-00813-5.
7. Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
8. Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
9. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
10. 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.
11. 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.
12. 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.
13. Taenzer A 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.
14. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
15. McGrath S 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.
16. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
17. Estimate: Masimo data on file.
18. 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 SpHb^®, Masimo PVi^®, and Masimo Radical-7^® Pulse CO-Oximeters^®. 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 SpHb, Masimo PVi, and Masimo Radical-7 Pulse CO-Oximeters, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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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