New Studies Investigate the Accuracy of Noninvasive, Continuous Hemoglobin Monitoring with Masimo SpHb on Neonates – BioSpace

Aug. 19, 2020 06:00 UTC

NEUCHATEL, Switzerland--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced that in a study recently published in the Journal of Tropical Pediatrics, researchers evaluating Masimo SpHb (noninvasive, continuous hemoglobin monitoring) on neonatal patients concluded that the technology offers reliable Hb [hemoglobin] values, which are comparable with the more traditional tHb [invasive venous blood sampling].1

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Masimo Root with SpHb (Photo: Business Wire)

Noting that iatrogenic anemia caused by diagnostic blood sampling is a common problem in intensive care units, especially in neonatal intensive care units (NICUs), and that diagnostic blood sampling also has implications for infection control and health care costs, Drs. Halil Kazanasmaz and Mahmut Demir at Harran University in Sanliurfa, Turkey sought to assess the efficacy of noninvasive, continuous hemoglobin monitoring with SpHb on neonates by comparing it to conventional tHb. To investigate this, they studied 310 neonatal patients in a level III NICU in Turkey. Immediately after patients had blood drawn for tHb analysis using a hematological laboratory analyzer, their SpHb values (alongside other noninvasive measurements) were recorded using a Masimo Radical-7 Pulse CO-Oximeter with rainbow sensors placed on the neonates left foot.

Using Bland-Altman analysis, the researchers found a mean bias of 0.05 g/dL between tHb and SpHb, with limits of agreement of -1.85 and 1.96 g/dL. Based on the study results, they concluded, In this study, it was found that the SpHb measurement method could yield reliable results similar to tHb measurement method in the newborns. It is thought that the SpHb method may have a complementary role in reducing unnecessary blood sampling and therefore iatrogenic anemia, especially in the newborns with anemia. Further clinical studies are needed to define the effectiveness of this measurement method in critically ill patients with circulatory disorders.

In a similar study published earlier this year in the Journal of Clinical Neonatology, Drs. Ahmed Jamal and Biju John at Armed Forces Medical College in Pune, India, compared conventional laboratory hemoglobin to SpHb in 100 hemodynamically stable neonatal patients at a tertiary hospital in southern India.2 To measure SpHb, they similarly used Radical-7 devices with rainbow sensors, but the sensors were placed on the babies wrists instead of the foot. Analyzing the paired Lab-Hb and SpHb data with Bland-Altman analysis, the researchers found a good visual agreement between the Lab-Hb and SpHb values, and calculated bias precision of 0.763 1.349 g/dL. Drs. Jamal and John similarly concluded that SpHb is an efficacious method of assessing Hb trend among neonates.

In clinical studies with adult patients, continuous monitoring with SpHb as part of blood management programs has been shown to improve outcomes, such as reducing the percentage of patients receiving transfusions,3 reducing the units of red blood cells transfused per patient,4-5 reducing the time to transfusion,6 reducing costs,7 and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively.8 Today, SpHb technology supports clinicians in over 75 countries around the world.9

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

Noninvasive, continuous SpHb for neonatal patients received CE marking in August 2019, and SpHb is now available for patients of all ages in CE marked countries. Noninvasive, continuous SpHb has received FDA clearance for patients > 3 kg but is not currently indicated for patients < 3 kg in the U.S.

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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. Our mission is to 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 according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.18 Masimo continues to refine SET and in 2018, announced that SpO2 accuracy on RD SET sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patients physiological status. 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. Masimos 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 and Radius PPG, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation platform, and include Iris Gateway, Patient SafetyNet, Replica, Halo ION, UniView, UniView: 60, and Masimo SafetyNet. Additional information about Masimo and its products may be found at http://www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi 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

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. 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, 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; 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 http://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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New Studies Investigate the Accuracy of Noninvasive, Continuous Hemoglobin Monitoring with Masimo SpHb on Neonates - BioSpace