Sri Lankan Study Expands Evidence Demonstrating the Benefits of Critical Congenital Heart Disease (CCHD) Screening Using Masimo SET ® Pulse Oximetry

Masimo (NASDAQ: MASI) today announced the results of a prospective study published in the Sri Lanka Journal of Child Health in which researchers in Colombo, Sri Lanka evaluated the efficacy of a pulse oximetry-based critical congenital heart disease (CCHD) newborn screening strategy using Masimo SET^® pulse oximetry.¹ The authors concluded that pulse oximetry is a “simple, noninvasive, cost-effective, feasible, and reliable test,” and found that it had higher CCHD screening sensitivity than physical exam. Combining the two methods led to detection of all cases of CCHD in the study cohort, and they recommended that, “Pulse oximetry screening as a combined strategy with newborn physical exam should be implemented as a basic routine at discharge for every newborn in maternity units island-wide.” As they note, their work is the first published CCHD study of this nature in Sri Lanka.

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Noting that while “developed countries have abundant research on pulse oximetry screening” for CCHD, “there are few studies in developing countries,” Dr. CR Gunaratne and colleagues sought to study the utility of such a screening strategy in their local setting. From November 2018 to April 2019, researchers assessed the rate of detection of CCHD using Masimo SET^® pulse oximetry compared to routine physical exam alone in 5,435 asymptomatic newborns admitted to the post-natal wards at Castle Street Hospital, Colombo. Physical exam was performed at ≥ 24 hours of age “to identify any visible central cyanosis, weak/absent femoral pulses or cardiac murmur” by an experienced medical officer, blinded to pulse oximetry results. Radical-7^® Pulse CO-Oximeters^® with Masimo SET^® pulse oximetry were used to measure pre-ductal and post-ductal oxygen saturation (SpO₂) on the right hand and right foot, respectively, as part of a standardized screening algorithm. For newborns with positive results, an echocardiogram was performed within 48 hours to diagnose CCHD.

The researchers found that Masimo SET^® pulse oximetry had a CCHD detection rate of 91%, compared to 82% for physical exam. The addition of Masimo SET^® pulse oximetry to physical exam screening led to the detection of 2 cases missed by physical exam alone, with a combined detection rate of 100%. The positive predictive value and positive likelihood ratio were both higher for SET^® pulse oximetry compared to physical exam (71.4% vs. 8.6% and 1232.7 vs. 46.2, p = 0.0001). The researchers also found that the false positive rate was “substantially” lower for SET^® pulse oximetry compared to physical exam (0.07% vs. 1.76%, p = 0.0001).

The researchers concluded, “Prevalence of CCHD in our study was 2.02 per 1000 live births. Using a pulse oximetry strategy as an adjunct to routine physical exam can substantially reduce the diagnostic gap in CCHD as [a] combined approach has an additive effect resulting in more efficient screening.”

Since its introduction in 1995, Masimo Measure-through Motion and Low Perfusion™ Signal Extraction Technology^® (SET^®) has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies, providing clinicians with increased sensitivity and specificity to help them make critical patient care decisions.² To date, nine other published CCHD screening studies, all with positive conclusions and representing over 300,000 infants, have used Masimo SET^®,^3-11 which includes the largest CCHD study to date, of 122,738 newborns.⁵ All of the CCHD studies with Masimo SET^® pulse oximetry have shown improved screening sensitivity with the use of Masimo SET^® alongside clinical assessment when compared to routine physical exam alone. Results from CCHD studies using other pulse oximetry technologies have shown that other technologies do not offer the same performance as Masimo SET^® during CCHD screening.^12-14

With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, SET^® stands out as the choice of pulse oximetry technology for clinicians and policy makers hoping to implement newborn-related screening processes—and has indeed been used in the establishment of screening guidelines used around the world.¹⁵

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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.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹⁶ improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^17-20 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,²¹ 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.²² 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 patient’s 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. 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^® 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, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView :60™, and Masimo SafetyNet™. 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 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

1. Gunaratne CR, Hewage I, Fonseka A, Thennakoon S. Comparison of pulse oximetry screening versus routine clinical examination in detecting critical congenital heart disease in newborns. Sri Lanka J Child Health, 2021; 50(1): 04-11. DOI: http://dx.doi.org/10.4038/sljch.v50i1.9393.
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. 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.
4. Slitine N, et al. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. Int J Neonatal Screen 6(53). 30 June 2020.
5. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
6. Ewer AK et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.
7. de-Wahl Granelli A et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr 2007; 96(10): 1455-9.
8. Meberg A et al. First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects. J Pediatr 2008; 152:761-5.
9. Schena F et al. Perfusion Index and Pulse Oximetry Screening for Congenital Heart Defects. J Pediatr. 2017 Apr;183:74-79.
10. Hamilçıkan S, Can E. Critical Congenital Heart Disease Screening With a Pulse Oximetry in Neonates. J Perinat Med. 2018 Feb 23;46(2):203-207.
11. Jawin V et al. Beyond Critical Congenital Heart Disease: Newborn Screening Using Pulse Oximetry for Neonatal Sepsis and Respiratory Diseases in a Middle-Income Country. PLoS One. 2015; 10(9): e0137580.
12. Tekleab AM, Sewnet YC. Role of pulse oximetry in detecting critical congenital heart disease among newborns delivered at a high altitude setting in Ethiopia. Pediatric Health Med Ther. 2019;10:83-88. https://doi.org/10.2147/PHMT.S217987.
13. Narayen IC et al. Accuracy of Pulse Oximetry Screening for Critical Congenital Heart Defects After Home Birth and Early Postnatal Discharge. J Pediatr. 2018;197:29-35.
14. Oakley JL et al. Effectiveness of Pulse-Oximetry in Addition to Routine Neonatal Examination in Detection of Congenital Heart Disease in Asymptomatic Newborns. J Matern Fetal Neonatal Med. 2015;28(14):1736-9.
15. Kemper et al. Strategies for implementing screening for critical congenital heart disease. Pediatrics. 2011 Nov;128(5):e1259-67. doi: 10.1542/peds.2011-1317.
16. 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.
17. 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.
18. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
19. 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.
20. 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.
21. Estimate: Masimo data on file.
22. 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 SET^®. 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 SET^®, 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 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