Masimo (NASDAQ: MASI) today announced Dual SET® Pulse Oximetry for Root®, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET® Oximetry is a significant advancement to Masimo SET®-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET® MOC-9® module and the addition of the Eve™ CCHD Newborn Screening Application for Root. Together, this combined solution enhances the automation of newborn screenings using Dual SET® Oximetry: two simultaneous measurements of oxygen saturation (SpO2) at pre- and post-ductal sites by the intuitive Eve application, customized to align with a hospital’s CCHD screening protocol.
CCHD affects approximately 2.5 to 3 newborns per 1000 live births1 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.2 Traditionally, newborns were observed for evidence of CCHD by physical assessment and monitoring for common symptoms, but studies have shown that physical assessment of newborns alone can be unreliable and may fail to detect some infants with CCHD before discharge.3-5
Adding screening with pulse oximetry can help clinicians identify CCHD before an infant becomes symptomatic.6 Clinically proven Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry has been shown in more than 10 CCHD screening studies – representing over 300,000 babies – to increase the effectiveness of screening newborns for CCHD.1,7-16 For example, in a study of almost 40,000 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and SET®.1
In another study of more than 120,000 infants – the largest CCHD screening study to date – combined use of clinical assessment and SET® increased screening sensitivity from 77% to 93%.7 Evidence from CCHD studies using SET® has even been used to help establish CCHD screening guidelines used around the world.17
Powered by Masimo SET® pulse oximetry, the Eve CCHD Newborn Screening Application is designed to simplify the CCHD screening process by providing step-by-step visual instructions, animations, and a detailed, easy-to-interpret display of screening results – standardizing and enhancing clinical workflows, improving consistency in screening practices among clinicians, and reducing the possibility of calculation errors. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD.18-19
Already available for Radical-7® and Rad-97® Pulse CO-Oximeters®, Eve is particularly well suited for display on Root’s large, high-resolution screen. With its built-in barcode scanner, Root can automatically associate patients with their screening results, and with its integration into the Masimo Hospital Automation™ platform, Root automates the transfer of those results to electronic medical records (EMRs) – eliminating the need for manual charting.
Now, with the addition of the new Masimo SET® MOC-9 module for Root – made possible by another key differentiator of the hub, its advanced, flexible connectivity capabilities – CCHD screening guided by Eve is even more streamlined and efficient: one pulse oximetry sensor can be connected to Root via Radical-7, and a second via the MOC-9 module, allowing for the pre- and post-ductal SpO2 readings needed for screening to be taken simultaneously rather than sequentially, with results conveniently displayed on one screen. This Dual SET® Oximetry technique streamlines the CCHD screening process, improving clinical workflows.
Gerard R. Martin, MD, C.R. Beyda Professor of Cardiology at Children’s National Hospital, said, “As an advocate for congenital heart disease efforts nationally and internationally, I believe Masimo SET® pulse oximetry is an excellent tool for pulse oximetry CCHD screening. Having access to accurate simultaneous pre-ductal and post-ductal measurements helps simplify the process of screening and allows for rapid recognition of discrepancies, ultimately improving newborn care.”
Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide centralized, multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with numerous measurements in addition to dual oximetry Masimo SET®, such as advanced rainbow® Pulse CO-Oximetry measurements, O3® regional oximetry, and SedLine® brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation platform, monitoring data from all connected devices can be automatically charted in EMRs.
Augusto Sola, MD, Vice President of Medical Affairs at Masimo, commented, “As a neonatologist who has worked nationally and internationally in the early diagnosis and treatment of hypoxemic and hyperoxemic conditions that affect neonates in order to improve neonatal survival and quality of life for these fragile infants, I know that Masimo SET® measure-through motion technology’s accuracy and reliability have not only enabled CCHD screening with pulse oximetry, but have helped dramatically reduce retinopathy of prematurity (ROP).20 SET® provides reliable, high-quality monitoring to prevent serious long-term morbidities and is now the standard of care for CCHD newborn screenings and ROP. With the availability of the SET® MOC-9 Module, clinicians can now obtain simultaneous, dual oximetry pre- and post- ductal measurements, using one display, and increase efficiency of CCHD newborn screenings with Root. Furthermore, the Eve application on Root is automated and therefore simplifies and systematizes the screening process. Millions of newborn babies and their families throughout the world will be greatly benefited by this unique solution.”
Eve and the SET® module have not obtained FDA clearance and are not available in the United States.
Source: Company Press Release
