Masimo announced today that it has received U.S. FDA 510(k) clearance for Masimo Signal Extraction Technology (SET) pulse oximeters, rainbow SET Pulse CO-Oximeters, and neonatal sensors with labeling for screening newborns for critical congenital heart disease (CCHD). Masimo SET pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but this marks the first time the FDA has cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

In conjunction with the FDA clearance, Masimo also announced the HEART Program (Help Ensure Access to the Right Technology) for CCHD screening enabling hospitals in countries where Masimo has a presence that want to perform CCHD screening with a Masimo SET pulse oximeter, but do not have one and do not have funds to purchase one, to receive a free Masimo SET pulse oximeter. More details are available at http://www.masimo.com/heartprogram.

CCHD causes up to 3% of all infant deaths in the first year of life.1 According to the U.S. Department of Health and Human Services (HHS), these types of heart defects affect about 7 to 9 of every 1,000 live births, one quarter of which could be detected and potentially treated by measuring blood oxygen saturation. FDA clearance comes as California recently became the latest state to mandate CCHD pulse oximetry screening (http://www.aroundthecapitol.com/Bills/AB_1731/20112012/), following HHS’s September 2011 action to add pulse oximetry CCHD screening for newborns as part of the Recommended Uniform Screening Panel.

HHS took this action based on the published findings of the CCHD Workgroup,2 which relied on two major independent, published, prospective clinical studies that exclusively used Masimo SET Measure-Through Motion and Low Perfusion pulse oximeters to recommend screening with “motion-tolerant pulse oximeters” that “have been validated in low perfusion conditions.” Both of the studies were submitted by Masimo to the FDA to support the new CCHD screening labeling.

  • Dr. Anne de-Wahl Granelli, et al., reported on the results of screening 39,821 newborn subjects at five maternity centers in Sweden. Investigators used the Masimo Radical with Masimo SET technology, and found pulse oximetry screening of all well babies in maternity units is practically feasible with a minimum use of nursing time, and that it significantly improves detection of duct dependent heart disease before hospital discharge. The low false positive rate, the fact that other important pathology is unearthed by the screening, and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective.3
  • Dr. Andrew Ewer, et al., studied 20,055 newborn subjects at six maternity centers in the UK. Investigators used the Radical-7 with Masimo rainbow SET technology and found pulse oximetry to be a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography, and the early detection of other diseases is an additional advantage.4

In spite of the wide availability of Masimo SET pulse oximetry, both as standalone products as well as integrated products in over 100 multiparameter monitors from over 50 brands, some hospitals still do not have Masimo SET® technology. Given the strong evidence supporting the use of Masimo SET pulse oximetry for CCHD screening and Masimo’s commitment to help save and improve babies’ lives through expanded CCHD screening programs, the company’s HEART Program (Help Ensure Access to the Right Technology) for CCHD screening will help ensure that hospitals have access to Masimo SET technology for CCHD screening.

“We are very proud of where we have taken pulse oximetry,” stated Masimo founder and CEO, Joe Kiani. “Before SET pulse oximetry, CCHD screening was impractical, if not impossible with pulse oximetry. Dr. Graneli’s initial study showed that even a so called ‘next generation’ pulse oximeter wasn’t able to reliably work for CCHD screening, and was abandoned in the middle of the trial, while Masimo SET delivered the groundbreaking results of high sensitivity and specificity that became the basis for this new standard of care. We are truly elated with this new FDA clearance. We feel that with it, comes the responsibility to make CCHD pulse oximetry screening more accessible for infants, the most defenseless patients in any healthcare setting. We are excited to announce that, in conjunction with this new FDA clearance, we are launching the HEART Program for CCHD screening—offering a free Masimo SET pulse oximeter to hospitals that need one but can’t afford it. In this way, we are helping to address unmet needs on behalf of newborns around the world.”

The Masimo pulse oximeters that were the subject of this 510(k) clearance are the Radical-7, Rad-57 and Rad-87 Pulse CO-Oximeters with Masimo rainbow SET, and the Rad-5, Rad-5v and Rad-8 Pulse Oximeters with Masimo SET.

* Hospitals must be located in a country where Masimo has a presence. Offer subject to rules and regulations of the country where the hospital is located. Full program details and eligibility requirements available at: http://www.masimo.com/heartprogram.

1 Secretary of Health & Human Services letter to the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); dated September 21, 2011. Available here
2 Alex R. Kemper, William T. Mahle, Gerard R. Martin, W. Carl Cooley, Praveen Kumar, W. Robert Morrow, Kellie Kelm, Gail D. Pearson, Jill Glidewell, Scott D. Grosse, R. Rodney Howell. “Strategies for Implementing Screening for Critical Congenital Heart Disease.” Pediatrics; Volume 128, No. 5; November 2011; e1-w10 DOI: 10.1542/peds.2011-1317. Available here
3 De-Wahl Granelli 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.” British Medical Journal (BMJ) January 2009; 338:a3037.
4 Ewer et al., “Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study.” The Lancet 2011: Vol. 378; No. 9793; pp. 785-794.
Additional references: De-Wahl Granelli A,Mellander M, Sunnegardh J, Sandberg K, �stman-Smith I. “Screening for duct-dependent congenital heart disease with pulse oximetry: a critical evaluation of strategies to maximize sensitivity.” Acta Paediatr 2005;94:1590-6. Available
here.
Wren C, Richmond S, Donaldson L. “Presentation of congenital heart disease in infancy: implications for routine examination.” Arch Dis Child Fetal Neonatal Ed. 1999;80:F49–F53. Available
here.

Source: Masimo.