IRVINE, CA -- (Marketwired) -- 05/06/14 -- Masimo (NASDAQ: MASI) today announced that the largest-ever study of newborn screening for congenital heart disease (CHD) was published online by The Lancet. The study of 122,738 newborns -- more than twice as large as any previous study of this type -- was conducted using Masimo SET® Measure-through Motion and Low Perfusion Pulse Oximetry and showed that Masimo SET® pulse oximetry screening significantly increased the rate of CHD detection and is "feasible and reliable" for detecting major congenital heart disease.(1)
Congenital heart defects are a leading cause of infant death in high-income countries, and affect eight of 1,000 livebirths.(2) Critical congenital heart disease (CCHD), defined as causing death or requiring invasive intervention in the neonatal period, occurs in one to two newborns per 1,000 livebirths.(3) Without CCHD detection and intervention, serious injury or death is common.
Senior researcher Dr. Guo-ying Huang and fellow researchers from the Paediatric Heart Centre, Children's Hospital of Fudan University, and the Shanghai Key Laboratory of Birth Defects in Shanghai, China conducted the study at 18 Chinese hospitals in 2011 and 2012. Each of the 122,738 newborns received a clinical assessment and pulse oximetry screening using a Masimo SET® hand-held pulse oximeter (Rad-5v®) with a Masimo SET® sensor (LNOP YI or LNOP Inf-L).
Congenital disease was detected in 1,071 cases, 157 of which were critical and 330 were major. In CCHD, clinical assessment alone had a sensitivity of 77.4% and pulse oximetry alone had a sensitivity of 83.6%. Compared to clinical assessment alone, Masimo SET® pulse oximetry screening increased the detection of CCHD from 77.4% to 93.2% and CHD from 81.3% to 90.2%. The false-positive rate for detection of critical disease was 2.7% (3,298 of 120,392) for clinical assessment alone and 0.3% (394 of 120,561) for pulse oximetry alone.
"Our findings showed that pulse oximetry alone had enough sensitivity and high specificity for detection of critical congenital heart disease," researchers stated. "Without pulse oximetry, discharge of asymptomatic newborn babies with undiagnosed congenital heart disease was three times more likely in babies with critical disease and almost twice as likely in babies with major disease. With combined pulse oximetry and clinical assessment, we detected 284 of 315 (90%) cases of critical congenital heart disease and 136 of 146 (93%) cases of major congenital heart disease." The researchers concluded: "This simple and accurate combined method should be used in maternity hospitals to screen for congenital heart disease."
The Lancet also published a commentary by renowned pediatrician Dr. Andrew K. Ewer, M.D., who said, "These findings would seem to put to rest any remaining concerns about accuracy, and therefore, clinical applicability of pulse oximetry screening." He noted that pulse oximetry screening also is useful in helping detect other disorders such as pneumonia and early onset sepsis, which "might be as lethal as critical congenital heart defect if not diagnosed in a timely manner."
In 2011, a U.S.-based CCHD workgroup recommended that all newborns be screened with "motion-tolerant pulse oximeters" that "have been validated in low-perfusion conditions." The workgroup relied upon two independent, published studies of nearly 60,000 subjects,(4,5) which like the present study, also exclusively used Masimo SET® pulse oximetry. Masimo invented Measure-through Motion and Low Perfusion pulse oximetry and was the first company to get FDA clearance for accurate monitoring during motion and low perfusion. In 2011, the U.S. Department of Health and Human Services adopted the recommendations and added universal newborn screening by "motion-tolerant pulse oximeters" that "have been validated in low perfusion conditions" to the federal Recommended Uniform Screening Panel Guidelines.(6) By the end of 2014, it is expected that 75% of U.S. states will require newborn screening for CCHD.(7) However, in spite of the devastating impact of undetected CCHD and the strong evidence and recommendations, multiple U.S. states still do not require newborn screening for CCHD and no country other than the U.S. has adopted a national standard. In China alone, with 16 million annual births,(8) there are up to 128,000 babies born with CHD and up to 32,000 born with CCHD each year -- a significant portion of which are undetected today.
Because pulse oximetry is widely available in hospitals, many mistakenly assume that any pulse oximeter can be used for newborn screening. In fact, there are no large, appropriately powered newborn screening studies using non-Masimo pulse oximetry with similar effectiveness as the three large studies of over 180,000 newborns using Masimo SET®.
Masimo SET® pulse oximetry provides accurate measurements during motion and low perfusion based on a revolutionary technology that utilizes multiple algorithms that run in parallel to extract the true arterial signal from the composite signal (arterial and venous blood signals) that occurs during motion and low perfusion.
Dr. Anne Granelli -- lead author on one of the largest published CCHD studies,(5) liaison to the HHS workgroup, and author of an award-winning doctoral thesis in this field -- has stated: "While working at one of the two centers in Sweden that performed pediatric cardiac surgery, I found a significant difference, when compared simultaneously with blood gas, between Masimo SET and all other pulse oximetry technologies we used on cyanotic children in the PICU and pediatric cardiac ward. We were not aware of the significant difference between oximeters before (our) clinical study. And, as a result, we upgraded all our pulse oximeters to Masimo SET."
"As we celebrate our 25th anniversary, we can't help but reflect upon what our technology has meant to tens of thousands of newborns and neonates who survive CCHD or no longer get Retinopathy of Prematurity. We are so happy to see yet another large study that shows what Masimo SET technology means to babies, their families and the clinicians who care for them around the globe," said Masimo founder and CEO Joe Kiani.
1 Zhao Q-m, Ma X-j, Ge X-l, Liu F, Yan W-l, Wu L, Ye M, Liang X-c, Zhang J, Gao Y, Jia B, Huang G-y, Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. The Lancet, Early Online Publication, 23 April 2014. doi:10.1016/S0140-6736(14)60198-7
2 van der Linde D, Konings EE, Slager MA, et al. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol 2011; 58: 2241-47.
3 Chang RK, Gurvitz M, Rodriguez S. Missed diagnosis of critical congenital heart disease. Arch Pediatr Adolesc Med 2008; 162: 969-74.
4 Ewer A.K., Middleton L.J., Furmston A.T., Bhoyar A., Daniels J.P., Thangaratinam S., Deeks J.J., Khan K.S. Lancet. 2011 Aug 27;378(9793):785-94.
5 de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
6 Secretary of Health & Human Services letter to the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); dated September 21, 2011.
7 The Newborn Foundation, http://newborn-foundation.org
8 Ministry of Health of the People's Republic of China. National birth defects control and prevention report (2012). Sept, 2012. http://www.gov.cn/gzdt/att/att/site1/20120912/1c6f6506c7f811bacf9301.pdf (accessed Oct 25, 2013).
About Masimo Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® 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®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.
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 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 belief that Masimo SET provides real-time results for all patients to help clinicians to more rapidly assess, diagnose, and treat every patient; risks related to our assumptions regarding the repeatability of clinical results; 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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