Study Finds Newborn Screening With Masimo SET Pulse Oximetry Increases Detection of Congenital Heart Disease

Researchers Show Multiple Defects Would Have Been Missed without Masimo SET

Jun 03, 2010, 12:00 ET from Masimo Corporation

IRVINE, Calif., June 3 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new clinical study published online in the German pediatric journal, Klinische Padiatrie, showed that adding Masimo SET pulse oximetry screening to the physical examination of newborns was an effective method to achieve early diagnosis of critical congenital heart disease (CHD). (1)

CHD affects five to ten of every 1,000 newborns, resulting in 3% of all infant mortalities.  Improving early detection and treatment is critical because up to 30% of all CHD-related deaths in the first year of life are due to failure to detect the condition.  However, critical duct-dependent CHD is often present without abnormal auscultation (listening to sounds within the body).  In total, fewer than 50% of cases are diagnosed with a clinical examination alone, so normal physical examination findings cannot exclude CHD.  Multiple previous studies have proven Masimo SET pulse oximetry, along with routine clinical examination, is an effective method capable of closing this diagnostic gap to reduce the morbidity and mortality associated with CHD.  In contrast, several studies using other pulse oximetry technologies have not shown effectiveness in reliably detecting CHD.

In the study, researchers from three obstetric departments in Mannheim, Germany, measured the postductal oxygen saturation of a total of 3,364 newborns between 6 and 36h of age over a year-long period.  Masimo SpO2 measurements were taken via noninvasive sensors placed on the right or left foot (using the VitaGuard VG 310 with integrated Masimo SET technology).  The length of the measurement procedure was 2-5min.  A standardized protocol was followed: In asymptomatic newborns with SpO2 =/+ 95%, no further steps were taken.  For newborns with values 90% - 94%, a check-up assessment was carried out 4-6h later and for persistent SpO2 < 90%, immediate echocardiography was ordered.  Following the standardized protocol, researchers found 18 babies that qualified for echocardiographic exam and 9 were diagnosed with CHD.  Five of the nine babies had normal auscultation finding in their physical exam, leading researchers to conclude: "These newborns were thus saved from potential cardiogenic shock and even sudden unexpected death."  On the basis of this data, a sensitivity of 82% and a specificity of 99.9% with a positive predictive value of 50% and negative predictive value of 99.9% were calculated for the group.  

The researchers concluded: "As the method is simple and reliable, has low cost, is not time consuming, creates no additional burden for the patient, and is available and usable anywhere, we would recommend that pulse oximetry screening, with its high sensitivity and specificity levels, should become established as a general screening method in the routine evaluation of the newborn."

Dr. Balaji Govindaswami, Chief of Neonatology and Director of the NICU at Santa Clara Valley Medical Center, stated, "There is overwhelming evidence that screening newborns with Masimo SET pulse oximetry improves our ability to recognize critical congenital heart disease in the first hours of life and that such early detection improves survival.  We have implemented pulse oximetry screening of all newborns with very positive results and believe that, based on the evidence and real-world success of CHD screening programs, physicians should advocate this approach as a standard of care in all nurseries."

(1)  Tautz J, Merkel C, Loersch F, Egen O, Hagele F, Thon HM, Schaible T.  "Implication of Pulse Oxymetry Screening for Detection of Congenital Heart Defects." Klinische Padiatrie May 10, 2010-Epub ahead of print. Available online here.

About Masimo

Masimo (NASDAQ: MASI) develops innovative 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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced Masimo Rainbow SET® Pulse CO-Oximetry™, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI).  In 2009, Masimo introduced Masimo Rainbow SET® Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." 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 assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo SET pulse oximetry noninvasive measurements will provide sufficient sensitivity and specificity to help clinicians proactively screen for and detect CHD, and risks related to our belief that Masimo SpO2 measurements and thresholds will be useful in detecting CHD in all newborns, 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 forward-looking 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.

Media Contacts:

Dana Banks

Masimo Corporation

(949) 297-7348

dbanks@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, RRa, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.

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