New Multi-Center Study Finds Clinical Practice Change with Masimo SET Pulse Oximetry Reduces Severe Eye Damage More Than 50% in Premature Newborns

IRVINE, Calif., Sept. 30 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI) announced today that a new multi-center study published in the International Peer-Reviewed Academic Journal, Acta Paediatrica, shows that a change in clinical practice with the use of Masimo SET pulse oximetry technology led to a significant reduction of severe Retinopathy of Prematurity (ROP)—a devastating eye disease resulting in partial or complete blindness—in premature newborns.  The study also confirmed that conventional pulse oximetry technology is not effective in reducing ROP, even when clinical practice is changed to reflect lowered oxygen saturation targets. (1)

ROP is the second leading cause of blindness in childhood in the United States—affecting over 20% of premature babies. (2) A major cause of ROP is the use of excess oxygen to treat respiratory problems in premature babies, which stimulates abnormal vessel growth within the eye.  Although the use of pulse oximetry is established as a standard-of-care technology for measuring oxygen saturation and appropriately titrating oxygen administration to prevent ROP, accuracy and reliability varies greatly by which pulse oximetry technology is used.  Masimo SET pulse oximetry technology is clinically-proven to measure-through motion and low perfusion, leading to accurate and reliable monitoring of oxygen saturation in premature newborns. Although previous clinical studies have shown a reduction in the incidence of ROP in premature newborns when Masimo SET pulse oximetry is used in combination with appropriate titration of oxygen administration, (3) (4) this is the first published study showing a head-to-head comparison of Masimo SET vs. another "next generation" pulse oximetry.

In the current study, researchers examined the role that SpO2 technology plays in the prevention of ROP in 571 high-risk premature newborns (weighing less than 1,250 grams / 2.75 lbs) at two Emory University (Atlanta, GA) hospitals during two consecutive three-year periods (Periods 1 and 2) and an 18-month follow-up period (Period 3).  During Period 1, Nellcor pulse oximeters were used in both centers and oxygen saturation targets were set at 92-100%.  In Period 2, new practice guidelines for lower oxygen saturation targets of 88-93% for premature infants were implemented at both centers, but only one center switched to Masimo SET oximeters.  In Period 3, the center previously using Nellcor oximeters switched to Masimo SET.

Study results showed that in Period 1, when both centers were using Nellcor, ROP rates were not different between centers.  In period 2, when both centers implemented a practice change, the center switching to Masimo SET reduced ROP rates from 12% to 5% while the center using Nellcor did not reduce ROP rates at all, remaining at a 13% ROP rate.  In period 3, the center previously using conventional pulse oximetry switched to Masimo SET and reduced ROP rates from 13% to 6%.  Researchers concluded that the "reduction in the incidence of severe ROP and need for laser therapy was associated with the use of signal extraction pulse oximetry (Masimo SET)" and the study "findings lend further support to the significance of using improved saturation monitors in managing critically-ill infants."  

According to lead researcher, Armando Castillo, MD, Neonatologist at Northeast Georgia Medical Center, "Our study findings show that Masimo SET is not only clinically beneficial, but uniquely impactful for reducing the incidence and prevalence of ROP in Extremely Low Birth Weight infants.  As such, NICU clinicians wanting to use evidence-based strategies should seriously consider implementing Masimo SET."

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 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 rainbow® SET Pulse CO-Oximetry™ technology, 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI).  In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events.  In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices.  Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world.  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 belief that using Masimo SET pulse oximetry technology will help to dramatically reduce the incidence of ROP, risks related to our belief that Masimo SET provides superior sensitivity and specificity to more accurately and reliably measure oxygen saturation in premature newborns weighing less than 1,250 grams than conventional pulse oximetry technologies, 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 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.

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

(1) Castillo A.,  Deulofeut R., Critz A.,  Sola A.  "Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology." Acta Paediatrica, accepted article published online ahead of print here.

(2) Naveed Hussain, Jonathan Clive, and Vineet Bhandari. "Current Incidence of Retinopathy of Prematurity." 1989-1997 Pediatrics, Sep 1999; 104: e26.

(3) Chow L, Wright K, Sola A. "Can Changes in Clinical Practice Decrease the Incidence of Severe Retinopathy of Prematurity in Very Low Birth Weight Infants?" Pediatrics 2003; 111(2):339-345.

(4) Sola A., Rogido, Marta, Deulofeut, Richard. "Oxygen as a Neonatal Health Hazard: Call for Detente in Clinical Practice." Acta Paediatrica 2007; 96:801-812.

SOURCE Masimo