New Clinical Study Finds Masimo Perfusion Index (PI) Predicts Low Systemic Blood Flow in Preterm Infants
IRVINE, Calif., Dec. 17 /PRNewswire-FirstCall/ — Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, today announced that new research findings, published in the November 2009 issue of the Journal of Perinatology, show that Masimo perfusion index (PI) accurately predicts low superior vena cava flow (SVC) in preterm, very-low-birth-weight infants–representing a promising method for continuous and noninvasive monitoring of systemic blood flow.(1)
SVC flow, a measure of blood flow returning to the heart from the upper body, is useful information in the cardiovascular management of neonates because it helps determine risk for intraventricular hemorrhage, developmental impairments, morbidity, and mortality.(2-4) However, detecting low SVC flow is challenging because current measurement methods are complicated, operator dependent, or can be inaccurate in certain neonatal conditions.(5-6) Masimo PI provides a reliable continuous, noninvasive measure of the ratio of pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue, which provides a rapid, reliable, and cost-effective method to help clinicians assess perfusion and circulatory status.
In the study, Dr. Takahashi and colleagues at the National Center for Child Health and Development in Tokyo, Japan, used the Masimo Radical pulse oximeter and Masimo LNOP NeoPt-L sensor to monitor PI in 24 preterm infants during the first 72-hours following birth. When comparing PI to echocardiography to directly measure SVC, they found that a PI of <0.44 detected low SVC flow (defined as <40ml kg -1 min -1) with good sensitivity (88%) and specificity (86%). A total of eight out of 24 infants were confirmed to have low SVC flow, and PI positively detecting seven–leading researchers to conclude that Masimo PI is a “useful index for detecting low SVC flow in very low birth weight infants born before 32 weeks of gestation” and that “the PI should be evaluated in the cardiovascular management of preterm infants.”
Masimo Executive Vice President of Medical Affairs Dr. Michael O’Reilly, stated, “The current study provides additional evidence supporting the clinical utility of Masimo PI, a reliable noninvasive measure of perfusion. Previous work demonstrated the value of Masimo PI as an early indicator of clinical deterioration in neonates and life-threatening congenital heart disease. Masimo PI has also been shown highly effective in assessing the response to painful stimuli and the proper placement of epidural and regional anesthesia. These results reinforce the value of Masimo PI to routinely assess circulatory disorders and improve detection and treatment of life-threatening conditions.”
(1) S Takahashi, S Kakiuchi, Y Nanba, K Tsukamoto, T Nakamura, Y Ito. “The Perfusion Index Derived from a Pulse Oximeter for Predicting Low Superior Vena Cava Flow in Very Low Birth Weight Infants.” Journal of Perinatology (12 November 2009) doi:10.1038/jp.2009.159. Available online at: http://www.nature.com/jp/journal/vaop/ncurrent/full/jp2009159a.html
(2) Kluckow M, Evans N. “Low Superior Vena Cava Flow and Intraventricular Haemorrhage in Preterm Infants.” Arch Dis Child Fetal Neonatal Ed 2000; 82: F188-F194.
(3) Osborn DA, Evans N, Kluckow M. “Hemodynamic and Antecedent Risk Factors of Early and Late Periventricular/Intraventricular Hemorrhage in Premature Infants.” Pediatrics 2003; 112: 33-39.
(4) Miletin J, Dempsey EM. “Low Superior Vena Cava Flow on Day 1 and Adverse Outcome in the Very Low Birthweight Infant.” Arch Dis Child Fetal Neonatal Ed 2008; 93: F368-F371.
(5) Kluckow M, Evans N. “Superior Vena Cava Flow in Newborn Infants: A Novel Marker of Systemic Blood Flow.” Arch Dis Child Fetal Neonatal Ed 2000; 82: F182-F187.
(6) Osborn DA, Evans N, Kluckow M. “Clinical Detection of Low Upper Body Blood Flow in Very Premature Infants Using Blood Pressure, Capillary Refill Time, and Central-Peripheral Temperature Difference.” Arch Dis Child Fetal Neonatal Ed 2004; 89:F168-F173.
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 SETÂ®, 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 SETÂ® Pulse CO-Oximetry(TM), a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCOÂ®), methemoglobin (SpMetÂ®), PVIÂ®, and acoustic respiration rate (RRa(TM)), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. 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 PI provides unique clinical advantages as an automatic noninvasive measurement of low SVC and intraventricular hemorrhage in very low birth weight, preterm infants, risks related to our assumptions that Masimo PI is a useful noninvasive indicator of perfusion, an early predictor of high illness severity in neonates, and an early detection tool for left heart obstruction, and risks related to our assumptions that Masimo PI represents a more rapid, reliable and cost-effective clinical alternative for assessing perfusion and circulatory status, 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.
Contact: Dana Banks Masimo Corporation 949-297-7348
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