TOKYO, JAPAN -- (Marketwired) - Masimo (NASDAQ: MASI) announced today that a new clinical study published in the Journal of Clinical Monitoring evaluated the relative trending accuracy of Masimo's noninvasive and continuous total hemoglobin (SpHb®) in patients with end-stage renal disease who underwent dialysis.1
Dr. Hiroshi Yamada, M.D., and colleagues at Fujisawa City Hospital in Fujisawa, Japan, assessed the relative trending accuracy of SpHb using a Masimo Radical-7® Pulse CO-Oximeter (ReSposable R2 25 Sensor, Rev. F) compared to in-line monitoring of hematocrit (Crit-Line) in end-stage renal disease patients undergoing dialysis. The researchers noted that while the Crit-Line device has proven to be clinically helpful, the high cost and low availability of the Crit-Line device has compelled clinicians to seek other options to assess changes in blood volume (?BV).
In the study, researchers determined the ?BV estimated by each method by calculating the change between the initial reading of the modality and the current value at the time of recording. A total of 95 data points from 12 patients over 20 dialysis sessions were analyzed. The regression correlation of changes in SpHb vs. changes in hematocrit from Crit-Line was 0.83 (P≤ 0.001).
Researchers noted, "Pulse CO-Oximetry measures ?BV from SpHb as reliably as Crit-Line," adding that, "SpHb by the pulse CO-Oximeter has good relative trending accuracy."
SpHb is available with Masimo's rainbow® SET® monitoring platform, enabling the noninvasive assessment of multiple blood constituents and physiologic parameters that previously required invasive or complicated procedures, in addition to providing Masimo SET® Measure-through Motion and Low Perfusion(tm) pulse oximetry. The rainbow® SET® platform -- including RRa®, SpCO® and SpMet® -- offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.
1 Yamada H., Saeki M., Ito J., Kawada K., Higurashi A., Funakoshi H., Takeda K. "The relative trending accuracy of noninvasive continuous hemoglobin monitoring during hemodialysis in critically ill patients." J Clin Monit Comput May 3, 2014, DOI 10.1007/s10877-014-9574-6. Available online here
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 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(tm)), 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.
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's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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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