New Study Evaluates Trending Accuracy and Reliability of Masimo's Continuous and Noninvasive SpHb(R) Technology

TOKYO, JAPAN--(Marketwired - Jul 9, 2014) - 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™ 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

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 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.