Masimo Corporation (MASI) presented results from a new clinical study evaluating its non-invasive and continuous hemoglobin (SpHb) patient monitoring technologies. The clinical data, published in the journal Anesthesia and Analgesia, demonstrates that MASI’s SpHb technology enables clinicians to non-invasively and accurately assess hemoglobin levels and trending in pediatric patients.
The study was conducted with the primary goal of comparing the magnitude and direction of change (trending) and point accuracy of SpHb with invasive lab measurements. Data samples were collected from 46 patients (aged 2 months to 17 years), undergoing surgeries that involve substantial blood loss, such as cardiac surgery, liver/small bowel transplantation, and multilevel spine surgeries.
Additionally, researchers evaluated the impact of SpHb Invivo Adjustment on accuracy comparisons. Invivo Adjustment – a feature currently available in select European and other non-U.S. markets – allows clinicians to adjust the SpHb measurement to that of an initial blood sample analyzed with the clinician's invasive reference hemoglobin analyzer.
Individual data points from the study demonstrated that changes in SpHb and hemoglobin were in the same direction. The findings thus assert that MASI’s SpHb technology has a high statistical efficiency to correctly detect directional changes in hemoglobin.
Researchers concluded that SpHb can help clinicians non-invasively assess hemoglobin levels and trending, leading to better clinical decisions and improved patient outcomes.
In June 2014, MASI presented data on yet another clinical study appraising its non-invasive and SpHb technologies. Results from the study illustrated that MASI’s SpHb technology provided clinically acceptable accuracy and helped determine when to perform invasive hemoglobin measurements in patients undergoing double-jaw surgery when massive hemorrhage is anticipated.
Earlier in the same month, MASI disclosed clinical data from two other SpHb studies. Results from the first study – comparing MASI’s SpHb with values from an invasive central laboratory device in laboring mothers – demonstrated that SpHb was able to detect changes in hemoglobin concentration during and after delivery. It may therefore provide a useful means for the early detection of bleeding and postpartum hemorrhage.
The second study – evaluating the accuracy of SpHb during prolonged oral surgery with laboratory CO-Oximetry measurements of total hemoglobin (tHb) – confirmed that the accuracy of SpHb monitoring was clinically acceptable.
MASI’s latest study adds to the growing body of clinical evidence supporting the value of SpHb's use with pediatric patients. Trending SpHb values have the potential to supplement detection of changes of hemoglobin concentration through invasive blood draws, thus helping identify life-threatening conditions and guide treatment decisions.
Currently, MASI carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical instruments industry include Alphatec Holdings, Inc. (ATEC), RTI Surgical Inc. (RTIX) and Bacterin International Holdings, Inc. (BONE). While Alphatec Holdings and RTI Surgical sport a Zacks Rank #1 (Strong Buy), Bacterin International Holdings carries a Zacks Rank #2 (Buy).