Healthcare Industry News: Pulse Oximetry
News Release - October 18, 2010
OrSense Continuous Non Invasive Hemoglobin Monitoring System Demonstrates Accurate Performance During Hemorrhage ConditionsData introduced in an oral presentation at the American Society of Anesthesiologists Meeting
SAN DIEGO--(Healthcare Sales & Marketing Network)-- OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, presented in an oral presentation at the American Society of Anesthesiologists (ASA) annual meeting in San Diego, results showing that hemoglobin (Hb) measurements obtained by its NBM 200MP, a non-invasive Hb measurement system, showed accurate performance during hemorrhage conditions compared with invasive point of care (POC) devices1.
Monitoring of Hb is essential for the detection of anemia and hemorrhage, and is widely used in the ICU, ER, operating and delivery rooms. The current measurement methods are invasive, painful, time consuming and labor intensive, and are inadequate for continuous Hb monitoring, often necessary during emergency situations. Non-invasive measurement of Hb has many advantages including the prevention of pain and potential transmission of infectious diseases, the reduced need for trained personnel and the freedom to take multiple measurements continuously. NBM 200MP offers a unique, breakthrough, non-invasive solution for accurate and quick Hb measurements.
Another study, presented as a poster in the same ASA conference, validated the performance of the non-invasive NBM 200MP for continual, safe and reliable monitoring of oxygen saturation levels, even in extreme cases of low perfusion and weak pulsation, when standard pulse oximeters fail. Thus, the NBM 200MP occlusion-based oximetry may overcome the limitations of Pulse Oximetry, and improve the ability to detect hypoxemia and related events in ICU, OR and other hospital units2. The NBM 200MP oximetry monitor is FDA cleared.
Lior Maayan, CEO of OrSense, said, "The study presented at the ASA meeting substantiates the potential of the non-invasive NBM 200MP for accurate, continual, safe, and easy-to-use monitoring of Hb, in particular under technological-challenging, potentially life-threatening conditions such as hemorrhage. We anticipate that the NBM 200MP will constitute a significant contribution to a safe and efficient critical care patient treatment."
Results of the non-invasive hemoglobin clinical trial
The study, which evaluated the performance of the NBM 200MP device in continuous monitoring of Hb under hemorrhage conditions, was conducted on 12 healthy volunteers in the VA Medical Center, Milwaukee, Wisconsin. Two units of blood were drawn from each subject, and subjects then received a corresponding amount if isolyte fluid, which compensated for the missing blood volume and rapidly reduced the level of Hb. After a series of measurements, the two removed units of blood were infused back through the intravenous line and increased the Hb again.
Reference Hb values ranged from 8.4 g/dl to 15 g/dl and the average reduction in Hb due to the hemodilution procedure was 3.4 g/dl. For a total of 407 paired data points, the mean bias between NBM readings and the arterial reference values was 0.29 g/dl. The mean personal correlation was 0.9 and the standard deviation of error (STD) was 0.78 g/dl. Use of the device did not cause any discomfort to the subjects, and was safe and well tolerated.
Results of the low signal oximetry trial
The study was conducted on 20 healthy volunteers in the VA Medical Center, Milwaukee, Wisconsin. As an emulation of weak pulse/low perfusion, a brachial cuff was used to occlude the blood flow in the measurement vicinity for up to 2 minutes. Half of the participants underwent induced hypoxia (using oxygen reduced air mixtures) down to 70% saturation.
In the hypoxia group, the NBM values had a correlation of 0.96 with the reference, an arms of 2.2% and a bias of 0.05%. During the periods of weak pulse emulation, the occlusion-based oximeter did not significantly change its accuracy levels, while standard pulse oximeters failed to work approximately 80% of the time, presenting in most of the sessions erroneous readings, with a bias of up to 30%.
OrSense's non-invasive hemoglobin Measurement
OrSense's portable non-invasive device operates via a ring-shaped sensor that is fitted on the donor's finger and applies pressure, temporarily occluding local blood flow. During the occlusion, optical elements in the sensor perform a sensitive measurement of the light transmitted through the finger. This method, called Occlusion Spectroscopy, provides a quick, accurate and painless measurement of the donor's blood constituents, while greatly improving the donor's comfort, eliminating infection risk, and providing the medical staff with accurate readings and immediate results.
OrSense is a medical device company developing non-invasive monitoring systems for measurements of oxygen saturation, hemoglobin, glucose and other blood parameters. The Company's FDA cleared NBM 200MP is a non-invasive blood oximetry monitor for use in hospitals. OrSense’s non-invasive hemoglobin/hematocrit monitor was granted the CE approval and was tested on over 8,000 patients and donors at 20 sites in the U.S. and Europe. The Company's products are based on its proprietary Occlusion Spectroscopy technology, which overcomes key obstacles that hinder the performance of competing approaches. OrSense's CE approved glucose monitor was tested on over 450 diabetic subjects, showing performance similar to those of invasive glucose sensors. Investors in the Company include Israel Health Care Ventures and STAR Ventures. For additional information, please visit OrSense’s corporate website at www.orsense.com.
1 Weinstein, A. Herzenstein, O. Gabis, E. Singer, P. Clifford P. Non-Invasive Monitoring of Hemoglobin Using Occlusion Spectroscopy (ASA Abs. A189 2010)
2 Weinstein, A. Herzenstein, O. Gabis, E. Kagan, I. Singer, P. Non-Invasive, Pulse Independent Monitoring of Oxygen Saturation (ASA Abs. A889 2010)
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