Pulse oximetry is a standard of care in ORs, recovery rooms and ICUs. The technology is vital, but it has been known to give incorrect oxygen saturation readings, or none at all, for patients in states of hypovolemia, hypothermia, vasoconstriction and during open heart surgery.
OrSense (Nes Ziona, Israel) fills that niche with its newly FDA-approved NBM-200MP, a non-invasive oximetry and low signal oximetry sensor. With this product approval, the company also gains its first FDA approval and U.S. product launch.
"The current solutions do not answer the most difficult patients, those where blood pressure or pulse or other elements of blood perfusion are not functioning optimally. This is the only solution today for those patients where normal technology doesn't perform well or at all," Lior Ma'ayan, CEO of OrSense, told Medical Device Daily.
The NBM-200MP's performance was validated by multi-center trials in the U.S. and Europe. The studies were comprised of desaturation (induced hypoxia) trials and long-term ICU patient monitoring. The noninvasive results were compared to an arterial gold standard.
NBM-200MP continuously monitors and displays multiple blood parameters including oxygen saturation of Hb (SpO2) and low perfusion oximetry. The system permits continuous patient monitoring with adjustable alarm limits for oximetry as well as visible and audible alarm signals.
A ring-shaped sensor is fitted on the patient's finger and applies gentle pressure, temporarily occluding the blood flow. During the occlusion optical elements in the sensor perform sensitive measurement of the light transmitted through the finger. This method, called occlusion spectroscopy, provides a quick, accurate and painless measurement of the patient's blood constituent.
"The small tourniquet generates a stronger optical signal," Ma'ayan said.
OrSense participated in two sets of clinical trials to validate the NBM-200MP. The first was a multi center validation study performed on 20 healthy volunteers in VA Medical Center (Milwaukee) and Rabin Medical Center (Petah Tikva, Israel). During a desaturation (induced hypoxia) down to a level of 70%, OrSense's device was compared with standard reference. To allow low pulse signal, a temporary cessation of blood flow was induced by a blood pressure cuff. Performance of OrSense's oximetry device in low signal/low perfusion situation was compared to a high-end pulse oximeter. The OrSense device produced a 100% readout whereas the other unnamed device produced a 16% readout.
The second study, conducted on 20 patients at the Rabin Medical Center, had the objective of establishing NBM-200MP's superior performance in patients exhibiting low signal/ low perfusion. OrSense's NBM 200MP sensor was placed on patients' fingers for up to 24 hours and continuously monitored oxygen saturation, hemoglobin and glucose. In a study of one patient undergoing severe hypoxia, OrSense's NBM-200MP performed in high correlation with a blood gas analyzer as reference while a high end pulse oximeter, commonly use in this site, failed to read during hypovolemia.
"The ability to accurately measure oxygen saturation in states of low perfusion in acute care patients is critical for intensive care units," said Professor Pierre Singer, head of the Intensive Care Unit at Rabin Medical Center. "OrSense's non-invasive oximeter could be used for accurate, safe and easy to use oxygen saturation evaluation in various hospital wards. Consequently, it will improve patient care and survival, as well as reduce staff workload."
Ma'ayan said the NBM 200MP is a natural development in the company's business strategy, subsequent to securing initial clients and third-party integration agreements in Europe, for the non-invasive multi-parameter sensor for hemoglobin and low signal oximetry measurements.
"This is the first in a line of products that will provide a better situation for critical care patients," Ma'ayan said. "Approval is first and foremost clear and substantial proof of the performance of the technology. In terms of being a commercial milestone for OrSense, this will establish our U.S. presence. We hope to announce future barometers such as one for hemoglobin in 2010."
Shimon Eckhouse, PhD, OrSense's chairman of the board said, "We view this clearance as the next step in OrSense's strategy to commercialize its technology for a wide range non-invasive measurement of blood parameters."
The company received CE mark approval for NBM-200MP last year (MDD, March 25, 2009).
Lynn Yoffee; 770-361-4789