SEATTLE, Nov. 1 /PRNewswire/ -- Redsense Medical's blood loss detection device for monitoring venous needle dislodgement has been granted FDA approval, and is now available for sale in the United States. The Swedish company's patented Redsense blood loss detection system is the world's first such device. Having met Europe's rigorous health & safety standards, the device has already been granted CE approval. With the FDA's approval, Redsense is the first clinically-tested, reliable blood loss monitoring system available in the U.S.
About 1.5 million patients worldwide receive over 200 million dialysis treatments every year. The size of the market is forecast to increase due to an aging population and the rise of diseases such as diabetes type II.
Medical professionals have long been aware of the risk of venous needle dislodgement during dialysis treatment. In the U.S. alone, 7 to 10 patients needlessly die each year due to needle dislodgement. It is feared that the true death rate is 3 to 4 times higher than reported. The total number of serious incidents is estimated to be in the thousands.
"Blood loss resulting from disconnection of the venous needle during hemodialysis is a potentially serious event. Redsense has developed an ingenious device to provide prompt warning when this adverse event occurs," said recognized hemodialysis expert Dr. Christopher R. Blagg, Professor Emeritus of Medicine, University of Washington.
Until now, the typical method of needle dislodgement detection for this common form of renal therapy has been venous pressure monitoring, a built-in function of all dialysis machines. However, incidents have been reported whereby significant blood loss occurred before the venous pressure alarm sounded, resulting in serious, even fatal consequences.
Developed in res
|SOURCE Redsense Medical|
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