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Redsense Medical Receives FDA Approval

November 2, 2007

The company's blood loss detection device allows early detection of blood loss from venuous needle dislodgement during dialysis.


SEATTLE, WA /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[1].

Developed in response to demands made by dialysis professionals, Redsense will become a vital aid to the dialysis caretaker, increasing patient safety.

"Even with careful monitoring by dialysis professionals, needles do become dislodged, and significant blood loss can occur before dislodgement is detected." Patrik Byhmer, CEO of Redsense Medical, explains. "Other monitoring systems rely on blood pressure or moisture detectors and the reliability of those techniques is uncertain at best. The Redsense blood loss detection device has been clinically tested and is proven to be reliable. Patients can change position or rest without risking an undetected dislodgement. For care providers, this device offers unprecedented peace of mind and the freedom to move freely around the unit."

Redsense consists of two parts: a sensor patch and an alarm unit. An infrared signal is transmitted from the alarm unit to the sensor patch using fiber optic cable. In the event of bleeding, inner layers of the patch smear blood over the optical sensor, which triggers the alarm. Redsense doesn't react to perspiration or water, so moisture alone will not cause an alarm. And because the signal to the sensor is continuous, the alarm reacts instantly to the first milliliter of blood. Nurses and doctors are free to focus on the tangible problems of hemodialysis. And the patient can benefit from the care of professionals who feel in control of their situation.

About Redsense Medical
After a number of incidents with venous needle dislodgement during hemodialysis at a dialysis clinic in Sweden, the clinic's technicians contacted a company specializing in medical technology. This cooperation between medical staff and engineers resulted in the startup of Redsense Medical in 2006. Redsense Medical has offices in Sweden and in the U.S. (Seattle, WA). For more information, contact Redsense Medical Ltd., 1750, 112th AVE NE #E170, Bellevue, WA, 98004; Phone: 425-503-8188; Fax: 425-688-0813; Email: info@redsensemedical.com. Or visit the Redsense Medical Web site.

[1] "Neglected Safety Aspects in Hemodialysis and Their Related Problems," H-D Polaschegg, Hemodialysis Horizons, 2006. "Undetected Venous Line Needle Dislodgment during Hemodialysis," Health Devices Nov 1998;27(11):404-6


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