Fresenius Medical Care (NYSE: FMS), the world’s largest provider of dialysis products and services, announced today its introduction of the WetAlert wireless wetness detector, designed to detect venous needle displacement and prevent blood loss for dialysis patients at home. The WetAlert transmitter is the only device in the U.S. market that senses moisture at the venous needle site and sets off a process to automatically stop the blood pump, close the venous clamp, display a visual alarm, and sound an audible alarm. The device transmits radio signals directly to the 2008K@home machine. It is unique and highly effective in design, and reusable for up to six months.
Venous needle dislodgement (VND) is a potential, serious complication related to dialysis therapy. If the venous needle becomes dislodged or disconnected from the patient’s vascular access, it could cause the patient to hemmorhage.
“The WetAlert wireless wetness detector is a brand new option that may help reduce the fear of blood leaks during home dialysis because the blood pump stops on the 2008K@home machine, thereby decreasing the amount of potential blood loss if VND occurs,” said Dr. Jose Diaz-Buxo, MD, FACP, Chief Medical Officer at Fresenius Medical Care. Recently, the U.S. Food and Drug Administration (FDA) cleared the WetAlert wireless wetness detector for use.
About Fresenius Medical Care North America
Through our leading network of more than 2,100 dialysis facilities in North America and our vascular access centers, laboratory, pharmacy and affiliated hospitals and nephrology practices, Fresenius Medical Care provides renal services to hundreds of thousands of people throughout the United States, Mexico and Canada. We are also the continent's top producer of dialysis equipment, dialyzers and related disposable products and a major supplier of renal pharmaceuticals. For more information about the company, visit www.fmcna.com; for information about patient services, visit www.ultracare-dialysis.com
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Indications for Use: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also intended for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. The WetAlert wireless wetness detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician or other licensed practitioner. For safe and proper use of this device refer to the device Instructions for Use.