LAWRENCE, Mass.—The U.S. Food and Drug Administration gave NxStage Ltd. clearance April 12 to market its PureFlow SL product, which prepares high purity dialysate from ordinary tap water in the dialysis patient’s home.
“The PureFlow SL helps NxStage and our partners achieve a core objective—making home hemodialysis therapy even more practical for all patients who might benefit,” said Jeff Burbank, NxStage president and CEO.
This product is designed to help patients with end-stage renal disease more conveniently and effectively manage their home hemodialysis therapy by eliminating the need for bagged fluids. NxStage said PureFlow SL meets and exceeds dialysis industry standards for purity.
The NxStage PureFlow SL, which is about the size of an endtable, is an accessory to the NxStage System One designed to prepare ultra pure water from ordinary tap water, and mix this water with concentrate to produce high purity dialysate.
