The OneSite employs a unique dual lumen needle design offered in both a sharp version with MasterGuard® and a buttonhole version with SteriPick® allowing the dialysis patient to have only one needle inserted per dialysis treatment instead of two. The combination of single site and buttonhole access is designed to provide patient comfort during needle insertion and dialysis treatment, as well as preservation of the patient's vascular access. The dual lumen design also enhances patient safety during treatment by having the machine alarm and shutdown upon access dislodgement, reducing the risk of undetected Venous Needle Dislodgement (VND) in the use of a two needle treatment.
"FDA clearance for OneSite is another significant milestone that illustrates the success of our innovation strategy. It represents a meaningful step forward in advancing the care of dialysis patients and will enhance the safety for our home dialysis patients," said Joseph E. Turk, President, NxStage Medical, Inc. "Building on our breadth of technology and expertise in fistula needles, we're bringing to market an elegant single needle solution that does not have the complexity and complications of other common approaches."