NxStage Medical Inc.'s single needle technology, OneSite, has received FDA clearance. OneSite uses a dual lumen needle design offered in 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. OneSite is designed to provide patient comfort during needle insertion and dialysis treatment, as well as preservation of the patient's vascular access. The company said the product also causes the dialysis machine to alarm and shutdown upon access dislodgement.
"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 of NxStage.. "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."