NxStage Medical has received the US Food and Drug Administration clearance for its single needle technology haemodialysis system, OneSite.
The technology uses a dual lumen needle design in both a sharp version with MasterGuard and a buttonhole version with SteriPick, allowing a dialysis patient to insert only one needle instead two during the treatment.
The sharp and buttonhole versions have been made available to make the dialysis procedure more comforting for the patient. It also helps in preventing the patient’s vascular access.
The machine alarm and option of shutdown upon access dislodgement helps in enhancing patient’s safety during treatment. It also reduces the risk of undetected Venous Needle Dislodgement (VND) during the dual needle treatment procedure.
Combining the NxStage PureFlow SL Dialysis preparation system with the device helps patients to use ordinary tapwater to create dialysis fluid. Unlike conventional haemodialysis systems, the System One requires no special infrastructure to operate.
Speaking about the clearance, NxStage Medical president Joseph E Turk said: "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.
"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."
The company claims that the NxStage System One is the only completely portable haemodialysis system cleared for home use by the US FDA.
The device’s compact size of over a foot tall is intended to make for convenient use at patient’s homes and also to make them easy to carry around.