LAWRENCE, Mass.—NxStage Medical announced its single needle technology, OneSite, has received CE Mark approval. In addition, initial patient experiences using this new product have demonstrated its benefits for dialysis patients.
The OneSite employs a revolutionary dual lumen needle design with a buttonhole approach to cannulation. The combination of single site and buttonhole access greatly reduces the challenges of self cannulation. Having a single site also enhances safety by having the machine alarm upon access dislodgement during treatment, thus helping prevent adverse events associated with venous needle dislodgement (VND).
As the requirement for certain medical devices to be sold in the European Union, this CE Mark approval will enable NxStage to make OneSite available in countries where it currently distributes its products, including the United Kingdom, the Nordic countries, Benelux, France, and Italy. Separately, NxStage has also received approval to market this product in Canada.
"CE Mark approval 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 success of our recent nocturnal approval for the NxStage System One in Europe," said Jeffrey Burbank, chief executive officer, 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."