NxStage Medical, Inc. (NXTM), a manufacturer of innovative dialysis products, said its single needle technology, OneSite, has received CE Mark approval. Further, 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 company added that the combination of single site and buttonhole access greatly reduces the challenges of self cannulation. Having a single site improves safety by having the machine alarm upon access dislodgement during treatment, thus helping prevent adverse events associated with Venous Needle Dislodgement or VND.
As the requirement for certain medical devices to be sold in the European Union, this CE Mark approval would enable NxStage to make OneSite available in countries where it currently distributes its products, including the UK, the Nordic countries, Benelux, France, and Italy. Separately, NxStage has also received approval to market this product in Canada.
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