NxStage’s Single Needle Dialysis Product Gets FDA Green Light

Lawrence, Mass.-based NxStage said Tuesday that the FDA granted 510(k) clearance for its single needle dialysis product, OneSite. The product is designed for use with the NxStage System One, the first and only truly portable dialysis system cleared for home use in the U.S., the company said.

The OneSite offers a unique dual lumen needle design in both sharp version and buttonhole version. The combination of single site and buttonhole access is intended to provide patient comfort during needle insertion and dialysis treatment, as well as preserve a patient’s vascular access, the company said. 

The single-needle system also signals an alarm and automatic shutdown function if the needle dislodges, boosting patient safety during treatment. This reduces the risk of undetected venous needle dislodgement.

NxStage plans to release the product in a controlled fashion starting in the fourth quarter of this year, company vice president Kristen Sheppard said. Full market launch is expected in the first quarter of 2015. The product was CE marked last year and is being used in countries that observe that designation, she said. — Kellen Owings

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