FDA CLEARS NXSTAGE'S HOME HEMODIALYSIS SYSTEM

Lawrence, Mass.-based NxStage Medical has received expanded 510(k) clearance from the FDA to market its System One portable daily hemodialysis device for home use.

The clearance was based on a formal clinical study comparing center-based and home-based daily hemodialysis with NxStage System One representing over 2,200 patient treatments. The study showed that hemodialysis with the System One is equivalent on a per treatment basis in-center and at home.

The NxStage System One is portable, allowing patients to travel, and is easy to use by patients with their trained partners. It plugs into standard electrical outlets and requires no special infrastructure to operate, allowing its easy use in patients' homes.