FDA OKs Overnight Use for NxStage Medical’s At-Home Dialysis System

Lawrence, Mass.-based NxStage Medical said Monday that the FDA has cleared its at-home hemodialysis system for nighttime use while patients sleep. The expanded indication makes the System One the only hemodialysis machine cleared for such use in the U.S., the company says.

Marketing for the overnight indication will ramp up in the first quarter of 2015, says Kristen Sheppard, vice president of NxStage.

Home nocturnal hemodialysis has both clinical and lifestyle advantages, according to NxStage. Besides freeing up patients’ days for other activities, the longer treatment time allows for flexibility in dialysis dose and schedule, matching treatment to patient need.

The new indication will open home hemodialysis therapy to a new segment of patients and improve care for patients with end-stage renal disease, says CEO Jeffery Burbank.

The portable System One is the only hemodialysis machine cleared specifically for home use in the U.S., receiving the FDA’s green light in 2005. It is already CE-marked for home overnight use in Europe and other CE mark countries. — Kellen Owings

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