NxStage Gets FDA Clearance for New High-Flow Capabilities

On April 30, the U.S. Food and Drug Administration (FDA) granted NxStage Medical clearance for its new high-flow capabilities with the NxStage System One, a portable hemodialysis system cleared for home use. With this clearance, NxStage Medical, based in Lawrence, Mass., expects to begin offering its System One with new higher flow capabilities in the United States later in 2013.

The higher flow capabilities will allow practitioners to adjust the duration and frequency of patient prescriptions for dialysis at home.

“This latest regulatory milestone reflects strong and systematic execution against our product pipeline,” said Jeffrey Burbank, chief executive officer at NxStage Medical, Inc. “NxStage therapy may be prescribed less frequently, for example, three times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center (in dialysis centers) today.”

NxStage’s high flow capabilities also received CE mark approval (CE marking is the manufacturer’s declaration that a product meets the requirements of the applicable European Union rules for marketing a product freely in those areas).