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Nocturnal Home Hemodialysis Earns CE Mark Approval

Manufacturing Group | February 27, 2013

NxStage System One enables dialysate flow rates, allowing expanded possibilities, treatments.

Executives from NxStage Medical Inc. announce receipt of CE Mark approval for new high flow capabilities with the NxStage System One. With this approval, the company expects to bring this advancement to customers in countries that recognize the CE Mark approval process later this year.

The new high flow capabilities for the System One will enable dialysate flow rates, which allow nephrologists expanded possibilities to adjust the duration and frequency of patient prescriptions with greater flexibility than they have today.

"Our new high flow capabilities advance the therapeutic flexibility of the System One as well as NxStage's leadership in home therapies," states Jeffrey Burbank, CEO, NxStage Medical Inc. "By providing expanded therapy options, high flow enables NxStage therapy to be even better tailored to the clinical and lifestyle needs of a broader range of patients."

About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration (FDA). Its simplicity and revolutionary size (just over a foot tall) provide convenient use in patients' homes and give patients the freedom to travel with their therapy. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, at home or on the road.

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