NxStage wins nocturnal dialysis CE Mark

February 19, 2013 by MassDevice staff

NxStage Medical notches CE Mark approval in the European Union for nocturnal use of its System 1 home hemodialysis device.

NxStage Medical wins CE Mark for nocturnal dialysis

NxStage Medical (NSDQ:NXTM) said it won CE Mark approval in the European Union for its System 1 home hemodialysis device, saying it expects to begin marketing the device for that indication in the 2nd half of this year.

The approval is a "significant milestone" for the Lawrence, Mass.-based medical device company, CEO Jeffrey Burbank said in prepared remarks.

"This approval gives us the unique ability to offer patients and nephrologists greater therapeutic flexibility and an expanded paradigm for dialysis treatment with the System 1," Burbank said.

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NxStage said nocturnal dialysis performed 3 to 5 times a week increases the time spent on dialysis without increasing its impact on patients and caregivers, conferring advantages but also carrying different risks.

"NxStage's nocturnal indication shows the company's leadership in safety and ease of use by minimizing those risks to the satisfaction of regulators," according to a press release.