Dialysis: NxStage notches 3rd Euro win with CE Mark for OneSite needle

February 27, 2013 by Arezu Sarvestani

NxStage Medical touts its 3rd European regulatory win this month with CE Mark approval for its OneSite single needle dialysis technology.

NxStage Medical logo

Massachusetts medical device maker NxStage Medical (NSDQ:NXTM) is on a roll, notching its 3rd regulatory win this month with CE Mark approval in the European Union for its OneSite single needle for dialysis patients.

The OneSite needle is part of NxStage's System One, which the company calls "the 1st and only truly portable hemodialysis system" with FDA clearance for home use.

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NxStage earlier this month won CE Mark approval for night-time use of System One, and the company plans to begin marketing to that indication later this year.

"Building on our breadth of technology and expertise in fistula needles, we're bringing to market an elegant single needle solution that does not have the complexity and complications of other common approaches," NxStage CEO Jeffrey Burbank said in prepared remarks.

The OneSite needle uses a dual lumen needle with a "buttonhole approach to cannulation," according to a press release.