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.
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.
"The combination of single site and buttonhole access greatly reduces the challenges of self cannulation," the company noted. "Having a single site also enhances safety by having the machine alarm upon access dislodgement during treatment, thus helping prevent adverse events associated with Venous Needle Dislodgement."
NxStage has been on a roll in February, just recently touting an additional CE Mark win for its high-flow System One.