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FDA approves NxStage’s single needle technology

Medical device company NxStage Medical has obtained approval from the US Food and Drug Administration (FDA) for its OneSite, a single needle technology.

The OneSite, which features dual lumen needle design, is available in a sharp version with MasterGuard and a buttonhole version with SteriPick.

The technology has been developed to provide comfort to the patient during needle insertion and dialysis treatment, as well as to preserve vascular access.

OneSite also features machine alarm, which reduces the risk of undetected Venous Needle Dislodgement (VND) in the use of a two needle treatment.

NxStage Medical president Joseph Turk said that FDA clearance for OneSite is another significant milestone that illustrates the success of firm’s innovation strategy.

"It represents a meaningful step forward in advancing the care of dialysis patients and will enhance the safety for our home dialysis patients," Turk added.

NxStage also received FDA approval for the System One, which is the hemodialysis system intended to use at the home by patients.
The company develops and markets products for the treatment of ESRD and acute kidney failure.