The European Union has granted CE mark certification to NxStage Medical's NxStage System One for nocturnal home hemodialysis.
Available in simplicity and revolutionary size, the portable hemodialysis system provides convenient use in patients’ homes and gives patients the freedom to travel with the therapy.
The company said the dialysis, which is carried out while the patient is sleeping usually between three and five nights per week, provides many benefits by minimizing the risks to the satisfaction of regulators.
NxStage Medical chief executive officer Jeffrey Burbank said, "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 One."
NxStage is planning to launch the System One for nocturnal dialysis in countries that recognize the CE mark in the second half of 2013.
The company said NxStage system One, which is not specifically cleared in the US for nocturnal home hemodialysis, is currently in a trial to support the indication.