Dialysis products manufacturer NxStage Medical has obtained approval from the US Food and Drug Administration for its System One, for home nocturnal hemodialysis.
According to the company, performing hemodialysis overnight while the patient is at home sleeping is known as home nocturnal hemodialysis.
NxStage founder and CEO Jeffrey Burbank said: "We are delighted with this milestone achievement, which we believe will open home hemodialysis therapy to new segments of patients, and improve patient care for ESRD patients by expanding therapeutic options and flexibility.
"This ‘first of its kind’ clearance is the culmination of significant product innovation, ongoing collaboration with the FDA, a rigorous clinical trial and our experience in delivering over 10 million treatments with the System One around the world."
The company plans for a US market launch in support of this expanded indication in 2015. The System One received CE mark approval for home nocturnal hemodialysis.
NxStage Medical develops and markets products for the treatment of ESRD and acute kidney failure.