The Lawrence, Mass.-based company said the System One is the only hemodialysis device cleared in the U.S. for nocturnal treatments. NxStage said it plans to begin marketing for the expanded indication in 2015.
NxStage won CE Mark approval for the nocturnal indication in February, 2013. At the time, founder & CEO Jeff Burbank told MassDevice.com that nocturnal treatment offers several clinical and quality-of-life benefits for dialysis patients.
"In essence what it can do for patients is reduce the burden of doing it during the day. Logistically, it reduces some of the burden on patients," Burbank told us back then. "There’s a clinical difference to it, because you deliver the therapy over a longer period of time."
"It seems to be a gentler therapy as well," he added. "In many cases, patients can have a more liberal diets and eat some foods they haven’t been able to eat."
In prepared remarks today, Burbank said the company is delighted with the U.S. milestone.
"This 1st 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," he said.