NxStage Medical announced that the U.S. Food and Drug Administration (FDA) has cleared its System One for solo home hemodialysis, without a care partner, during waking hours.
Since receiving its first clearance for home hemodialysis from the FDA in 2005 and the first and only home nocturnal hemodialysis clearance in 2014, the NxStage System One has provided over 14 million treatments to thousands of patients in their homes around the world, during the day and at night.
However, certain patients have not had access to this therapy option due to the fact that the System One's indication has required that a care partner be present when a patient performs home hemodialysis. This new expanded indication provides both new and existing System One patients, trained to perform solo home hemodialysis, the freedom to dialyze at home without a care partner during waking hours.
"Patients have been asking for an FDA-cleared solo option for years," stated Dr. Allan Collins, Chief Medical Officer, NxStage.
"Many patients have been turned away from home hemodialysis simply because they did not have a care partner. The ability to train and treat solo provides a broader patient base with access to the clinical and quality of life benefits associated with home hemodialysis."
"We are thrilled with this milestone achievement," said Todd Snell, SVP of QA, Regulatory & Clinical Affairs, NxStage.
"Our interaction with the FDA first began at a patient preference workshop followed by regular dialogue throughout the pre-submission and submission processes. The solo home hemodialysis clearance makes NxStage the first company to formally conduct a patient preference study leading to a label expansion."
"With much credit to our decade long history in the home, we continue to do amazing things for dialysis patients," said Joe Turk, President, NxStage.
"As a company, we are incredibly passionate about providing patients with as much freedom and flexibility as possible to do their dialysis therapy when they want and where they want, day or night. This expanded indication for solo therapy is another significant step forward for patients."
NxStage will be working with its customers and partners to implement additional patient training for this new indication later this year and into 2018. Interested patients should talk to their nephrologist and care teams to fully understand both the risks and benefits of solo therapy to determine if solo home hemodialysis is right for them.
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis, home nocturnal hemodialysis and solo home hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.
When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate.
Under the guidance of their physician, patients can use the NxStage System One, with their trained partners (or for patients prescribed to receive solo dialysis, alone), where, how and when it best meets their needs, including while they are sleeping – at home or on vacation and at a medically appropriate treatment frequency.