Nephrology News & Issues article “FDA clears NxStage System One for use without a care partner”

FDA clears NxStage System One for use without a care partner


The U.S. Food and Drug Administration has cleared NxStage Medical Inc.’s System One for solo home hemodialysis, without a care partner, during waking hours.

“Patients have been asking for an FDA-cleared solo option for years,” said 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.”

NxStage said it 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 the risks and benefits of solo therapy to determine if solo home hemodialysis is right for them, NxStage said in a news release.

“Our interaction with the FDA first began at a patient preference workshop followed by regular dialogue throughout the pre-submission and submission processes,” said Todd Snell, senior vice president of quality assurance, regulatory and clinical affairs. “The solo home hemodialysis clearance makes NxStage the first company to formally conduct a patient preference study leading to a label expansion.”

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It has been Nichole Jefferson‘s personal mission to tell her story and promote awareness. She was diagnosed with end-stage renal disease (ESRD) in October 2003. At that time, not only was she unaware of what that meant; she also did not know she was a high-risk factor for developing the disease.
After the initial shock of the diagnosis, she decided peritoneal dialysis (PD) was the best option and utilized PD for a few years until she needed to switch to hemodialysis.
She received a kidney transplant from a deceased donor on June 12, 2008, but at the time, she didn’t realize it was simply another form of treatment and not a cure. Today, Nichole is waiting for a new transplant.
Nichole has worked with many advocacy groups on Capitol Hill and has provided her personal experience with ESRD to leaders in the field of nephrology. She tries to express the feelings of those who are unable or unwilling to speak for themselves.