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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