NxStage Medical, a medical technology outfit focused on advancing renal care, has received clearance from the FDA for its System One, which allows for solo home hemodialysis, without a care partner, during waking hours.
The company received its first clearance for home hemodialysis from the FDA in 2005, and in 2014 was cleared for home nocturnal hemodialysis. Since then, NxStage estimates that System One has provided somewhere in the ballpark of 14 million treatments.
Certain patients, however, have not had access to this therapy option because, to date, System One has required that a care partner be present when a patient performs home hemodialysis. With its capabilities now expanded, new and existing System One patients who are trained to perform solo home hemodialysis can do so at home without a care partner.
"Patients have been asking for an FDA-cleared solo option for years," said NxStage Chief Medical Officer Dr. Allan Collins in a statement. "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."
Todd Snell, senior vice president of QA, regulatory and clinical affairs for NxStage, said in a statement that the company was “thrilled” with the achievement.
"Our interaction with the FDA first began at a patient preference workshop followed by regular dialogue throughout the pre-submission and submission processes,” he said. “The solo home hemodialysis clearance makes NxStage the first company to formally conduct a patient preference study leading to a label expansion."
NxStage will be working with its customers and partners to implement additional patient training 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 the best option for them.
The company does stress that there are certain risks to going it alone; certainly it’s a riskier situation when no one is around to help the patient with any important health emergencies. If patients experience needles coming out, blood loss or very low blood pressure during solo home hemodialysis, they may lose consciousness or become physically unable to correct the health emergency -- possibly resulting in injury or death. NxStage advises patients to consult with their physicians to understand the risks before undertaking such treatment.