FDA extends the indication of System One to include solo home hemodialysis without presence of a care partner.-NxStage Medical.

NxStage Medical, Inc. announced that the 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. 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.

A trained and qualified patient may dialyze alone, without a care partner present (solo home hemodialysis), provided the patient and physician agree that solo home hemodialysis is appropriate. Certain risks associated with hemodialysis treatment are increased when performing solo home hemodialysis because no one is present to help the patient respond to 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. Losing consciousness or otherwise becoming impaired during any health emergency while alone could result in significant injury or death. Additional ancillary devices and training are required when performing solo home hemodialysis. Patients should consult with their physician to understand the risks and responsibilities associated with solo home hemodialysis using the NxStage System One.