What is the NxStage System One?

The NxStage System One is the first and only truly portable hemodialysis system cleared for home use in the United States, including solo hemodialysis during waking hours, and nocturnal hemodialysis, while both the patient and care partner sleep. It was specifically designed for patients to use in their homes, and is small enough to allow patients to travel and bring their treatment supplies with them.

Risks and Responsibilities

Patients should review the following information carefully and discuss it with their doctors to decide whether home hemodialysis with NxStage systems is right for them.

Users should weigh the risks and benefits of performing home hemodialysis with NxStage systems.

• Medical staff will not be present to respond to health emergencies that might happen during home treatments, including, among other things, dizziness, nausea, low blood pressure, and fluid or blood leaks.
• Users may not experience the reported benefits of home, more frequent, or nocturnal hemodialysis with the NxStage systems.
• The NxStage systems require a prescription for use.

• Medical staff will not be present to perform home treatments. Users will be responsible for, among other things, equipment setup, needle insertions, responding to and resolving system alarms, system tear-down after treatment, monitoring blood pressure, ensuring proper aseptic technique is followed, and following all the training material and instructions that nurses provide.

Users will need additional resources to perform home hemodialysis.

• Users will need a trained care partner to be present during your treatment at home (unless their doctor prescribes “solo/independent” home hemodialysis, described below).
• Users must have a clean and safe environment for their home treatments.
• Users will need space in their home for boxes of supplies necessary to perform home hemodialysis with NxStage systems.

Certain forms of home hemodialysis have additional risks.

• If a doctor prescribes home hemodialysis more than 3 times a week, vascular access is exposed to more frequent use which may lead to access related complications, including infection of the site. Doctors should evaluate the medical necessity of more frequent treatments and discuss the risks and benefits of more frequent therapy with users.
• If a doctor prescribes “solo/independent” home hemodialysis without a care partner during waking hours, risks of significant injury or death increase because no one is present to help users respond to health emergencies. If users experience needles coming out, blood loss, or very low blood pressure during solo/independent home hemodialysis, they may lose consciousness or become physically unable to correct the health emergency. Users will need additional ancillary devices and training to perform solo/independent home hemodialysis.
• If a doctor prescribes “nocturnal” home hemodialysis at night while the user and a care partner are sleeping, risks increase due to the length of treatment time and because therapy is performed while the user and a care partner are sleeping. These risks include, among other things, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. A doctor may need to adjust users’ medications for nocturnal home hemodialysis, including, among other things, iron, Erythropoiesis-Stimulating Agents (ESA), insulin/oral hypoglycemics, anticoagulants, and phosphate binders.

The reported benefits of peritoneal dialysis may not be experienced by all patients.

Peritoneal dialysis does involve some risks that may be related to the patient, center, or equipment. These include, but are not limited to, infectious complications. Examples of infectious complications include peritonitis and exit-site and tunnel infections. Non-infectious complications include catheter complication such as migration and obstruction, peritoneal leaks, constipation, hemoperitoneum, hydrothorax, increased intraperitoneal volume, and respiratory and gastric issues. It is important for healthcare providers to monitor patient prescriptions and achievement of adequate fluid management goals.

Patients should consult their doctor to understand the risks and responsibilities of performing peritoneal dialysis.

APM2098 Rev. G