Frequently Asked Questions

Questions about the NxStage System One

The NxStage System One obtained 510(k) clearance in the United States and is CE marked for use in the EU for home haemodialysis, including home nocturnal haemodialysis. It is the smallest commercially available haemodialysis system.

Its simplicity and compact size are intended to allow easy use in patients’ homes and give patients the opportunity to travel with their therapy. It plugs into a standard electrical outlet and, unlike conventional haemodialysis systems, requires no special infrastructure modifications to operate. Under the guidance of their doctor, patients can use the NxStage System One, with their trained partners, where, how, and when it best meets their needs, at home or while travelling.

Recent clinical data supports much broader adoption of more frequent home haemodialysis with the System One. Objective data from large, well-designed trials, including the FHN trial1, FREEDOM and the CDRG2 studies, suggest that more frequent haemodialysis can have a positive impact on patient survival, clinical outcomes, and quality of life.

The data are consistent, compelling, and overwhelmingly positive. It suggests that more patients can and should benefit from NxStage's more frequent life-changing therapy, and that these patients may live longer lives.

The NxStage System One was designed from the ground up to provide the simplicity, flexibility, and portability to make more frequent home haemodialysis a practical reality, without compromising safety. It was designed to overcome the challenges of home and more frequent haemodialysis posed by traditional equipment. The NxStage System One’s prescription flexibility and simple set-up and clean-up make it well-suited for home and more frequent therapies.

  1. The FHN Trial Group. In-centre haemodialysis six times per week versus three time per week. N Engl J Med. 2010;363:2287-2300.
  2. Weinhandl, E et al. Relative mortality in daily home and matched, thrice weekly in-centre haemodialysis patients. Abstract Presentation at the 2011 National Kidney Foundation Spring Clinical Meeting.

A combination of factors makes NxStage unique among dialysis therapies:

  • It was designed for home use by patients and care partners
  • It plugs into any standard electrical outlet and requires no special electrical connections
  • It requires no special plumbing modifications; the dialysate preparation system utilises a simple faucet, under sink, or washer connection, and drains into any sink, toilet, or drain
  • Sterile premixed dialysate bags are available so patients can take their treatment on the road

The NxStage System One is designed to deliver haemodialysis therapy in a home setting. The System One consists of the following elements:

  • A small control unit containing a fluid pump and user interface (Cycler).
  • A disposable dialyser and tubing set (cartridge).
  • Ultrapure fluid (dialysate), prepared by the PureFlow SL dialysate preparation system or in premixed bags for travel.

For each treatment, a new cartridge is inserted into the Cycler, where it is prepared for use or primed prior to treatment. The ultrapure dialysate is generally prepared in advance, in batches, by the PureFlow SL, and is then connected to the cartridge.

During treatment, the cartridge tubing is attached to the patient’s blood access. Blood and dialysate pass through the filter to clean the blood. Used dialysate, wastes known as effluent, and excess fluids removed from the blood are routed through a waste line on the cartridge and into a drain.

Therapy is complete when the prescribed dialysate volume has been delivered. Daily supplies are thrown away, and the Cycler is simply wiped down after use.

The NxStage System One cycler is just over a foot tall, measuring approximately 38 centimetres high by 38 centimetres wide by 46 centimetres deep. It easily fits into any room at home without any home modifications, and can also be packed into a car or checked (with the appropriate preliminary steps and protective case) for airplane travel. The system plugs into a standard 230V electrical outlet.

The PureFlow SL dialysate purification system is about the size of an end table, and the System One sits on top of it. The PureFlow SL is not portable for travel.

Storage space is required for the disposable supplies, such as cartridges, sacks of concentrated dialysate, and bags of premixed dialysate (for back up and travel), as well as access-related supplies and saline bags.

The NxStage System One S is the latest version of the NxStage System One. The designs of the System One and System One S are similar but the System One S is capable of higher dialysate flow rates.

Questions about the responsibilities and risks of more frequent home haemodialysis with the NxStage System One

Home haemodialysis with NxStage requires a patient and partner who are committed to being trained on and to follow the guidelines for proper system operation. If your patients choose to do more frequent home haemodialysis, they will be responsible for complying with your dialysis prescription, which may require treatments up to six days per week. Each treatment can take about 2½ to 3 hours or more including set-up and tear-down.

If your patients choose to do home haemodialysis, your patients and their care partners will need to take on the responsibility for tasks that would normally be taken care of by centre staff when receiving treatment in-centre. They will need to perform all aspects of the dialysis treatment from start to finish, including setting up the dialysis equipment, needle sticks, responding to and resolving all system alarms, and system tear-down at the end of treatment.

In addition, they must monitor their blood pressure, ensure that proper aseptic technique is followed, and follow all of the training material and instructions given to them by their training nurses. Your patients and their care partners will also be trained on and need to know how to respond to any health emergencies that might happen during treatment at home, including dizziness, nausea, hypotension (low blood pressure), and fluid or blood leaks.

To do home haemodialysis successfully, your patients must take care to ensure that they have a clean and safe environment for their treatments. Your patients will also need to set aside space in their home for the needed supplies.

Studies suggest that patients performing more frequent home haemodialysis may experience slightly fewer complications associated with their treatments, and actually may enjoy improved clinical outcomes.1-3 However, there are certain risks unique to treatment in the home environment. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed. When vascular access is exposed to daily use, infection of the site, and other access-related complications may also be potential risks.

With more frequent home haemodialysis, your patients and their care partners would be taking on a great deal of responsibility, but many NxStage patients feel that the benefits of this therapy are worth taking on these responsibilities. Thousands of patients are performing more frequent home haemodialysis with the NxStage System One and are enjoying the health benefits, improved quality of life, and additional freedom it can provide.

When performed correctly under the direction and with the support of a medical care team, more frequent home haemodialysis with NxStage may offer tremendous health and quality of life benefits. Talk to your patients and their care partners to better understand the risks involved and how they might apply to your patients and to determine if more frequent home haemodialysis is right for them.

  1. The FHN Trial Group. In-centre haemodialysis six times per week versus three time per week. N Engl J Med. 2010;363:2287-2300.
  2. Jaber BL, Lee Y, Collins AJ, et al. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010;56(3):531-539.
  3. Finkelstein FO, Schiller B, Daoui R, et al. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012;82(5):561-569.

Questions about using the NxStage System One

One of the requirements for doing home dialysis with NxStage is that your patients have a care partner who is willing to share in the training and responsibility for their home care. Your dialysis centre will train your patients and their care partners on home-care dialysis therapy. During the training, your patients and their care partners will learn how to access their blood, operate the NxStage system, monitor their vital signs, administer their drugs, and handle emergency situations.

The training nurse will adapt the programme to meet their needs. Your patients may be encouraged to do as much of the therapy as they can, and your centre may not require their care partner to attend every day of their training programme.

Patients generally complete training in 3 to 4 weeks. However, patients will not start treatments at home until your patients, their care partner, and the centre staff feel comfortable that they can safely and confidently perform their treatments.

Patients are prescribed the dialysis therapy that is best for them. Based on their needs, you will decide how frequently your patients will perform their therapy, how much and what kind of dialysate they will use, how long the treatment will last, and what their weight at the end of each treatment should be.

Treatment times will vary based upon your patient's body size and their prescription. A typical more frequent treatment uses 20 to 30 litres of dialysate and takes 2½ to 3 hours to complete.

NxStage resources are available 24/7 to support your patients with any technical or equipment questions that might arise.

When doing home therapy, patients will most likely visit their dialysis centre at least once a month. Centres will also give patients a number to call if they ever have questions about their therapy or their system.

If problems with a patient's system cannot be resolved by phone, NxStage has a "service-swap" programme. This means that a replacement machine will be sent to your patient within one business day, and the machine with problems will be exchanged. This service is provided at no cost to your patient.

APM2100-ENG Rev. A

Fresenius Medical Care has successfully completed its merger with NxStage Medical, Inc.

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