Frequently Asked Questions

Questions about the NxStage® System One™

What is the NxStage System One?

The NxStage System One is the only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration (FDA). It is the smallest commercially-available hemodialysis 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 standard electrical outlets and, unlike conventional hemodialysis systems, requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how, and when it best meets their needs, at home or on vacation.

Why is there a need for NxStage System One?

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

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

Traditional hemodialysis equipment is designed for use in dialysis clinics, not the home setting. The NxStage System One was designed from the ground up to provide the simplicity, flexibility and portability to make more frequent home hemodialysis a practical reality, without compromising safety. It was designed to overcome the challenges of home and more frequent hemodialysis posed by traditional equipment. The NxStage System One’s prescription flexibility and simple set-up and take-down make it well-suited for home and more frequent therapies.
What makes NxStage different?

A combination of factors makes NxStage unique among dialysis therapies:

  • The System One is small and portable; it weighs roughly 70 pounds and is just over a foot tall.
  • 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 utilizes a simple faucet, under-sink, or washer connection and drains into any sink, toilet, or drain.
  • Sterile premixed dialysate bags are available so you can take your treatment on the road.
How does the NxStage System One work?

The NxStage System One delivers hemodialysis 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 dialyzer and tubing set (cartridge).
  • High-purity fluid (dialysate), prepared by the PureFlow™ SL dialysate preparation system or in premixed bags for travel.

For each treatment, a cartridge is inserted into the cycler, where it is then prepared for use - or "primed" - prior to treatment. The 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 your blood access. Blood and dialysate pass through the dialyzer to clean the blood. Used dialysate, wastes, and excess fluids removed from the blood pass through the cartridge, and then through a waste line into a standard 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.

How much physical space does the NxStage System One occupy?

The NxStage System One cycler is just over a foot tall, measuring approximately 15 inches high by 15 inches wide by 18 inches deep. It easily fits into any room at home without any construction or plumbing requirements, 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 110V 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.

 

Questions about more frequent home hemodialysis

Why more frequent therapy?

The naturally functioning kidney works continuously: 24 hours a day, 7 days a week. It plays an essential role balancing fluids and electrolytes in the body while removing toxins.

The most common form of hemodialysis is performed three times a week, approximately four hours per session. This therapy is known as "traditional in-center" or "intermittent" dialysis. This schedule was arrived at decades ago as a "practical compromise" between clinical benefits, dialysis provider resources, and the conventional work week. Because of the number of days (2 to 3) between treatments, intermittent dialysis can lead to large fluctuations in body weight due to water retention, accumulation of wastes, and electrolyte imbalances.

Some have proposed that this dialysis "unphysiology" drives many of the side effects patients may experience on traditional three-times-weekly therapy. More frequent home hemodialysis reduces these wide fluctuations by shortening the time between treatments. As a result, it is gentler on the body and may lead to meaningful health benefits.

What benefits are associated with more frequent hemodialysis?

Many patients report - and various studies have confirmed - that, compared to three-times-weekly in-center hemodialysis, more frequent home hemodialysis may offer the following health and quality of life benefits1:

  • Less stress on the heart
  • Better blood pressure control with fewer medications
  • Much quicker recovery time after treatment
  • Improved appetite and the ability to drink more
  • Fewer depressive symptoms
  • Better mental and physical health
  • More energy and vitality
  • Feeling of being in control of treatment and life
  • Lower risk of death

Click here for more information on the reported health and quality of life benefits of more frequent hemodialysis.

Despite the health benefits that more frequent home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream, and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. 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.

For additional information on the responsibilities and risks of more frequent home hemodialysis, please read the FAQ section below. And, talk to your doctor to see if more frequent home hemodialysis with NxStage is right for you.

 

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

What responsibilities should I and my care partner expect?

Home hemodialysis with NxStage requires a patient and partner who are committed to being trained on and following the guidelines for proper system operation. If you choose to do more frequent home hemodialysis, you 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 you choose to do home hemodialysis, you and your partner will need to take on the responsibility for tasks that would normally be taken care of by center staff when receiving treatment in-center. You 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, you must monitor your blood pressure, ensure that proper aseptic technique is followed, and follow all of the training material and instructions given to you by your training nurses. You and your partner 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 hemodialysis successfully, you must take care to ensure that you have a clean and safe environment for your treatments. You will also need to set aside space in your home for the needed supplies.

What risks are associated with more frequent home hemodialysis?

Studies suggest that patients performing more frequent home hemodialysis may experience slightly fewer complications associated with their treatments, and actually may enjoy improved clinical outcomes1. 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 hemodialysis, you and your partner 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 hemodialysis 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 your medical care team, more frequent home hemodialysis with NxStage may offer tremendous health and quality of life benefits. You should talk to your doctor to better understand the risks involved and how they might apply to you - and to determine if more frequent home hemodialysis is right for you.

 

Questions about using the NxStage System One

Content is geared to United States customers.

How will I be trained?

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

The training nurse will adapt the program to meet your needs. You may be encouraged to do as much of the therapy as you can, and your center may not require your care partner to attend every day of your training program.

You will generally complete training in 3 to 4 weeks. However you will not start treatments at home until you, your partner, and the center staff feel comfortable that you can safely and confidently perform your treatments.

How is NxStage therapy prescribed?

Your doctor prescribes the dialysis therapy that is best for you. Based on your needs, he or she will decide how frequently you will perform your therapy, how much and what kind of dialysate you will use, how long the treatment will last, and what your weight at the end of each treatment should be.

Most physicians have taken advantage of the simplicity and flexibility of the NxStage System One with PureFlow SL to prescribe "more frequent" therapy (which is actually 5 or 6 days per week rather than 7 days per week).

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

Which blood access will I use? Can I access my blood myself?

Any of the three types of access - fistula, graft, or catheter - may be used with the NxStage therapy. You will learn how to access your blood during training if you do not already know how.

Don't worry - you can do it! Consider this: you are the best person to feel the location of the needle. If you are uncomfortable with sticking yourself, or self-cannulating, your trained care partner may also be an option. Home dialysis programs have found that virtually everyone can learn, and you may actually prefer self-access after being trained.

Patients report that they are less anxious and have less discomfort when doing the access procedure themselves because they are in control. One patient said "It's like the difference between being a passenger and the driver of a car on a twisting mountain road. The passenger may feel uncomfortable or sick. As the driver, though, you are in control and you feel fine."

What help is available?

Your dialysis center is always there to support you. Additionally, NxStage resources are available 24/7 to support you and your dialysis center with any technical or equipment questions that might arise.

When doing home therapy, you will most likely visit your dialysis center at least once a month. They will also give you a number to call if you ever have questions about your therapy or your system.

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

How will I get my supplies?

Supplies for the System One and PureFlow SL are delivered once a month. NxStage Customer Service will work with you and your center so that the delivery schedule fits your needs.

On average, you will use one box of cartridges per week and, depending on your prescription, one to two boxes of PureFlow SL dialysate sacks per week.

NxStage has a lot of experience shipping supplies to remote residential locations and vacation spots. In the event of a natural disaster or other emergency situation, NxStage will ship supplies to your evacuation location.

 

Questions about traveling with the NxStage System One

Content is geared to United States customers.

Can I travel with the NxStage System One?

NxStage supports your travel plans, when approved by your physician and center. The NxStage System One is designed to be portable and taken with you when you travel. The PureFlow SL is not designed for travel, so you'll use premixed bagged dialysate when you travel.

Patients are responsible for transporting their System One cycler. Soft cases are available for personal travel, and hard cases are available for commercial travel.

For short trips, patients typically take supplies from home. For longer trips, NxStage can ship supplies to your destination (within the United States) if prescribed by your doctor. Your center can provide specific instructions on how to coordinate all travel plans. And, of course, NxStage technical support is available when you travel.

Can I travel outside of the United States with the NxStage System One?

Due to regulatory requirements, NxStage is only able to support travel within the United States. Unfortunately, NxStage cannot support international travel at this time.

 

Additional questions you might have

Content is geared to United States customers.

Where is the NxStage System One currently available?

NxStage System One therapy is offered by hundreds of dialysis centers across the United States. Find a center near you offering the NxStage System One.

Is System One available for sale to consumers?

No. The System One is a prescription device and is not sold directly to patients.

 

References related to health and quality of life benefits:

Less stress on the heart
Better blood pressure control with fewer medications
Much quicker recovery time after treatment
Improved appetite and the freedom to drink more
Fewer symptoms of depression
Better mental and physical health
More energy and vitality
  1. The FHN Trial Group. In-center hemodialysis six times per week versus three time per week. New England Journal of Medicine 2010; 363:2287-2300
  2. Weinhandl, E et al. Relative Mortality in Daily Home and Matched, Thrice-Weekly In-Center Hemodialysis Patients. Abstract Presentation at the 2011 National Kidney Foundation Spring Clinical Meeting.
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