FAQs

Frequently Asked Questions

Questions about the NxStage® System One™
Questions about daily home dialysis and other therapies
Questions about using the NxStage® System One™
Questions about traveling with the NxStage® System One™
Additional questions

Questions about the NxStage® System One™

What is the NxStage® System One™?
The NxStage System One is the first 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?
Home dialysis is recognized as the most cost- and resource-efficient method of providing dialysis therapy to people with end stage renal disease (ESRD). Yet today, home dialysis has been limited to only 10 percent of kidney failure patients, virtually all of whom are performing peritoneal dialysis.  Current alternatives, as prescribed today, are unlikely to grow home dialysis therapy. Traditional hemodialysis equipment has been designed for use in outpatient dialysis clinics, and is not designed for the home setting. Peritoneal dialysis has historically provided the most viable home dialysis alternative, but utilization of this therapy has not grown in recent years.

There is also developing interest in more frequent dialysis (5 or more times weekly). Hundreds of published articles support that daily hemodialysis is healthier and less physically draining than conventional three-times-a-week treatment. Unfortunately, practical limitations of more frequent in-center therapy, including the inconvenience of traveling to and from the dialysis center on a nearly daily basis, have limited adoption of this promising treatment alternative. These limitations are reduced significantly in the home setting. Increased adoption of home hemodialysis may, therefore, also stimulate broader adoption of more frequent therapy, and thereby enable improved clinical outcomes for more ESRD patients. 

The NxStage System One’s prescription flexibility and simple set-up and take-down make it well-suited for more frequent therapies.

How does the NxStage System One work?
The NxStage System One delivers hemodialysis therapy. It uses a small control unit (“cycler”), a daily blood filter and tubing set (“cartridge”) and bags of sterile fluid (“dialysate”). For each treatment, the cartridge tubing is attached to the patient’s blood access. Blood and dialysate pass through the cartridge dialyzer to clean the blood. Used dialysate, wastes, and excess fluids removed from the blood pass through the cartridge, and then run into a drain. Therapy is complete when the bags the patient hangs are empty. Daily supplies are thrown away and the patient simply wipes down the machine after use.

How much physical space does the NxStage System One occupy?
The NxStage System One cycler measures approximately 15 inches high by 15 inches wide by 18 inches deep (about the same size as a 13-inch TV set).  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.  Some storage space is required for the cartridges and bags of fluid that the patient will use for their treatments.  

Can the NxStage System One also be used in hospitals and dialysis centers?
Yes. The System One can be, and has been, prescribed in hospitals and dialysis clinics, as well as the home. In all settings, the System One has been designed with the simplicity and functionality to ease the burdens of training, operations, and maintenance commonly associated with traditional equipment.

Questions about daily home dialysis and other therapies

What benefits are associated with more frequent hemodialysis?
A naturally functioning kidney works around the clock. The most common form of hemodialysis, called “intermittent” dialysis, is performed three times per week, approximately 4 hours per session. Because of the number of days (2-3) between treatments, intermittent dialysis can lead to large fluctuations in body weight (due to water retention), accumulation of wastes generated by your metabolism, and electrolyte balance. Some have proposed that this “unphysiology” drives many of the ill effects of traditional intermittent therapy: hypertension, anemia and general decline in well-being. By reducing the time between treatments, daily dialysis can reduce these wide fluctuations. As a result, it is often gentler on the patient’s body and may lead to meaningful clinical benefits.

Will patients feel different with daily therapy?
Many doctors have published on the long-term benefits reported by their patients on daily dialysis, even before the NxStage System One was available. They have reported that daily dialysis has helped their patients stay healthier. Specific benefits they report include:

• Reduced strain on the heart (left ventricular hypertrophy) and fluid overload
• Improved blood pressure control
• Improved anemia control with lower medications
• Reduced amyloid disease (carpal tunnel syndrome and joint disorders)
• Improved phosphorous control, particularly with longer therapies
• Improved nutritional status
• Improved qualify of life

The NxStage System One has helped make doing daily home hemodialysis more accessible for many patients.  Note that daily therapy may not be for everyone. Patients  should consult with their doctor, center and partner to see what is right for them.

What’s the difference between daily, home-based treatment with NxStage Therapy and daily, home-based treatment with peritoneal dialysis?
NxStage Therapy is a portable and less complicated application of hemodialysis, which uses an external filter to remove waste products directly from the patient’s blood. In contrast, peritoneal dialysis involves the catheter-based delivery of a solution into an abdominal membrane called the peritoneum that is rich in blood vessels and acts as a filter to eliminate toxins and excess fluid from a patient’s blood. Patient treatment with peritoneal dialysis is less common than conventional hemodialysis, because of some of the clinical and practical limitations of the therapy. However its simplicity and portability has allowed great flexibility in how and where therapy is delivered, with nearly all peritoneal dialysis patients choosing to treat themselves at home.

NxStage Therapy unites the distinctive benefits of hemodialysis and peritoneal dialysis into a single, unique system, intended to expand home treatment options for patients.

Questions about using the NxStage® System One™

Is it easy to learn how to operate the NxStage System One?
The System One is designed to be simple. Physicians and staff at dialysis centers using the System One work with patients and their caregivers to ensure that they are optimally trained in the proper use of the system. In the NxStage clinical trial, approximately three weeks were required on average for patient/partner training. While professional nursing assistance is not required to use the System One, a patient should not dialyze alone, regardless of whether they are "trained and qualified".

Can a patient learn and use the NxStage System One on their own? 
NxStage requires that patients using the system have a dedicated partner who is trained to use the system along with the patient.  Often, the patient will do all or nearly all of the steps needed to use and maintain the system, but the partner should always be present to help out with the system or with any alarms or hazards, or in case of any health emergency. 

What types of vascular access can be used with the NxStage System One?
The NxStage System One can be used with any type of vascular access, including arteriovenous fistula (AVF), synthetic graft, or catheter.  Patients who use the system with an AVF or graft are taught in their training how to insert the dialysis needles into their AVF or graft.  Many have found that, once they get accustomed to it, which takes just a few times, they actually prefer placing their own needles because they prefer the consistency of doing it themselves and because they know they are in control.

Is the NxStage System sanitary and easy to maintain?
The NxStage System One is designed for ease of maintenance. It eliminates the plumbing and electrical infrastructure, water processing, and disinfection needs associated with conventional hemodialysis equipment. A physician prescribes the number of bags of dialysate to deliver, and empty bags as well as  the daily disposable cartridge are simply thrown away when treatment is concluded. The cycler is designed to be simply wiped clean at the end of treatment.

Questions about traveling with the NxStage® System One™

What type of travel can a patient do with the NxStage System One, and how would they go about it?
For shorter car trips (of 4 days or less), the cycler can be loaded in the car (patients should always have their partner help them lift the 75-pound cycler), and supplies should be taken from home.  For longer car trips, NxStage can ship supplies to the travel destination if prescribed by the patient’s doctor.  The patient is still responsible for transporting the cycler.  Many centers have obtained soft-sided rolling cases from NxStage for their patients to use for car travel. 

Airline travel with the System One is possible and has been done by a number of patients, but is more challenging and takes good preparation.  For commercial transport, patients can use the original System One shipping box. Prototype hard shipping cases are currently in development. NxStage is working with its centers and with travel providers to continue to simplify air travel with the NxStage System One.  Patients should contact their center for specific instructions for airline travel. 

Can a patient travel outside of the United States with the NxStage System One?
At this time, NxStage is only selling and supporting the System One in the United States, so travel with the System One must be kept within the United States. 

How easy is it to move the system around?
The NxStage cycler weighs approximately 75 pounds. Patients should always have their partner help them lift the 75-pound cycler when moving it (loading it into a car, etc.).  NxStage offers a soft-sided, durable travel bag with sturdy nylon handles, wheels, and a pop-up handle, which can be purchased and used for personal travel. For commercial transport, patients can use the original System One shipping box. Prototype hard shipping cases are currently in development.

Learn more about traveling with the NxStage System One.

Additional Questions

Is treatment with NxStage System One covered by Medicare?
Yes. dialysis therapy is covered by Medicare under the composite rate as part of the Medicare End Stage Renal Disease program.

Where is the NxStage System One currently available?
NxStage System One therapy is offered by a number of partnering hospitals and dialysis centers across the United States. NxStage  is currently expanding the number of locations and centers that offer the System One, so that it can become more available to physicians and their patients. In addition to FDA clearance, NxStage currently has its CE Mark and Health Canada licenses for the System One and other accessories, but is not presently marketing devices in Europe or Canada.

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. 

What clinical studies have been conducted with the System?
From February 2004 through November 2004, a study was conducted to determine whether or not delivery of hemodialysis with the NxStage System One in the home and in-center settings is equivalent on a per-treatment basis. The protocol for this study was approved by the United States Food and Drug Administration (FDA) as an Investigational Device Exemption (IDE) study. The study was conducted at 6 centers. 32 patients were enrolled, and 25 patients completed the study. During the formal clinical trial, approximately 2,200 treatments were administered. The study concluded that hemodialysis with the System One was equivalent on a per-treatment basis in the home and in-center settings. This means that the study showed that using the NxStage system for daily treatments in the home setting was as safe and effective as using it for daily treatments in the clinic setting.

After completing this study, NxStage compared the clinical results of 26 eligible patients using the System One with their clinical results in the period prior to using the System One, when they were using traditional in-center thrice-weekly treatments.  The findings from this study will be published soon.

NxStage is currently beginning to enroll patients in its FREEDOM (Following Rehabiltation, Economic, and Everyday Dialysis Outcome Measurements) study. This study is intended to determine the level of benefit of more frequent home hemodialysis with the NxStage System One in the areas of clinical outcomes and health system cost savings.

For more information on published clinical literature regarding more frequent home hemodialysis, and on ongoing research, go to Published Literature  in the Chronic Renal Care Community section of site.

NxStage plans to conduct further clinical studies with the NxStage System One.  Please check our website for announcements about when such studies are begun and published.