Another company has entered the home hemodialysis sector and, taking that use even further, is putting its technology on wheels and over the road.

NxStage Medical (Lawrence, Massachusetts) this week reported receiving expanded 510(k) clearance from the FDA for its System One portable daily hemodialysis device for home use.

Weighing in at about 70 pounds and easily movable with a wheeled cart to a van, SUV or other vehicle, System One, backed by the support of a “trained partner,” enables a person on dialysis to visit far-away family, pursue RV-style travel, even take a cruise.

NxStage bills System One as the smallest commercial hemodialysis system now available, and the expanded 510(k) means the company now can grow its market beyond the hospital sector to dialysis clinics – and their patients who can manage their own dialysis at home.

With a footprint somewhat like a early stage personal computer, System One also features a reduced and simplified infrastructure to provide the patient mobility that NxStage will focus on in its marketing.

Joe Turk, senior vice president for NxStage, noted that the system’s ability to be moved from place to place received its first elaboration and demonstration in hospital care sites “where it is really important to be portable, to take the machine and fluids [necessary] to the bedside.” That portability also is enhanced by use of standard electricity and water, he told Medical Device Daily, essentially allowing a sort of plug-and-play use.

That portability he pits against the home dialysis system from Aksys (Lincolnshire, Illinois), a breakthrough home dialysis system approved by the FDA in 2002 (Medical Device Daily, April 2, 2002), but refrigerator-sized and weighing in at hundreds of pounds, hardly mobile (see sidebar).

Agency approval for hospital use for System One was granted in 2003, but Jeffrey Burbank, president and CEO of NxStage, told MDD that “the company was built on the idea of servicing both markets, and it was just most appropriate to go to the hospital first.”

The target market for the expanded use is dialysis clinics, Burbank says, which is those clinics identifying patients who can be trained on the machine, with NxStage providing supportive marketing programs.

Setting such patients up on home dialysis increases the number of patients these clinics can serve without expanding their own capacity and, for the future, will be a way of handling the increasing numbers who will require dialysis – unfortunately growing, Burbank estimates, at a rate of 6% annually, but offering large potential for NxStage.

As a small private company, NxStage declines giving out specific unit figures, but Burbank cites strong relationships with a group of selected hospitals using the system, which he describes as “top institutions.” And it now is working with selected dialysis clinics during initial product rollout.

He says it then “progressively” will broaden “geographic access” to System One for wider availability.

A key role for a clinic deploying System One is patient training.

From two to three weeks is needed to train a patient in the system’s use before beginning home operation. Additionally, a “trained partner” who will work with the patient must receive a level of what Turk calls “trouble-shooting” instruction in cases where problems may arise.

Turk notes that this partner does not have to be a clinician but can be a lay person, such as a family member, “that the patient can rely on to provide support if there’s a need to intervene.”

Burbank is quick to acknowledge that the training required and the ability of the patient to use the system in a self-managed mode is perhaps the primary barrier to up-take for System One.

“We don’t believe that every dialysis patient makes a good home patient,” he says. “Some patients may choose not to take on that level of responsibility, some may not be able to be accomplished with the system.”

But, he adds: “This is a significant option for a significant portion of patients – that’s how I characterize the opportunity.”

Citing an estimated 1.2 million dialysis patients worldwide and 330,000 in the U.S., Burbank puts 25% to 30% of those in the U.S. – around 100,000 or so – as candidates for “self-therapy” using System One.

Typically, the physician prescribes a dialysis regimen for System One use of 2-1/2 hours a day, six days a week, and thus – also typically – requiring check-ups at a dialysis clinic about once a month.

This compares to the regimen of in-clinic dialysis three times a week, with three- to four-hour treatments, and the related logistical headaches.

Overall, the more frequent home dialysis, he adds, is supported by increasing evidence for the effectiveness of more continuous treatment in a sector marked by a high rate of fatality among end-stage patients.

The company said that the clearance was based on a “formal” clinical study comparing center-based and home-based daily hemodialysis with System One, representing more than 2,200 patient treatments. The study showed that hemodialysis at home with System One is equivalent, on a per-treatment basis, to in-center treatment.

Michael Kraus, MD, clinical director of home and acute dialysis at the Indiana University School of Medicine/ Clarian Health Partners (Indianapolis) and principal investigator in the clinical trial, said, “Making daily, home-based hemodialysis easier and more flexible presents a tremendous opportunity to improve care for patients. Patients who convert to daily hemodialysis usually show more stable blood pressure, increased appetites and lower anemia rates.”

Citing System One’s “simplicity” as well as portability, he said that it “breaks new ground” and “can make daily hemodialysis more appealing and practical for a larger number of patients.”

As with other treatments for end-stage renal disease, System One is covered by Medicare, NxStage notes.

Besides the home dialysis systems from NxStage and Aksys, National Quality Care (Los Angeles) last year reported the development of a “wearable artificial kidney,” unnamed but dubbed WAK (MDD, Nov. 19, 2004). Introduced at the annual meeting of the American Society of Nephrology (Washington) as an alternative or augmentation to regular dialysis treatments, the device weighs less than 5 pounds, is a belt-worn device and would operate 24/7, powered by six AAA batteries.

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