FDA clears NxStage device for 'nocturnal hemodialysis' in another victory for home healthcare

The System One hemodialysis system--Courtesy of NxStage

Home healthcare is a buzzphrase these days, and with good justification, including the aging population and a growing focus on cost-cutting within the healthcare system. Medical device companies are responding in kind. In the latest example, NxStage Medical won an expanded indication from the FDA for overnight home use of its System One hemodialysis system.

The company brags that the product for end-stage renal disease "is the only truly portable hemodialysis system cleared for home use," and now says the new clearance enabling "nocturnal hemodialysis" will result in longer and more convenient therapy, giving patients more flexibility in dialysis dose and schedule.

"For years, patients and physicians in the United States have been asking for an FDA-cleared home nocturnal hemodialysis option for the improved outcomes and quality of life the modality can deliver," said Dr. Brigitte Schiller, chief medical officer of Satellite Healthcare and principal investigator of NxStage's home nocturnal hemodialysis trial, in a statement. "I, along with my fellow investigators in this trailblazing trial, am pleased that we were able to demonstrate the NxStage System One can safely and effectively deliver this important treatment option."

The company sponsored a trial using System One in the home setting to determine whether so-called nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, according to ClinicalTrials.Gov. A company spokeswoman said in an email that NxStage submitted the data to the FDA for review in August 2014.

According to the release, the company will conduct a full U.S. market launch to promote overnight use of the product in 2015. System One is also CE-marked for this in Europe, the company says.

In November, NxStage launched the Streamline Express dialyzer for in-center use to reduce machine setup time and potential sites for contamination, but its real bread-and butter-business is the home dialyzer business, which the company expects to bring in about $150 million this year.

Home healthcare presents unique and well-documented patient safety challenges. To that end, NxStage's Hemodialysis at Home initiative is lobbying Medicare for reimbursement to support home hemodialysis training. Without it, "patients may continue to be deprived access to home hemodialysis" the company says.

In 2004, more than 7 million patients received home healthcare annually, the FDA says, and that number has surely increased since then.

- read the release
- here's a link to the clearance in the FDA database

Related Articles:
NxStage launches faster, easier dialyzer for in-center market
NxStage narrows loss in Q2 with record revenue
FDA publishes its warning letter to Baxter over home dialysis and infusion devices
Home healthcare design considerations addressed in FDA final guidance

Suggested Articles

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients.

OR-focused AI provider Caresyntax has garnered $45.6 million in new funding and picked up a data analytics firm to broaden its footprint.

A study of Foundation Medicine’s FoundationOne liquid biopsy test found it was able to predict the risk that a person’s breast cancer would return.