NxStage Medical (NSDQ:NXTM) said today it won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours.
The system won initial clearance in 2005 and added clearance for home nocturnal hemodialysis in 2014, the Lawrence, Mass.-based company said, but has always required a care partner be present during hemodialysis.
“Patients have been asking for an FDA-cleared solo option for years,. Many patients have been turned away from home hemodialysis simply because they did not have a care partner. The ability to train and treat solo provides a broader patient base with access to the clinical and quality of life benefits associated with home hemodialysis,” chief medical officer Dr. Allan Collins said in a prepared statement.
NxStage Medical said it is working to implement additional patient training for the indication this year and into next year, and that patients should speak to their nephrologist and care teams to learn both the risks and benefits of solo home hemodialysis.
“We are thrilled with this milestone achievement. Our interaction with the FDA 1st began at a patient preference workshop followed by regular dialogue throughout the pre-submission and submission processes. The solo home hemodialysis clearance makes NxStage the 1st company to formally conduct a patient preference study leading to a label expansion,” QA, regulatory & clinical affairs senior VP Todd Snell said in prepared remarks.
“With much credit to our decade long history in the home, we continue to do amazing things for dialysis patients. As a company, we are incredibly passionate about providing patients with as much freedom and flexibility as possible to do their dialysis therapy when they want and where they want, day or night. This expanded indication for solo therapy is another significant step forward for patients,” prez Joe Turk said in a press release.
Earlier this month, Fresenius Medical Care (NYSE:FMS; ETR:FRE) said it agreed to pay $2 billion to acquire NxStage Medical and the carlisle pa home health care technology developed.
