Quanta submits 510(k) application for use of its dialysis machine for treatment at home
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Key takeaways:
- Quanta has submitted a 510(k) premarket notification to the FDA for use of its dialysis machine in the home.
- Patients in the Home Run trial were treated four times a week at home for 3.5 hours.
Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for an expanded indication of its dialysis machine to include home hemodialysis.
The dialysis machine has been approved by the FDA for use in chronic and acute care settings and has received CE approval for use in the home in the United Kingdom and other countries, including nocturnal home hemodialysis.
“We have over 100 patients using the Quanta machine for home hemodialysis in the U.K. currently,” Paul Komenda, MD, FRCPC, MHA, FACP, chief medical officer for Quanta, told Healio. “A significant number of those patients have been using the machine successfully for over 18 months with a very low drop off rate.”
If approved by the FDA, the system would be the third device in the United States indicated for home hemodialysis for patients with end-stage kidney disease, following approval of dialysis machines from NxStage Medical in 2005 and from Outset Medical in 2020 for home use.
“The FDA submission for in-home use of the Quanta Dialysis System represents a significant milestone for Quanta in our journey to make dialysis more accessible to every patient in every setting,” Alejandro Galindo, Quanta CEO, said in a press release. “The Quanta Dialysis System is already providing patients in the U.K. with the freedom and flexibility that [home hemodialysis] HHD offers. With clearance of this 510(k), patients in the U.S. will have more control over their care and choice in where, when and how they receive treatment.”
Quanta, headquartered in Beverley, Massachusetts, said in the release that FDA clearance for the expanded indication is expected in 2024.
The 510(K) submission is supported by clinical data from the Home Run study, a company-sponsored multicenter, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for HHD. Komenda told Healio that the trial had been delayed because of the pandemic and “didn’t really start until April 2022” with 13 sites around the country. Patients had to be on 90 days of dialysis prior to the trial and many were previously not on HHD. “The FDA did allow us to include patients who had been on [peritoneal dialysis] PD,” Komenda said.
Patients selected for the trial were given up to 8 weeks for training and were treated in-center before transitioning to a home setting. For in-center care, patients received dialysis 4 hours per session, three times a week.
Patients then transitioned home for 8 weeks of treatment, and the prescription was modified to 4 days a week for 3.5 hours.
“Our endpoints of the trials were measured Kt/Vs and we looked at adverse event rates in addition to a host of other outcomes,” he said. “Based on the outcomes, we felt confident in submitting our 510(k) application to the FDA,” he said.
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