FDA clears Fresenius Medical Care high-volume hemodiafiltration system for US trials
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Key takeaways:
- The device offers high-volume hemodiafiltration using diffusion and convection.
- The FDA clearance comes after results of the multinational research CONVINCE study.
Fresenius Medical Care has received FDA 510(k) clearance for its 5008X Hemodialysis System, allowing for the start of U.S.-based clinical trials, according to a press release.
The medical device is designated for adults with renal disease and offers high-volume hemodiafiltration using diffusion and convection techniques to remove molecules from the blood and manage fluid replacement. It works jointly with the company’s companion FX CorAL dialyzer for novel engineering and membrane technology.
“Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases,” Helen Giza, CEO of Fresenius Medical Care AG, said in the release. “The 5008X Hemodialysis System demonstrates our company's ability to innovate at scale.”
The FDA clearance comes after results of the CONVINCE study showed that patients treated with high-volume hemodiafiltration had a 23% decrease in mortality compared with patients treated with high-flux hemodialysis. The 3-year trial was performed at 61 dialysis centers in eight European countries.
According to the release, the clearance opens a pathway for U.S.-based clinical evaluations and user-studies for high-volume hemodiafiltration, which is widely used in Europe, ahead of a planned broad market launch for the 5008X Hemodialysis System in 2025.
“This innovation builds on the proven track record of our hemodialysis system series in Europe, Latin America and Asia Pacific,” Giza said. “We’re pleased to achieve this important milestone to bring a new standard of care in dialysis therapy to one of the world's largest health care markets, where there is significant opportunity to make meaningful impact.”
There is currently an estimated installed base of around 160,000 in-center hemodialysis machines across U.S. service providers that could be replaced to offer adults with kidney disease a new standard of care, according to the press release.
References:
Blankestijn P, et al. NEJM. 2023;doi:10.1056/NEJMoa2304820.
Fresenius Medical care brings industry-leading dialysis therapy to kidney disease patients in the U.S., demonstrating global leadership in medical device and membrane engineering technologies. https://www.freseniusmedicalcare.com/en/news/industry-leading-dialysis-therapy-us. Published Feb. 8, 2024. Accessed Feb. 8, 2023.
Editor’s note: The headline of this article was updated on March 7, 2024, to represent the legal structure of Fresenius Medical Care. The editors regret the error.
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