- Fresenius Medical Care has received 510(k) clearance for its high-volume hemodiafiltration dialysis therapy system, the company said Thursday.
- The device, the 5008X Hemodialysis System, uses both diffusion and convection to remove waste products from the blood of kidney disease patients. Using diffusion, the standard mechanism for hemodialysis, and convection is intended to improve the removal of larger waste products.
- Fresenius plans to start a broad market launch next year and push to establish hemodiafiltration, which is already widely used in Europe, as the new standard of care in the U.S.
Hemodiafiltration has existed since at least the early 1970s and has been linked to benefits including better cardiovascular stability and improved clearance of certain molecules. Fresenius added to the evidence 10 years ago with a clinical trial that reported a 30% reduced risk of all-cause mortality in people treated with hemodiafiltration.
Use of the technique varies by geography. In 2017, more than one-quarter of hemodialysis patients were on hemodiafiltration in Europe, compared with less than 1% of their counterparts in North America. The difference reflects regulatory barriers and the lack of hemodiafiltration machines in the U.S.
Clearance of Fresenius’ 5008X by the Food and Drug Administration removes one of the barriers. The FDA clearance follows the publication of data from a study funded by the European Union. Investigators at 61 dialysis centers in eight European countries randomized 1,360 kidney failure patients to receive high-dose hemodiafiltration or high-flux hemodialysis.
After a median follow up of 30 months, the rate of death from any cause was 17.3% in the hemodiafiltration group and 21.9% in the hemodialysis arm. Hemodiafiltration was statistically no better than hemodialysis on secondary endpoints that looked at fatal and non-fatal cardiovascular event rates.
Fresenius sees hemodiafiltration as the new standard of care and has created a strategy for converting U.S. sites, which it estimates have 160,000 in-center hemodialysis machines, to the technology. The company plans to run U.S.-based clinical evaluations and user studies this year ahead of a broad market launch in 2025. Sales at Fresenius’ care enablement unit, which sells devices, fell 3% in the third quarter.
The experience of regions with a longer history of hemodiafiltration show the approach is only suitable for some patients. In the U.K., healthcare providers restrict use of the technique to patients who have good vascular access and are free from heart conditions that limit pump speed.