Fresenius Medical Care recently announced via press release that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new 5008X haemodialysis system, which they hope will allow them to “bring a new standard of care in dialysis therapy to people living with kidney disease in the USA”.
This new product, Fresenius states, will differ from conventional high-flux haemodialysis by incorporating both diffusion and convection techniques to “eliminate larger molecules and effectively manage fluid replacement through convection” that are already widely used in Europe.
Results from the CONVICE study—a three-year, multinational research study conducted in eight European countries that compared these two types of haemodialysis techniques—that were recently published in the New England Journal of Medicine (NEJM) have demonstrated that patients treated with high-volume haemodiafiltration experienced a 23% decrease in mortality rates when compared to those treated with the more commonly used high-flux haemodialysis.
Fresenius states that, in the USA, there are currently an estimated 160,000 in-centre haemodialysis machines across all service providers that could be replaced to adapt to this “new standard of care”.
Commenting on this announcement, Fresenius Medical Care chief executive officer (CEO) Helen Giza stated that “making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases. The 5008X haemodialysis system demonstrates our company’s ability to innovate at scale. This innovation builds on the proven track record of our haemodialysis system series in Europe, Latin America and Asia Pacific.” Giza added: “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 healthcare markets, where there is significant opportunity to make meaningful impact”.
