US FDA grants 510(k) clearance to Fresenius Medical Care’s 5008X Hemodialysis System
Fresenius Medical Care (FME), the world's leading provider of products and services for individuals with renal diseases, announced the company has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s 5008X Hemodialysis System. Now the company wants to bring a new standard of care in dialysis therapy to people living with kidney diseases in the US.
“Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases,” says Helen Giza, CEO for Fresenius Medical Care AG. “The 5008X Hemodialysis 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.” Helen Giza says: “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.”
Dialysis is a life-saving treatment for people whose kidneys are failing and who can no longer naturally filter their blood in order to remove excess water, solutes, and toxins from the body. Unlike conventional high-flux haemodialysis, which primarily employs diffusion to remove small molecules and fluid from the blood, high-volume haemodiafiltration incorporates both diffusion and convection techniques to eliminate larger molecules and effectively manage fluid replacement through convection.
The results of the recently published groundbreaking CONVINCE study demonstrated that patients treated with high-volume haemodiafiltration experienced a remarkable 23% decrease in mortality rates compared to those treated with the more commonly used high-flux haemodialysis. This study was a multinational research study that compared these two types of haemodialysis techniques. It was a three-year trial performed at 61 dialysis centres in eight European countries.
Cleared for the start of US-based clinical evaluations and user studies ahead of a planned broad market launch in 2025, the 5008X Hemodialysis System is one of Fresenius Medical Care’s latest medical device innovations, capable of providing industry-leading, high-volume haemodiafiltration dialysis therapy. Along with the companion FX CorAL dialyzer - already registered in the US -, the 5008X Hemodialysis System combines the latest device engineering and cutting-edge membrane technologies required to make high-volume haemodiafiltration possible.
In the US there is currently an estimated installed base of around 160.000 in-centre haemodialysis machines across all service providers that could be replaced to adapt this new standard of care.
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.9 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,050 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 344,000 patients around the globe and is the leading provider of dialysis products such as dialysis machines and dialyzers.
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