Fresenius Medical Care Initiates Expanded U.S. Rollout of 5008X™ CAREsystem for Kidney Disease Treatment
Fresenius Medical Care, recognized globally as the premier provider of renal disease solutions, is poised to make significant advancements in the treatment of kidney disease across the U.S. The company has recently secured FDA 510(k) clearance for an upgraded version of its innovative 5008X CAREsystem, which features high-volume hemodiafiltration (HVHDF) capabilities. This notable development is a key part of the company’s strategy to introduce leading-edge dialysis therapy to American patients over the course of 2026.
The updated 5008X CAREsystem will facilitate the delivery of high-volume hemodiafiltration, a dialysis modality that has already set a standard of care in various territories including Europe and Latin America. Helen Giza, CEO of Fresenius Medical Care AG, stated, "The FDA clearance of our enhanced 5008X CAREsystem is pivotal in our commitment to elevate the quality of life for patients with kidney disease. This system represents a turning point, as we aim to redefine the landscape of kidney care in the U.S."
Building on previous approvals, the updated system features Fresenius’ Clinical Data Exchange® (CDX). This cutting-edge technology ensures seamless, one-touch access to a provider's medical information systems directly at the patient’s chair, eliminating the need for cumbersome computer stations while optimizing clinic operations and minimizing contamination risks. This advancement not only improves the workflow within clinical settings but also enhances patient safety through greater efficiency.
Beginning later this year, Fresenius plans to roll out hemodiafiltration therapy in select clinics as part of this phased implementation. With approximately 160,000 hemodialysis machines in current use across the U.S., the transition to this advanced therapy will represent a major shift in standard care practices.
The 5008X CAREsystem stands at the forefront of innovation, collaborating with the companion FX CorAL® dialyzer, which has met regulatory standards as well. These dual systems leverage advanced engineering principles and state-of-the-art membrane technology to provide effective high-volume hemodiafiltration. Supported by extensive clinical research, including the groundbreaking CONVINCE* study funded by the European Union, evidence shows that patients receiving high-volume hemodiafiltration have demonstrated remarkable medical outcomes, including a 23% lower mortality rate compared to standard high-flux hemodialysis.
Fresenius Medical Care operates a total of 3,674 dialysis clinics worldwide, catering to nearly 299,000 patients. The introduction of the 5008X CAREsystem is structured in a way that reflects both the demands of recent studies and the company's comprehensive understanding of dialysis therapy, underscoring its commitment to innovation, patient-centric care, and continuous improvement. As Fresenius Medical Care lays out plans for widespread implementation across the country, the company reiterates its pledge to establishing new benchmarks in the treatment and management of kidney diseases. This initiative not only aims at enhancing standards but also at ensuring that millions of patients receive the best possible care.
For further details on Fresenius Medical Care and its innovative products, visit their official website at www.freseniusmedicalcare.com.
The updated 5008X CAREsystem will facilitate the delivery of high-volume hemodiafiltration, a dialysis modality that has already set a standard of care in various territories including Europe and Latin America. Helen Giza, CEO of Fresenius Medical Care AG, stated, "The FDA clearance of our enhanced 5008X CAREsystem is pivotal in our commitment to elevate the quality of life for patients with kidney disease. This system represents a turning point, as we aim to redefine the landscape of kidney care in the U.S."
Building on previous approvals, the updated system features Fresenius’ Clinical Data Exchange® (CDX). This cutting-edge technology ensures seamless, one-touch access to a provider's medical information systems directly at the patient’s chair, eliminating the need for cumbersome computer stations while optimizing clinic operations and minimizing contamination risks. This advancement not only improves the workflow within clinical settings but also enhances patient safety through greater efficiency.
Beginning later this year, Fresenius plans to roll out hemodiafiltration therapy in select clinics as part of this phased implementation. With approximately 160,000 hemodialysis machines in current use across the U.S., the transition to this advanced therapy will represent a major shift in standard care practices.
The 5008X CAREsystem stands at the forefront of innovation, collaborating with the companion FX CorAL® dialyzer, which has met regulatory standards as well. These dual systems leverage advanced engineering principles and state-of-the-art membrane technology to provide effective high-volume hemodiafiltration. Supported by extensive clinical research, including the groundbreaking CONVINCE* study funded by the European Union, evidence shows that patients receiving high-volume hemodiafiltration have demonstrated remarkable medical outcomes, including a 23% lower mortality rate compared to standard high-flux hemodialysis.
Fresenius Medical Care operates a total of 3,674 dialysis clinics worldwide, catering to nearly 299,000 patients. The introduction of the 5008X CAREsystem is structured in a way that reflects both the demands of recent studies and the company's comprehensive understanding of dialysis therapy, underscoring its commitment to innovation, patient-centric care, and continuous improvement. As Fresenius Medical Care lays out plans for widespread implementation across the country, the company reiterates its pledge to establishing new benchmarks in the treatment and management of kidney diseases. This initiative not only aims at enhancing standards but also at ensuring that millions of patients receive the best possible care.
For further details on Fresenius Medical Care and its innovative products, visit their official website at www.freseniusmedicalcare.com.
Topics Health）
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