Based on reduced mortality risk and slower decline in quality of life in patients treated with HVHDF compared to standard HD.
HDF is an advanced dialysis therapy that helps clean your blood when your kidneys stop working. It is similar to conventional hemodialysis (HD) and can effectively remove a wider range of waste and toxins from your blood.1
Studies show that when a sufficiently high volume of fluids is removed during HDF, patients tend to experience better clinical outcomes. This is known as HighVolumeHDF (HVHDF).1,b
HVHDF is delivered on a schedule that is very much like conventional HD. In most cases, patients receive HVHDF treatments 3 days per week, and in about the same amount of time. To fully benefit from HVHDF, it is important to complete the full treatment as prescribed by your physician.
b. The clinical studies showing the above potential outcomes with HVHDF were conducted outside of the United States and did not involve the 5008X CAREsystem. Patient experiences may vary when being treated with HVHDF therapy.
Compared to Conventional HDb
HDF is an advanced dialysis treatment and one of the fastest growing dialysis therapies around the world. When high volume is achieved in the HDF treatment, it can help you:
a. Based on reduced mortality risk and slower decline in quality of life in patients treated with HVHDF compared to standard HD.
b. The clinical studies showing the above potential outcomes with HVHDF were conducted outside of the United States and did not involve the 5008X CAREsystem. Patient experiences may vary when being treated with HVHDF therapy.
c. Not all studies show the same outcome and not all patients will experience the same benefit.
d. HDF patients in this study were younger and had fewer comorbidities.
Fresenius Medical Care is proud to introduce the 5008X CAREsystem, the first in-center dialysis device designed to perform HVHDF for patients in the United States. The 5008X CAREsystem allows your care team to provide advanced dialysis therapy.
To learn more about the 5008X CAREsystem, click here.
Learn more about HighVolumeHDF and the 5008X CAREsystem.
by Dr. Stefano Stuard
and Dr. Michael Anger
The clinics shown here use the 5008X CAREsystem for all or most of their in‑center machines.
I used to feel weak and wobbly after in-center hemodialysis—sometimes I’d lose my balance. Since switching to HDF with the 5008X CAREsystem, I’m steadier on my feet and recover faster after treatment.
Alexander
Patient
I felt a difference very soon after starting the hemodiafiltration (HDF) therapy. I achieved HighVolumeHDF in three weeks. I felt lighter and my energy came back quickly after treatment. I was coaching baseball again, leading outreach at church, and spending time with my kids without needing hours of rest. I even returned to fishing, working out, and doing things around the house. HighVolumeHDF helped me regain strength and independence.
Ronald
Patient
Before HighVolumeHDF, Ronnie used to be exhausted, frustrated, and sometimes I had to leave work to pick him up from the clinic because he couldn’t drive home. Since starting the new therapy, everything has changed. His recovery is quicker, his mood is better, and he is himself again. HighVolumeHDF has brought stability, energy, and peace back into our home.
Chris
Care Partner
Patient Ronald who is featured on this page is also a Patient Advocates who receives compensation from Fresenius Medical Care. Patient experiences may vary and not all patients will experience the same benefit.
References:
1. Blankestijn PJ, Vernooij RWM, Hockman C, et al; on behalf of the CONVINCE Scientific Committee Investigators. Effect of hemodiafiltration or hemodialysis on mortality in kidney failure. N Engl J Med. 2023;389(8):700-709. doi:10.1056/NEJMoa2304820
2. Rose M, Fischer FH, Liegl G, et al; on behalf of the CONVINCE Scientific Committee and CONVINCE Investigators. The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration. Kidney Int. 2024;106(5):961-971. doi:10.1016/j.kint.2024.07.014
3. Maduell F, Moreso F, Pons M, et al; on behalf of the ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013;24(3):487-497. doi:10.1681/ASN.2012080875
4. Rootjes PA, Chaara S, de Roij van Zuijdewijn CLM, Nubé MJ , Wijngaarden G, Grooteman MPC. High-volume hemodiafiltration and cool hemodialysis have a beneficial effect on intradialytic hemodynamics: a randomized cross-over trial of four intermittent dialysis strategies. Kidney Int Rep. 2022;7(9):1980-1990. doi:10.1016/j.ekir.2022.06.021
5. Karkar A, Abdelrahman M, Locatelli F. A randomized trial on health-related patient satisfaction level with high-efficiency online hemodiafiltration versus high-flux dialysis. Blood Purif. 2015;40(1):84-91. doi:10.1159/000381255
6. Nenova DD, Chausheva GM, Yankov YG. Online hemodiafiltration: a new perspective for patients with end-stage renal disease. Cureus. 2024;16(8):e66076. doi:10.7759/cureus.66076
7. Zhang Y, Winter A, Ficociello LH, et al. Real-world hospitalization outcomes with on-line hemodiafiltration versus high-flux hemodialysis: a retrospective, international cohort study. Clin J Am Soc Nephrol. Published online December 23, 2025. doi:10.2215/CJN.0000000955
Indications for Use:
Machine:
The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.
The 5008X Machine is equipped with a bibag® system, but it may also be used with liquid bicarbonate using the connector included with the machine. The bibag system is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag system is intended to be used as one component in the preparation of dialysate according to a physician’s prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.
The 5008X Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System. The optional CLiC system is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.
© 2026 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, 5008X, bibag, Crit-Line, and CLiC are trademarks for which Fresenius Medical Care AG holds rights. All other trademarks are the property of their respective owners.
D/N US-5008X-000036 Rev B 07/2026
© 2026 Fresenius Medical Care. All Rights Reserved.
© 2026 Fresenius Medical Care. All Rights Reserved.