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*HD helps to clean your blood if your kidneys are failing or no longer work. It can remove waste, toxins, and extra fluids from your body. If you need HD, it can help to balance electrolytes.
†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.
Potential Benefits of HighVolumeHDF Therapy
Compared to Conventional HD
The opportunity for patients to live longer and feel better1*
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 patients:
LIVE LONGER1†
Lower risk of death by up to 23%, based on a recent large-scale study
PRESERVE QUALITY OF LIFE1,2
- Slower decline in cognitive and physical functions
- Extended ability for social participation
- Reduced interference with daily activities due to pain
MAINTAIN STABLE BLOOD PRESSURE3,4‡§
HVHDF may help patients have fewer blood pressure drops during dialysis
IMPROVE RECOVERY TIME5,6§
Some patients may experience less postdialysis fatigue and shorter postdialysis recovery time with HVHDF
LOWER RISK OF HOSPITAL STAYS3,7§
HVHDF may lower the chances of going to the hospital due to infections or heart-related complications
*Based on reduced mortality risk and slower decline in quality of life in patients treated with HVHDF compared to standard HD.
†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.
‡HDF patients in this study were younger and had fewer comorbidities.
§Not all studies show the same outcome and not all patients will experience the same benefit.
What Is the 5008X CAREsystem?
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.
- First device in the United States that can do both conventional HD and HVHDF
- Smart alarm technology to reduce noise
- Intelligent technology customized to your individual needs
To learn more about the 5008X CAREsystem, click here.
I used to feel weak and wobbly after in-center hemodialysis—sometimes I’d lose my balance. Since switching to the new therapy on the new device, I’m steadier on my feet and recover faster after treatment.
Alexander
Patient
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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 A 04/2026