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HighVolumeHDF with Ģý as your partner

HighVolumeHDF isFreseniusMedicalCare

We want to makeᾱմDZܳHDF available for all patients. We are committed to supporting you foraseamless and reliable implementation with our specializedHighVolumeHDF product line and with dedicated support from our experts;
so that it feels likejust pushing a button.

Efficient and environmentally sustainable use of resources

Percentage has been obtained from an internal calculation based on average treatment factors and at an Autoflow factor 1.2

Explore budget saving options, thanks to the ONLINEplustechnology with dialysate savings features.

ճ5008 CorDiax seriesԻ6008 CAREsystemare equipped with the ONLINEplustechnology, eliminating further requirements for the preparation and infusion of substitution fluid.

  • AutoFlow automatically adjusts the dialysate flow rate to the effective blood flow rate during treatment
    • Savings can be substantial for water, wastewater, concentrates, and energy, leading to cost reduction1,2
  • EcoFlow reduces dialysate and energy consumption during preparation and after reinfusion

1 Mesic E, et al. Dialysate saving by automated control of flow rates: comparison between individualized online hemodiafiltration and standard hemodialysis. Hemodialysis International. 2011;15(4):522 9.
2 KultJ, StapfE. Changing emphasis in modern hemodialysis therapies: cost effectiveness of delivering higher doses of dialysis. The International Journal of Artificial Organs. 2007;30(7):577 82

Percentage has been obtained from an internal calculation based on average treatment factors and at an Autoflow factor 1.2

Watch the video to learn more about these features:

Online production of substitution fluid makesHighVolumeHDF easy and efficient

  • The preparation of sterile, non-pyrogenic and bicarbonate-buffered substitution fluid forHighVolumeHDF by ONLINEplustechnology is based on a double-stage filtration process via DIASAFE®plusdialysis fluid filters and offers:
    • No extra costs for an additional single-use filter
    • No need for ready-made rinse solutions for priming, bolus or reinfusion with ONLINE fluid in all treatment modes
    • Extensive amounts of substitution fluid for HDF available
    • No waste bag needed due to rinse port
  • The water quality forHighVolumeHDF has to meet the same international standards (ISO 23500-5) as for high-flux HD
    • Ģý offers easy and reliable water quality management as part of a complete therapeutic system forHighVolumeHDF Ģý technically advanced, affordable and sustainable

Do it for your patients:Just push the button.

HighVolumeHDF Ģý The clinical & economic value

Advanced and still cost-effective

Lower overall treatment costs compared to high-flux HD

The main drivers of dialysis-related treatment costs are, in addition to direct procedure costs,hospitalisation, erythropoietin (EPO) and phosphate binder usage.10,11

In an economically tight environment, every opportunity to reduce the overall treatment cost should be examined. A high hospitalisation rate not only impacts patients' quality of life but is the most expensive form of medical care in every healthcare system.
Based on the ESHOL data, HighVolumeHDFhas the potential to significantly reduce hospitalisation rates and hypotensive episodes.8Some studies suggest that anemia correction may be facilitated in HDF-treated patients.7,10,11Studies showed superior phosphate removal with HDF compared to standard HD, which may also result in better control of the phosphate level in the long term.10,28Thus, higher quality of care has the potential to be provided at a lower medication burden and medication cost.

HighVolumeHDF Ģý The clinical & economic value

NICE(The National Institute for Health and Care Excellence) states thatin-center HDF should be considered rather than in-center HD1,12

As per the NICE guidelines, it is suggested that HDF may have mortality benefits compared to standard HD and is cost-effective.15

win

win

win

Payer

Delivering HD therapy in a cost-efficient and sustainable way

Patient

Improved clinical outcomes (i.e. Potential for increased survival and the potential for reduced medication requirements)

Provider

Offering therapy that is cost effective12,14

It is suggested that HDF may have mortality benefits compared to standard HD and is more cost-effective.15

HDF versus HD: Cost effectiveness analysis12,14-16

HDF considered as cost effective to HD

Reduced EPO requirements of up to 9 %14with HDF based on weighted average calculation

Economic benefitsfor units using Ģý equipment as no switching costs from HD to HDF (including higher convection volumes), which means neutral budget impact

Fewer side effects for HDF compared to high-flux HD14
The NICE committee indicated additional benefit of HDF over high flux HD, the potential reduction in dialysis-related amyloidosis in patients on long term dialysis(for example more than 10 years)

Convection volume15
The NICE committee did not make any specific recommendation, but agreed that it was likely that patients who achieved higher convection volumes would get a greater benefit from HDF

Do it for your patients:Just push the button.

HighVolumeHDF powered by machine technologyĢý

Volume matters in haemodiafiltration

Automatically improves substitution volumes forHighVolumeHDF via AutoSubplus18

AutoSubplusĢýInsight and continuity make the difference

  • To perform high-volume HDF, a dialysis machine should fulfill certain requirements.17The 5008 series and the 6008 CAREsystem fulfill these prerequisites. Their sophisticated features enable the easy integration ofHighVolumeHDF in daily clinical routines
  • AutoSubplusautomatically improves the substitution flow rates, thus allowing patient-individualized substitution volumes without additional user interaction. The basic principle of this approach is to avoid excessive hemoconcentration within the dialyser by continuously adapting the substitution flow18
  • With AutoSubplus,HighVolumeHDF can be feasible in routine practice without additional workload and hemoconcentration-induced interruptions4
  • It has been demonstrated that approximately 79% of HDF sessions can be achieved withHighVolumeHDF with AutoSubplus4

Functional principle of AutoSubplus19

  • While other systems check and adjust the transmembrane pressure (TMP) at defined time intervals, AutoSubplusmeasures and evaluates the conditions directly inside the filter several times per minute. The innovative technology behind it is based on a dynamic signal analysis of pressure pulses. As a result, substitution volumes can be improved individually for every patient without any user interaction18
  • Very precise information on the conditions in the dialyser is provided - not just across the membrane but also along the blood flow pathway
  • Several checks per minute enable the continuous adaptionof the substitution rates18
  • The system is automatically activated at the start of treatment
  • AutoSubplussupports the nephrologist in establishingHighVolumeHDF as standard therapy

Do it for your patients:Just push the button.

HighVolumeHDF - Simple & reliable

HighVolumeHDF is easy to perform

HighVolumeHDF has become as simple and reliable as HD without any need for additional user interaction

ONLINEplustechnology ĢýReducing workload, increasing usage

  • An advanced therapy often means more complexity, more handling steps and an increased workload for healthcare professionals. But thanks to sophisticated products and technology from Ģý, the application ofHighVolumeHDF in daily clinical routine has been greatly simplified4,18,20
  • In addition, unique features such as AutoSubplusautomatically improve substitution rates in post-dilution HDF and support the application ofHighVolumeHDF4,18
  • Our innovative blood lines are developed based on the idea thatHighVolumeHDF shouldbe as easy and safe to handle as HD. With a standard setup of a 5008S or 6008 CAREsystem, you can already performHighVolumeHDF without additional preparations
  • As a result, the application ofHighVolumeHDF is not more complex or costly* than conventional HD. You can even switch from HD mode toHighVolumeHDF mode with the same equipment and disposables

* Cost should always be considered in the context of relevant local healthcare systems.

Your question

ĢýPatients with dementia often do not understand the dialysis process. Sometimes they pull out the needleĢý.21

What if dialysis machines could feel the position of the venous needle?

Our answer

Our answer

If an alarm is emitted, the blood pump is stopped immediately, and the venous clamp is closed. This aims to give the nursing staff more time to react appropriately to critical pressure changes.

Back

Safety features createconfidence

In particular during HighVolumeHDF where high blood flows are aspired for, monitoring of the venous access is essential as blood loss would become critical within a very short time. The 5008 series and 6008 CAREsystem offer a sophisticated safety feature as standard in all machines that has been designed to reduce the risk of external blood loss:

  • Venous Access Monitor (VAM)Ģý if an alarm is emitted, the blood pump is stopped immediately, and the venous clamp is closed. This aims to give the nursing staff more time to react appropriately to critical pressure changes
  • BloodlinekinkingԻfilterclottingmonitoring(BLK) -Clotting and Kinking detection - Kinks in the tubing system might result in a mechanically generated hemolysis. The BLK function detects kinked tubing between the blood pump and the venous bubble catcher as well as clots beginning to develop in the dialyser, and issues a warning.

The innovative and highly automated features support nursing staff by streamlining daily workflows and support high and consistent levels of patient safety. The result is easy integration of HighVolumeHDF into daily routine.

Do it for your patients.Just push the button.

HighVolumeHDFdialysers

FX dialysers designed for HighVolumeHDF

Haemodiafilters developed for improved middle molecule removal & albumin retention

Graph adapted from Melchior et al., 2021, p. 623

Albumin retention capabilities of FX CorALĢý

Maintenance hemodialysis patients often experience increased protein catabolism, amino acid and albumin loss during dialysis, which contributes to malnutrition.

According to a study by Ehlerding et al., the albumin loss withFXCorAL600 was less than 1.4 g during a typical HDF treatment of four hours.6

In another study by Melchior et al.,FXCorALwas found to have the lowest albumin sieving coefficient decrease over time compared to other seven dialysers.
Dialysers investigated in this study:FXCorAL600/80 (Ģý); FXCorDiax600/80 (Ģý); xevontaHi15/20 (B. Braun); Polyflux140H/170H (Baxter); ELISIO™-15H/19H (Nipro); FDX-150GW/210GW (Nikkiso Medical); THERANOVA400 (Baxter); SUREFLUX™-15UX/19UX (Nipro).Ģý

Graph adapted from Melchior et al., 2021, p. 623

Albumin retention capabilities of FX CorALĢý

Maintenance hemodialysis patients often experience increased protein catabolism, amino acid and albumin loss during dialysis, which contributes to malnutrition.

According to a study by Ehlerding et al., the albumin loss withFXCorAL600 was less than 1.4 g during a typical HDF treatment of four hours.6

In another study by Melchior et al.,FXCorALwas found to have the lowest albumin sieving coefficient decrease over time compared to other seven dialysers.
Dialysers investigated in this study:FXCorAL600/80 (Ģý); FXCorDiax600/80 (Ģý); xevontaHi15/20 (B. Braun); Polyflux140H/170H (Baxter); ELISIO™-15H/19H (Nipro); FDX-150GW/210GW (Nikkiso Medical); THERANOVA400 (Baxter); SUREFLUX™-15UX/19UX (Nipro).Ģý

Effective middle molecules removal

Clinical evidence shows better removal rates of β2-microglobulin and myoglobulin forFXCorALcompared to reference dialysers during four hourhigh-volume HDF treatment.6

Own illustration based on data from Ehlerding et al., 2021b6

FXCorALHDF Dialyzer fiber

Fiber geometry to facilitate high subsitution volume

Study subgroup analysis showed an inverse relationship between convection volume and risk of mortality.8,24According Basile et al., the recommended convection volume is the maximum possible, of at least 23 L.It is proposed that a convection volume of at least 23 L (for 1.73m2body surface area) is suggested to enhance the clinical outcomes of HDF therapy.25

FXCorALHDF Dialyser fiber

Variations on pressure drop within the FX CorAL HDF dialysers.26,27

Illustration adapted from IFU

  • Increased inner diameter of 210 µm compared to 185 µm substantially reduces the pressure drop within the hollow fiber (according to the Hagan-Poiseuille law)26,27
  • Lower flow resistance leads to a decrease in pressure drops which is proposed to cause less stress fortheblood22

Learn more about

    Do it for your patients:Just push the button.

    Related content

    1https://www.nice.org.uk/guidance/ng107, Renal replacement therapy and conservative management, published date: October 2018.
    * All statements and assessments by NICE are based on care practice and costs in England.

    3Internal calculation is based on an example at QB = 300 mL/min and a 240-minute treatment. There are savings of 34 L of dialysis fluid with post HDF at AutoFlow factor 1.2, with QD = 360 mL/min, compared to post HDF, with a fixed QD = 500 mL/min.

    4Marcelli, D. et al., High-Volume Postdilution Hemodiafiltration Is a Feasible Option in Routine Clinical Practice, Artificial Organs 2015, 39(2): 142Ģý149.

    5Moustapha et al, (2020) Manual Individualization of the Dialysate Flow According to Blood Flow: Effects on the Hemodialysis Dose Delivered and on Dialysate Consumption. J Kidney 6:181. doi-10.35248/2472-1220.20.6.181.

    6Ehlerding, G. et al., Randomized comparison of three high-flux dialyzers during high volume online hemodiafiltration Ģý the comPERFORM study, Clin Kidney J 2021 Oct 5;15(4):672-680. https://doi.org/10.1093/ckj/sfab196

    7Krick G, Ronco C (eds): On- Line Hemodiafiltration: The Journey and the Vision. Contrib Nephrol. Basel, Karger, 2011, vol 175, pp 170Ģý185.

    8Maduell F. et al., High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients, Journal of the American Society of Nephrology (2013); 24: 487-497.

    10Pedrini, L. et al., Long-term effects of high-efficiency on-line haemodiafiltration on uraemic toxicity. A multicentre prospective randomized study, Nephrology Dialysis Transplantation (2011); 26: 2617-2624.

    11Ok E., et al., Mortality and cardiovascular events in online haemodiafiltration (OL-HDF) compared with high-flux dialysis: results from the Turkish OL-HDF Study, Nephrology Dialysis Transplantation (2013); 28: 192-202.

    12Hornig C. et al., Switching from high-flux dialysis to hemodiafiltration: Cost-consequences for patients, providers, and payers. Semin Dial. 2022

    14NICE, Renal replacement therapy and conservative management; NICE guideline. 2018: https://www.nice.org.uk/guidance/ng107/chapter/Recommendations#.

    15NICE, RRT and conservative management; Cost-effectiveness analysis: HDF versus high flux HD. 2018: https://www.nice.org.uk/guidance/ng107/evidence/costeffectiveness-

    16NICE, RRT and conservative management; Modalities of RRT. 2018: https://www.nice.org.uk/guidance/ng107/evidence/b-modalities-of-rrt-pdf-6542344047.

    17Canaud, B. et al., Hemodiafiltration to Address Unmet Medical Needs ESKD Patients, Clin J Am Soc Nephrol 13: 1435Ģý1443, 2018.

    18Maduel, F. et al., Impact of the 5008 monitor software update on total convective volume, Nefrologia (English Version) 2014; 34: 599Ģý604.

    19Imamović G. et al., Principles of Haemodiafiltration: Rationale for Improved PatientsĢý Survival. Advances in Hemodiafiltration. InTech; 2016, Chapter 2. dx.doi.org/10.5772/63067

    20Marcelli, D. et al., Modifiable factors associated with achievement of high-volume post-dilution hemodiafiltration: results from an international study, Int J Artif Organs 2015; 38 (5): 244Ģý250.

    21Ying I, Levitt Z, Jassal SV. Should an elderly patient with stage V CKD and dementia be started on dialysis? Clin J Am Soc Nephrol. 2014 May;9(5):971-7. doi: 10.2215/CJN.05870513.

    22Lang T. et.al., Hemodiafiltration: Technical and Medical Insights. Bioengineering (Basel). 2023 Jan 21;10(2):145.

    23Melchior, P. et al., Complement activation by dialysis membranes and its association with secondary membrane formation and surface charge. Artif Organs 2021 Jul;45(7):770-778 https://doi.org/10.1111/aor.13887

    24Peters et al., Haemodiafiltration and mortality in end-stage kidney disease patients: a pooled individual participant data analysis from four randomized controlled trials Nephrol Dial Transplant (2016) 31: 978Ģý984

    25Basile, C. et al., Why choose high volume online post-dilution hemodiafiltration? J Nephrol 30, 181Ģý186 (2017).

    26FX CorDiaxHDF, Haemodiafilter Instructions for Use.

    27FX CorDiax, High-Flux Dialysers. Instructions for Use.

    28Penne et al., Short-term effects of online hemodiafiltration on phosphate control: a result from the randomized controlled Convective Transport Study (CONTRAST) Am J Kidney Dis 2010 Jan;55(1):77-87.