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    Key features

    High selective permeability for middle molecules

    The new FX CorDiax is the most efficient dialyzer within the FX-class®. The core of the FX CorDiax is the Helixone® plus membrane, a targeted enhancement of the Helixone® membrane. Improved fiber design allows for better sieving of middle molecules such as β2-microglobulin (β2-m) while restricting the loss of vital albumin. As increased levels of β2-m are associated with higher mortality risk, the use of FX CorDiax High-Flux dialyzers or hemodiafilters facilitate best possible therapy outcomes.

    Refined membrane architecture

    New production technology combined with INLINE steam sterilization allows crucial enhancements of membrane porosity, reducing flow resistance and improving transport across the membrane.

    Helixoneplus
    Close-up of the inner surface and the support region of the Helixone®plus membrane

    Benefit of refined membrane architecture

    Significantly improved removal of middle molecules while preventing the loss of useful substances, such as serum albumin.

    Purity enhanced — with steam

    The benefits of INLINE steam sterilization
    No chemical residuals No need for gamma sterilization – high energy ionizing  radiation can degrade and alter the material chemistry.  
    Low rinsing volumes Rinsing time and volume is substantially lower compared to gamma sterilized dialyzers
    Lower costs Lower rinsing volumes mean reduced preparation costs.

    INLINE steam sterilization process

    Integrity test

    Integrity test
    Air pressure is applied to the fiber bundle from one side while the other side contains sterile water. If any leakages were present in the membrane, air would pass the membrane and create bubbles.

    Technology

    Advances in fiber design allow for better removal of uremic toxins

    • The fiber support region underneath the inner surface has been “opened up”, optimizing porosity and therefore also the convective filtration (“flushing”) of larger uremic toxins such as β2-microglobulin (≈ 11,800 Da) or myoglobin (≈ 17,000 Da)
    • At the same time the size of the pores of the inner surface area was not increased to avoid flushing of albumin

    Superior by design

    Several state-of-the-art technologies have been combined to create the distinctive, functional features of FX-class® dialyzers, which are refined and optimized for performance and handling:

    • Design of dialyzer housing and fiber bundle for more uniform dialysate flow
    • Refined blood inlet port for improved hemodynamics  

    Advances in material and production technologies have permitted improvements in the wall structure of the Helixone®plus membrane of the FX CorDiax.  

    • More porous membrane wall for higher clearance of middle molecules
    Optimized dialysate flow The 3-dimensional microwave structure of the fiber ensures uniform radial dialysate flow around each fiber within the bundle by preventing fluid channeling, thereby enhancing clearance values and improving the overall performance of the dialyzer.  
    Better hemodynamics The lateral blood-inlet port ensures more homogenous blood flow in the dialyzer header, preventing stagnation zones. The design essentially minimizes the risk of kinking, contributing to improved safety.
    Enhanced convection The more open structure of the Helixone®plus membrane support region serves to reduce diffusion resistance and increases convective filtration. This facilitates clearance of a broad range of uremic toxins, especially the middle molecules.
    Kind to the environment Advanced design goes beyond direct functionality, it also has to be easy on the environment. FX-class® dialyzers weigh half as much as dialyzers with polycarbonate housing, and at the same time use ecologically friendly plastics. This means a lower carbon-footprint as a result of fewer materials, less packaging, less fuel for transport and cleaner waste management.
    FX-class dialyzers design
    FX-class® dialyzers design

    Key to optimal middle molecule removal

    Solutes encounter resistance while traversing the membrane wall. Resistance to solute transport is affected, in part, by pore size at the inner surface and the porosity of the membrane wall. Furthermore, wall structure and thickness as well as inner fiber dimensions and 3-dimensional microwave structure play important roles in transmembrane flux. The new membrane structure of Helixone®plus allows the easy passage of middle molecules across the more porous support region of the membrane.

    • The structure of the support region is crucial to overall performance
    • Membrane porosity, together with the pore size, regulates the transport of middle molecules

    Fiber design for HD

    In an HD treatment, reducing the inner fiber diameter from 200 μm (F-series) to 185 μm (FX-class®) acts to increase internal filtration, thereby increasing the pressure gradient along the length of the fiber. This results in a greater pressure difference between the blood and dialysate compartments. Together with structural refinements to the support region of the fiber, this enables improvements in both diffusive and convective transport, which is of particular importance when performing High-Flux hemodialysis.

    Fiber pressure profile
    Benefit of reduced inner fiber diameter
    (Both Graphs are adapted from original publication)
    Reduced inner diameter improves middle molecule elimination
    Reduced inner diameter improves middle molecule elimination1

    Design of the HD fiber

    • A small inner diameter of the hollow fiber increases the pressure gradient between blood and dialysate compartments
    • The result is improved clearance of middle molecules such as vitamin B12, inulin, β2-microglobulin and myoglobin1  
    • The increased pressure gradient combined with structural refinements to the membrane (support region) enhances diffusive as well as convective filtration, especially when performing High-Flux hemodialysis with FX CorDiax

    FX CorDiax hemodiafilter

    HighVolumeHDF® therapy requires specially designed filters. Stepping up to this challenge, FX CorDiax hemodiafilter were developed for HighVolumeHDF®

    Increased fiber lumen for better flow conditions

    • An increase of its inner diameter results in a reduced pressure drop within a hollow fiber
    • The  capillary diameter of a dialyzer can affect performance and treatment quality
    • The inner diameter of hemodiafilters is 210 μm compared to 185 μm of HD filters. The larger diameter facilitates improved flow conditions, allowing for higher convective volumes in an HDF treatment2
    FX CorDiax hemodiafilters
    The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters
    Reduced dialyzer inlet pressure of FX 800 (210 μm) vs. FX 80 (185 μm)2 (Both Graphs adapted from original publication)
    FX CorDiax hemodiafilters
    The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters
    The 210 μm fiber lumen of FX CorDiax hemodiafilters optimizes blood flow conditions within the dialyzer for maximal HighVolumeHDF® performance

    Performance Data

    Sieving coefficients of FX CorDiax High-Flux Dialyzers and Haemodiafilters

    Sieving coefficients of FX CorDiax High-Flux Dialyzers and Haemodiafilters Molecular weight (Dalton)  
    Albumin 66,500 < 0.001
    Myoglobin 17,053 0.5
    β2-microglobulin 11,731 0.9
    Inulin 5,200 1
    Membrane material   Helixone®plus
    Sterilisation method   INLINE steam
    Housing material   Polypropylene
    Potting compound   Polyurethane
    Units per box   24

    FX CorDiax High-Flux Dialysers

    FX CorDiax High-Flux Dialyzers   FX CorDiax 40 FX CorDiax 50 FX CorDiax 60 FX CorDiax 80 FX CorDiax 100 FX CorDiax 120
    Clearance (QB = 300 mL/min) Molecular weight (Dalton)            
    Cytochrome c 12,230 48 * 76 96 111 125 136
    Inulin 5,200 56 * 88 116 127 144 149
    Vitamin B12 1,355 96 * 144 175 190 207 213
    Phosphate 132 142 * 215 237 248 258 262
     Creatinine 113 155 * 229 252 261 272 274
    Urea 60 175 * 255 271 280 283 284
    Clearance (QB = 400 mL/min)              
    Cytochrome c 12,230     100 117 133 145
    Inulin 5,200     122 135 154 160
    Vitamin B12 1,355     191 209 229 237
    Phosphate 132     270 285 299 305
    Creatinine 113     290 303 321 325
    Urea 60     319 336 341 343
    * Clearance (QB = 200 mL/min)
    Ultrafiltration coeff. (mL/h x mmHg)   21 33 47 64 74 87
    In vitro performance: QD = 500mL/min, QF = 0mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, QBmax, QF = 0.2 x QBmax (ISO8637). Ultrafiltration coefficients: human blood (Hct 32%, protein content 6%).
    Effective surface (m2)   0.6 1.0 1.4 1.8 2.2 2.5
    K0A Urea   547 886 1,164 1,429 1,545 1,584
    Priming volume (mL)   32 53 74 95 116 132

    FX CorDiax Haemodiafilters

    FX CorDiax Haemodiafilters   FX CorDiax 600 FX CorDiax 800 FX CorDiax 1000
    Clearance (QB = 300 mL/min, QF = 75 mL/min) Molecular weight (Dalton)      
    Cytochrome c 12,230 131 141 151
    Inulin 5,200 144 156 166
    Vitamin B12 1,355 204 217 225
    Phosphate 132 257 267 271
     Creatinine 113 271 277 280
    Urea 60 285 291 292
    Clearance (QB = 400 mL/min, QF = 100 mL/min)        
    Cytochrome c 12,230 149 160 172
    Inulin 5,200 166 178 190
    Vitamin B12 1,355 235 251 262
    Phosphate 132 307 321 328
    Creatinine 113 327 339 343
    Urea 60 354 365 367  
    Ultrafiltration coeff. (mL/h x mmHg)   47 64 68  
    n vitro performance: QD = 500 mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, QBmax, QF = 0.2 x QBmax (ISO8637). Ultrafiltration coefficients: human blood (Hct 32%, protein content 6%).
    Effective surface (m2)   1.6 2.0 2.3
    K0A Urea   1,148 1,365 1,421
    Priming volume (mL)   95 115 136

    Studies

    FX CorDiax has a high middle molecule removal capacity

    Maduell et al. determined the removal capacity of FX CorDiax 60 compared to FX 60 in HDF postdilution treatments. Significantly higher removal rates were observed with FX CorDiax for:

    • Urea (60 Da)
    • β2-microglobulin (11.8 kDa)
    • Myoglobin (17.2 kDa)
    • Prolactin (22.9 kDa)
    • α1-microglobulin (33 kDa)  
    Removal ratios of FX 60 and FX CorDiax 60
    Removal ratios of FX 60 and FX CorDiax 60 dialyzers in postdilution HDF3 (QB = 400 mL/min, QD = 500 mL/min)

    “… treating patients with online hemodiafiltration and FX CorDiax 60 instead of FX 60 dialyzers results in significantly increased reduction ratios of middle sized molecules without clinically relevant changes in albumin loss.”

    Maduell et. al.

    In a postdilution HDF treatment the use of FX CorDiax 100 dialyzers resulted in a significantly higher clearance of β2-microglobulin than FX 100 and Polyflux® 210H dialyzers. The albumin loss was low and similar for all dialysers.4

    Comparison of albumin loss in a post-dilution HDF treatment

    (QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)4
      Albumin loss (g/4h)
    FX CorDiax 100 1.74 ± 1.01
    FX 100 2.10 ± 1.00
    Polyflux® 210 H 1.31 ± 0.12
    FXCorDiax
    FX CorDiax offers significantly better β2-m clearance than FX and Polyflux®4

    Phosphate clearance of FX CorDiax dialyzers

    Comparison of aqueous in-vitro clearances of phosphate (QB = 300 mL/min, QD = 500 mL/min). Investigations carried out by EXcorLab GmbH, an Accredited Calibration and Testing Laboratory.

    FXCorDiax
    Phosphate clearance of FX CorDiax dialyzers

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    1 Dellanna F. et al., (1996); Nephrology Dialysis Transplantation 11 (Suppl 2): 83-86.

    2 Vega Vega O. et.al.; ERA-EDTA Congress 2012, Poster 457—FP.

    3 Maduell et. al.; ERA-EDTA Congress 2013, May 20, Poster Number MP 390.

    4 Bock A. et al., Journal of the American Society of Nephrology (2013); 24: SA-PO404.

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