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FX CorDiax

FX CorDiax 100

Designed to dialyse

  • Efficient middle molecule removal
  • INLINE steam sterilised
  • Low rinsing volume
The Helixoneplus membrane

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

High selective permeability for middle molecules

The FX CorDiax is the most efficient dialyser within the FX class®. The core of the FX CorDiax is the Helixone® plus membrane, a targeted enhancement of the Helixone® membrane.

Refined membrane architecture

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

Benefits 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 sterilisation
No chemical residues No need for gamma sterilisation: high-energy ionising  radiation can degrade and alter the material chemistry
Low rinsing volumes Rinsing time and volume is substantially lower compared to gamma-sterilised dialysers
Less rinsing, lower costs Lower rinsing volumes mean reduced preparation costs

INLINE steam sterilisation process

Integrity test

Integrity test of fibres

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

Advances in fibre design allow for the better removal of uraemic toxins

  • The fibre support region underneath the inner surface has been “opened up”, optimising porosity and therefore also the convective filtration (“flushing”) of larger uraemic 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 the flushing of albumin

Superior by design

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

  • Design of dialyser housing and fibre bundle for more uniform dialysate flow
  • Refined blood inlet port for improved haemodynamics
     

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

  • More porous membrane wall for the higher clearance of middle molecules
FX-class® dialyser design

FX-class® dialyser design

Optimised dialysate flow

The three-dimensional microwave structure of the fibres ensures uniform radial dialysate flow around each fibre within the bundle by preventing fluid channeling, therefore enhancing clearance values and improving the overall performance of the dialyser.  

Better haemodynamics The lateral blood-inlet port ensures more homogenous blood flow in the dialyser header, preventing stagnation zones. The design essentially minimises 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 the clearance of a broad range of uraemic 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® dialysers weigh half as much as dialysers 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.

 

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, inner fibre dimensions and three-dimensional microwave structure play important roles in transmembrane flux. The new membrane structure of Helixone®plus allows for 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, regulate the transport of middle molecules

Fibre design for HD

In an HD treatment, reducing the inner fibre 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 fibre. This results in a greater pressure difference between the blood and dialysate compartments. Together with structural refinements to the support region of the fibres, this enables improvements in both diffusive and convective transport, which is of particular importance when performing High-Flux haemodialysis.

Benefits of the reduced inner fibre diameter

Fibre pressure profile

Clearance versus the inner diameter of the fibre

Clearance versus the inner diameter of the fibre

A reduced inner diameter improves middle molecule elimination1 (graph adapted from the original publication)

Design of the HD fibre

  • A small inner diameter of the hollow fibre 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 haemodialysis with FX CorDiax

FX CorDiax haemodiafilter

HighVolumeHDF therapy requires specially designed filters. As a result, FX CorDiax haemodiafilters were developed for HighVolumeHDF

Increased fibre lumens for better flow conditions

  • An increase of its inner diameter results in a reduced pressure drop within a hollow fibre
  • The capillary diameter of a dialyser can affect performance and treatment quality
  • The inner diameter of haemodiafilters is 210 μm, compared to 185 μm in HD filters. The larger diameter facilitates improved flow conditions, allowing for higher convective volumes in an HDF treatment.2

The benefit of enlarged fibre lumen in FX CorDiax haemodiafilters

Dialyser inlet pressure

Reduced dialyser inlet pressure of FX 800 (210 μm) vs. FX 80 (185 μm)2 (Graph adapted from the original publication)

Fibre lumen of FX CorDiax haemodiafilters

The 210 μm fibre lumen of FX CorDiax haemodiafilters optimises blood flow conditions within the dialyser for maximal HighVolumeHDF performance.

Sieving coefficients of FX CorDiax High-Flux Dialysers and Haemodiafilters

Sieving coefficients of FX CorDiax High-Flux
Dialysers and Haemodiafilters
Molecular weight (Daltons)  
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 Dialysers   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 (Daltons)            
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 (ISO 8637). Sieving coefficients: human plasma, QBmax, QF = 0.2 x QBmax (ISO 8637). 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
Article number   F00001588 F00001589 F00001590 F00001591 F00001592 F00002384

 

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 (Daltons)      
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)
In vitro performance: QD = 500 ml/min, T = 37°C (ISO 8637). Sieving coefficients: human plasma, QBmax, QF = 0.2 x QBmax (ISO 8637). 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
Article number   F00001593 F00001594 F00001595

 

Removal ratios of the FX 60 and FX CorDiax 60 dialysers

Removal ratios of the FX 60 and FX CorDiax 60 dialysers in postdilution HDF3 (QB = 400 ml/min, QD = 500 ml/min)

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) 
     

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

… 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 dialysers resulted in a significantly higher clearance of β2-microglobulin than in FX 100 and Polyflux® 210H dialysers. 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/four hours)
FX CorDiax 100 1.74 ± 1.01
FX 100 2.10 ± 1.00
Polyflux® 21 OH 1.31 ± 0.12

 

ß2-m clearance of FX CorDiax

FX CorDiax offers significantly better β2-m clearance than FX and Polyflux®4

The phosphate clearance of FX CorDiax dialysers

The phosphate clearance of FX CorDiax dialysers

The phosphate clearance of FX CorDiax dialysers

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.

Contact us for a product brochure:

If you would like to order this product via the NHS Supply Chain Catalogue, please visit the following link: NHS Supply Chain Online Catalogue

Additional information relating to multiBic or Calrecia can be found in the critical care section of our product information page.

Adverse Events Reporting 

Adverse events should be reported. Reporting forms and information can be found at 

https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple app store. Adverse events should also be reported to Fresenius Medical Care on 01623 445100.

UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

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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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