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Key features
Technology
Performance Data
Studies

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.

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.

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.

Benefit of reduced inner fiber diameter

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

The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters

csm_BAS021_dialyzer-inlet-pressure_e4a6929736
 

Reduced dialyzer inlet pressure of FX 800 (210 μm) vs. FX 80 (185 μm)2 (Both Graphs adapted from original publication)

csm_BAS021_fiber-lumen-FXCorDiax_b2a1f42491
 

The 210 μm fiber lumen of FX CorDiax hemodiafilters optimizes blood flow conditions within the dialyzer for maximal HighVolumeHDF® performance

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 (Q= 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

 

“… 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

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.

Key features

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.

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.

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.

Benefit of reduced inner fiber diameter

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

The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters

csm_BAS021_dialyzer-inlet-pressure_e4a6929736
 

Reduced dialyzer inlet pressure of FX 800 (210 μm) vs. FX 80 (185 μm)2 (Both Graphs adapted from original publication)

csm_BAS021_fiber-lumen-FXCorDiax_b2a1f42491
 

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 (Q= 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
 

“… 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

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.

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.