FX CorDiax dialyzer - Fresenius Medical Care

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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 (Q_B = 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 (Q_B = 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 (Q_B = 200 mL/min)
Ultrafiltration coeff. (mL/h x mmHg)		21	33	47	64	74	87
In vitro performance: Q_D = 500mL/min, Q_F = 0mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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_B= 300 mL/min, Q_F = 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 (Q_B = 400 mL/min, Q_F = 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: Q_D = 500 mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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.

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.

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.

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.

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

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

Membrane material

Helixone^®plus

Sterilisation method

INLINE steam

Housing material

Polypropylene

Potting compound

Polyurethane

Units per box

FX CorDiax High-Flux Dialyzers		FX _CorDiax 40	FX _CorDiax 50	FX _CorDiax 60	FX _CorDiax 80	FX _CorDiax 100	FX _CorDiax 120
Clearance (Q_B = 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 (Q_B = 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 (Q_B = 200 mL/min)
Ultrafiltration coeff. (mL/h x mmHg)		21	33	47	64	74	87
In vitro performance: Q_D = 500mL/min, Q_F = 0mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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 High-Flux Dialyzers

FX _CorDiax 40

FX _CorDiax 50

FX _CorDiax 60

FX _CorDiax 80

FX _CorDiax 100

FX _CorDiax 120

Clearance (Q_B = 300 mL/min)

Molecular weight (Dalton)

Cytochrome c

12,230

48 *

111

125

136

Inulin

5,200

56 *

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

175 *

255

271

280

283

284

Clearance (Q_B = 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

319

336

341

343

* Clearance (Q_B = 200 mL/min)

Ultrafiltration coeff. (mL/h x mmHg)

In vitro performance: Q_D = 500mL/min, Q_F = 0mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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)

116

132

FX CorDiax Haemodiafilters		FX _CorDiax 600	FX _CorDiax 800	FX _CorDiax 1000
Clearance (Q_B= 300 mL/min, Q_F = 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 (Q_B = 400 mL/min, Q_F = 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: Q_D = 500 mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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

FX CorDiax Haemodiafilters

FX _CorDiax 600

FX _CorDiax 800

FX _CorDiax 1000

Clearance (Q_B= 300 mL/min, Q_F = 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

285

291

292

Clearance (Q_B = 400 mL/min, Q_F = 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

354

365

367

Ultrafiltration coeff. (mL/h x mmHg)

n vitro performance: Q_D = 500 mL/min, T = 37°C (ISO8637). Sieving coefficients: human plasma, Q_Bmax, Q_F = 0.2 x Q_Bmax (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)

115

136

	Albumin loss (g/4h)
FX CorDiax 100	1.74 ± 1.01
FX 100	2.10 ± 1.00
Polyflux^® 210 H	1.31 ± 0.12

Albumin loss (g/4h)

FX CorDiax 100

1.74 ± 1.01

FX 100

2.10 ± 1.00

Polyflux^® 210 H

1.31 ± 0.12

Attention

FX CorDiax

Designed to dialyze.Built for cardioprotection.

High selective permeability for middle molecules

Refined membrane architecture

Benefit of refined membrane architecture

Purity enhanced — with steam

INLINE steam sterilization process

Integrity test

Advances in fiber design allow for better removal of uremic toxins

Superior by design

Key to optimal middle molecule removal

Fiber design for HD

Benefit of reduced inner fiber diameter

Fiber pressure profile

Clearance versus inner diameter of fiber

Design of the HD fiber

FX CorDiax hemodiafilter

Increased fiber lumen for better flow conditions

The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters

Sieving coefficients of FX CorDiax High-Flux Dialyzers and Haemodiafilters

FX CorDiax High-Flux Dialysers

FX CorDiax Haemodiafilters

FX CorDiax has a high middle molecule removal capacity

Comparison of albumin loss in a post-dilution HDF treatment

(QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)4

Phosphate clearance of FX CorDiax dialyzers

High selective permeability for middle molecules

Refined membrane architecture

Benefit of refined membrane architecture

Purity enhanced — with steam

INLINE steam sterilization process

Integrity test

Advances in fiber design allow for better removal of uremic toxins

Superior by design

Key to optimal middle molecule removal

Fiber design for HD

Benefit of reduced inner fiber diameter

Fiber pressure profile

Clearance versus inner diameter of fiber

Design of the HD fiber

FX CorDiax hemodiafilter

Increased fiber lumen for better flow conditions

The benefit of enlarged fiber lumen of FX CorDiax hemodiafilters

Sieving coefficients of FX CorDiax High-Flux Dialyzers and Haemodiafilters

FX CorDiax High-Flux Dialysers

FX CorDiax Haemodiafilters

FX CorDiax has a high middle molecule removal capacity

Comparison of albumin loss in a post-dilution HDF treatment

(QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)4

Phosphate clearance of FX CorDiax dialyzers

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(QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)⁴

(QB = 350 mL/min, QD = 800 mL/min, QS = 80 mL/min)⁴