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FX CorDiax At the heart of long-term haemodialysis Protecting the Endothelium

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Page 1: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

FX CorDiax At the heart of long-term haemodialysis

Protecting the Endothelium

Page 2: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Protect your patient

Innovative Helixone®plus membraneOptimised membrane porosity for enhanced middle molecule removal

Unique FX-class® designFacilitates the best in cardioprotective haemodialysis therapy

Outstanding endotoxin retentionPrevents the transfer of endotoxins into patients blood

Unique INLINE steam sterilisationNo chemical residuals

Page 3: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Designed to Dialyse.

Built for Cardioprotection.

The new FX CorDiax

Page 4: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Innovative Helixone®plus membraneAdvances in fibre design allow better removal

of uremic toxin

Inner surface

Support region

Close-up of the inner surface and the support region of the membrane.

The new membrane structure of Helixone®plus allows the

easy passage of middle molecules across the more porous

support region of the membrane.

The fibre support region underneath the inner surface has

been opened up, optimising porosity and therefore 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 retention of beneficial molecules such

as albumin is improved.

The reduced transmembrane resistance improves the

removal of a broad range of middle molecules as well as

low molecular weight substances.

Comparison of sieving coefficient data of FX 60 and FX CorDiax 60

FX CorDiax 60 FX 60 S

ievi

ng C

oeffi

cien

t

Molecular Mass/Dalton

SCMyo 0.50

SCMyo 0.28

SCβ2-m 0.80

SCβ2-m 0.90

1,000 10,000 100,000

1.00

0.90

0.80

0.70

0.60

0.50

0.40

0.30

0.20

0.10

Comparison of sieving coefficients of FX CorDiax, Xevonta Hi, PolyfluxTM H, and ElisioTM-H.

(All data taken from manufacturer’s brochures. 1) > 0.8, 2) < 0.001, 3) < 0.01)

Sie

ving

Coe

ffici

ent

1

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

β2-microglobulin

(11,731 Da)

n.a.

FX CorDiax

FX CorDiax

Xevonta Hi

Xevonta Hi

PolyfluxT

M H

PolyfluxT

M H

ElisioTM -H

ElisioTM -H

Myoglobin

(17,053 Da)

n.a. n.a.

1)

Sie

ving

Coe

ffici

ent o

f Alb

umin

FX CorDiax

Xevonta Hi

PolyfluxT

M H

ElisioTM -H

Albumin

(66,500 Da)

0.014

0.012

0.010

0.008

0.006

0.004

0.002

02) 2)

3)

Page 5: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Homogenous bloodflow path

AdvancedHelixone®plus membrane

3-dimensional wave structureof the fibre

Radial dialysate flow

Reference1. Weber V. et al., Blood Purif (2003); 21: 365.2. Shintani H. et al., Journal of Analytical Toxicology (1989); 13: 354-357.3. Müller T. F. et al., Nephron (1998); 78: 139-142.

Unique FX-class® design

Outstanding endotoxin retention

Optimised dialysate flowThe 3-dimensional microwave structure, in combination with

the design of dialyser housing, ensures uniform dialysate

flow. This improves clearance values and the overall filter

performance.

Better haemodynamicsThe refined blood inlet port improves haemodynamics and

the new design eliminates the risk of bloodline kinking.

Environmentally friendlyThe FX-class® dialysers weigh less than 50% of previous

dialysers and use ecologically friendly materials.

Greater protection through active preventionMembranes such as Helixone®, which have a high

endotoxin retention capacity1, protect the patient from

inflammation, particularly when ultrapure dialysate is not

available.

Amyloidosis, immune disorders, or accelerated

atherosclerosis can be the result of using a membrane

with a low endotoxin retention capacity, and inflammation

can lead to an increased need for EPO.

Unique INLINE steam sterilisation

Clean and safeFX-class® dialysers are sterilised using the unique INLINE

steam sterilisation process specifically developed by

Fresenius Medical Care.

This protects your patient from cytotoxic and carcinogenic

residuals2 caused by degraded and altered material inside

the dialyser produced during gamma sterilisation.

A further effect of this clean and safe process is the reduced

activation of the complement system3 and the low rinsing

volume helps reduce costs and preparation time.

Page 6: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Reference1. Tattersall J. et al., Nephrol Dial (2007); 22(Suppl.2); ii5-ii21.2. Locatelli F. et al., Journal of American Society of Nephrology (2009); 20: 645-654.3. Pedrini L. A. et al., Nephrol Dial Transplant (2011); 26(8): 2617-2624.

Improved Survival – Better Outcomes

The use of High-Flux membranes such as FX-class® High-Flux

dialysers improves patient survival rates.

Enhanced middle molecule removal contributes to a reduction

of the complications of haemodialysis as well as improving

long-term patient outcomes.1

The results of the MPO study indicate the beneficial effect of High-Flux membranes in terms of reduced mortality for patients with serum albumin levels ≤ 4.0 g/dL or diabetes.2

Improved patient survival2

Reduced inflammation3

Better anemia control with reduced EPO doses4

Immune dysfunctions may be reversed5

Kaplan-Meier survival curves for the population of patients with serum albumin levels <_ 4.0 g/dL (log-rank test p = 0.032).2 (Graph adapted from original publication)

Sur

viva

l Pro

babi

lity

of P

atie

nts

Months

1.00

0.90

0.80

0.70

0.60

0.50

0.40

0.30

0.20

High-Flux Membrane Low-Flux Membrane

Patients with Serum Albumin ≤ 4 g/dL (p = 0.032)

0 12 24 36 60 8448 72

β2-microglobulinAlbumin

4. Bonforte G.et al., Blood Purif (2002); 20: 357-363.5. Lonnemann G. et al., Blood Purif (2003); 21(3): 225-231.

Page 7: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

The new FX CorDiax

Performance Data

Sieving coefficients of FX CorDiax

High-Flux Dialysers and HaemodiafiltersMolecular weight

(Dalton)Albumin 66,500

17,053< 0.001

Myoglobin 0.5-microglobulin 11,731

5,200

0.9Inulin 1Membrane material Helixone®plusSterilisation method INLINE steamHousing material PolypropylenePotting compound PolyurethaneUnits per box 24

Clearance (QB = mL/min)

Cytochrome c 12,230Inulin 5,200Vitamin B12 1,355Phosphate 132Creatinine 113Urea 60

Clearance (QB = mL/min)

Cytochrome c 12,230

Vitamin B12 1,355

Creatinine 113

Ultrafiltration coeff. (mL/h x mmHg)Effective surface (m²)K A UreaPriming volume (mL)Article number

FX CorDiax Haemodiafilters

Clearance (QB = 300 mL/min, Q

F = 75 mL/min)

Cytochrome c 12,230Inulin 5,200Vitamin B12 1,355Phosphate 132Creatinine 113Urea 60

60

Clearance (QB = 400 mL/min, QF = 100 mL/min)

Cytochrome c 12,230InulinVitamin B12 1,355

5,200

PhosphateCreatinine 113

132

Urea

Ultrafiltration coeff. (mL/h x mmHg)Effective surface (m²)K A UreaPriming volume (mL)Article number

In vitro performance: QD = 500 mL/min, T = 37°C (EN 1283, ISO 8637). Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.

%, protein content 6 %. In vitro performance: QD = 500 mL/min, Q

F = 0 mL/min, T = 37°C (EN 1283, ISO 8637). Ultrafiltration coefficients: human blood, Hct 32

Inulin 5,200

Phosphate 132

Urea 60

FX CorDiax 60

96116175237252271

100

191

290

471.4

1,16474

F00005651

122

270

319

FX CorDiax 50

7181126173180191

76

144

229

331.088653

F00005650

88

215

255

FX CorDiax 80

111127190248261280

117

209

303

641.8

1,42995

F00005652

CorDiax 800

141156217267277291

160178251321339365

622.0

1,365115

F00005656

135

285

336

FX CorDiax 100

125144207258272283

133

229

321

742.2

1,545116

FX 1000CorDiax

151166225271280292

172190262328343367

762.3

1,421136

F00005657

154

299

341

F00005653

FX CorDiax 120

136149213262274284

145

237

325

872.5

1,584132

160

305

343

F00005654

300200

300 400 400 400

FX FX CorDiax High-Flux Dialysers CorDiax 40

485696142155175

210.654732

F00005649

FX CorDiax 600

131144204257271285

149166235307327354

461.6

1,14895

F00005655

200 300 300

400

300

O

FX

β2

O

Page 8: AP367 FX CorDiax Brochure 8 pages AUS - fmc-au.com CorDiax.pdf · FX CorDiax 60 96 116 175 237 252 271 100 191 290 47 1.4 1,164 74 F00005651 122 270 319 FX CorDiax 50 71 81 126 173

Fresenius Medical Care Australia Pty Ltd. · Level 17, 61 Lavender Street, Milsons Point, NSW 2061, Sydney, Australia �Telephone: (61 2) 9466 8000 · Fax: (61 2) 9929 5595 · www.fmc-ag.com A

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