150

Dialyser Factfile No. 13

Information for Sales & Marketing
For internal use only November 2009
October 2009

B.Braun Xevonta Dialyser Series

Overview
• The Xevonta high flux (HF) and low flux (LF) dialysers consist of a
polysulfone-based membrane called Amembris. The chemical composition of
the membrane is not precisely specified. We assume it is an α-
polysulfone/PVP blend like in the B.Braun Diacap α-polysulfone dialysers.

Dialyser types
• Low flux: Lo 10 (1.0 m²), Lo 12 (1.2 m²), Lo 15 (1.5 m²),
Lo 18 (1.8 m²), Lo 20 (2.0 m²), Lo 23 (2.3 m²)
• High flux: Hi 10 (1.0 m²), Hi 12 (1.2 m²), Hi 15 (1.5 m²),
Hi 18 (1.8 m²), Hi 20 (2.0 m²), Hi 23 (2.3 m²)

Sterilization mode
• Gamma sterilisation for low and high flux dialysers

Fibre dimensions
• Wall thickness: 35 µm
• Internal diameter: 195 µm

Counterargumentation

• Using γ irradiation for sterilization is not preferable.

It may lead to chemical and physical altering of the membrane and the potting material.
Generated cytotoxic or pyrogenic residues remain in the dialyser.
• The membrane material Amembris is partly negatively.
This could activate the coagulation and could lead to anaphylactoid reactions! (similar to
ANST membrane of Hospal)
• No comparable values for endotoxin retention and albumin loss are available.
• Wrong information on the FX-class® sieving coefficient.
The given sieving coefficient for β2-microglobulin for the FX-class® HF dialysers is too
low with 0.65. Actually, they are in the same order as the once for Xevonta HF filters.
• Higher clearance values for urea lie within the standard deviation.
The values are just 4 % higher than the urea clearance for FX-class® dialysers.
• Higher phosphate clearance values, but…
The good phosphate clearance of the Xevonta dialysers is emphasized but a medical
study to prevent secondary hyperparathyroidism and renal osteodystrophy is missing.
Performance

Low MW compound removal

FX high flux dialysers
300
Urea clearance [ml/min]
Xevonta high flux dialysers QB=300 ml/min, QD=500 ml/min
The Xevonta dialysers exhibit slightly higher
clearances compared to FX-class® dialysers.

280

260
The presentation of the data in the Xevonta
240
brochure is disadvantageous for us because
220 the amplification of the x-axis scale
200 exaggerates minor differences.
0.9 1.1 1.3 1.5 1.7 1.9 2.1 2.3
Effective surface area [m²]

A comparison between FX-class® HF dialysers

FX high flux dialysers Xevonta high flux dialysers QB=300 ml/min, QD=500 ml/min
and Xevonta HF dialysers regarding the urea
Phosphate clearance [ml/min]

300

280 clearance is shown on the left. The values

260
differ around ± 4 % which lies within the
240
accuracy of the measurement.
220

200 The phosphate clearances of the FX-class®

180 dialysers are lower throughout the surface
0.9 1.1 1.3 1.5 1.7 1.9 2.1 2.3
Effective surface area [m²] area range of 5 % to 9 % (standard deviation).

Middle molecule removal /albumin loss

Xevonta LF dialysers exhibit lower clearance values for middle molecules but considering HF
dialysers the clearance data for Vitamin B12 and Inulin from Xevonta are slightly higher.
The sieving coefficients (ß2-m, albumin) for the HF dialysers are shown in a graphical
comparison with the FX-class® HF filters (obtained by B.Braun in an unpublished investigation
(EXcorLab 2009). No information on the measurement conditions (QB, QD, QF) are given. B

The sieving coefficients presented for the FX-class® dialysers do not accord to the data given in
our brochure: 0.8 for β2-m and 0.001 for albumin. Especially the determined sieving coefficient
for β2-m for FX-class® HF dialysers seems to be too low with a value of 0.65.

Ultrafiltration coefficient
The Xevonta HF dialysers exhibit much higher UFcoeff values.
The UFcoeff is the product of the hydraulic permeability and the
dialyser surface area. The higher UFcoeff from Xevonta can be
explained by looking at the relationship of the ultrafiltration rate
(UFR) from the applied TMP [mmHg]:
FME determines the UFcoeff of the FX-class® HF dialysers by
using a TMP of 100 mmHg (blue arrow). An increased pressure of
50 mmHg already results in a higher UFcoeff (red arrow).

Biocompatibility
The Amembris membrane is claimed to possess a smooth inner surface and containing
hydrophilic and hydrophobic domains. Parts of the membrane material are positively or
negatively charged. No further information is available in the brochure.
However, a partly negatively charged dialysis membrane is in general undesireable because it
could lead to coagulation activation (clot formation in the extracorporal circuit) and to the
activation of the kinin system (anaphylactoid reactions due to vasodilation and decrease of the
blood pressure). Thus, this could be a major disadvantage of the Amembris membrane.
Endotoxin retention
Although B.Braun emphazises the importance of the retention of endotoxins from the dialysate
into the patients blood, no further data is given on this for their dialysers.
4.5
Alpha polysulfone as used in B.Brauns Diacap dialysers
4
is propably the basis material of the Amembris
Endotoxin adsorption

3.5
[EU/cm² membrane]

3 membrane.
2.5 Weber et al. (Blood Purif. 2003) investigated the
2
endotoxin permeability of HF dialysers made of different
1.5
polymers. The Helixone® membrane exhibits the highest
1
0.5 endotoxin retention while the Diacap membrane made
0 of α-polysulfone has a significantly lower (>50%)
Polyamid S AN69 ST Helixone® alpha
Polysulfone endotoxin adsorption capacity.

Sterilization

Sterilization residues
• Highly energised γ radiation causes changes of the chemical structure and the physical
properties of the membrane, as well as the potting compound which might lead to the
formation of cytotoxic substances.
• An intensive priming and rinsing is therefore necessary before using an γ irradiated dialyser
from B.Braun but this may not completely prevent the transfer into the blood compartment.
• In comparison, during the INLINE steam sterilization process used for the FME dialysers,
fibres are continuously rinsed with steam (at 121°C), thereby flushing out any toxic
chemicals, sterilisation by-products or pyrogenic residues.
• During this process every dialyser is additionally tested for fibre integrity to ensure absence
blood leaks when the dialysers are in use.

Metabolic activity and DNA synthesis

• An unpublished study by the Fraunhofer Institute in
Germany shows the effect of residual cytotoxins on
the viability of cells in culture obtained from dialysers
after undergoing different sterilisation procedures.
• Irradiated dialysers inhibited metabolic activity of
cells by 70 % to 97% while INLINE steam sterilised
FX-class® dialysers showed a negligible influence.
• Additionally, DNA synthesis was tested. Irradiated
dialysers killed a majority of the cells, while FME
dialysers affected the cells only non-significant.

Contact:
Dr. Konstanze Schröck Dr. Bernd Breuer Dr. Sudhir K. Bowry
+49-(0)6172-609-6985 +49-(0)6172-609-8364 +49-(0)6172-609-2128
Konstanze.Schroeck@fmc-ag.com Bernd.Breuer@fmc-ag.com Sudhir.Bowry@fmc-ag.com