110317 purema(r)
TRANSCRIPT
-
PUREMAfi - one step closerto physiological sieving
Dr. Stefan Breiter
MEMBRANA GmbHWuppertal Germany
www.membrana.com
-
PUREMAfi : Overview
Based on breakthrough process innovation (patented)
A member of the DIAPES fi family, polymer: polyethersulfone
outstanding biocompatibility
renowned clinical records
Unique process technology provides sharpest sieving cu rve (S.E.T.)
new pore forming technology with patent protection
active blood side surface management facilitates to xin removal
highest middle molecular removal (e.g. 2m)
low albumin loss
improved patented bundle makeup P.E.T. fi
LMW removal: performing better than any other synthetic membrane
The PUREMA fi membrane family covers the range from low to super flux
-
PUREMAfi : New Technology
Unique process technology influences separation profile of membraneformation
thicker separation layer sharpened sieving profile (S.E.T.) optimized dialysate side distribution higher mechanical strength
resulting in
low albumin loss high middle molecule removal maximum low molecular clearance Very high CIS retention
5280
-
PUREMAfi - Chemical Structure
4533
S
0
0
0
PUREMAfi : polyethersulfone
S
0
0
0
conventional polysulfone
0 C
CH3
CH3
-
Polysulfone and Polyethersulfone
Polysulfone and Polyethersulfone are given trivial nam es forsubstances from the same class (polyethers, polysulfones )
chemically, both are very similar
minor differences in hydrophilicity, mechanical and th ermal stability
generally different production principles of the basicpolymer
both are equally suitable as membrane materials
similar production prinicples of the membranes
minute, but decisive differences from manufacturer to manufacturer
-
Cross Section of Different MembranesPolysulfonAPS
PolyfluxPUREMAfi
1069
-
Coreliquid
Polymersolution Cross-section view
Polymer spinningsolution
Core liquid
Spinneret
make-up
winding cutting
wrapping of capillary bundles
PUREMAfi Production Process
membraneformation
pre-extraction
S.E.T. washing drying
4695
-
PET (Poly Ethylene Terephthalate) spacer yarns consist of multifilament threadsintegrated into the fiber bundles
Improves dialysate distribution throughout the dialyzer
Increases clearance values
Maintains consistent performance throughout the entire treatment from dialyser to dialyser
0319
P.E.T.fi : Performance Enhancing Technology
-
Comparison of Bundle Make Up I
Fresenius F-series DIAPES fi Gambro Polyflux S-series
0969
-
Comparison of Bundle Make Up II
Fresenius Optiflux-series PUREMA fi Gambro Polyflux L-series
0970
-
PUREMAfi H
1065
-
PUREMAfi : highest LMW Clearancein vitro Benchmark
220
230
240
250
260
270
280
290
300
1 1,2 1,4 1,6 1,8 2 2,2
Surface area [m]
PUREMAfi HFXOptifluxPolyflux HFPolyflux SAPS
5270
Ure
a cl
eara
nce
[ml/m
in]
QB 300 [ml/min]
PUREMAfi
Fesenius FX-SeriesFresenius Optiflux fi
Gambro Polyflux fi HFresenius F-SeriesGambro Polyflux fi SAsahi Polysulfone
-
PUREMAfi : Stable Low Molecular Clearance
QB = 300 ml/minQD = 500 ml/min8 patients
Clinical Study, March 2005
* p< 0.0530 min vs. 240 min
5524
*
0
50
100
150
200
250
300
Urea Creatinine Phosphate
Cle
ara
nce
[ m
l / m
in ]
30 min.
240 min.*
-
S.E.T.
S.E.T. stands for Sieving Enhancing Technology
unique patented process technology
1. thicker separation layer
2. unchanged ultrafiltration
3. more uniform pore distribution
4. active surface management
steeper sieving curve
more selective removal
5525
-
PUREMAfi H: Uniform Pore Size Distribution
cross-section outer surface inner surface
first generation PES membrane
PUREMAfi
sepa
ratio
nla
yer
1072
-
S.E.T. Sieving Enhancing TechnologyPore Size Distribution
5282
PUREMAfi
Conventional Polysulfone
BSA:10,64 nm //// m: 8,28 nm2-m: 5,94 nmInulin:4,60 nmVit. B12: 2,88 nm
pore size
%
PUREMA H
Fresenius FX
Poly flux S
-
PUREMAfi H sieving curve
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
100 1000 10000 100000
Molecular Weight [Dalton]
SC PUREMA(R) H
FMC FX
Optiflux
Human Kidney
Polyflux H
-
S.E.T. Sieving enhancing technology:active surface management
during the production process, active centres are createdon the blood side (patent protected technology)
these active centres mediate the electrostatic, polar an d hydrophobic interactions of proteins and middle molecul artoxins with the membrane wall
protein adsorption to the membrane and the pores isreduced (reduced clogging)
middle molecular toxins can move more easily through thepores
unprecedented removal characteristics
-
S.E.T. Active Surface ManagementPUREMAfi Blood Side Surface
red: hydrophobicdomains (PES)
green: hydrophilicdomains (PVP)
blue: active centre
1268
-
PUREMAfi : Visibly Reduced Protein Adsorption
1300
Polyamix Polysulfone FXPUREMAfi
Protein adsorption visualised with fluorescent 2m
-
PUREMAfi H Reduced Protein AdsorptionAdsorption of Radioactive Labelled Albumin
5598
0
1
2
3
4
5
6
7
8
9
10
11
Purema H Purema H without S.E.T . Polyflux H140 Polysul fon FX60
Alb
um
in A
dso
rptio
n / u
nits
PUREMAfi H PUREMAfi H
-
SC Profile of PUREMA fi Compared to Other SyntheticMembranes
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
Cytochrome C
siev
ing
coef
ficie
nt
PUREMAfi
Fresenius F-series
Fresenius FX-series
Fresenius Optiflux-series
Gambro Polyflux H-series
0
0,005
0,01
0,015
0,02
BSA
siev
ing
coef
ficie
nt
PUREMAfi
Fresenius F-series
Fresenius FX-series
Fresenius Optiflux-series
Gambro Polyflux H-series
In vitro testing in minimodules5% BSA in PBSQB 200 ml/ min mQF 30 ml/ min m
5276
-
2M Removal
5526
Clinical Studies, July 2004 / March 2005
QB = 300 ml/minQD = 500 ml/min8 patients
* p< 0.05PUREMAfi H vs. FX80and 170H
* *
0
10
20
30
40
50
60
70
80
90
100
corrected by hematocrit corrected according to Bergs trm-Wehle
2M
- r
emo
val R
atio
[ %
]
Polysulfon FX80
Purema H
Polyflux 170 H
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
* *
-
PUREMAfi :Consistently high 2M Clearance Over Time
QB = 300 ml/minQD = 500 ml/min8 patients
Clinical Studies, July 2004 / March 20055527
* *
* p< 0.05PUREMAfi H vs. FX80and 170H
****
** p< 0.0530 min vs. 240 min
0
20
40
60
80
100
120
140
160
30 min 240 min
2M
- C
lea
ranc
e [
ml /
min
]
Polysulfon FX80
Purema H
Polyflux 170 H
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
* *
* ** *
-
Albumin Removal
QB = 300 ml/minQD = 500 ml/min8 patients
Clinical Studies, July 2004 / March 20055528
0
0,5
1
1,5
2
2,5
3
Alb
umin
in d
ialy
sate
[g /
4h]
Polysulfon FX80
Purema H
Polyflux 170H
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
-
Cystatin C Removal
QB = 300 ml/minQD = 500 ml/min8 patients
Clinical Studies, July 2004 / March 20055530
* p< 0.05PUREMAfi H vs. FX80and 170H
* *
0
10
20
30
40
50
60
70
80
corrected by hematocrit corrected according to Bergs trm-Wehle
Cys
tatin
C -
Rem
ova
l Ra
tio [
% ]
Polysulfon FX80
Purema HPolyflux 170 H
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
* *
-
Cystatin C Clearance
Clinical Studies, July 2004 / March 20055531
0
20
40
60
80
100
120
140
30 min 240 min
Cys
tatin
C -
Cle
aran
ce [m
l/min
]
Polysulfon FX80Purema HPolyflux 170 H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
** p< 0.05vs. FX80 and 170H
* p< 0.0530 min vs. 240 min
*
*** **
*
0
20
40
60
80
100
120
140
30 min 240 min
Cys
tatin
C -
Cle
aran
ce [m
l/min
]
Polysulfon FX80Purema HPolyflux 170 H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H, 1.7m
** p< 0.05vs. FX80 and 170H
* p< 0.0530 min vs. 240 min
*
*** **
*
-
Myoglobin Removal
Clinical Study, March 20055532
0
10
20
30
40
50
60
70
80
corrected by hematocrit corrected according toBergstrm-Wehle
Myo
glob
in -
Rem
oval
Rat
io [%
Polysulfon FX80
Purema H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7m
*
* p< 0.05vs. FX80
*
0
10
20
30
40
50
60
70
80
corrected by hematocrit corrected according toBergstrm-Wehle
Myo
glob
in -
Rem
oval
Rat
io [%
Polysulfon FX80
Purema H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7m
*
* p< 0.05vs. FX80
* QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7m
*
* p< 0.05vs. FX80
*
-
Myoglobin Clearance
Clinical Studies, July 2004 / March 20055533
0
10
20
30
40
50
60
70
80
30 min 240 min
Myo
glob
in -
Cle
aran
ce [
ml/
min
]
Polysulfon FX80Purema HPolyflux 170H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8m
PUREMAfi H, 1.7m
Polyflux 170H
0
10
20
30
40
50
60
70
80
30 min 240 min
Myo
glob
in -
Cle
aran
ce [
ml/
min
]
Polysulfon FX80Purema HPolyflux 170H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8m
PUREMAfi H, 1.7m
Polyflux 170H
-
PUREMAfi H Separation Profile
5534
Clinical Studies, July 2004 / March 2005
-50
-25
0
25
50
75
100
125
150
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000Molecular weight [Da]
30
min
Cle
ara
nce
[ml/m
in]
Polysulfon FX 80
Purema H
Polyflux 170H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H
-50
-25
0
25
50
75
100
125
150
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000Molecular weight [Da]
30
min
Cle
ara
nce
[ml/m
in]
Polysulfon FX 80
Purema H
Polyflux 170H
QB = 300 ml/minQD = 500 ml/min8 patients
Polysulfone FX80, 1.8mPUREMAfi H, 1.7mPolyflux 170H
-
PUREMAfi Biocompatibility:White Blood Cell Count
Clinical Studies, July 2004 / March 20055535
QB = 300 ml/minQD = 500 ml/min8 patients
50
60
70
80
90
100
110
0 30 60 90 120 150 180 210 240
T ime [ min ]
WB
C [
% ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
QB = 300 ml/minQD = 500 ml/min8 patients
50
60
70
80
90
100
110
0 30 60 90 120 150 180 210 240
T ime [ min ]
WB
C [
% ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
-
PUREMAfi Biocompatibility:Complement Activation
Clinical Studies, July 2004 / March 20055536
QB = 300 ml/minQD = 500 ml/min8 patients
0
1
2
3
4
5
6
7
0 30 60 90 120 150 180 210 240
Time [ min ]
C5a
[ g
/l ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
QB = 300 ml/minQD = 500 ml/min8 patients
0
1
2
3
4
5
6
7
0 30 60 90 120 150 180 210 240
Time [ min ]
C5a
[ g
/l ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
-
PUREMAfi Biocompatibility:Platelet Count
Clinical Studies, July 2004 / March 20055537
QB = 300 ml/minQD = 500 ml/min8 patients
50
60
70
80
90
100
110
120
0 30 60 90 120 150 180 210 240
T ime [ min ]
Pla
tele
t Cou
nt [
% ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
QB = 300 ml/minQD = 500 ml/min8 patients
50
60
70
80
90
100
110
120
0 30 60 90 120 150 180 210 240
T ime [ min ]
Pla
tele
t Cou
nt [
% ]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
-
PUREMAfi Biocompatibility:Activation of Coagulation
Clinical Studies, July 2004 / March 20055538
QB = 300 ml/minQD = 500 ml/min8 patients
0
2
4
6
8
10
12
14
0 30 60 90 120 150 180 210 240
Time [ min ]
TA
T [
g/l
]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
QB = 300 ml/minQD = 500 ml/min8 patients
0
2
4
6
8
10
12
14
0 30 60 90 120 150 180 210 240
Time [ min ]
TA
T [
g/l
]
Polysulfon FX80Polyflux 170HPurema H
Polysulfone FX80, 1.8mPolyflux 170H, 1.7mPUREMAfi H, 1.7m
-
Reduced Mortality Risk in High-efficiency Hemodiafiltration
Canaud B et al., Kidney Int, 69: 2087-2093, 2006
5638
-
high efficiency (i.e. high volume) HDF has a signif icant survival benefit over HD
it is common sense that this is due to the superior removal of toxins, in particular middle molecules (low mol ecular weight proteins)
in the first clinical studies, PUREMAfi proved its outstanding performance
the 2m clearance and removal found with PUREMAfi in HD corresponds to HDF with replacement volumes exceedi ng 60ml/min with conventional polysulfone membranes
-
2 -Microglobulin Removal in Online Post-dilution HDF with Conventional High-flux Polysulfone
Lornoy W et al (2000)Nephrol Dial Transplant, 15 (Suppl. 1): 49-555
663
orange line representsperformance of PUREMA fi
in HD in first clinical trials
-
2 -Microglobulin Removal in Online Post-dilution HDF with Conventional High-flux Polysulfone
Lornoy W et al (2000)Nephrol Dial Transplant, 15 (Suppl. 1): 49-555
663
orange line representsperformance of PUREMA fi
in HD in first clinical trials
-
Clinical study PUREMA fi H in HDvs. competitors in HDF Prospective, cross-over design, 8 patients,
PUREMAfi H (Bellco "Phylther", 1.7 m) in HD
Fresenius HF80S (1.8 m) in postdilution HDF : QS=60ml/min
Gambro Polyflux 170H (1.7 m) in postdilution HDF : QS=60ml/min
QB=300 ml/min, Q D=500-QS ml/min, 240 min
3 treatments (1 week) with each dialyser
Determination of dialyser efficiency
Instantaneous clearances and reduction rates of low -molecular weight proteins
Albumin loss
-
Low Molecular Clearances (Plasma) 30 Minutes
Clinical Study KSPU0603 October 20065743
0
50
100
150
200
250
Urea Creatinine Phosphate
30 m
in C
lear
ance
[ml/m
in]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
n= 8corrected for surface area
ns
p
-
2-Microglobulin Plasma Clearance
Clinical Study KSPU0603 October 2006
0
20
40
60
80
100
30 min 180 min
2M
- C
lear
ance
[ml/m
in]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
n= 8corrected for surface area
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
HD HDF HDF HD HDF HDF
n.s. n.s.
0
20
40
60
80
100
30 min 180 min
2M
- C
lear
ance
[ml/m
in]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
n= 8corrected for surface area
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
HD HDF HDF HD HDF HDF
n.s. n.s.
-
2-Microglobulin - Removal Rate
Clinical Study KSPU0603 October 20065687
0
10
20
30
40
50
60
70
80
90
100
Removal Ratio
2M
- R
emov
al R
ate
[%]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
p< 0.05 ns
HD HDF HDF0
10
20
30
40
50
60
70
80
90
100
Removal Ratio
2M
- R
emov
al R
ate
[%]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
p< 0.05 ns
HD HDF HDF
-
for comparison: 2-Microglobulin Plasma Clearance for all membranes in HD mode
Clinical Study KSPU0603 October 2006
0
20
40
60
80
100
30 min 180 min
2M
- C
lear
ance
[m
l/min
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
n= 8corrected for surface area
PUREMAfi H1,7HD
Polysulfone HF80SHD, QS= 0ml/min
Polyflux 170HHD, QS= 0ml/min
p< 0.05
p< 0.05
p< 0.05
p< 0.05
p< 0.05
HD HD HD HD HD HD0
20
40
60
80
100
30 min 180 min
2M
- C
lear
ance
[m
l/min
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
n= 8corrected for surface area
PUREMAfi H1,7HD
Polysulfone HF80SHD, QS= 0ml/min
Polyflux 170HHD, QS= 0ml/min
p< 0.05
p< 0.05
p< 0.05
p< 0.05
p< 0.05
HD HD HD HD HD HD
-
Cystatin C - Removal Rate
Clinical Study KSPU0603 October 20065697
0
10
20
30
40
50
60
70
80
RR by BW
Cys
tatin
C -
Rem
oval
Rat
e [%
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
n.s.
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
0
10
20
30
40
50
60
70
80
RR by BW
Cys
tatin
C -
Rem
oval
Rat
e [%
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
n.s.
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
-
Myoglobin - Removal Rate
Clinical Study KSPU0603 October 20065707
0
10
20
30
40
50
60
70
80
RR by BW
Myo
glob
in R
emov
al R
atio
[%]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
p< 0.05
p< 0.05
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
0
10
20
30
40
50
60
70
80
RR by BW
Myo
glob
in R
emov
al R
atio
[%]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
Removal Rate corrected by Bergstrm-Wehle
p< 0.05
p< 0.05
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
-
Retinol Binding Protein - Removal Rate
Clinical Study KSPU0603 October 20065726
-20
-10
0
10
20
30
40
50
60
70
RR by BW
RbP
Rem
oval
Rat
e [%
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
Removal Rate corrected by Bergstrm-Wehle
ns ns
-20
-10
0
10
20
30
40
50
60
70
RR by BW
RbP
Rem
oval
Rat
e [%
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
Removal Rate corrected by Bergstrm-Wehle
ns ns
-
Plasma - 30 min Clearance of Middle Molecules
Clinical Study KSPU0603 October 20065735
-50
-25
0
25
50
75
100
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000
Molecular weight [Da]
30 m
in C
lear
ance
[ml/m
in]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
n= 8 2m CyC
Myo
RbP
-50
-25
0
25
50
75
100
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000
Molecular weight [Da]
30 m
in C
lear
ance
[ml/m
in]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
n= 8 2m CyC
Myo
RbP
-
Plasma - 180 min Clearance of Middle Molecules
Clinical Study KSPU0603 October 20065739
-50
-25
0
25
50
75
100
125
150
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000
Molecular weight [Da]
180
min
Cle
aran
ce [m
l/min
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
n= 8 2m CyC
MyoRbP
-50
-25
0
25
50
75
100
125
150
11000 12000 13000 14000 15000 16000 17000 18000 19000 20000 21000 22000
Molecular weight [Da]
180
min
Cle
aran
ce [m
l/min
]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
n= 8 2m CyC
MyoRbP
-
Albumin in Dialysate
Clinical Study KSPU0603 October 20065709
0,0
0,5
1,0
1,5
2,0
Albumin in dialysate
Alb
umin
in d
alys
ate
[g/4
h]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
ns
ns
0,0
0,5
1,0
1,5
2,0
Albumin in dialysate
Alb
umin
in d
alys
ate
[g/4
h]
PUREMA H1,7
Polysulfone HF80S
Polyflux 170H
HD HDF HDF
n= 8
PUREMAfi H1,7HD
Polysulfone HF80SHDF, QS= 60ml/min
Polyflux 170HHDF, QS= 60ml/min
ns
ns
-
Summary of PUREMA fi H Characteristics in Haemodialysis
Improved biocompatibility with significantly lower complement generation
Significantly enhanced LMW protein removal
Low albumin loss
Steeper sieving profile
PUREMAfi in HD provides LMW protein removal comparabl e to online post-dilution HDF with conventional high- flux membranes
-
Conclusion
Simple haemodialysis with PUREMAfi H may have beneficial effects on the outcome of maintenance dialysis patients similar to high-efficiency HDF wi th conventional synthetic high-flux membranes .
-
Summary of PUREMA fi H
a member of the DIAPES(R) family:proven clinical record, renowned biocompatibility
Significantly enhanced LMW protein removal
Low albumin loss
Steeper sieving profile
stable clearance throughout the treatment
-
Dr. Stefan BreiterScientific Marketing Manager, Healthcare
Membrana GmbHhder Strasse 2842289 Wuppertal
+49 (202) 6099 [email protected]