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Making possible personal.
MED
IUM
CUT
-OFF
MEM
BRAN
E
TYPICAL PATIENT PROFILE: PATIENTS REQUIRING HIGHER CLEARANCES OF LARGER UREMIC TOXINS, WITHOUT ACCESS TO HDF
HDx THERAPY, ENABLED BY THE THERANOVA DIALYZERThe THERANOVA dialyzer, featuring an innovative membrane, effectively targets large middle molecules not efficiently removed by currently available dialysis treatments. It provides the opportunity for an expanded hemodialysis therapy, HDx, providing HDF performance and beyond in the removal of middle and larger middle molecules, using regular HD infrastructure.
Do not use THERANOVA dialyzers for HDF or HF due to higher permeability of larger molecular weight proteins such as albumin.
HDF PERFORMANCE AND BEYOND, AS SIMPLE AS HD• Markedly greater clearances and intradialytic reduction ratios than
regular HD – at ordinary blood flow rates1
• Equivalent removal of small and conventional middle molecules to high-volume HDF – Greater removal possible for larger middle molecules2
• Albumin removal limited to between 1 and 4 grams1,2
• Compatible with any HD monitor3 and with standard-quality dialysis fluid quality4,5
ACHIEVED THROUGH MEMBRANE INNOVATION• Higher permeability6,7
• Enhanced selectivity by size exclusion6,7
• A step closer to the natural kidney6,7
CLINICAL PERFORMANCE1,2
IN VITRO CLEARANCESIn vitro clearances are indicated in (ml/min) ± 10%
UREA
60
Da
PHOS
PHAT
E
95 D
a
Qd 300 Qd 500 Qd 800540
500
460
420
380
340
300
260
220
180
140
100
Clea
ranc
e [m
l/min
]
THERANOVA 400 – UREA
Qb 200 Qb 300 Qb 400 Qb 500
191198
199246
272
344
376
285
445
388
282
293
540
500
460
420
380
340
300
260
220
180
140
100
THERANOVA 500 – UREA
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
192199
200250
276
351
381
288
454
397
285
295
500
460
420
380
340
300
260
220
180
140
100
THERANOVA 400 – PHOSPHATE
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
179192
196225
250
311
345
266
400
348
261
279
500
460
420
380
340
300
260
220
180
140
100
THERANOVA 500 – PHOSPHATE
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
182194
197230
256
320
354
271
413
358
267
283
100
ml/min
80
60
40
20
0beta 2
microglobulin 11818 Da
myoglobin
17000 Da
kappa free light chains
22500 Da
complement factor D24000 Da
alpha 1microglobulin
33000 Da
lambda free light chains
45000 Da
HD FX Cordiax 80HDx Theranova 400 Standard error (SE)
OVERALL CLEARANCE HDx VS. HD1
HDx with THERANOVA 400 dialyzer HD with latest generation high-flux dialyzer Qb = 300 ml/min – Treatment Time = 4 h (Mean) – n = 19
100
%
80
60
40
20
0beta 2
microglobulin 11818 Da
myoglobin
17000 Da
kappa free light chains
22500 Da
complement factor D24000 Da
alpha 1microglobulin
33000 Da
YKL-40
40000 Da
lambda free light chains
45000 Da
HD FX Cordiax 80HDx Theranova 400 Standard error (SE)
REDUCTION RATIO HDx VS. HD1
HDx with THERANOVA 400 dialyzer HD with latest generation high-flux dialyzer Qb = 300 ml/min – Treatment Time = 4 h (Mean) – n = 19
100
ml/min
80
60
40
20
0beta 2
microglobulin 11818 Da
myoglobin
17000 Da
kappa free light chains
22500 Da
complement factor D24000 Da
alpha 1microglobulin
33000 Da
lambda free light chains
45000 Da
HDF post FX Cordiax 800HDx with Theranova 400 Standard error (SE)
OVERALL CLEARANCE HDx VS. HDF2
HDx with THERANOVA 400 dialyzer HDF with latest generation high-flux dialyzer for HDF Qb = 400 ml/min – Treatment Time = 4.4 h – Vconv = 24L (Mean) – n = 20
100
%
80
60
40
20
0beta 2
microglobulin 11818 Da
myoglobin
17000 Da
kappa free light chains
22500 Da
complement factor D24000 Da
alpha 1microglobulin
33000 Da
YKL-40
40000 Da
lambda free light chains
45000 Da
HDF post FX Cordiax 800HDx with Theranova 400 Standard error (SE)
REDUCTION RATIO HDx VS. HDF2
HDx with THERANOVA 400 dialyzer HDF with latest generation high-flux dialyzer for HDF Qb = 400 ml/min – Treatment Time = 4.4 h – Vconv = 24L (Mean) – n = 20
**p<0.001 vs. high-flux HD *p<0.01 vs. HDF**p<0.001 vs HDF
340
300
260
220
180
140
100
THERANOVA 400 – VITAMIN B12
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
148
164
174
178
199
239
267
214
301
264
207
227
340
300
260
220
180
140
100
THERANOVA 500 – VITAMIN 12B
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
152
169
178
185
206
249
280
222
317
277
215
236
CREA
TINI
NE
113
Da
500
460
420
380
340
300
260
220
180
140
100
THERANOVA 400 – CREATININE
Qd 300 Qd 500 Qd 800Cl
eara
nce
[ml/m
in]
Qb 200 Qb 300 Qb 400 Qb 500
184194
198232
258
323
357
273
416
362
269
285
500
460
420
380
340
300
260
220
180
140
100
THERANOVA 500 – CREATININE
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
186
196
199237
263
331
365
278
428
372
274
288
INUL
IN
5.2
kDa
VITA
MIN
B12
1.
4 kD
aCY
TOCH
ROM
E C
12
kDa
MYO
GLOB
IN
17 k
Da
260
220
180
140
100
THERANOVA 400 – INULIN
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
119
133
144
140
156
183
204
169
225
200
161
178
260
220
180
140
100
THERANOVA 500 – INSULIN
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
124
139
150
147
164
193
216
178
241
213
170
188
220
180
140
100
THERANOVA 400 – CYTOCHROME C
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
109
122
133
128
142
165
183
153
202
180
146
161
220
180
140
100
THERANOVA 500 – CYTOCHROME C
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
114
128
139
134
150
175
196
162
217
192
155
171
180
140
100
60
THERANOVA 400 – MYOGLOBIN
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
93
104
114
108
119
137
152
129
166
150
123
135
180
140
100
60
THERANOVA 400 – MYOGLOBIN
Qd 300 Qd 500 Qd 800
Clea
ranc
e [m
l/min
]
Qb 200 Qb 300 Qb 400 Qb 500
98
110
120
114
127
147
163
138
180
161
130
144
DISTRIBUTORBaxter Corporation7125 Mississauga RoadMississauga, ON L5N 0C2
INDICATIONS FOR USE
Indications For Use THERANOVA dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. Do not use for hemodia - filtration, hemofiltration due to higher permeability of larger molecular weight proteins such as albumin
COMPONENTS MATERIALS
Membrane Polyarylethersulfone / PAES / PVP – BPA-free
Polyvinylpyrrolidone
Potting Polyurethane PUR
Housing, Header Polycarbonate PC
Gasket Silicon rubber SIR
Protection Cap Polypropylene PP
MEMBRANE
Membrane design Asymmetric wall, 3-layer finger structure Medium Cut-Off, narrow pore size distribution For the safe and proper use of device, please refer the Instructions for Use
Effective Membrane Area [m2] 1.7 2.0
Fiber Dimension
– Inner diameter [µm] 180– Wall thickness [µm] 35
Sterilizing Agent Steam
Sterile Barrier Medical Grade Paper
BLOOD COMPARTMENT
Blood Compartment Volume [ml] 91 105
Residual Blood Volume [ml] <1
DIALYSIS FLUID QUALITY REQUIREMENTS4,5
Minimum Requirements Standard Dialysis Fluid Quality ISO 11663:2014 or ANSI/AAMI RD62 standard
PERFORMANCES*
UF-coefficient [ml/(h-mmHg)] 48 59
Pressure Drop – Blood Compartment [mmHg]
Qb=200 ≤90 ≤80
Qb=300 ≤130 ≤120
Qb=400 ≤170 ≤160
Qb=500 ≤210 ≤200
Qb=600 ≤250 ≤240Pressure Drop – Dialysate Compartment [mmHg]Qd=300 ≤20 ≤15
Qd=500 ≤30 ≤25
Qd=800 ≤50 ≤40
LIMITS FOR USE
Maximum TMP [mmHg] 600
Operating blood flow range [ml/min] 200-600
Operating dialysate flow range [ml/min] 300-800
STORAGE CONDITIONS
Storage conditions <30 °C; <86 °F
The Dialyzer
CAM
P/M
G20
9/17
-000
6
THERANOVA 400 THERANOVA 400THERANOVA 500 THERANOVA 500
The products meet the applicable provisions of Annex I (Essential Requirements) and Annex II (Full quality assurance system of the Council Directive 93/42/EEC of 14 June 1993, amended by Directive 2007/47/EC)
For safe and proper use of the device, please refer to the Instructions for Use
1. Kirsch A, et al. Large Middle Molecule Removal During Hemodialysis Using A Novel Medium Cutoff Dialyzer. ERA-EDTA 2016, Abstract SP4162. Krieter D, et al. Clinical Performance of Medium Cutoff Hemodialysis versus High-Flux Hemodialysis and High-Volume Hemodiafiltration. ERA-EDTA 2016, Abstract MP4643. Baxter. Data on file. Theranova Limited Controlled Distribution Report 20164. Baxter. Theranova 400/500 Instructions For Use. N50 6485. Hulko M, et al. Dialysis membrane pore size does not determine LPS retention. ERA-EDTA 2015, Abstract FP5166. Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports (2015); 5: 184487. Krause B, et al. Highly selective membranes for blood purification. Euromembrane Congress 2015, Abstract E139
Baxter, Gambro, Making Possible Personal and Theranova
are trademarks of Baxter International Inc. or its subsidiaries.
* According to ISO 8637: UF-coefficient: measured with bovine blood, Hct 32%, Pct 60g/l, 37°CPressure drop blood: measured with bovine blood, Hct 32%, Pct 60g/l, 37°C, UF = 0 ml/minPressure drop dialysate: measured with dialysate