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