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SOLACEA™

HIGH FLUX, ATA™ FIBER DIALYZER

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SOLACEA™HIGH F LU X , ATA™ F IBER DI A LY ZER

IMAGINEHistorically, the first membranes used for the hemodialysis were cellulose based. Even today, modified cellulose membranes, cellulose triacetate membranes, are remaining the fibers of choice for patients with hypersensitivity reactions against synthetic fibers.Nowadays, however, synthetic fibers have become the preferred membrane. This switch is empowered by the demand of the new dialysis treatments. High volume hemodiafiltration (HDF), only partially possible with cellulose based membranes, is made achievable by the characteristics of a synthetic membrane, like the asymmetric fibers and chemical composition. The improvement of the dialysis treatments with synthetic fibers is however associated with an increased risk of hypersensitivity reactions.

For these reasons, healthcare providers and patients remain divided between these two different types of dialyzers, due to the unavailability of a product which combines the strengths of both membranes.

Till today.

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UNIQUE FEATURES

Now imagine, a technology able to combine all the advantages typical of the synthetic membranes in terms of treatment, with the benefits of the natural fibers in terms of reduced allergic reactions. A product able to cover the entire range of therapies from standard hemodialysis (HD) up to high volume HDF, reducing at the same time the needs for anticoagulants and limiting the risk of hypersensitivity reactions associated with a synthetic membrane.

This product finally exists: it’s the new SOLACEA™, brought to you by Nipro.

ATA™ (ASYMMETRIC TRIACETATE)SOLACEA allows outstanding performance thanks to its asymmetric structure, yet keeping all the advantages of semi-natural fibers.

SMOOTH MEMBRANE SURFACEReduced membrane fouling, minimizes clogging of the pores and generates a limited TMP build-up.

FULL RANGE OF APPLICATIONS The SOLACEA can perform the ‘simple’ HD treatments up to the ‘advanced’ high volume ‘convective’ HDF.

BPA - FREESOLACEA is free of bisphenol-A, a proven endocrine disruptor and associated with the increased risk of residual kidney function loss.

GAMMA STERILIZEDSterilized by low dose gamma ray. This eliminates the use of ethylene oxide or inline steam with associated extra handling for packaging.

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SOLACEA features an ATA membrane made by a state of the art spinning technique for dialyzer fibers. This results into a thin membrane that, due to its asymmetric structure, can withstand high volume throughput. Its uniform pore distribution on the inner membrane safeguards high clearance of middle size molecules and low albumin loss.

CUTTING-EDGE MEMBRANE TECHNOLOGY

ASYMMETRIC TRIACETATE MEMBRANE

Inner surface (x10.000)

Smooth membrane surface with optimized pore distribution

Membrane cross section (x 5000) Outer surface (x10.000)

Asymmetric supporting layer reduces pressure build-up

HELIXONE™ (PS/PVP) SOLACEA (ATA)

Ra = 11nm | RMS = 15nm Ra = 3.8nm | RMS = 5.0nm

SMOOTH MEMBRANE SURFACESOLACEA’s smooth surface reduces membrane fouling. This decreases pore clogging and the associated performance drop at the beginning of the dialysis session.

Atomic force microscopic (AMF) image. Ra: average roughness; RMS: square-mean roughness

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Effective high volume HDF treatments depend on fibers that can withstand high fluid transferal over the membrane and keeping transmembrane pressure (TMP) at a minimum. SOLACEA features an asymmetric membrane with a smooth surface, which limits TMP buildup, making the membrane ideal for treatments that require high volume fluid subtraction.

INNOVATIVE DIALYZER FOR HIGH VOLUME HDF

EFFECTIVE HIGH VOLUME HDF KEEPING TMP AT MINIMUMAs demonstrated in the graph, the SOLACEA has very low TMP values and the TMP buildup is very low in the first 30 min of HDF treatment.

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EXCELLENT PERFORMANCE WITH LIMITED ALBUMIN LOSS As demonstrated in the graph, the SOLACEA has an excellent performance in high volume HDF, as proven by the removal rate of middle size molecules, as measured by beta-2-microglobulin (β2-M) and myoglobin, with limited loss of albumin. In both cases, the SOLACEA shows low albumin loss, with comparable removal rate for β2-M and high removal rate for myoglobin.

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β2-M removal and albumin loss** Myoglobin removal and albumin loss**

* Qb 350mL/min, Qd 600mL/min, Qs 85mL/min; ** Qb 350mL/min, Qd 600mL/min, Qs 100mL/min. Clinical data from in vivo experiments performed by BioArtProducts, Rostock, Germany in 2015.

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BIOCOMPATIBLE MEMBRANESOLACEA has excellent thrombogenicity and biocompatibility characteristics.

SOLACEA-19H FX CorDiax 800 FX80 Polyflux® 210H

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C5a generation*White blood cell count*

In the first 30 min of the HD treatment the white blood cell count shows a small drop. The increase of complement activation, measured by C5a, is in line with synthetic membranes.

When we look at the platelet count in the first 30 min, we see that there is only a very minor drop, after which it returns to normal levels.

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* Qb 350ml/min, Qd 600ml/min, Qs 0mL/min. Clinical data from in vivo experiments performed by BioArtProducts, Rostock, Germany in 2015.

PERFORMANCEClearance (ml/min)(5) Qb/ Qd (ml/min) 15H 17H 19H 21H 25H

Urea

200/500 196 197 198 199 199

300/500 266 274 278 283 289

400/500 312 323 332 340 352

Creatinine

200/500 191 193 195 198 198

300/500 251 260 267 273 279

400/500 289 301 311 320 331

Phosphate

200/500 185 188 190 194 196

300/500 236 246 254 262 271

400/500 268 282 293 301 318

Vitamin B12

200/500 150 158 164 169 176

300/500 178 189 199 208 220

400/500 193 208 219 230 246

Ultrafiltration CoefficientKUF [mL/hr/mmHg]2 61 69 72 76 87

Sieving Coefficient3

Vitamin B12 1,00

Inulin 1,00

ϐ2-microglobulin 0,85

Myoglobin 0,80

Albumin 0,013

SPECIFICATIONSEffective surface area (m2) 1,5 1,7 1,9 2,1 2,5

Priming volume (ml) 86 98 108 118 139

Effective length (mm) 227 233 245 254 280

Inner Diameter (μm) 200 200 200 200 200

Membrane thickness (μm) 25 25 25 25 25

Maximum TMP (mmHg) 500 500 500 500 500

Pressure DropQb/Qd [mL/min] 200/500 200/500 200/500 200/500 200/500

Blood/Dialysate [mmHg] 51/16 47/18 47/16 45/15 43/8

Material

Membrane ATA™

Housing and Header Polypropylene

Potting compound Polyurethane

Sterilization method Dry gamma

Package 24 pcs/box

In vitro testing conditions (ISO 8637)1. Clearance: Qf 0mL/min2. KUF: bovine blood (Hct 32+- 3%, Protein 60g/L, 37°C), Qb 200mL/min3. SC: Qb 300 mL/min, Qf 60mL/min

SOLACEA™ - H HIGH FLUX

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NIPRO MEDICAL AUSTRIA GMBH : Divischgasse 4, 1210 Wien, AUSTRIA | T: +43 1 532  23 14 | F: +43 1 532  23 14  89NIPRO EUROPE - EGYPT : Nile City Towers, 22nd Floor, North Tower, Nile City, Towers, Cornich El Nile, 11624 Ramelt Beaulac, Cairo, EGYPTNIPRO MEDICAL FRANCE S.A. :Biopôle Clermont-Limagne, 63360 Saint Beauzire, FRANCE | T: +33 (0)473 33 41 00 | F: +33 (0)473 33 41 09NIPRO MEDICAL GERMANY GMBH : Kokkolastrasse 5, 40882 Ratingen, GERMANY | T: +49 (0)2102 564 60 81 | F: +49 (0)2102 564 60 90NIPRO MEDICAL EUROPE NV - ITALY : Centro Direzionale Milanofiori, Strada 1 - Palazzo F1, 20090 Assago (Milano), ITALY | T: +39 (0)2 57 50 00 57 | F: +39 (0)2 57 51 81 11NIPRO MEDICAL EUROPE NV - NETHERLANDS : Verlengde Poolseweg 16, 4818 CL Breda, NETHERLANDS | T: +31 (0)76 524 50 99 | F: +31 (0)76 524 46 66NIPRO MEDICAL NIGERIA LTD. : 9 Adelabu Close, Off Toyin Street, 100271 Ikeja, Lagos State, NIGERIA | T: +234 (0)802 706 7065NIPRO MEDICAL POLAND SP. Z O.O. : Ul. Panska 73, 00-834 Warszawa, POLAND | T: +48 (0)22 31 47 155 | F: +48 (0)22 31 47 152NIPRO EUROPE - PORTUGAL : Avd. Da Liberdade 249, 1° Andar, 1205-143 Lisboa, PORTUGAL | T: +34 (0)91 878 29 21 | F: +34 (0)91 878 28 40

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Please contact your local representative for more information.

ENNipro Renal Care is part of Nipro Corporation Japan, a leading global healthcare company established in 1954. With over 28.000 employees worldwide, Nipro serves the Medical Device, Pharmaceutical, and Pharmaceutical Packaging industries.

Nipro Renal Care is a global market leader with over 5 decades providing renal solutions for dialysis and dialysis-related treatment. We specialize in developing dialysis machines, water treatment systems, and a comprehensive portfolio of disposable medical equipment.

In order to address the needs of patients, healthcare professionals, and procurement managers alike, Nipro Renal Care is driven by innovation and patient safety to offer the highest quality products that optimize time, effort, and costs.

BECAUSE EVERY LIFE DESERVES AFFORDABLE CARE

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