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Page 1: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne
Page 2: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

When we designed this dialyzer, we once again reviewed the human kidney function. Thehuman kidney is an assembly of nephron ele-ments. Therefore, as a starting point, welooked at a single nephron before designing a single hollow fiber. From there, we focused onthe overall human kidney functions byredesigning the dialyzer housing and its inside structure.

Back To Basics

The redesigned housing and its inside structure improve the removal of small molecules as well as low molecular weight proteins, while retaining such essential proteins as albumin. The ELISIO™ dialyzer might look similar to competing pro-ducts. Our exclusive POLYNEPHRON™ membrane and the other dialyzer components have been finely tuned based onyears of experience and expertise, and this distinguishes ourproduct. The ultra-smooth PU cut surface and the finely-finished inner lumen of hollow fibers will not damage blood cells. The inner design of the fiber ensures smooth blood flow. Consequently, the return of blood is easier and there will be minimum residual blood in the dialyzer.

The ELISIO™ dialyzer with its POLYNEPHRON™ membrane is a state-of-the-art and unique dialyzer ready for the current dialysis demands.

Dialyzer DesignPolynephronTMinside

Page 3: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

BPA-FreePolynephrontm Fibers

Improvedheadershape

The caps have been redesignedto reduce channeling

at the blood side.

BPA is an endocrine disruptor,like phthalate “DEHP“

BPA is a component of polycarbonate,polysulfone, epoxy resins, ...

BPA research comments:• There are reports about health risks associated with exposure to BPA (Calafat et al, 2008; Hugo et al, 2008; Lang et al 2008)

• In a recent JAMA editorial, vom Saal (2008) concludes: “even while awaiting confirmation of the findings of Lang et al, developing alternatives to its use are the logical next step to minimize risks to public health”.

Bisphenol A (BPA)

Lighter (BPA-Free)Polypropylene

Housing & Headers

References:1) Calafat et al 2008. Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants. Environ Health Perspect; doi:10.1289/ehp.0800265 [Online 10 December 2008]2) Hugo et al 2008. Bisphenol A at environmentally relevant doses inhibits adiponectin release from human adipose tissue explants and adipocytes. Environ Health Perspect 116:1642-1647.3) Lang et al 2008. Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults. JAMA 300(11):1303-13104) vom Saal et al 2008. Bisphenol A and risk of metabolic disorders. JAMA 300(11):1353-1355 (editorial)

CH3

CH3

HO OH

*Entire Product **Housing & Headers

Page 4: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

Improved fibers withPoLynEPHronTM membrane

The new rippled structure of the membrane fibersmakes spacer yarns unnecessary, resulting in a more

homogeneous dialysate flow and a slimmer dialyzer design.

3D-structure of the membraneThe well-balanced mix of hydrophobic (reddish) and

hydrophilic (bluish) domains reduces membrane fouling.

optimised asymmetric structureand wall thickness

Improved mechanical strengthof the fibersReduces the risk of fiber leakage.

Better contact between dialysate and blood compartment,and higher package densityResulting in higher performances.

Uniform distribution of pore sizesPore sizes are optimized to have the highest possible clearancesfor low molecular weight proteins, like ß2m, whilst avoiding albuminloss.

Page 5: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

Urea

Phosphate ELISIO HPolyflux H

Fx-seriesHI-PS

Clinical data obtained in Germany, 8 patients, Feb-Mar 2010

White Blood Cell count C5a generation

In-vitroClearances

In-vivoClearances

Best ß2m and Myoglobin Clearances in HDFor middle molecule clearances, the Nipro ELISIO™ 17H dialyzer demonstrated muchbetter performances than the reference filters, with regard to ß2 microglobulin and myoglobin.Remark: Qb300 mL/min; Qd500 mL/min, 8 patients

Excellent biocompatibilityThe POLYNEPHRON™ membrane showed an excellent biocompatibility (WBC, C5a) and thrombogenicity (Platelet count, TAT) as could be expected from a synthetic membrane.

Manufacturers’ catalogue data

Page 6: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

Performance Qf=0

SErIES

Performance Qf=0

Specifications

Specifications

SErIES

1 In Vitro Test Condition (EN1283) : Qf 0mL/min2 KUF (EN1283) : Bovine Blood (Hct 32±2%, Protein 60g/L, 37°C), Qb 300mL/min3 SC (EN1283) : Qb 300mL/min, Qf 60mL/min

Page 7: Back To Basics Dialyzer Design Polynephron · Poligono Los Frailes n° 93 y 94 Daganzo SP-28814 Madrid Spain T: +34-91-884 5531 F: +34-91-878 2840 Nipro Europe - France Biôpole Clermont-Limagne

ELIPP-EN

G-201009-002

NIPRO EUROPE N.V.Europe Headquarters

Weihoek 3H1930 Zaventem

BelgiumT +32-(0)2-7255533F +32-(0)2-7257041

www.nipro-europe.com

Nipro Europe - NetherlandsRegus Business Center

Verlengde Poolseweg 16NL-4818 CL Breda

NetherlandsT: +31-(0)76-524 50 99F: +31-(0)76-524 46 66

Nipro Europe - ItalyCentro Direzionale Milanofiori

Strada 1 - Palazzo F1I-20090 Assago Milano

ItalyT: +39-02-575 000 57F: +39-02-575 181 11

Nipro Europe - SpainPoligono Los Frailes n° 93 y 94

DaganzoSP-28814 Madrid

SpainT: +34-91-884 5531F: +34-91-878 2840

Nipro Europe - FranceBiôpole Clermont-Limagne63360 GerzatFranceT +33 (0)473 33 41 00F +33 (0)473 33 41 09

Nipro Europe - PolandUl. Aleja Jana Pawla II, 2300-854 WarsawPolandT +48 (0)22 653 85 98F +48 (0)22 653 85 06

Nipro Europe - Russia12 KrasnopresnenskayaNab. Office nr. 140810th Floor - entrance nr. 6World Trade CenterRF-123610 MoscowRussiaT: +7-495 258 1364F: +7-495 258 1367