Dialyzer Design Polynephron TM inside. Back To Basics

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Merilyn Boyd
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Back To Basics When we designed this dialyzer, we once again reviewed the human kidney function. The human kidney is an assembly of nephron elements.

2 Back To Basics When we designed this dialyzer, we once again reviewed the human kidney function. The human kidney is an assembly of nephron elements. Therefore, as a starting point, we looked at a single nephron before designing a single hollow fiber. From there, we focused on the overall human kidney functions by redesigning the dialyzer housing and its inside structure. Dialyzer Design Polynephron TM inside 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 products. Our exclusive POLYNEPHRON membrane and the other dialyzer components have been finely tuned based on years of experience and expertise, and this distinguishes our product. The ultra-smooth PU cut surface and the finelyfinished 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.

BPA-Free Polynephron tm Fibers Lighter (BPA-Free) Polypropylene Housing & Headers BPA is an endocrine disruptor, like phthalate DEHP BPA is a component of polycarbonate, polysulfone, epoxy resins,.

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.

3 BPA-Free Polynephron tm Fibers Lighter (BPA-Free) Polypropylene Housing & Headers 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. HO Bisphenol A (BPA) CH 3 OH Improved header shape The caps have been redesigned to reduce channeling at the blood side. CH 3 References: 1) Calafat et al Exposure to bisphenol A and other phenols in neonatal intensive care unit premature infants. Environ Health Perspect; doi: /ehp [Online 10 December 2008] 2) Hugo et al Bisphenol A at environmentally relevant doses inhibits adiponectin release from human adipose tissue explants and adipocytes. Environ Health Perspect 116: ) Lang et al Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults. JAMA 300(11): ) vom Saal et al Bisphenol A and risk of metabolic disorders. JAMA 300(11): (editorial) *Entire Product **Housing & Headers

Improved fibers with Polynephron TM membrane The new rippled structure of the membrane fibers makes spacer yarns unnecessary, resulting in a more homogeneous dialysate flow and a slimmer dialyzer

4 Improved fibers with Polynephron TM membrane The new rippled structure of the membrane fibers makes spacer yarns unnecessary, resulting in a more homogeneous dialysate flow and a slimmer dialyzer design. Optimised asymmetric structure and wall thickness 3D-structure of the membrane The well-balanced mix of hydrophobic (reddish) and hydrophilic (bluish) domains reduces membrane fouling. Improved mechanical strength of the fibers Reduces the risk of fiber leakage. Better contact between dialysate and blood compartment, and higher package density Resulting in higher performances. Uniform distribution of pore sizes Pore sizes are optimized to have the highest possible clearances for low molecular weight proteins, like ß2m, whilst avoiding albumin loss.

In-vitro Clearances Urea In-vivo Clearances Best ß2m and Myoglobin Clearances in HD For middle molecule clearances, the Nipro ELISIO 17H dialyzer demonstrated much better performances than the

5 In-vitro Clearances Urea In-vivo Clearances Best ß2m and Myoglobin Clearances in HD For middle molecule clearances, the Nipro ELISIO 17H dialyzer demonstrated much better performances than the reference filters, with regard to ß2 microglobulin and myoglobin. Remark: Qb300 ml/min; Qd500 ml/min, 8 patients Phosphate ELISIO H Polyflux H Fx-series HI-PS Excellent biocompatibility The Polynephron membrane showed an excellent biocompatibility (WBC, C5a) and thrombogenicity (Platelet count, TAT) as could be expected from a synthetic membrane. White Blood Cell count C5a generation Manufacturers catalogue data Clinical data obtained in Germany, 8 patients, Feb-Mar 2010

6 SERIES SERIES Performance Qf=0 Performance Qf=0 Specifications Specifications 1 In Vitro Test Condition (EN1283) : Qf 0mL/min 2 KUF (EN1283) : Bovine Blood (Hct 32±2%, Protein 60g/L, 37 C), Qb 300mL/min 3 SC (EN1283) : Qb 300mL/min, Qf 60mL/min

NIPRO EUROPE N.V. Europe Headquarters Weihoek 3H 1930 Zaventem Belgium T +32-(0)2-7255533 F +32-(0)2-7257041 www.nipro-europe.

7 NIPRO EUROPE N.V. Europe Headquarters Weihoek 3H 1930 Zaventem Belgium T +32-(0) F +32-(0) Nipro Europe - Netherlands Regus Business Center Verlengde Poolseweg 16 NL-4818 CL Breda Netherlands T: +31-(0) F: +31-(0) Nipro Europe - Italy Centro Direzionale Milanofiori Strada 1 - Palazzo F1 I Assago Milano Italy T: F: Nipro Europe - Spain Poligono Los Frailes n 93 y 94 Daganzo SP Madrid Spain T: F: Nipro Europe - France Biôpole Clermont-Limagne Gerzat France T +33 (0) F +33 (0) Nipro Europe - Poland Ul. Aleja Jana Pawla II, Warsaw Poland T +48 (0) F +48 (0) Nipro Europe - Russia 12 Krasnopresnenskaya Nab. Office nr th Floor - entrance nr. 6 World Trade Center RF Moscow Russia T: F: ELIPP-ENG

RENAL. Cellentia -H. Cellulose triacetate, single-use, hollow-fiber, high-flux hemodialyzer.

RENAL. Cellentia -H. Cellulose triacetate, single-use, hollow-fiber, high-flux hemodialyzer. RENAL Cellentia -H Cellulose triacetate, single-use, hollow-fiber, high-flux hemodialyzer www.nipro.com Confidence from the inside out 30 R & D Industry expertise Trusted worldwide Innovative solutions