Dialyser Design PolynephronTMinside

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2 Back To Basics When we designed this dialyser, 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 fibre. From there, we focused on the overall human kidney functions by redesigning the dialyser housing and its inside structure.

3 Dialyser Design PolynephronTMinside The redesigned housing and its inside structure improves removal of small molecules as well as low molecular weight proteins, while conserving such essential proteins as albumin. The ELISIO dialyser might look similar to competing products. Our exclusive POLYNEPHRON membrane and the other dialyser elements 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 fibres will not damage blood cells. The inner design of the fibre ensures smooth blood flow. Consequently, the return of blood is easier and there will be minimum residual blood in the dialyser. The ELISIO dialyser with its POLYNEPHRON membrane is state of the art and unique dialyser ready for the current dialysis demands.

4 Optimized use of m Optimized dialysa Perfect d Treatment for all patients This dialyser uses less priming solution than other dialysers currently on the market. The ELISIO TM dialysers are available from 0,9-2,5 m 2. Weight reduction During the development of the ELISIO TM dialyser we also looked at the environmental impact. This resulted in a significant weight reduction.

5 embrane quantity te flow dynamics egassing Improved header shape The caps have been redesigned to reduce channeling at the blood side. Ultra-smooth PU-cut surface During the production of the dialyser the cutting of the potting is done in such away that the surface is mirror-like, making it smoother and less damaging for blood cells. ELISIO TM Competitor ELISIO TM Competitor

6 Improved fibres with POLYNEPHRON TM membrane The new rippled structure of the membrane fibres makes spacer yarns unnecessary, resulting in a more homogeneous dialysate flow and a slimmer dialyser design. 3D-structure of the membrane The well-balanced mix of hydrophobic (reddish) and hydrophilic (bluish) domains reduces membrane fouling.

7 Optimised asymmetric structure and wall thickness Improved mechanical strength of the fibres Reduces the risk of fibre 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.

8 In-vitro Clearances Urea Phosphate ELISIO H Polyflux H Fx-series HI-PS

9 In-vivo Clearances Best ß2m Clearances in HD and HDF Independently of the treatment mode, the Nipro ELISIO 190H dialyser demonstrated much better performances than the reference filters, with regard to ß2 microglobulin Remarks : Qb400/Qd700 /Qs 80 ml/min Excellent biocompatibility The POLYNEPHRON TM 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 Clinical data obtained in Germany, 8 patients, Jan 2008

10 SERIES Performance Qf=0 ELISIO Clearances (ml/min) 1 Qb/Qd(mL/min) 90H 110H 130H 150H 170H 190H 210H 250H Urea 200/ / / / / Creatinine 200/ / / / / Phosphate 200/ / / / / Vitamin B12 200/ / / / / Inulin 200/ / / / / Myoglobin 200/ / / / / KUF (ml/hr/mmhg) Sieving Coefficient 3 Vitamin B12 0,989 Inulin 0,926 Myoglobin 0,223 Albumin 0,002 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

11 Specifications ELISIO 90H 110H 130H 150H 170H 190H 210H 250H Effective Surface Area (m 2 ) 0,9 1,1 1,3 1,5 1,7 1,9 2,1 2,5 Priming Volume (ml) Effective Length (mm) Inner Diameter (µm) Membrane Thickness (µm) Maximum TMP (mmhg) Membrane Polynephron TM Materials Housing Polycarbonate Header Polycarbonate Potting Compound Polyurethane Sterilization Method Dry Gamma Package 24 pcs/box

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