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REXEED REXEED Achieving a new level of comprehensive dialyzer performance

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Page 1: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEEDREXEEDAchieving a new level of comprehensive

dialyzer performance

Page 2: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

The Features of REXEED

The new Membrane REXBRANE and new JACKETenable the best and comprehensive Performance

by Uniform Dialysate Flow Distributionwith Patient friendly Features

Page 3: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED Concept

1. Uniform Flow Distribution of Dialysate

2. Uniform Flow Distribution of Blood

3. World first 2.5 ㎡㎡㎡㎡ Polysulfone Membrane

4. Smaller Priming Volume

5. Retained Biocompatibility Advantage

Ultimate Small MW Clearance and

Comprehensive Performance

Page 4: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

A Combination of new Jacket and REXBRANE

gives the uniform FlowUniform Dialysate Flow Distributiongives great Clearance Performance

REXBRANE

Waved Fiber

Proprietary Biocompatibility

Small Priming Volume

The largest PS ever-2.5 m2

New JacketFull Baffle

Short Taper Structure

Page 5: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Totally New Jacket DesignPC Simulation-1: Effect of Full Baffle

APS REXEED

Page 6: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Short Taper Optimizationby Comp. Simulation

long and gradual taper

polyurethane

Baffle panel partially surrounding bundle

short & sharp taper

polyurethane

Baffle panel wholly surrounding bundle

Straight Bigger

Header

Page 7: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Uniform Dialysate DistributionUniform Dialysate Distribution

DialysateDialysate

Homogenenousdialysate distribution

DialysateDialysate

Uneven dialysate distribution

Page 8: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Impact of Dialysate Flow Distribution on Blood Return (Image)

Un-uniform PressureUniform Pressure

Page 9: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Ideal Pressure Image inside of Jacket

Pressure Distribution

Blood Side P1≒P2

Dialysate P3≒P4

Dialysate

Housing

P1 P2

P3 P4

Fiber

Page 10: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Demonstration of Dialysate Uniform Flow<Dye Analysis>>>>

Fractionated by each ca. 10ml

QD=500ml/min

IncubatorBPB sol.

Each fraction was analyzed for BPB Absorbance

Page 11: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

0.40

0 10 20 30 40 50

Number of exhaust fractions (-)

Abs.(-)590nm

REXEED-15A(199.6)

OPTIFLUX 200NR (199.2)

Polyflux-21R(191.0)

Demonstration of DialysateUniform Flow

REXEED-15

○○○○ Ideal

×××× Broad

×××× Tailing

「「「「Time Course of Absorbance of Dye」」」」

Qb=200mL, QD=500mL/min

Others

Page 12: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Dialyzer

Flexible receiver coil

Dialysate & Blood pumps

MR Imager

receiver coil

dG-DTPA:

Contrast Agent

Wooden Support frame

Proof of Good Flow Distribution-2

- Visualization of Dialysate Flow by MRI -

2005

ASN

Page 13: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

◎◎◎◎ Quick and complete Penetration X No Dialysate Penetration

Page 14: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED-15 FX80

FC1 HTrReXeed

Qb=200/Qd=500 ml/min

Average Speed of Dialysate Flow

In MRI

FPX-180

Qb=200/Qd=500 ml/min

0

5

10

15

20

25

30

35

40

45

50

-20 -15 -10 -5 0 5 10 15 20

Radius (mm)

Sp

eed

(m

m/s

)

Sagittal

2005 ASN TH-PO629

Radius (mm)

0

5

10

15

20

25

30

35

40

45

50

-20 -15 -10 -5 0 5 10 15 20

Sp

eed

(m

m/s

)

Sagittal

Page 15: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED Concept

1. Uniform Flow Distribution of Dialysate

2. Uniform Flow Distribution of Blood

3. World first 2.5 ㎡㎡㎡㎡ Polysulfone Membrane

4. Smaller Priming Volume

5. Retained Biocompatibility Advantage

Ultimate Small MW Clearance and

Total Performance

Ultimate Small MW Clearance and

Comprehensive Performance

Page 16: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Waved Fibers

JA Nagano Koseiren Shinonoi General Hospital

The 20th Congress for High Performance Membrane, ‘05

Waved Fibers make the most of Polysulfone Membrane

Page 17: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXBRANE: A New Waved FiberDesigned to maximize the Performance

in conjunction with new Jacket Structure

APS-S:Straight Φ200μm

REXEED-A:Waved

Φ185μm

Fresenius FX

Fresenius Optiflux

Fresenius F-HPS PS-UW

Polyflux 21RPolyflux 21RPolyflux 21RPolyflux 21R

Page 18: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Expectation

1. Uniform Blood Return

2. Less residual Blood

3. Higher SM Clearance

4. Uniform Performance

Conventional REXEED

Uniform Pressure Balance Imagefor Blood and Dialysate

Page 19: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED Concept

1. Uniform Flow Distribution of Dialysate

2. Uniform Flow Distribution of Blood

3. World first 2.5 ㎡㎡㎡㎡ Polysulfone Membrane

4. Smaller Priming Volume

5. Retained Biocompatibility Advantage

Ultimate Small MW Clearance and

Total Performance

Ultimate Small MW Clearance and

Comprehensive Performance

Page 20: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

In Vitro Performance of REXEEDIn Vitro Performance of REXEED--2525and other Dialyzersand other Dialyzers

REXEED-25

Optiflux 200NR

EXELTRA-210 Plus

ββββ2MG Clearance (mL/min)

Urea Clearance(mL/min)

Alb S.C. 0.010

50

125

0.033330000

0.020

400

350

375

100

75

(in vitro, bovine plasma, Qb=400mL/min. Qd=800mL/min. Qf=17, 20, 25mL/min)

Page 21: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED-S PERFORMANCEmanufacturer’s published data

UREA CLEARANCE

260

265

270

275

280

285

290

REXE

ED 2

5SRE

XEED

21S

Polyflu

x 21

0HRE

XEED

18S

Opt

iflux

F20

0NR

Opt

iflux

F18

0NR

REXE

ED 1

5SPo

lyflu

x 17

0HOpt

iflux

F16

0NR

Polyflu

x 14

0H

Flow Rates Qb 300/Qd 500 (mL/min)

Clearance (mL/min)

Page 22: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED-A Concept

1. Uniform Flow Distribution of Dialysate

2. Uniform Flow Distribution of Blood

3. World first 2.5 ㎡㎡㎡㎡ Polysulfone Membrane

4. Smaller Priming Volume

5. Retained Biocompatibility Advantage

Ultimate Small MW Clearance and

Total Performance

Ultimate Small MW Clearance and

Comprehensive Performance

Page 23: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Priming Volumes

unit::::mmmm

llll

1. Less Priming Volume with same Surface Area

2. Larger Surface Area with NO Priming Volume Increase

81-90

91-100

101-110

111-120

121-130

130<

1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.4 2.5

REXEED 82 95 112 128

Optiflux-NR 83 112

Polyflux-R 121 152 165

Polyflux-H 115 125

Exeltra 95 105 115

Page 24: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

REXEED-A Concept

1. Uniform Flow Distribution of Dialysate

2. Uniform Flow Distribution of Blood

3. World first 2.5 ㎡㎡㎡㎡ Polysulfone Membrane

4. Smaller Priming Volume

5. Retained Biocompatibility Advantage

Ultimate Small MW Clearance and

Total Performance

Ultimate Small MW Clearance and

Comprehensive Performance

Page 25: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Excellent Biocompatibility of Asahi’s PS

W BC406080

1001201400 60 120 180 240Dialysis Duration (m in)Changed Ratio 

(%) APS-15SAA社 PS膜B社 PS膜 C 3a50150250350450550

0 60 120 180 240Dialysis Duration (m in)Changed Ratio  (%) APS-15SAA社 PS膜B社 PS膜WBC C3a

Page 26: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Technical Aspects of REXEEDTechnical Aspects of REXEED

Clinical ExperienceClinical Experience

Page 27: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Clinical Evaluation of Clinical Evaluation of

REXEEDREXEED--15 and PES15 and PESQb=200mL/minQd=500mL/min

0

20

40

60

80

BUN Crea UA iP β2-MG

********

0

2

4

6

****

Alb

Reduction rate (%)

Albumin loss (g/session)(11,800)

REXEED-15 PES

membrane surface area 1.5m2

Kushiro Urology Clinic

The 20th Congress for High Performance Membrane, ‘05

n=4 4hr

* P<0.05**P<0.005

Page 28: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Clinical Evaluation of Clinical Evaluation of

REXEEDREXEED--25 and FB25 and FB--250F250F

0

10

20

30

40

50

60

70

80

UN Crea UA IP β2-MG α1-MG

0.0

0.5

1.0

1.5

2.0

(11,800) (33,000)

Albumin

Reduction rate (%)

Kidney Center, Shirasagi Hospital

The 20th Congress for High Performance Membrane, ‘05Albumin loss (g/session)

Qb=200mL/minQd=500mL/min

REXEED-25 CTA (2.5m2)

Average weight of dialysis patients 75.8±±±±17.6Kg nnnn=8

4hrs

*** **

*** P<0.0001** P<0.01

Mean±SD

Page 29: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

63.0

53.6

68.1

79.5

70.7

55.9

69.1

80.2

0 20 40 60 80 100

Urée

Créatinine

Phosphore

b2m

% Removal Rate

FX 60 Rexeed 15

n=10, Qb=300 Qd=500

France - Cabestany

FX 60 REXEED-15A

Page 30: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Minimum Heparin Requirement (Average)

Saitama School of Medicine

Page 31: Appendix 1C - REXEED PowerPoint · Dialyzer Flexible receiver coil Dialysate & Blood pumps MR Imager receiver coil dG-DTPA: Contrast Agent Wooden Support frame Proof of Good Flow

Complications and possible Causes to Dialyzers

REXEED will Help the Pts by

well Balanced SMW Permeability and Biocompatibility

Solute PermeabilitySolute Permeability

BiocompatibilityBiocompatibility

Dialysis-related Amyloidosis

Numbness Fatigue Hypotension

Swelling Pain Hypertension

Gout Anemia Arrhythmia

Headache Itch Coughing