Speciﬁcation
Plasma Separator Evaclio

Hollow ﬁber

Housing

EC-4C20

EC-4C10Material

Ethylene-vinyl alcohol co-polymer

Inner diameter

175 ㎛

Wall thickness

40 ㎛

Material

Polycarbonate

Membrane surface area

2.0 ㎡

1.0 ㎡

Outer dimension

57φx 280 L mm

45φx 280 L mm

Approx. 150 mL

Approx. 82 mL

Priming volumeSterilization

Selective Plasma Exchange with～Reduced loss of coagulation factors～

Gamma-ray irradiation

Note●Please read instructions carefully before using the product.
●Evaclio™ is a trademark of SB-KAWSUMI LABORATORIES, INC.

ANCA - associated Vasculitis

Myasthenia Gravis

Drug Toxication

Toxic Epidermal Necrolysis
KLE-EC4C-2301-03-FF

What is Evaclio?

Selective Plasma Exchange (Selective PE)

Membrane plasma separator with unique permeability

Evaclio is a membrane separator with smaller pore size than conventional plasma

Selective Plasma Exchange using the Evaclio EC-4C retains more coagulation factors than conventional plasma exchange,

separators. It allows small and medium molecular weight proteins to be removed, while

therefore the use of FFP is unlikely to be required. The potential problems with conventional plasma exchange as shown below
can be eliminated by using selective PE.

retaining large molecular weight proteins.

Molecular weight

Small
Potassium
19

Toxic Hepatic Substances

Urea
60

Myoglobin
17,500Creatinine
113

Ammonia17

Large
Complement
170,000

Cytokines
8,000 ˜ 30,000

Albumin
66,000IgG
160,000

Fibrinogen
340,000

Immunocomplex

Problems

high dose of acid citrate

LDL-cholesterol(35nm)

Plasma Exchange with Albumin

IgM
900,000

Selective

Risk of infection or allergic reaction,

Plasma Exchange with FFP

PlasmaLoss of coagulation factors andExchange withother useful substancesEvaclio EC-4C

CRRT

EvaclioTM EC-4C

Flow diagram & setting (example)

PEBlood cell

Replacement ﬂuid

High molecular weight substance (e.g. coagulation factor)(4% Albumin)

Middle molecular weight substance(e.g. Albumin)
Cytokines

Sieving Coeﬃcient
Evaclio EC-4C has sieving coeﬃcient "0" for ﬁbrinogen. It can remove IgG and lower weight molecules, while retaining

QB= 80 〜 100mL/minﬁbrinogen in patients' blood.
EC-2C
EC-4C

●in vitro, human blood●QB=100mL/min, QF=30mL/min

Evaclio EC-4C

1.20
1.07

1.000.80

0.85

0.99

0.95

QF< QB x 30%

0.82
0.73
0.73

0.60
0.46

0.40

0.56

0.62
0.32

Operating procedure

0.50

0.25

0.20
IL-8(8,000)

TNF-α(17,000)

IL-6(21,000)

AT-Ⅲ(65,000)

Alb(66,000)

TPlgG(160,000)

1-1.5 plasma volume

Setting of TMP alarm

150mmHg

0.17

0.16
0.07

0.00

Treatment volume

0FXⅢ(310,000)

0Fib(340,000)

A.Ohkubo et al. Therapeutic Apheresis and Dialysis 17(5):484‒489,2013

Clinical eﬀectiveness

ANCA-associated Vasculitis

Selective PE was performed for 17 patients with MPO-ANCA associated vasculitis.
(2 times/week, average 3.6 times/patient)

Potential indications●MPO-ANCA level decreased an averege of 81% (Fig.1).
●Reduction of ﬁbrinogen was less than DFPP or IAPP (Fig 2).
●Selective PE can be performed with albumin solution for substitution ﬂuid.

Indication

Target substance

Molecular weight

Selective PE may be a safe and eﬀective treatment taking into consideration of the risk of infection or bleeding tendency.

Fig 1. Change of MPO-ANCA

IgG antibody related autoimmune disorders(e.g. ANCA-associated Vasculitis /IgG antibody

160,000（EU）

Myasthenia Gravis / Pemphigus Vulgaris /Cytokines

8,000 〜 30,000

700

Bullous Pemphigoid)

263.8±185.4

600

Toxic Epidermal Necrolysis

soluble Fas-ligand

26,000 (in trimer)(Steven-Johnson syndrome)

Cytokines

8,000 〜 30,000

Fig 2. Fibrinogen reduction（n=17）
Average RR=81%

Circulating Factors

30,000 〜 50,000

Drug Toxication(with molecular weightsmaller than albumin)＜66,000

50.8

40
30

200

067.1

70
50400

24.6

20100

Causative drug

8060

500

300
Recurrent Focal Segmental Glomerulosclerosis（%）

40.3±20.6
Pre treatment

Post treatment

100EC-4C(n=17)
DFPP(n=1)
IAPP(n=1)
Y. Maya et al. Jpn Journal of Apheresis 33(1):26-30,2014