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Sirolimus coated, over the wire (OTW) .035" PTA 316LVM-Stent for dilatation in peripheral angioplasty - Of course Made In Germany

 

 

PRODUCT DETAILS .035

 

Sirolimus coating to prevent restenosis, with a conformal coating of a biodegradable polymer carrier loaded with 1.4 g sirolimus per mm2 stent surface.

Exceptionally smooth and tapered soft tip.

Ultra low entry profile for excellent trackability.

Stent diameter: 4/5/6/7/8/9/10/12mm.

Stent length: 20/40/60/80/100/120/ 150mm.

Catheter length (.035): 80 and 135cm.

Guidewire: Max .035".

Over-the-wire Design, Bi-Lumen design

Nominalpressure 6 bar

RBP between 10 and 16 bar (atm), depending on balloon diameter and length

4-fold for balloon diameters 4 and 5 mm, 5-fold for all other diameters

5F introducer sheath compatibility for diameters 4, 5 and 6 mm, but only up to 6x80 mm. The 6x100 and longer are 6 F compatible.

6F introducer sheath compatibility for all other diameters.

 

 

Technical specifications

 

Type of catheter design

Specially designed for reaching the outmost remote infra-popliteal lesions

Best balance performance:

Pushability, Crossability, Trackability, kink resistance & Flexibility

OTW, semi-compliant, with 2 radio markers; Balloon: max. 0.5 mm longer than the stent

Type of stent design

Slotted tube, open cell

Strut thickness / width

0.0063" (0.16 mm) / 0.0065" (0.165 mm)

Stent Coating

Sirolimus + Fully biodegradable matrix for drug release up to six weeks.

Stent magnetism

Non magnetic

Max. guide wire O.D.

0.035

Catheter lengths

80, 135 cm

Stent and Balloon material

316LVM (stent), Polyn-P (Balloon)

Balloon folds 4 to 5 mm

4 folds memory

Balloon folds 6 to 12 mm

5 folds memory

Stent diameter

4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0 mm

Stent length

20, 40, 60, 80, 100, 120, 150 mm

Introducer

5F introducer sheath compatibility for diameters 4, 5 and 6 mm, but only up to 6x80 mm. The 6x100 and longer are 6 F compatible.

6F introducer sheath compatibility for all other diameters.

Nominal inflation pressure

6 atm (0.6 MPa)

Rated burst inflation pressure

10 and 16 bar (atm), depending on balloon diameter and length

Flexibility

Excellent

Storage

Store in a dry place below 30 C

Keep away from light and heat

Other characteristics

Ultra low entry profile for a-traumatic & excellent trackability

Sterilization

Ethylene oxide gas (ETO)

 

 

Compliance Data (In vitro compliance @ 37.5C, tolerance 0.10 mm)

 

Pressure

atm / MPa

Balloon Diameter (mm)

4.00

5.00

6.00

7.00

8.00

9.00

10.00

12.00

4 / 0.4

3.78

4.80

5.68

6.67

7.45

8.44

9.54

11.53

NOM 6 / 0.6

4.00

5.00

6.00

7.00

8.00

9.00

10.00

12.00

8 / 0.8

4.15

5.15

6.16

7.19

8.31

9.34

10.27

12.24

10 / 1.0

4.28

5.26

6.30

7.33

8.53

9.61

10.45

12.45

11 / 1.1

4.33

5.31

6.37

7.41

8.64

9.76

10.56

12.56

12 / 1.2

4.40

5.37

6.44

7.48

8.77

9.91

10.74

12.69

13 / 1.3

4.46

5.43

6.52

7.55

8.89

10.07

10.83

--

14 / 1.4

4.53

5.49

6.59

7.63

9.00

10.21

10.92

--

15 / 1.5

4.60

5.58

6.67

7.70

9.12

--

--

--

16 / 1.6

4.67

5.64

6.79

7.78

9.25

--

--

--

17 / 1.7

4.75

5.72

6.84

--

--

--

--

--

18 / 1.8

4.83

5.80

--

--

--

--

--

--

 

Nom.: Nominal Pressure: 6 atm/bar, RBP: Rated Burst Pressure (do not exceed):

RBP .035 caths.: 16 atm/bar for 4.0 (all lengths) and 5.0/6.0 (length 20-60 mm);
14 atm/bar for
5.0/6.0 (length 80-150 mm) and 7.0/8.0 (length 20-60 mm);
12 atm/bar for
7.0/8.0 (length 80-150 mm) and 9.0/10.0 (length 20-60 mm);
10 atm/bar for
12.0 (length 20-60 mm)

 

 

Order-Number

 

Stent

Length

(mm)

Stent (mm)

4

5

6

7

8

9

10

12

20

AL162040R

AL162050R

AL162060R

AL162070R

AL162080R

AL162090R

AL1620100R

AL1620120R

40

AL164040R

AL164050R

AL164060R

AL164070R

AL164080R

AL164090R

AL1640100R

AL1640120R

60

AL166040R

AL166050R

AL166060R

AL166070R

AL166080R

AL166090R

AL1660100R

AL1660120R

80

AL168040R

AL168050R

AL168060R

AL168070R

AL168080R

-

-

-

100

AL1610040R

AL1610050R

AL1610060R

AL1610070R

AL1610080R

-

-

-

120

AL1612040R

AL1612050R

AL1612060R

AL1612070R

AL1612080R

-

-

-

150

AL1615040R

AL1615050R

AL1615060R

AL1615070R

AL1615080R

-

-

-

 

 

Drug release rate

 

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