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Software: Microsoft Office

The paclitaxel eluting 316LVM coronary stent with fully bio-degradable and high-elastic matrix for precisely controlled drug release up to six weeks

Of course Made In Germany

 

 

PRODUCT DETAILS

 

Drug product:

A conformal coating of a polymer carrier loaded with 1.0 g paclitaxel per mm2 stent surface.

Pre-mounted stent onto a double lumen PTCA catheter for rapid exchange use with a semi-compliant balloon, two radio-opaque markers, proximal and distal. 140 cm working length, 25 cm from tip.

Nominal inflation pressure at 8 atm, Rated burst inflation pressure at 16 atm / 14 atm for 3.50 mm @ L > 35 mm and for 4.00 mm @ L > 30 mm.

0.037 average crossing profile. 0.064 min. guiding catheter I.D. 0.014 max. guide wire O.D.

 

 

Technical specifications

 

Type of stent design

Slotted tube, open cell design connected with 3 interlinks per segment

Stent design details

6 zigzag elements per ringelement

Standard lengths

8/12/16/20/24/28/32/38/42 mm

Stent material

316 LVM

Expansion range

2.5/2.75/3.0/3.5/4.0 mm

Strut thickness

0.0039" (0.10 mm)

Strut width (main segment)

0.0047" (0.12 mm)

Strut width (interlink)

0.0039" (0.10 mm)

Shortening after expansion

< 2 %

Mechanical recoil

< 3.0 %

Metal coverage

~ 15 %

Longitudinal flexibility

Excellent

Average crossing profile

0.037" (0.94 mm)

Stent magnetism

Non magnetic

Min. guiding catheter I.D.

0.064 (1.63 mm)

Max. guide wire O.D.

0.014 (0.36 mm)

Stent delivery system

Rapid exchange delivery system, 140 cm working length, 25 cm from tip. A semi-compliant balloon, nominally max. 0.5 mm longer than the stent, with two radiopaque markers. Nominal inflation pressure: 8 atm (0.8 MPa); Rated burst inflation pressure: 16 atm (1.6 MPa) / 14 atm (1.4 MPa) for 3.50 mm, 3.75 mm @ L > 35 mm and for 4.00 mm @ L > 30 mm

Drug product

A conformal coating of a polymer carrier loaded with

1.0 g paclitaxel per sqmm stent surface

 

 

Order-Number

 

Stent

length

Stent diameter

2.5 mm

2.75 mm

3.0 mm

3.5 mm

4.0 mm

8 mm

AL200825x

AL2008275x

AL200830x

AL200835x

AL200840x

12 mm

AL201225x

AL2012275x

AL201230x

AL201235x

AL201240x

16 mm

AL201625x

AL2016275x

AL201630x

AL201635x

AL201640x

20 mm

AL202025x

AL2020275x

AL202030x

AL202035x

AL202040x

24 mm

AL202425x

AL2024275x

AL202430x

AL202435x

AL202440x

28 mm

AL202825x

AL2028275x

AL202830x

AL202835x

AL202840x

32 mm

AL203225x

AL2032275x

AL203230x

AL203235x

AL203240x

38 mm

AL203825x

AL2038275x

AL203830x

AL203835x

AL203840x

42 mm

AL204225x

AL2042275x

AL204230x

AL204235x

AL204240x

other lengths and diameters on request

 

 

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

 

Pressure

atm/MPa

Stent Placement I.D. (mm)

2.50

2.75

3.00

3.25

3.50

3.75

4.00

2 / 0.2

2.21

2.46

2.71

2.96

3.21

3.46

3.71

4 / 0.4

2.31

2.56

2.81

3.06

3.31

3.56

3.81

6 / 0.6

2.41

2.66

2.91

3.16

3.41

3.66

3.91

8 / 0.8 (Nom.)

2.50

2.75

3.00

3.25

3.50

3.75

4.00

10 / 1.0

2.56

2.81

3.06

3.31

3.56

3.78

4.08

12 / 1.2

2.62

2.87

3.12

3.37

3.62

3.89

4.16

14 / 1.4

2.68

2.93

3.18

3.43

3.68

3.96

4.24

16 / 1.6 (RBP)

2.74

2.99

3.24

3.49

3.74*

4.02*

4.30*

18 / 1.8

2.78

3.03

3.29

3.55

3.80

4.08

4.36

22 / 2.2

--

--

--

--

--

--

--

24 / 2.4

--

--

--

ABP

ABP

ABP

ABP

26 / 2.6

ABP

ABP

ABP

--

--

--

--

Nom./Nominal Pressure ABP: Average Burst Pressure

RBP/Rated Burst Pressure (do not exceed)

*14 atm (1.4 MPa) for 3.50 mm, 3.75 mm and L > 35 mm / for 4.00 mm and L > 30 mm

 

 

Drug release rate

 

Software: Microsoft Office

 

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