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Software: Microsoft Office

The Sirolimus 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 1.4 g Sirolimus/rapamycin 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

1.4 g Sirolimus(Rapamycin) 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

AL200825r

AL2008275r

AL200830r

AL200835r

AL200840r

12 mm

AL201225r

AL2012275r

AL201230r

AL201235r

AL201240r

16 mm

AL201625r

AL2016275r

AL201630r

AL201635r

AL201640r

20 mm

AL202025r

AL2020275r

AL202030r

AL202035r

AL202040r

24 mm

AL202425r

AL2024275r

AL202430r

AL202435r

AL202440rr

28 mm

AL202825r

AL2028275r

AL202830r

AL202835r

AL202840r

32 mm

AL203225r

AL2032275r

AL203230r

AL203235r

AL203240r

38 mm

AL203825r

AL2038275r

AL203830r

AL203835r

AL203840r

42 mm

AL204225r

AL2042275r

AL204230r

AL204235r

AL204240r

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

 

 

 

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