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Software: Microsoft Office

The filigree Sirolimus eluting cobalt chromium coronary stent with fully bio-degradable matrix for 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.

0.035 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

cobalt chromium alloy L605 (ASTM F 90-01)

Expansion range

2.5/2.75/3.0/3.5/4.0 mm

Strut thickness

0.00315" (0.08 mm)

Strut width (main segment)

0.00315" (0.08 mm)

Strut width (interlink)

0.00315" (0.08 mm)

Shortening after expansion

< 2 %

Mechanical recoil

< 3.0 %

Metal coverage

~ 10 %

Longitudinal flexibility

Excellent

Average crossing profile

0.035" (0.90 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

AL200825cr

AL2008275cr

AL200830cr

AL200835cr

AL200840cr

12 mm

AL201225cr

AL2012275cr

AL201230cr

AL201235cr

AL201240cr

16 mm

AL201625cr

AL2016275cr

AL201630cr

AL201635cr

AL201640cr

20 mm

AL202025cr

AL2020275cr

AL202030cr

AL202035cr

AL202040cr

24 mm

AL202425cr

AL2024275cr

AL202430cr

AL202435cr

AL202440cr

28 mm

AL202825cr

AL2028275cr

AL202830cr

AL202835cr

AL202840cr

32 mm

AL203225cr

AL2032275cr

AL203230cr

AL203235cr

AL203240cr

38 mm

AL203825cr

AL2038275cr

AL203830cr

AL203835cr

AL203840cr

42 mm

AL204225cr

AL2042275cr

AL204230cr

AL204235cr

AL204240cr

 

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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