alco
• advanced lightweight constructions • GmbH |
|
|
|||||
The paclitaxel eluting
316LVM coronary stent with fully bio-degradable and high-elastic matrix for
precisely controlled drug release up to six weeks |
|
PRODUCT DETAILS Drug product: A conformal coating of a polymer carrier loaded with
1.0 µg 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 µg 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 @ 37.5°C, 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
Copyright
© alco GmbH, All rights reserved
http://www.alco-gmbh.de/