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alco • advanced lightweight constructions • GmbH |
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The Sirolimus
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 1.4 µg 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
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Type of stent design |
Slotted tube, open cell design connected with 3 interlinks per segment |
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Stent design details |
6 zigzag elements per ringelement |
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Standard lengths |
8/12/16/20/24/28/32/38/42 mm |
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Stent material |
316 LVM |
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Expansion range |
2.5/2.75/3.0/3.5/4.0 mm |
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Strut thickness |
0.0039" (0.10 mm) |
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Strut width (main segment) |
0.0047" (0.12 mm) |
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Strut width (interlink) |
0.0039" (0.10 mm) |
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Shortening after expansion |
< 2 % |
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Mechanical recoil |
< 3.0 % |
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Metal coverage |
~ 15 % |
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Longitudinal flexibility |
Excellent |
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Average crossing profile |
0.037" (0.94 mm) |
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Stent magnetism |
Non magnetic |
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Min. guiding catheter I.D. |
0.064” (1.63 mm) |
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Max. guide wire O.D. |
0.014” (0.36 mm) |
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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 |
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Drug product |
A conformal coating of a polymer carrier loaded with 1.4 µg Sirolimus(Rapamycin) per sqmm stent surface |
Order-Number
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Stent length |
Stent diameter |
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2.5 mm |
2.75 mm |
3.0 mm |
3.5 mm |
4.0 mm |
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8 mm |
AL200825r |
AL2008275r |
AL200830r |
AL200835r |
AL200840r |
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12 mm |
AL201225r |
AL2012275r |
AL201230r |
AL201235r |
AL201240r |
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16 mm |
AL201625r |
AL2016275r |
AL201630r |
AL201635r |
AL201640r |
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20 mm |
AL202025r |
AL2020275r |
AL202030r |
AL202035r |
AL202040r |
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24 mm |
AL202425r |
AL2024275r |
AL202430r |
AL202435r |
AL202440rr |
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28 mm |
AL202825r |
AL2028275r |
AL202830r |
AL202835r |
AL202840r |
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32 mm |
AL203225r |
AL2032275r |
AL203230r |
AL203235r |
AL203240r |
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38 mm |
AL203825r |
AL2038275r |
AL203830r |
AL203835r |
AL203840r |
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42 mm |
AL204225r |
AL2042275r |
AL204230r |
AL204235r |
AL204240r |
other lengths and diameters on request
Compliance Data (In vitro compliance @ 37.5°C, tolerance ± 0.10 mm)
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Pressure atm/MPa |
Stent Placement I.D. (mm) |
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2.50 |
2.75 |
3.00 |
3.25 |
3.50 |
3.75 |
4.00 |
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2 / 0.2 |
2.21 |
2.46 |
2.71 |
2.96 |
3.21 |
3.46 |
3.71 |
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4 / 0.4 |
2.31 |
2.56 |
2.81 |
3.06 |
3.31 |
3.56 |
3.81 |
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6 / 0.6 |
2.41 |
2.66 |
2.91 |
3.16 |
3.41 |
3.66 |
3.91 |
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8 / 0.8 (Nom.) |
2.50 |
2.75 |
3.00 |
3.25 |
3.50 |
3.75 |
4.00 |
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10 / 1.0 |
2.56 |
2.81 |
3.06 |
3.31 |
3.56 |
3.78 |
4.08 |
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12 / 1.2 |
2.62 |
2.87 |
3.12 |
3.37 |
3.62 |
3.89 |
4.16 |
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14 / 1.4 |
2.68 |
2.93 |
3.18 |
3.43 |
3.68 |
3.96 |
4.24 |
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16
/ 1.6 (RBP) |
2.74 |
2.99 |
3.24 |
3.49 |
3.74* |
4.02* |
4.30* |
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18 / 1.8 |
2.78 |
3.03 |
3.29 |
3.55 |
3.80 |
4.08 |
4.36 |
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22 / 2.2 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
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24 / 2.4 |
-- |
-- |
-- |
ABP |
ABP |
ABP |
ABP |
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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/