Chapter 6 Gregory J. Dubel and Timothy P. Murphy Stents and stent-grafts have a variety of applications for image-guided interventions, including both vascular and nonvascular uses. Many stents marketed in the United States are U.S. Food and Drug Administration (FDA) approved for treating biliary or tracheobronchial stenoses, although recently more have gained FDA approval for intravascular use (Tables e6-1, e6-2, and e6-3; also see discussions of individual stents). TABLE e6-1 Balloon-Expandable (BX) Stents TABLE e6-2 TABLE e6-3
Stents
Introduction
Device
Company Name
FDA Indication
Critical Features
Metal
Minimum Introducer (F)
Maximum wire (in)
Stent Diam. (mm)
Stent Length (mm)
Assurant Cobalt
Medtronic Inc.
Iliac, Biliary
High strength/radiopacity, minimal foreshortening, mod flexibility, fused module design, smaller cells
CoCr
6
0.035
6-8
20, 30, 40, 60
9-10
30, 40, 60
Express Iliac LD
Boston Scientific
Iliac, Biliary
Mod strength, min foreshortening, flexible, micro/macro modules assist conformability
316 L-SS
6
0.035
5-8
17, 27, 37
7
0.035
8
57
7
0.035
9, 10
25, 37, 57
Express Renal SD
Boston Scientific
Renal, biliary
Low-profile version of Express with similar attributes
316 L-SS
5
0.018
4, 5
15, 19
5
0.018
6
14, 18
6
0.018
7
15, 19
Formula 414 RX/Formula 418
Cook Medical
Biliary
Mod strength/radiopacity, no foreshortening, low-profile on par w/Cobalt designs, min balloon overhang
316 L-SS
5,6
0.014 (414 RX) 0.018 (418)
3-8
12, 16, 20, 24, 30
IntraStent Double Strut LD
ev3/Covidien
Biliary
Mod-high radial strength/radiopacity, mod-high flexibility, no foreshortening, open-cell
316 L-SS
8
Unmounted
9-12
16, 26, 36, 56, 76
IntraStent Mega LD
ev3/Covidien
Biliary
Mod-high radial strength/radiopacity, mod flexibility, no foreshortening, open-cell
316 L-SS
9
Unmounted
9-12
16, 26, 36
IntraStent Max LD
ev3/Covidien
Biliary
High radial strength/radiopacity, moderate flexibility, no foreshortening, open-cell
316 L-SS
11
Unmounted
12
16, 26, 36
Palmaz (M, L, or XL)
Cordis Endovascular
Iliac (L), Iliac/Renal (M), Biliary (XL)
High strength/radiopacity, closed-cell design, variable foreshortening, can be overdilated, poor flexibility, unmounted stents require crimper from manufacturer
316 L-SS
6, 7 (M)
Unmounted
4-8
10, 15, 20, 29, 39 (biliary ind)
8-12 (L)
8-12
30
10-12 (XL)
Unmounted
10 (over dil 14-26)
30, 40, 50
Palmaz Blue
Cordis Endovascular
Biliary
As per Palmaz Blue with monorail delivery
CoCr alloy (L605)
5
0.014
5-6
15, 18
Increased strength/flexibility/radiopacity, decreased metal surface area, increased cell size compared with Genesis, improved MRA
5
0.018
4-7
12, 15, 18, 24
Palmaz Genesis
Cordis Endovascular
Biliary
As per Genesis with monorail delivery
316 L-SS
4-6
0.014
4-7
12, 15, 18, 24
Strength near Palmaz, more flexible/conformable/trackable, less foreshortening, closed cell, proprietary nesting on balloon, final length dependent upon dilation diameter
5, 6
0.018
3-8
12, 15, 18, 24, 29, 39
6,7
0.035
4-10
12, 15, 18, 24, 29, 39, 59, 79
Palmaz Genesis (unmounted)
Biliary
As per Genesis, unmounted, requires manufacturer crimper
316 L-SS
6
7-7.5
8
Unmounted
5-8
5-10
10-12
12, 15, 18, 24
29, 39, 59, 79
19, 25, 29, 39, 59
ParaMount Mini GPS
ev3/Covidien
Biliary
Tantalum markers at end, low-profile, minimal foreshortening, open small cells, conformable, flexible, zero balloon overhang
316 L-SS
5
6
0.014, 0.018
5, 6
7
14, 18, 21
14, 18, 21
Visi-Pro
ev3/Covidien
Biliary
Tantalum markers at end, no foreshortening, low-profile, open small cells, conformable, flexible, zero balloon overhang
316 L-SS
6
0.035
5-8
12 (ex 8 mm), 17, 27, 37, 57
7
0.035
9-10
17, 27, 37, 57
Racer
Medtronic Inc.
Biliary
Mod-high strength, more flexible/conformable/trackable, min foreshortening, small cells, proprietary stent retention system, improved MRA
Co alloy (MP35N)
5, 6
0.014, 0.018
4-7
12, 18
RX Herculink Elite
Abbott Vascular
Renal, biliary
Mod-high strength/radiopacity, mod-high flexibility, open small cell, low foreshortening, stent retention system, monorail
CoCr
5
0.018
4, 4.5, 5, 5.5, 6, 6.5, 7
12 (ex 7 mm), 15, 18
Omnilink
Abbott Vascular
Biliary
Mod strength/radiopacity, mod-high flexibility, low foreshortening, small cells, can be overdilated
316 L SS
5, 6, 7, 8
0.018
4-10
18, 28, 38, 58
5, 6, 7, 8
0.035
5-10
12, 16, 18, 28, 38, 58
Valeo
Bard Peripheral Vascular
Biliary
Mod radial strength and radiopacity, flexible, open cell
316 L SS
6
7
0.035
0.035
6,7,8
9,10
18, 26, 36, 56 (ex 8 × 56)
18, 26, 36, 56 (ex 8 × 56)
Device
Manufacturer
FDA Indication
Critical Features
Metal
Min Introducer (OD) (F)
Max wire (in)
Stent Diameter (mm)
Stent Length (mm)
Delivery System Length (cm)
Notes
Rx Acculink
Abbott Vascular
Carotid
Monorail, small cells/good scaffolding, fixed handle deployment, for use with Accunet EPS
Nitinol
6
0.014
5-10 straight
20, 30, 40
126
6-8, 7-10 taper
30, 40
Absolute Pro
Abbott Vascular
Biliary
Injectable triaxial delivery catheter, platinum markers at ends
Nitinol
6
0.035
5-10
20, 30, 40, 60, 80, 100
80, 135
Inject delivery catheter
Complete SE
Medtronic Inc.
Iliac
Open small cells, tantalum markers at ends
Nitinol
6
0.035
6-10
20, 40, 60, 80, 100
80, 120
Iliac, biliary
Nitinol
6
0.035
4-10
20-150
120
Gold markers
Supera Veritas
IDEV Technologies
Biliary
Woven, highly flexible, conformable, closed cell
Nitinol
6
0.035
4-8
40, 60, 80, 100, 120
120
Dynalink
Guidant
Biliary
Mod size open cells, highly conformable, fixed handle deployment
Nitinol
6
0.018
5-10
28, 38, 56, 80, 100
80, 120
Can inject sheath w/stent in place, accurate deployment system
LifeStent Vascular
LifeStent XL
LifeStent Solo
Bard Peripheral Vascular
SFA/prox pop
Small open-cell design, platinum markers, rotating knob delivery catheter
As LifeStent but with ratchet handle delivery system
Nitinol
6
0.035
0.035
0.035
6-7
6-7
6-7
20, 30, 40, 60, 80,
100, 120, 150, 170
200
80, 130
80, 130
80, 130
E·Luminexx
Bard Peripheral Vascular
Iliac, biliary
Small cell size, large welded Ta markers, enhanced electropolishing, ratchet delivery
Nitinol
6
0.035
7-10
20, 30, 40, 50, 60, 80, 100
80, 135
Tantalum markers
Neuroform
Boston Scientific
HDE wide-neck intracranial aneurysms
Designed for intracranial/small-vessel use, min foreshortening, highly conformable, Humanitarian Device Exemption (HDE)
Nitinol
5
0.014
2.5, 3, 3.5, 4, 4.5
10, 15, 20, 30
Precise
Cordis Endovascular
Biliary
OTW, low-profile S.M.A.R.T., extremely flexible/conformable, segmented
Nitinol
6
0.018
5-10
20, 30, 40
135
Precise RX
Cordis Endovascular
Biliary
Monorail version of Precise
Nitinol
5
0.014
5-7
20, 30, 40
135
6
0.014
8-10
20, 30, 40
135
Precise Carotid
Cordis Endovascular
Carotid
OTW, autotapering, use with Emboshield EPS
Nitinol
5.5
6
0.018
0.018
5-8
9-10
20, 30, 40
20, 30, 40
135
135
Precise Pro RX
Cordis Endovascular
Carotid
Monorail, autotapering, use with Emboshield EPS
Nitinol
5
0.014
5-18
20, 30, 40
135
5 F 6-8, 6F 9-10
6
0.014
9-10
20, 30, 40
135
Protege GPS
ev3/Covidien
Biliary
Flexible, retention lock prevents stent jumping, tantalum markers at ends, zero foreshortening
Nitinol
6
0.018
6-10
20, 30, 40, 60, 80
135
6
0.035
9, 10, 12, 14
20, 30, 40, 60, 80
80, 120
Protege EverFlex
ev3/Covidien
Biliary
As per Protege GPS with added flexibility
Nitinol
6
0.035
5-8
20, 30, 40, 60, 80, 100, 120, 150 (150 not avail in 5 mm)
80, 120
Protege BIGGS
ev3/Covidien
Biliary
Large-diameter version of Protege EverFlex
Nitinol
6
0.035
9-14
20, 30, 40, 60, 80
80, 120
Protege RX
ev3/Covidien
Carotid
Carotid version of Protege, monorail, use w/SpiderFX EPS
Nitinol
6
0.018
6-10 straight
20, 30, 40, 60
n/a
6
0.018
6-8, 7-10 taper
30, 40
n/a
Sentinol
Boston Scientific
Biliary
Variable cell size, platinum markers, proprietary surface prep to decrease corrosion
Nitinol
6
0.035
5-10
20, 40, 60, 80,
75, 135
S.M.A.R.T.
Cordis Endovascular
Biliary
Small cell size, highly conformable, segmented
Nitinol
7
0.035
6-8
120, 150
120
S.M.A.R.T. Control
Cordis Endovascular
Biliary
As per S.M.A.R.T. plus coined tantalum markers, w/thumb screw delivery system
Nitinol
6
0.035
9-10
30, 40, 60, 80
80, 120
7
0.035
12-14
30, 40, 60, 80
80, 120
Iliac
6
0.035
6, 7, 8
20, 30, 40, 60, 80, 100
80, 120
6
0.035
9, 10
20, 30, 40, 60
80, 120
Symphony
Boston Scientific
Biliary
Hexagonal, large cells from shaped nitinol wire, less flexible, mod hoop strength, platinum markers
Nitinol
7
0.035
5-8, 10, 12, 14
20, 22, 23, 40, 44, 60
75, 110
Wallstent (various designs)
Boston Scientific
Carotid
Iliac
Venous
Biliary
Tracheobronchial
TIPS
Braided, foreshortens, use with FilterWire EPS
Elgiloy
5-6
0.014
6, 8, 10
21, 22, 24, 29, 36, 37
135
Braided, high flexible/scaffolding, closed-cell, 20%-50% foreshortening, reconstrainable, multiple designs (iliac, biliary, etc.)
6
0.035
6-10
18-69 various
100, 160
6-10
0.035
10, 12, 14, 16
20, 40, 42, 60, 68, 90, 94
75
6-9
0.035
8, 10, 12
20, 40, 42, 60, 68, 90, 94
75
6-12
0.035
5-24 various
20-94 various
135
7-9
0.035
10, 12
40, 42, 60, 68, 90, 94
75
Xact
Abbot Vascular
Carotid
Monorail, closed cell, straight and tapered styles, use w/Emboshield
Nitinol
6
0.014
7-10 straight
20, 30
135
0.014
6-8, 7-9, 8-10 taper
30, 40
Xceed
Abbott Vascular
Biliary
Small cell size, highly conformable, coined radiopaque markers
Nitinol
6
0.035
5-8
20, 30, 40, 60, 80
80, 120
Xpert
Abbott Vascular
Biliary
Very low profile, highly open cell, low chronic outward force, small vessel applications
Nitinol
4
0.018
3-6
20, 30, 40, 60
80, 120
Nitinol
5
0.018
8
30, 40, 60
80, 120
Zilver 518
Zilver 518 RX
Zilver 635
Zilver 635 Biliary
Cook Medical
IliacBiliary
Small, open cell design, gold markers, no foreshortening
Nitinol
5
0.018
6-10
20, 30, 40, 60, 80
125
Nitinol
5
0.018
6-10
125
Nitinol
6
0.035
6-10
80, 125
Nitinol
6
0.035
4, 5, 12, 14
80, 125
Enterprise
Codman Neurovascular
Wide-neck intracranial aneurysms
Closed-cell, one-time recapture, radiopaque markers at ends of stent
Nitinol
via microcath >0.021 ID
n/a
4.5
14, 22, 28, 37
135
Wingspan
Boston Scientific
HDE for intracranial atherosclerotic disease
Open-cell, flexible, radiopaque markers at ends, HDE
Nitinol
5
0.014
2.5, 3, 3.5, 4, 4.5
9, 15, 20
131
Device
Company Name
FDA Indication
Critical Features
Construction
Introducer Size (F)
Max wire (in)
Device Diameter (mm)
Device Length (mm)
aSpire
Vascular Architects
Vascular Architects
Biliary
Flexible, mod foreshortening, reconstrainable, tantalum markers, side-branch patency
ePTFE-covered helically shaped nitinol ribbon
7
8
0.018
0.035
6 -9
6-10, 12
25, 50, 100, 150
25, 50, 100, 150
Fluency Plus
Bard Peripheral Vascular
Tracheobronchial
Flexible, min foreshortening, low profile, tantalum markers
Nitinol w/internal and external layer ePTFE
8-9
0.035
6-10
40, 60, 80
Flair
Bard Peripheral Vascular
AV hemodialysis Grafts
Flared end, flexible, min foreshortening, low profile, tantalum markers
Nitinol w/internal and external layer ePTFE
9
0.035
6-9
30, 40, 50
iCast/Advanta
Atrium Medical
Tracheobronchial
Balloon-expandable, min foreshortening, small delivery sheath
316 L-SS balloon-expandable stent encapsulated w/ePTFE
6
0.035
5-9
16, 22, 38, 59
7
0.035
10,12
38, 59
Viabahn
W.L. Gore & Associates
SFA, iliac, tracheobronchial
Min foreshortening, flexible/conformable, must be covered w/sheath, heparin coating
ePTFE externally supported with nitinol wire
6
0.018
5-6
25, 50, 100, 150
7
0.018
7-8
11-12
0.035
9-11, 13
25, 50, 100, 150
Viabil
W.L. Gore & Associates
Biliary
Biliary use, proximal anchors, w or w/o drainage holes
ePTFE externally supported with nitinol wire
10
0.035
8, 10
40, 60, 80, 100
Viatorr
W.L. Gore & Associates
TIPS
A 2-cm uncovered portal end, markers at hepatic end, and junction uncovered/covered
Dual-layer ePTFE externally supported with nitinol wire
10
0.038
8,10,12
60, 70, 80, 90, 100
Wallgraft
Boston Scientific
Tracheobronchial, biliary
Reconstrainable, 20%-50% foreshortening, non-flared ends
Braided Elgiloy filaments covered w/ PET
9-12
0.035
6-12
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