Talent® Abdominal Stent Graft

ILIAC EXTENSIONS
Multiple Options for Unique Patient Customization
WITH THE XCELERANT® HYDRO DELIVERY SYSTEM
Product Code
For Medtronic ordering information contact your Medtronic Field Representative.
IXW1010C81XH
IXW1208C75XH
IXW1212C81XH
IXW1410C75XH
IXW1414C80XH
IXW1612C75XH
IXW1616C80XH
IXW1812C140XH
IXW1812C80XH
IXW1814C140XH
IXW1814C75XH
IXW1816C140XH
IXW1816C80XH
IXW1818C140XH
IXW1818C80XH
IXW1820C80XH
IXW1822C80XH
IXW1824C80XH
IXW2016C74XH
IXW2020C79XH
IXW2218C74XH
IXW2222C79XH
BIFURCATED
Product Code
Aortic Extension
22-36 mm
Bifurcated Graft
22-36 mm
~15 mm
~15 mm
~15 mm
Align radiopaque markers for
maximum extension
60 mm
26-30 mm
50 mm
Contralateral
Limb
Flow divider
30 mm
Radiopaque markers
15 mm
Align radiopaque
markers to ensure
30 mm overlap
14 mm
14 mm
Connecting bars
Iliac Extension
AB2212C140XH
AB2212C155XH
AB2214C140XH
AB2214C155XH
AF2412C140XH
AF2412C170XH
AF2414C140XH
AF2414C170XH
AF2612C140XH
AF2612C170XH
AF2614C140XH
AF2614C170XH
AF2616C140XH
AF2616C170XH
AF2618C140XH
AF2618C170XH
AF2814C140XH
AF2814C170XH
AF2816C140XH
AF2816C170XH
AF2818C140XH
AF2818C170XH
AF2820C140XH
AF2820C170XH
AF3014C140XH
AF3014C170XH
AF3016C140XH
AF3016C170XH
AF3018C140XH
AF3018C170XH
AF3020C140XH
AF3020C170XH
AF3214C155XH
AF3214C170XH
AF3216C155XH
AF3216C170XH
AF3218C155XH
AF3218C170XH
AF3220C155XH
AF3220C170XH
AF3416C155XH
AF3416C170XH
AF3418C155XH
AF3418C170XH
AF3420C155XH
AF3420C170XH
AF3618C155XH
AF3618C170XH
AF3620C155XH
AF3620C170XH
Distal
Diameter
(mm)
12
12
14
14
12
12
14
14
12
12
14
14
16
16
18
18
14
14
16
16
18
18
20
20
14
14
16
16
18
18
20
20
14
14
16
16
18
18
20
20
16
16
18
18
20
20
18
18
20
20
Graft Covered
Length
(mm)
140
155
140
155
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
140
170
155
170
155
170
155
170
155
170
155
170
155
170
155
170
155
170
155
170
Stent Graft
Total Length
(mm)
155
170
155
170
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
155
185
170
185
170
185
170
185
170
185
170
185
170
185
170
185
170
185
170
185
Catheter
Diameter
(F)
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
22
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
24
Distal
Diameter
(mm)
8
10
12
12
12
14
14
14
16
16
16
18
18
18
20
20
20
22
22
22
24
24
24
Graft Covered
Length
(mm)
105
105
105
75
90
105
75
90
105
75
90
105
75
90
105
75
90
105
75
90
105
75
90
Stent Graft
Total Length
(mm)
120
120
120
90
105
120
90
105
120
90
105
120
90
105
120
90
105
120
90
105
120
90
105
Catheter
Diameter
(F)
18
18
18
18
18
18
18
18
18
18
18
18
18
18
18
18
18
20
20
20
20
20
20
Distal
Diameter
(mm)
22
24
26
28
30
32
34
36
Graft Covered
Length
(mm)
30
30
30
29
28
28
28
26
Stent Graft
Total Length
(mm)
60
60
60
60
60
60
60
60
Catheter
Diameter
(F)
20
20
20
20
22
22
22
22
CONTRALATERAL LIMBS
Product Code
10-22 mm
30 mm
Align radiopaque markers
to ensure 30 mm
minimum overlap
Proximal
Diameter
(mm)
22
22
22
22
24
24
24
24
26
26
26
26
26
26
26
26
28
28
28
28
28
28
28
28
30
30
30
30
30
30
30
30
32
32
32
32
32
32
32
32
34
34
34
34
34
34
36
36
36
36
8-24 mm
12-20 mm
IW1408C105XH
IW1410C105XH
IW1412C105XH
IW1412C75XH
IW1412C90XH
IW1414C105XH
IW1414C75XH
IW1414C90XH
IW1416C105XH
IW1416C75XH
IW1416C90XH
IW1418C105XH
IW1418C75XH
IW1418C90XH
IW1420C105XH
IW1420C75XH
IW1420C90XH
IW1422C105XH
IW1422C75XH
IW1422C90XH
IW1424C105XH
IW1424C75XH
IW1424C90XH
Proximal
Diameter
(mm)
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
AORTIC EXTENSIONS
8-24 mm
Product Code
F–FreeFlo
B–Bare spring
W–Open web
C–Closed web
Choose from various lengths, diameters, variable tapering and
flaring, and an array of proximal and distal designs to create a
stent graft to your exact specifications.
AXB2222W30XH
AXF2424W30XH
AXF2626W30XH
AXF2828W29XH
AXF3030W28XH
AXF3232W28XH
AXF3434W28XH
AXF3636W26XH
Proximal
Diameter
(mm)
22
24
26
28
30
32
34
36
Proximal
Diameter
(mm)
10
12
12
14
14
16
16
18
18
18
18
18
18
18
18
18
18
18
20
20
22
22
Distal
Diameter
(mm)
10
8
12
10
14
12
16
12
12
14
14
16
16
18
18
20
22
24
16
20
18
22
Indications
The Talent® Abdominal Stent Graft is indicated for the
endovascular treatment of abdominal aortic
aneurysms with or without iliac involvement having:
• Iliac/femoral access vessel morphology that is
compatible with vascular access techniques,
devices, and/or accessories;
• A proximal aortic neck length of ≥ 10 mm;
• Proximal aortic neck angulation ≤ 60°;
• Distal iliac artery fixation length of ≥ 15 mm;
• An aortic neck diameter of 18–32 mm and iliac
artery diameters of 8–22 mm; and
• Vessel morphology suitable for endovascular
repair.
Contraindications
The Talent Abdominal Stent Graft is contraindicated in:
• Patients who have a condition that threatens to
infect the graft.
• Patients with sensitivities or allergies to the
device materials.
Warnings and Precautions
• The long-term performance of endovascular grafts
has not yet been established. All patients should
be advised that endovascular treatment requires
lifelong, regular follow-up to assess their health
and the performance of their endovascular graft.
Patients with specific clinical findings (e.g.,
endoleaks, enlarging aneurysms or changes in the
structure or position of the endovascular graft)
should receive enhanced follow-up. Specific
follow-up guidelines are described in the
Instructions for Use.
• The Talent Abdominal Stent Graft System should
only be used by physicians and teams trained in
vascular interventional techniques, including
training in the use of the device. Specific training
expectations are described in the Instructions
for Use.
• Always have a vascular surgery team available
during implantation or reintervention procedures
in the event that conversion to open surgical
repair is necessary.
• The Talent Abdominal Stent Graft System is not
recommended in patients unable to undergo or
who will not be compliant with the necessary
preoperative and postoperative imaging and
implantation studies as described in the
Instructions for Use.
• After endovascular graft placement, patients
should be regularly monitored for perigraft flow,
aneurysm growth or changes in the structure or
position of the endovascular graft.
• Inappropriate patient selection may contribute to
poor device performance.
• Exercise care in handling and delivery technique
to aid in the prevention of vessel rupture.
• Patients experiencing reduced blood flow through
the graft limb and/or leaks may be required
to undergo secondary interventions or surgical
procedures.
• Intervention or conversion to standard open
surgical repair following initial endovascular repair
should be considered for patients experiencing
enlarging aneurysms and/or endoleak. An
increase in aneurysm size and/or persistent
endoleak may lead to aneurysm rupture.
• Prior to the procedure, pre-operative planning for
access and placement should be performed.
See Instructions for Use.
• Renal complications may occur:
- From an excess use of contrast agents.
- As a result of emboli or a misplaced stent graft.
The radiopaque marker along the edge of the
stent graft should be aligned immediately
below the lower-most renal arterial origin.
Graft Covered
Length
(mm)
81
75
81
75
80
75
80
140
80
140
75
140
80
140
80
80
80
80
74
79
74
79
Stent Graft
Total Length
(mm)
95
90
95
90
95
90
95
155
95
155
90
155
95
155
95
95
95
95
90
95
90
95
Catheter
Diameter
(F)
18
18
18
18
18
18
18
20
18
20
18
20
18
20
18
18
20
20
18
18
20
20
WITH THE XCELERANT® HYDRO DELIVERY SYSTEM
• Studies indicate that the danger of microembolization increases with increased duration of
the procedure.
• Inadequate seal zone may result in increased risk
of leakage into the aneurysm or migration of the
stent graft. Other possible causes of migration are
deployment of the proximal spring into a
thrombus-filled or severely angled vessel wall.
• The safety and effectiveness of the Talent
Abdominal Stent Graft System has not been
evaluated in some patient populations. Please
refer to the product Instructions for Use for details.
MRI Safety and Compatibility
Non-clinical testing has demonstrated that the Talent
Abdominal Stent Graft is MR Conditional. It can be
scanned safely in both 1.5T & 3.0T MR systems under
certain conditions as described in the product
Instructions for Use. For additional information
regarding MRI please refer to the product Instructions
for Use.
Adverse Events
Potential adverse events include (not arranged in any
particular order): Amputation; Anesthetic
complications and subsequent attendant problems
(e.g., aspiration); Aneurysm enlargement; Aneurysm
rupture and death; Aortic damage (including
perforation, dissection, bleeding, rupture and death);
Arterial or venous thrombosis and/or
pseudoaneurysm; Arteriovenous fistula; Bleeding,
hematoma or coagulopathy; Bowel complications
(e.g., ileus, transient ischemia, infarction, necrosis);
Cardiac complications and subsequent attendant
problems (e.g., arrhythmia, myocardial infarction,
congestive heart failure, hypotension, hypertension);
Claudication (e.g., buttock, lower limb); Death;
Edema; Embolization (micro and macro) with
transient or permanent ischemia or infarction;
Endoleak; Fever and localized inflammation;
Genitourinary complications and subsequent
attendant problems (e.g., ischemia, erosion, fistula,
incontinence, hematuria, infection); Hepatic failure;
Impotence; Infection of the aneurysm, device access
site, including abscess formation, transient fever and
pain; Lymphatic complications and subsequent
attendant problems (e.g., lymph fistula); Neurologic
local or systemic complications and subsequent
attendant problems (e.g., confusion, stroke, transient
ischemic attack, paraplegia, paraparesis, paralysis);
Occlusion of device or native vessel; Pulmonary/
respiratory complications and subsequent attendant
problems (e.g., pneumonia, respiratory failure,
prolonged intubation); Renal complications and
subsequent attendant problems (e.g., artery
occlusion, contrast toxicity, insufficiency, failure);
Surgical conversion to open repair; Vascular access
site complications (including infection, pain,
hematoma, pseudoaneurysm, arteriovenous fistula,
dissection); Vascular spasm or vascular trauma (e.g.,
iliofemoral vessel dissection, bleeding, rupture,
death); Vessel damage; Wound complications and
subsequent attendant problems (e.g., dehiscence,
infection, hematoma, seroma, cellulitis); Stent graft
complications: improper component placement,
incomplete component deployment, component
migration, suture break, occlusion, infection, stent
fracture, graft twisting and/or kinking, insertion and
removal difficulties, graft material wear, dilatation,
erosion, puncture, and perigraft flow.
Please reference product Instructions for Use for more
information regarding indications, warnings,
precautions, contraindications and adverse events.
CAUTION: Federal (USA) law restricts this device to
sale by or on the order of a physician.
Notes and References:
1. Difficult access is defined as tortuous iliac anatomies. Bench testing data on file. 2. Crossing profile similar to
or lower than closest competitors. 3. Competitive devices were tested with Cook Introducer sheaths, 18F with
the Gore Excluder, and 20F with the Cook Zenith. Test units were all 28 mm bifurcated stent grafts. 4. Talent®
Abdominal Stent Graft System Instructions For Use. 5. Gore Excluder® AAA Endoprosthesis Instructions for Use.
6. Zenith® AAA Endovascular Graft Instructions For Use. 7. Talent on all delivery systems.
www.medtronic.com
www.talentstentgraft.com
Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
USA
Tel: 707.525.0111
Talent® Abdominal Stent Graft
CardioVascular LifeLine
Customer Support
Tel: 877.526.7890
Tel: 763.526.7890
Product Services
Tel: 888.283.7868
Fax: 800.838.3103
For distribution in the USA only. © 2008 Medtronic, Inc. All rights reserved. Printed in the USA. Trademarks are property of their respective owners. UC200902101aEN 11/09
Talent® Abdominal Stent Graft
Expanding the Indications for EVAR
Treat More Patients
Designed to Deliver
Short Necks
Excellent Patient Outcomes
Low Profile
• The Talent Abdominal Stent Graft is the only FDA-approved
device for proximal aortic neck length as short as 10 mm
Over 12 Years of Worldwide Experience7
• Xcelerant Hydro Delivery System facilitates stent graft treatment in patients with difficult access1
• More than 45,000 patients implanted worldwide
• System does not require a sheath, unlike Gore and Cook systems
• Over 150 peer-reviewed articles
• Never withdrawn from any market for reasons related to safety and effectiveness
A Comparison of Delivery System Profiles2,3
Talent Xcelerant
Hydro Delivery System4
Gore Excluder System5
Artery Diameter: 7.3 mm
Artery Diameter: 7.3 mm
Angled Necks
• Designed with approximately 15 mm suprarenal stent
length for conformability to angulated anatomy
Sheath Diameter: 24F
Inner
Diameter:
(18F)
Inner
Diameter:
(20F)
Sheath Required
Sheath Required
Inner
Diameter:
N/A
Sheath Not Required
Artery Diameter: 8 mm
Sheath Diameter: 22F
Delivery System
Diameter: 22F
• Approved for aortic neck angulation up to 60 degrees
Cook Zenith System6
Excellent Clinical Results
US PMA Pivotal Clinical Data at 12 Months
98%
Hydrophilic Coating
Large Necks
0
• Designed to aid navigation through tight and tortuous iliacs
• Approved to treat up to 32 mm diameter necks
• Available in stent graft sizes from 22-36 mm
Wide Range of Sizes
• Most extensive offering of main bodies and extensions
on the market – over 1,150 combinations
Pre-Operative Angiogram
• Tapered and flared iliac limb sizes from 8 to 24 mm
• Full spectrum of sizes available up to 36 mm, including 34 mm for complete spectrum of choice
Easy and Accurate Three-Step Deployment
A Comparison of Aortic Neck Device Diameters
1
2
Medtronic Talent
Cook Zenith®
Gore Excluder®
22
24
26
28
30
Size (mm)
32
34
36
Post-Operative Angiogram
3
Freedom from aneurysm-related mortality
No reported ruptures or conversions
96.5%
Freedom from secondary endovascular procedures
100%
Stent graft patency
0.8%
Migration