AneuRx AAAdvAntAge Stent graft Xcelerant

AneuRx AAAdvantagE Stent Graft
with Xcelerant® Hydro Delivery System
Medtronic Ordering Information
Contact your Medtronic sales representative
BIFURCATED
Xcelerant® Hydro System—Designed to Deliver
Expect the same ease of use, accuracy, and control—now with advanced hydrophilic
technology to aid stent graft delivery
Drag/Friction Force of Outer Sheath2
Reduced Friction
Xcelerant Delivery
System
Hydrophilic coating to aid navigation
through tight and tortuous iliacs
Product
Code
Aortic
Diameter
(mm)
Iliac
Diameter
(mm)
Stent
Graft Length
(cm)
Catheter
Diameter
(F)
BFXCH2012135
20
BFXCH2012165
20
12
13.5
21
12
16.5
BFXCH2213135
22
21
13
13.5
21
BFXCH2213165
BFXCH2414135
22
13
16.5
21
24
14
13.5
21
BFXCH2414165
24
14
16.5
21
BFXCH2615135
26
15
13.5
21
BFXCH2615165
26
15
16.5
21
BFXCH2816135
28
16
13.5
21
BFXCH2816165
28
16
16.5
21
ILIAC LIMBS (STRAIGHT)
Product
Code
68x reduction
in friction
Xcelerant Hydro
Delivery System
0
2
4
6
8
10
12
14
Force (N)
Dual Taper
Currently the only dual-tapered sheath on the market facilitates insertion and retraction
of entire delivery catheter
21F
18F
Low Profile
Low profile characteristics for excellent tracking and access through small vessels
28 mm Bifurcated AAA Device Outer Diameter Profiles3-5,a
16
ILIAC LIMBS (FLARED)
Stent Graft Catheter
Diameter Length Diameter
(mm)
(cm)
(F)
Inner
Diameter
N/A
Outer Diameter: 21.4F
Sheath Not Required
a
Excluder
®
Inner
Diameter
(18F)
Outer Diameter: 22F
Sheath Required
Zenith
®
Inner
Diameter
(20F)
Outer Diameter: 24F
Sheath Required
ompetitive devices were tested with Cook introducer sheaths, 18F with the Gore Excluder, and 20F
C
with the Cook Zenith.
Product
Code
Proximal Distal Stent Graft Catheter
Diameter Diameter Length Diameter
(mm)
(mm)
(cm)
(F)
ILXCH121285
12
8.5
16
>ILXCH1620115
16
20
11.5
19
ILXCH1212115
12
11.5
16
>ILXCH1620135
16
20
13.5
19
>ILXCH1212135
12
13.5
16
>ILXCH1822115
18
22
11.5
19
ILXCH131385
13
8.5
16
>ILXCH1822135
18
22
13.5
19
ILXCH1313115
13
11.5
16
>ILXCH1824115
18
24
11.5
19
>ILXCH1313135
13
13.5
16
>ILXCH1824135
18
24
13.5
19
ILXCH141485
14
8.5
16
ILXCH1414115
14
11.5
16
>ILXCH1414135
14
13.5
16
ILXCH151585
15
8.5
16
ILXCH1515115
15
11.5
16
>ILXCH1515135
15
13.5
16
ILXCH161685
16
8.5
16
ILXCH1616115
16
11.5
16
>ILXCH1616135
16
13.5
16
>ILXCH181885
18
8.5
19
>ILXCH1818115
18
11.5
19
>ILXCH1818135
18
13.5
19
>ILXCH202085
20
8.5
19
>ILXCH2020115
20
11.5
19
>ILXCH2020135
20
13.5
19
ILIAC EXTENDER CUFFS (STRAIGHT)
AneuRx
AAAdvantage®
Contraindications
There are no known contraindications currently
associated with this device.
Stent Graft Catheter
Length Diameter
(cm)
(F)
Product
Code
Diameter
(mm)
IEXCH121255
12
5.5
16
IEXCH131355
13
5.5
16
IEXCH141455
14
5.5
16
IEXCH151555
15
5.5
16
IEXCH161655
16
5.5
16
>IEXCH181855
18
5.5
19
>IEXCH202055
20
5.5
19
ILIAC EXTENDER CUFFS (FLARED)
Product
Code
Proximal Distal Stent Graft Catheter
Diameter Diameter Length Diameter
(mm)
(mm)
(cm)
(F)
>IEXCH162085
16
20
8.5
19
>IEXCH182285
18
22
8.5
19
>IEXCH182485
18
24
8.5
19
> I ndicates expanded product offerings with AneuRx
AAAdvantage.
AORTIC EXTENDER CUFF
Stent Graft Catheter
Length Diameter
(cm)
(F)
Product
Code
Diameter
(mm)
AEXCH202040
20
4
21
AEXCH222240
22
4
21
AEXCH242440
24
4
21
AEXCH262640
26
4
21
AEXCH282840
28
4
21
NOTE: Aortic extender cuffs do not feature Resilient
graft material.
Medtronic CardioVascular Product Services
3576 Unocal PlaceTel: 800.961.9055
Santa Rosa, CA 95403
Fax: 800.929.2133
USA
Tel: 707.525.0111
www.Medtronic.com
References: 1. AneuRx® AAA Stent Graft System Clinical Update—Volume IV. Medtronic, Inc. 2007. 2. Data on file.
Medtronic CardioVascular; Santa Rosa, CA.; 2007. 3. AneuRx AAAdvantage® Stent Graft with Xcelerant® Hydro Delivery
System Instructions for Use. 4. Gore Excluder® AAA Endoprosthesis Instructions For Use. 5. Zenith® AAA Endovascular
Graft Instructions For Use. 6. Heikkinen MA, Alsac JM, Arko FR, Metsänoja R, Zvaigzne A, Zarins CK. The importance of
iliac fixation in prevention of stent graft migration. J Vasc Surg. 2006;43(6):1130-1137.
Warnings and Precautions
FDA approval of the AneuRx device on September, 28, 1999
was based upon one-year follow-up data. The clinical
information in this Brief Statement has been updated
from the information originally submitted to the FDA for
approval to include updated clinical information available
to Medtronic as of August 1, 2003 (the clinical data
freeze date for the 2003 PMA Annual Report).
The AneuRx Stent Graft is intended to
prevent rupture of abdominal aortic
aneurysms. however, this risk is not
completely eliminated. Based on reports
received for patients enrolled in all phases
of the clinical study, through August 1, 2003,
ruptures have occurred in 2/1193 (0.167%)
patients during the operative period; in 3/1193
(0.251%) patients within 30 days of treatment;
and in 15/1193 (1.257%) patients greater than 30
days after treatment. The one-year freedom
from rupture rate for patients enrolled in
all phases of the clinical study is 99.5%; the
two-year freedom from rupture rate is 98.6%;
the three-year freedom from rupture rate is
98.5%; the four-year freedom from rupture
rate is 97.2%; and the five-year freedom from
rupture rate is 97.2%.
The long-term safety and effectiveness of this implant
have not been established. All patients with endovascular
aneurysm repair must undergo periodic imaging to
evaluate the stent graft, aneurysm size, and occlusion
of vessels in the treatment area. Significant aneurysm
enlargement (>5 mm), the appearance of a new
endoleak, evidence of perigraft flow, change in
aneurysm pulsatility, or migration resulting in an
inadequate seal zone should prompt further
investigation and may indicate the need for additional
intervention or surgical conversion.
Exercise care in the handling and delivery technique to aid
in the prevention of vessel rupture. If an AneuRx Stent
Graft is placed with less than one centimeter length of
nonaneurysmal tissue at the proximal or distal end
attachment sites, there is potential for leaking or migration
due to inadequate apposition of the stent graft.
• Inappropriate patient selection may contribute to poor
device performance. Preliminary data indicate that
patients with an aortic neck angle >45 degrees may
have a higher likelihood of suboptimal outcomes
compared to patients with an aortic neck angle <45
degrees. The same data indicate that patients with an
aortic seal length of <15 mm and an iliac seal length of
<25 mm may also have a higher likelihood of
sub-optimal outcomes.
• This device should only be used by physicians and
teams trained in vascular interventional techniques,
including training in the use of the device.
• Do not use the AneuRx Stent Graft in patients unable
to undergo the necessary preoperative and
postoperative imaging and implantation studies.
• The results of the clinical studies indicated that
patients who experience an unsuccessful endovascular
repair attempt, and as a result undergo conversion to
surgical Abdominal Aortic Aneurysm (AAA) repair, are
likely to have increased complications arising from both
procedures (i.e., cardiac complications, fever, infection,
musculoskeletal complications, neurological
complications, pulmonary complications, vascular
disease, vessel dissection, wound healing issues, and
mortality).
• The safety and effectiveness of the AneuRx Stent
Graft System for the treatment of abdominal aortic
aneurysms have not been evaluated in patients:
– With aneurysms pending rupture
– With connective tissue disorder
– With hypercoagulability
– With mesenteric artery occlusive disease
– With ilio-femoral, thoracic, or inflammatory
aneurysms
– With juxtarenal AAA
– With pararenal AAA
– With suprarenal or thoracoabdominal aneurysms
– Who are morbidly obese
– Pregnant or nursing
– Less than 18 years old
– With less than one-year life expectancy
• Always have a vascular surgery team available at
institutions performing endovascular grafting in the
event that conversion to open surgical repair is
required.
Patient Selection, Treatment and Follow-Up
• Do not use this device in patients having an active
systemic infection.
• Do not use this device in patients with sensitivities or
allergies to the device materials. The materials include:
polyether block amide (PEBA); polyether block amide
(PEBA) with tungsten filler; polyether block amide
(PEBA) with barium sulfate filler; acrylonitrilebutadiene-styrene (ABS) copolymer; glass-filled
acrylonitrile-butadiene-styrene (ABS) copolymer;
polyethe­retherketone (PEEK); polyvinyl chloride (PVC);
stainless steel; ethylene propylene rubber; Nylon;
silicone; polycarbonate; cyanoacrylate; nickel/titanium
(nitinol); tantalum; and polyester. The AneuRx Stent
Graft with Xcelerant Delivery System is latex-free.
• The results of the clinical study indicate that women
treated with this device may have a higher mortality
rate as compared to their male counterparts.
• The use of this device requires administration of
radiographic agents. Patients with preexisting renal
insufficiency may have an increased risk of renal failure
postoperatively.
• Proper use of this device requires accurate fluoroscopic
imaging. This device is not recommended for patients
whose weight exceeds 350 lb (150 kg) or whose weight
may impede accurate fluoroscopic imaging.
• Regular follow-up including imaging of the device
should be performed every 3 to 6 months for patients
in the enhanced surveillance group and at least every
6 to 12 months for patients in the routine surveillance
group (see IFU for patient follow-up
recommendations). During the recommended
follow-up imaging schedule, patients should be
monitored for aneurysm size, occlusion of vessels,
change in pulsatility, migration, leaks, and device
integrity.
• Additional treatment including endovascular
treatment or surgical conversion should be strongly
considered in the following cases:
– Aneurysm growth >5 mm (with or without leak)
since last follow-up
– Change in aneurysm pulsatility (with or without
growth or leak)
– Persistent endoleak with or without aneurysm
growth
– Stent graft migration resulting in an inadequate
seal zone
• The results of the clinical study indicate that subjects
experiencing reduced blood flow through the graft
limbs and/or leaks may be required to undergo
secondary interventions or minor surgical procedures.
• Non-clinical testing has demonstrated that the
AneuRx Stent Graft is MR Conditional. It can be
scanned safely under the following conditions:
– Static magnetic field of 3-Tesla or less
– Spatial gradient field of 720 Gauss/cm or less
– Maximum whole-body-averaged specific absorption
rate (SAR) of 3 W/kg for 15 minutes of scanning.
Adverse Events
Death, AAA rupture, bleeding, cardiac failure/infarction,
edema, wound healing complications, impotence,
pulmonary complications, renal failure, gastrointestinal
complications, arterial vascular occlusion, and venous
vascular occlusion.
Potential adverse events include: arterial and venous
occlusion (includes thrombosis and thromboembolism),
arterial trauma/dissection/perforation, bleeding, cardiac
failure/infarction, central or peripheral nervous system
impairment, coagulopathy, death, edema, endoleak,
erosion with fistula or pseudo-aneurysm, gastrointestinal complications, graft dilatation, graft migration,
graft occlusion, impotence, infection, loss of device
integrity: stent fractures, graft wear holes, suture
breaks, pulmonary/respiratory complications, renal
insufficiency/failure, ruptured vessel/aneurysm, and
wound healing complications.
Please reference appropriate product Instructions for
Use for a more detailed list of indications, warnings,
precautions and potential adverse events.
CAUTION: Federal (USA) law restricts this device to
sale by or on the order of a physician.
AneuRx AAAdvantage® Stent Graft
with Xcelerant® Hydro Delivery System
For distribution in the USA only. ©2008 Medtronic, Inc. All rights reserved. Trademarks are the property of their respective owners. UC200804112EN 1/08
Indications
The AneuRx Stent Graft System is indicated for the
endovascular treatment of infrarenal abdominal aortic
or aorto-iliac aneurysms having:
• Adequate iliac/femoral access
• Infrarenal nonaneurysmal neck length of greater than
1 cm at the proximal and distal ends of the aneurysm
and an inner vessel diameter approximately 10-20%
smaller than the labeled device diameter
• Morphology suitable for endovascular repair
• One of the following:
– Aneurysm diameter of >5 cm
– Aneurysm diameter of 4-5 cm which has also
increased in size by 0.5 cm in the last 6 months
– Aneurysm which is twice the diameter of the normal
infrarenal aorta.
®
Designed to deliver
The Evolution of the 7th Generation—
Built on a Solid Foundation
Post-Market Clinical Data Are More Reflective of Current
Implant Techniques and Designs
AAAdvantage Stent Graft—Designed to Perform
AneuRx AAAdvantage® Stent Graft System is safe and effective, without
compromise, for your EVAR procedures1,a
Contemporary clinical data continue to show the safety and efficacy of the AneuRx platform
AAAdvantage stent graft is uniquely designed with 3 methods of fixation for better stability,
durability, and performance, leading to improved patient outcomes
1
Post-Market Surveillance Resultsa
• Eleven years of continuous improvement in techniques and design
Three Methods of Fixation
Columnar Strength
Superior columnar strength2 facilitates graft stability using solid anatomical fixation6
• The most robust long-term data set of any AAA stent graft
• The most implanted AAA stent graft in the world
No. of Patientsb
Results
Migration
334
1
AneurysmRelated Rupture
334
1
c
Radial force
Active, high radial force2 offers excellent support and conformability with aortic wall
• The most peer-reviewed publications of any AAA stent graft
a
Results from 600 patients followed out to 5 years demonstrate freedom from aneurysm-related rupture 97% and freedom from aneurysm-related death 96%.
Trusted Leader in Endovascular Stent Graft Innovation
2002
1998
2004
2006
2008
FDA Approval
1999
a
These results reflect the Society for Vascular Surgery Lifeline Registry (LR) and the Medtronic-sponsored Post-Market Surveillance
(PS) registry.
b
Combined LR (n=185) and PS (n=149) registries, total (n=334). Enrollment and 5-year follow-up are still continuing for the PS registry.
c
igration was defined for both registries as longitudinal movement of all or part of a stent or attachment system for a distance of
M
greater than 5 mm relative to anatomical landmarks determined at the time of the initial endovascular procedure.
Designed for enhanced circumferential fixation and sealing
Eleven years of experience and testing
Lumen
NiTi Struts
Continuum of
Innovation
1st-Generation
• “Stiff Body” stent design
• Pre-RPM graft material
• “Bullet” Delivery System
Exoskeleton provides a structure for tissue ingrowth and friction
2005
1996
1996 to 1999 Clinical Trial
Exoskeleton
Vessel wall
2nd-Generation
• Flex-body stent design
introduced
• 1 cm stent rings for
greater conformability
• “Reduced Porosity
Material” graft
3rd-Generation
•Xpedient® Taper Tip
Delivery System
introduced
•Lubricated coating on
inner wall of graft cover
•Anatomical
recommendations
added to IFU
Durable Fixation
4th-Generation
• Resilient graft material
• High-density polyester
graft material
• Low porosity and
excellent durability2
1996
5th-Generation
• Xcelerant Delivery
System introduced
• Integrated handle for
greater control
• Radiopaque markers
for increased accuracy
6th-Generation
AAAdvantage SG
• Enhanced,
strategically placed
RO markers
• Extended aortic body
•Longer, wider and
flared limbs
1999
2001
2003
2005
Provide active high radial force, durable
fixation, seal, and lumen patency
Present
7th-Generation
Xcelerant
Hydro System
Super-Elastic Nitinol Struts
Offer dynamic conformability to a variety of
neck shapes
• Reduced friction
to aid navigation2
•Facilitates
insertion and
retraction
• Low profile
characteristics
> There were no reports of migration in the PS registry 1
Solid Anatomical Fixation
Device Conformability
with columnar support anchored at the
hypogastric bifurcation6
One-centimeter long, diamond-shaped
stent segments provide great anatomical
conformability