STAYING ON TOP OF IT:
Cardiothoracic and
THE PROXIMAL NECK
A FOCUS ON THE
SIGNIFICANCE OF THE
PROXIMAL NECK IN EVARf
WHY DID EVAR EVOLVE WITH SPECIFIC FOCUS
ON THE PROXIMAL NECK?
Today, Endovascular aneurysm repair (EVAR) is the preferred, most
common mode of intervention for abdominal aortic aneurysms
(AAAs). However, if we look back at history, since the first EVARs
completed in the early 1990’s, significant evolutionary design and
technical changes were required to bring EVAR to where it is today.
Today, most patients that would have previously been opted for
open surgical repair are now being treated with high confidence
using EVAR.
The seal at the proximal aortic neck, widely acknowledged as the
greatest challenge – the Achilles Heel - to aneurysm exclusion,
has prompted significant concentration by developers to engineer
design features that can enhance this performance aspect, such
as self-expanding stent graft materials and active fixation
mechanisms. While significant improvement to the applicability
of EVAR has been achieved, proximal necks with hostile
characteristics continue to challenge clinicians. A 2016 study
reported type Ia endoleak was associated with 100% of delayed
ruptures following EVAR in a large cohort (45 of 3,081; mean time
to rupture of 38 months).1 Despite these concerns, physicians
continue to push the limits of third generation graft design, often
to the demise of both early and late proximal graft seal. A study by
Schanzer and colleagues reporting on a large data set of 10,228
patients that included prior and current generation EVAR
technology showed that the use of endografts outside their
respective IFUs was rampant and resulted in significantly higher
sac enlargement rates.2
Thanks to significant high-quality research, we now have a clearer
understanding of how to proactively assess risk for complications
in our patients, and therefore, providing us the opportunity to
administer better upfront care. Antoniou et al. in 2013 showed that
hostile necks continue to be a strong predictor for type I endoleaks
and major complications after EVAR with current commercial
technology. In a meta-analysis of 7 studies, hostile necks were
shown to be 4.5 times more likely, compared to non-hostile necks,
By Mazin Foteh, MD
Vascular Surgeons
Austin, Texas, USA
to be accompanied by a type I endoleak at 1-year follow-up
(OR = 4.56, P = .010).3 In patients with hostile neck characteristics,
10% developed type I endoleak at 1-year follow-up, compared to
1% in patients with non-hostile necks (P = 0.01). The same analysis
reported that hostile necks were associated with 9 times greater
risk of aneurysm-related mortality at 1-year follow-up (P = 0.013).3
Although this shows strong performance of EVAR in non-hostile
necks, this data validates that hostile proximal necks present
greater risk and therefore warrants special consideration for how
to optimize the durability of the repair.
Multiple studies have reported on the different anatomical
characteristics constituting “hostile” proximal necks. These include
proximal, infrarenal necks of short length, large diameter,
moderate to severe circumferential calcification and/or high
angulation.4 Additionally, certain proximal necks may be considered
hostile if they present in a variety of morphologically-documented
types: conical, reverse conical or bulging (focal aneurysmal
degeneration). In 2014, Speziale et al found the combination of
more than one “hostile” neck factor further increased risk of
reinterventions and aneurysm-related mortality.5
...hostile proximal necks
present greater risk and
therefore warrants special
consideration for how to
optimize the durability
of the repair
Hostile neck anatomies present another practical concern for
clinicians. What endovascular salvage options may be viable if the
patient were to develop a type Ia endoleak? Often, anatomical
challenges can preclude the success of an endovascular
re-intervention for a type Ia endoleak. Therefore conversion to
open surgical repair has remained a necessary bailout option.
The majority of explants indicated for type Ia endoleaks have been
1 OF 9
reported in hostile necks, particularly those that are short,
angulated, conical or heavily calcified.6,7 Unfortunately, conversion
to surgery and graft explantation is a risky endeavor, with an
estimated risk of mortality of 50% and 20% for early and late
conversions, respectively.8 Conversions are also quite detrimental
to the patients’ psyche, requiring a much longer recovery time and
return to daily activities.
In order to provide optimal upfront repair that minimizes risk of
future complications, the anatomy of the aortic neck must be
carefully assessed and considered in selecting appropriate EVAR
technology. Table 2 (shown on page 7) lays out major anatomical
criteria based on the IFU (Instructions for Use) of US commercially-
available EVAR stent grafts, as well as on-label endovascular
bail-out options in the event they should become necessary to
avoid surgical conversion. Currently, among available standard-of-
care infrarenal platforms, the Endurant™ platform offers the shortest
neck indication of ≥10mm, as well as compatibility with different
adjunctive options to re-inforce (or if needed, re-establish)
proximal seal (Aptus™ Heli-FX™ EndoAnchor™ implants, aortic
cuff extension). Ultimately each patient should receive the most
appropriate treatment option based on their anatomy and
considerations with respect to their physiological condition
and lifestyle.
EVAR VS AORTIC DISEASE PROGRESSION
In 2009, Dr. Timothy Chuter suggested the evolution of
endovascular devices was quick to remedy problems recognized
with acute failures through the cyclical process of design, failure
and redesign, but slow to address late failures.9 Today we have
endograft technologies available that have demonstrated
significant advancements in durability and some with certain
capability to conform to a level of anatomical remodeling.
Irrespective of these improvements, disease progression is
unavoidable in certain patients and inevitably must be confronted.
Device failures may not happen until later in follow-up. Antoniou
and colleagues have reported that at just 1-year aneurysm-related
revision are needed for 5% of EVARs.10 In a large, randomized trial,
Greenhalgh and colleagues have shown the risk for complications
after EVAR increases with time, however does not increase with
time after open repair.11 To further delineate on the reason for this
risk after EVAR, Turney and colleagues have suggested that late
failures may occur because of aneurysmal degeneration directly at
the seal zones.12 Past the short-and mid-term time horizons,
the threat of disease progression and aortic dilatation looms
for patients who are now essentially outliving their
endovascular repairs.
STAYING ON TOP OF IT
Newer generation devices may promise better outcomes in the
long-term, however there are hints problems may persist despite
technologic advances in endograft design and delivery. These
lingering challenges include an aging population and lack of
follow-up compliance associated with elderly, sick patients - those
at greatest risk of complications.13,14 Certain physiological and
lifestyle factors have also been linked with disease progression.
For instance, late changes in aneurysmal necks post-EVAR have
been suggested to be associated with not only hyperlipidemia and
persistent hypertension, but also smoking.15,16 Current or former
smoking status is one of the strongest risk factors linked with aortic
disease progression.17 As physicians we must carefully consider
these variables and risk factors as we determine the most
appropriate treatment for our patients that ensures durable repair.
Failure of the proximal neck attachment and seal leading to
endoleak and migration can be catastrophic, and salvage
reinterventions to address this can be complex and pose high
risks for patients.18 Preventing proximal seal complications in the
first place has therefore been a top priority for many device
manufacturers.
In order to provide optimal upfront
repair that minimizes risk of future
complications, the anatomy of the
aortic neck must be carefully
assessed and considered in selecting
appropriate EVAR technology.
The advent of hooks and barbs, angled downward to embed into
the aorta, were direct remedies to prevent downward migration
and rectify the problems reported at the time. These active fixation
techniques have been employed to engage the aorta in either the
infrarenal or suprarenal positions. While the suprarenal form of
active fixation promises to improve graft position stability, neither
suprarenal nor infrarenal fixation stent grafts are immune to the
ensuing effects of disease progression and neck dilatation.
While fenestrated endograft systems promise the ability to treat
patients with hostile infrarenal necks, these devices carry an added
dimension of complexity, not only in the number and types of
components, but also in the time needed to deploy them. This
added time is associated with increased radiation exposure for
both the patient and treating physician.19 Fenestrations are also
correlated with increasing risk of post op renal function decline and
AAA related mortality due to their renal interference and patency
stability.19 In addition to the added risks of these procedures, they
are not immune to proximal seal-related complications.
2 OF 9
The FEVAR case example below [Intra-op type Ia endoleak in
FEVAR] illustrates the presence of a type Ia endoleak immediately
upon full deployment of a fenestrated platform. While
EndoAnchor™ implants resolved this endoleak, this experience
highlighted the potential for an alternative option for this patient:
comprising of on-label use of the Endurant™ stent graft (unlike
other standard-of-care infrarenal platforms with a 15mm neck
length indication, the Endurant™ stent graft has a 10mm neck
length indication) in conjunction with EndoAnchor™ fixation. By
avoiding the need for fenestrations, this may have simplified the
procedure and reduced overall risk to the patient.
CASE EXAMPLE:
INTRA-OP TYPE IA ENDOLEAK IN FEVAR
A B
A. F
 enestrated EVAR chosen for patient
with 10mm long conical proximal neck
C. I ntra-operative type Ia endoleak
observed, likely due to non-
alignment of graft with aorta
C. E
 ndoAnchor™ fixation employed to
target source of type Ia endoleak and
establish aneurysm exclusion
C
Seeing this unmet clinical need, EndoAnchor™ implants were
developed as a viable solution for these problems. Similar in
function to an interrupted suture in open aneurysm repair,
EndoAnchor™ fixation was designed to provide radial support
and resist aortic neck dilatation, and thereby intended to
provide a simple and durable solution for patients with hostile
neck anatomies.20
STAYING ON TOP OF IT
EndoAnchor™ Fixation Enhances the
Durability of EVAR
APTUS™ HELI-FX™ ENDOANCHOR™
SYSTEM OVERVIEW
Applier provides controlled two-stage deployment
Guide features user controlled deflectable tip
EndoAnchor™ Implant Size and Shape
3 mm
Cross Bar
1.0 mm
3.5 mm
The Aptus™ Heli-FX™ EndoAnchor™ system (Medtronic, Santa Rosa,
CA, USA) is not a newcomer to the endovascular arena. The system
is approaching a decade of proven use and is available in both the
United States and Europe, and is the only device specifically
developed for endovascular fixation in EVAR and TEVAR.21 More
than 50,000 EndoAnchor™ implants have been implanted globally
in more than 10,000 patients treated to date since the first case in
2005. A registry was formed in 2012, the Heli-FX Aortic
Securement System Global Registry (ANCHOR). ANCHOR is a
prospective, observational, international, multicenter postmarket
registry designed to evaluate the real world use and outcomes of
the Heli-FX™ EndoAnchor™ system with independent core lab
adjudication (ClinicalTrials.gov identifier: NCT01534819). This
registry is a window into the real-world application of EVAR,
representing the most challenging cases due to unfavorable
anatomical conditions and/or limited viable endovascular bailout
options. Informally, physicians will refer to such cases are those
that “keep us up at night.” To date, more than 680 patients have
been enrolled.22
3 OF 9
CASE EXAMPLE:
ENDOANCHOR™ FIXATION IN HOSTILE NECK EVAR
Short and conical proximal neck Intra-operative type Ia endoleak
highlights potential for complications observed resulting from non-
alignment of graft to proximal neck
EndoAnchor™ fixation employed to Post-operative CT confirms
improve graft alignment and seal successful aneurysm exclusion
endoleak and non-presence of endoleak
EndoAnchor™ implants are specifically indicated for use in patients
whose endovascular grafts have exhibited migration or endoleak,
or who are at risk of such complications, in whom augmented
radial fixation and/or sealing is required to regain or maintain
adequate aneurysm exclusion. EndoAnchor™ fixation is an
innovative endovascular adjunct to EVAR that models the proven
concept of the sutured anastomosis in open surgery.23
Functionally, the helical EndoAnchor™ implant “sutures” the
endograft from within and through the aorta’s adventitia layer.
They are compatible with a number of commercial EVAR
endografts (See Table 1 on page 7). In these endografts,
EndoAnchor™ implants have established compatibility and proven
to reinforce a more comprehensive seal at the proximal neck in a
prophylactic or primary use and within the revision setting,
STAYING ON TOP OF IT
including rupture.21,24 Based on the Instructions for Use,
EndoAnchor™ implants are contraindicated for use with the
Endologix AFX™* endograft, as well as in patients with known
allergies to the implant material (MP35NLT), a condition that
threatens to infect the endograft (OUS IFU only) and bleeding
diathesis (OUS IFU only). In addition they do not have established
compatibility with Nellix™*, Ovation™*, Relay™*, InCraft™*, Aorfix™*
or Anaconda devices.
Another practical feature of EndoAnchor™ implants is that they do
not present challenges relative to future intervention options or
ability to evaluate endoleaks post-operatively. The EndoAnchor™
implant has been designed to ensure flush seating with the inner
surface of the endograft, so as to not interfere with placement
or sealing with any future grafts implanted. Furthermore in our
experience, historical challenges to endoleak detection in
post-operative imaging, such as “starbursts” from certain
polymers, have not been an issue with EndoAnchor™ implants.
In 2012, Melas et al.25 tested the utility of EndoAnchor™ implants
to withstand migration using a human cadaver model. Aortas were
tested with 8 endografts alone and with EndoAnchor™ implants
adjunctively implanted and left in situ and challenged with
significant displacement force until tissue failure. When 4
EndoAnchor™ implants were added, the endograft’s fixation
strength increased to withstand a mean of 30 N displacement force.
With 6 EndoAnchor™ implants placed, fixation strength increased
by a mean of 57 N. Ultimately, EndoAnchor™ implants were found
to withstand significant displacement force and to augment an
endograft’s ability to actively fixate in the aorta at a level equal or
superior to that of a hand-sewn surgical stitch in open surgical
repair (refer to Table 3).
Table 3. Comparison of displacement force of EVAR with
EndoAnchor™ fixation to a hand sewn anastomosis
150
Displacement force
in Newtons
100
50
0
Talent™ Endurant™ Excluder™* Zenith™* Hand Sewn
No EndoAnchor™ implants With EndoAnchor™ implants
Source: Melas et al. JVS 2012;55(6):1726-33
4 OF 9
CASE EXAMPLE:
ENDOANCHOR™ FIXATION IN HOSTILE NECK EVAR
Highly angulated infrarenal neck
anatomy brings concern for future
complications
EndoAnchor™ fixation employed to enhance durability and address
concerns for future complications. Post-operative CT demonstrates
successful aneurysm exclusion
†
Data on file at Medtronic.
STAYING ON TOP OF IT
EVAR successfully and precisely
deployed without intra-operative
endoleak
The Heli-FX™ EndoAnchor™ system is a simple two-stage
deployment. To achieve secure implantation, an EndoAnchor™
implant requires adventitial purchase, therefore, the instructions
for use recommends the implantation site at the proximal neck
avoid areas of significant calcification. The deployment angle of
attack to obtain complete anastomosis with the adventitia from
inside the wall of the endograft is 90 degrees, or perpendicular to
the site of EndoAnchor™ implantation. Loss of perpendicular
apposition may result in deployment difficulty or suboptimal
implant performance.23 Between 4 and 6 EndoAnchor™ implants are
typically needed to be deployed in a circumferential configuration
in the infrarenal seal zone and can be accurately delivered in
16 minutes on average.22 Once the relatively short device learning
curve is achieved, in our experience, case planning and device use
becomes quite simple and easy. For example, our implantation
time is now routinely below ANCHOR’s† 16 minute average,22 and
we are able to place EndoAnchor™ implants in alternative positions
that avoid calcium (such as on either side of a calcium shelf), while
achieving the intended result.
EndoAnchor™ fixation
has delivered on its
promise to improve
the performance of
EVAR technology
EndoAnchor™ fixation has delivered on its promise to improve the
performance of EVAR technology. Its straightforward and simple
approach is an elegant alternative to the more complex and costly
branched and/or fenestrated endovascular repairs, while
promising a safe, viable therapy for patients previously unfit
for complex interventions. This simple approach that has
demonstrated strong outcomes in real-world experience promises
the ability to bolster the capabilities of smaller aortic centers to
treat more complex patients.
5 OF 9
CASE EXAMPLE:
ENDOANCHOR™ FIXATION IN RUPTURED EVAR

A B
Reinforcement of the
proximal seal may provide
improved stability and
long-term exclusion of
the aneurysm, which
helps better achieve the
ultimate goal of EVAR

C D
Patient presented with rupture of a 9 cm AAA. Proximal aortic neck was
deemed high-risk, as shown by preoperative CT (A, B, and C). EndoAnchor™
fixation was employed to enhance durability of proximal seal and address
concerns for future complications (D).
DISCUSSION
The proximal aortic neck, particularly in the presence of one or
more hostile characteristics, is widely acknowledged to be one
of the most challenging aspects of EVAR. EndoAnchor™ fixation,
in concert with a compatible endograft, has shown usefulness in
reinforcing the proximal seal in EVAR prophylactically or in the
primary treatment of type Ia endoleak. Reinforcement of the
proximal seal may provide improved stability and long-term
exclusion of the aneurysm, which helps better achieve the ultimate
goal of EVAR.
DISCLAIMER
These views and opinions are those of the individual physicians.
Patient results may vary.

This therapy is not for everyone. Please consult your physician.

A prescription is required. For further information, please call
Medtronic at (888) 283-7868.

STAYING ON TOP OF IT 6 OF 9
TABLES

Table 1. Compatible endograft systems per the OUS instructions for use.23
Cook Medical Zenith™*, Zenith™* TX2™*
The Aptus™ Heli-FX™ and Heli-FX™ Thoracic EndoAnchor™ systems have been
evaluated and determined to be compatible with the following endografts. Gore & Associates Excluder™*, TAG™*
CAUTION: The EndoAnchor™ implant has undergone in vitro evaluations for compatibility and Jotec GmbH Jotec E™*-vita
durability with the endograft devices listed in the Warnings and Precautions section of the IFU
(section 4). The transferability of these data to other endograft designs is not known and therefore Medtronic Endurant™, Valiant™, AneuRx™, Talent™
use with other endografts is not recommended.

Table 2. Major AAA Anatomic Criteria IFU Recommendations for FDA-approved nonfenestrated endovascular stent grafts
Main Body AFX™* Endurant™ II/IIs Excluder™* AAA Excluder™* Iliac Ovation iX™* System Zenith Flex™*
Stent Branch
Graft System  AFX™*2 Endoprosthesis
Manufacturer Endologix Medtronic Gore & Gore & Trivascular Cook Medical
Associates Associates (an Endologix company)
Major Anatomic Criteria
Proximal Diameter ≥ 18 to ≤ 32 mm 19 to 32 mm 19 to 32 mm n/a 16 to 30 mm 18 to 28 mm
aortic neck
Neck Length ≥ 15 mm ≥ 10 mm ≥ 15 mm n/a n/a ≥ 15 mm
(Infrarenal) (diameter must be
between 16 and 30 mm
at 13 mm below the
inferior renal artery)
Angulation ≤ 60° ≤ 60° ≤ 60° n/a < 60° if neck length ≤ 60°
≥ 10 mm; ≤ 45° if neck
length < 10 mm
Common Iliac Landing Zone ≥ 10 to ≤ 23 mm 8 to 25 mm 8 to 25 mm 6.5 to 25 mm 8 to 25 mm 7.5 to 20 mm
Arteries Diameters
Length of distal ≥ 15mm ≥ 15mm ≥ 10 mm ≥ 10 mm ≥ 10 mm ≥ 10 mm
fixation zone
On-label VELA™ Aptus™ Aptus™ n/a n/a Aptus™
Bailout Extension Heli-FX™ Heli-FX™ Heli-FX™
Options for the EndoAnchor™ EndoAnchor™ EndoAnchor™
Proximal Seal System System System

Aortic cuff Aortic cuff Aortic cuff

STAYING ON TOP OF IT 7 OF 9
REFERENCES
1. Zacharias N, Warner CJ, Taggert JB, Roddy SP, Kreienberg PB, Ozsvath KJ, et al. Anatomic 13. Schanzer A, Messina LM, Ghosh K, Simons JP, Robinson WP, 3rd, Aiello FA, et al. Follow-up
characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular compliance after endovascular abdominal aortic aneurysm repair in Medicare beneficiaries. J Vasc
aneurysm repair. J Vasc Surg 2016, DOI: 10.1016/j.jvs.2016.04.048 Surg 2015;61:16-22 e1.

2. S
 chanzer A, Greenberg RK, Hevelone N, Robinson WP, Eslami MH, Goldberg RJ, et al.
Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation
2011;123:2848-55.
3. A
 ntoniou GA, Georgiadis GS, Antoniou SA, Kuhan G, Murray D. A meta-analysis of outcomes of
endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy.
J Vasc Surg 2013;57:527-38.
4. S
 ampaio SM, Panneton JM, Mozes GI, Andrews JC, Bower TC, Karla M, et al. Proximal type I
endoleak after endovascular abdominal aortic aneurysm repair: predictive factors. Ann Vasc Surg
2004;18:621-8.
5. S
 peziale F, Sirignano P, Setacci F, Menna D, Capoccia L, Mansour W, et al. Immediate and
two-year outcomes after EVAR in “on-label” and “off-label” neck anatomies using different
commercially available devices. analysis of the experience of two Italian vascular centers.
Ann Vasc Surg 2014;28:1892-900.
14. AbuRahma AF, Yacoub M, Hass SM, AbuRahma J, Mousa AY, Dean LS, et al. Compliance of
postendovascular aortic aneurysm repair imaging surveillance. J Vasc Surg 2016;63:589-95.
15. Mohan IV, Harris PL, Van Marrewijk CJ, Laheij RJ, How TV. Factors and forces influencing
stent-graft migration after endovascular aortic aneurysm repair. J Endovasc Ther 2002;9:748-55.
16. Nordon IM, Hinchliffe RJ, Loftus IM, Thompson MM. Pathophysiology and epidemiology of
abdominal aortic aneurysms. Nat Rev Cardiol 2011;8:92-102.
17. Teixido-Tura G, Almeida AL, Choi EY, Gjesdal O, Jacobs DR, Jr., Dietz HC, et al. Determinants of
Aortic Root Dilatation and Reference Values Among Young Adults Over a 20-Year Period: Coronary
Artery Risk Development in Young Adults Study. Hypertension 2015;66:23-9.
18. Thomas BG, Sanchez LA, Geraghty PJ, Rubin BG, Money SR, Sicard GA. A comparative analysis
of the outcomes of aortic cuffs and converters for endovascular graft migration. J Vasc Surg
2010;51:1373-80.

6. T
 urney EJ, Steenberge SP, Lyden SP, Eagleton MJ, Srivastava SD, Sarac TP, et al. Late graft explants
in endovascular aneurysm repair. J Vasc Surg 2014;59:886-93.
7. M
 oulakakis KG, Dalainas I, Mylonas S, Giannakopoulos TG, Avgerinos ED, Liapis CD. Conversion
to open repair after endografting for abdominal aortic aneurysm: a review of causes, incidence,
results, and surgical techniques of reconstruction. J Endovasc Ther 2010;17:694-702.
19. Martin Z, Greenberg RK, Mastracci TM, Eagleton MJ, O’Callaghan A, Bena J. Late rescue of
proximal endograft failure using fenestrated and branched devices. J Vasc Surg. 2014;
59:1479-1487.
20. De Vries JP, Van De Pavoordt HD, Jordan WD, Jr. Rationale of EndoAnchors in abdominal aortic
aneurysms with short or angulated necks. J Cardiovasc Surg (Torino) 2014;55:103-7.

8. F
 errero E, Ferri M, Viazzo A, Pecchio A, Berardi G, Piazza S, et al. Open conversion after 21. Deaton DH. Improving proximal fixation and seal with the HeliFx Aortic EndoAnchor. Semin Vasc
endovascular aortic aneurysm repair: a single-center experience. Ann Vasc Surg 2013;27:856-64. Surg 2012;25:187-92.

9. C
 huter TA. Durability of endovascular infrarenal aneurysm repair: when does late failure occur and 22. Medtronic SR, CA. Data on File.; December 2015
why? Semin Vasc Surg 2009;22:102-10.
23. [Anonymous]. Instructions for Use (United States). Heli-FX™ and Heli-FX™ Thoracic EndoAnchor™
10. A
 ntoniou GA, Georgiadis GS, Antoniou SA, Kuhan G, Murray D. A meta-analysis of outcomes of Systems. Medtronic Vascular, Inc., Santa Rosa, CA. In; July 2015
endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy.
J Vasc Surg 2013;57:527-38.
24. De Vries JP. Use of EndoAnchors to secure thoracic and abdominal aortic endografts: key to
overcoming apposition failures? J Endovasc Ther 2013;20:481-3.
11. G
 reenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, et al. Endovascular versus open
repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1863-71.
25. Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton DH. Helical EndoStaples
enhance endograft fixation in an experimental model using human cadaveric aortas. J Vasc Surg
12. T
 urney EJ, Steenberge SP, Lyden SP, Eagleton MJ, Srivastava SD, Sarac TP, et al. Late graft explants 2012;55:1726-33.
in endovascular aneurysm repair. J Vasc Surg 2014;59:886-93.

STAYING ON TOP OF IT 8 OF 9
 US SAFETY INFORMATION

Indications for Use
The Aptus™ Heli-FX™ EndoAnchor™ System is intended to provide fixation and sealing between
endovascular aortic grafts and the native artery. The Aptus Heli-FX EndoAnchor System is indicated for
use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such
complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate
aneurysm exclusion. The EndoAnchor may be implanted at the time of the initial endograft placement, or
during a secondary (i.e. repair) procedure.
Contraindications
Treatment with the Aptus Heli-FX EndoAnchor system is contraindicated for use in the following
circumstances:
• In patients with known allergies to the EndoAnchor implant material (MP35N-LT)
• In conjunction with the Endologix Powerlink™* endograft
Warnings
• The long term performance of the Aptus EndoAnchor has not been established. All patients should be
advised endovascular aneurysm treatment requires long-term, regular follow-up to assess the patient’s
health status and endograft performance, and the EndoAnchor does not reduce this requirement.
• The EndoAnchor, Heli-FX EndoAnchor System and Heli-FX Thoracic EndoAnchor System have been
evaluated via in vitro testing and determined to be compatible with the Cook Zenith™*, Cook Zenith
TX2™*, Gore Excluder™*, Gore TAG™, Jotec E™-vita abdominal, Jotec E™-vita thoracic, Medtronic
AneuRx™, Medtronic Endurant™, Medtronic Talent™, and Medtronic Valiant™ endografts. Use with
endografts other than those listed above has not been evaluated.
• The performance of the Aptus EndoAnchor has not been evaluated for securing multiple endograft
components to one another. Not securing EndoAnchor implants into aortic tissue could result in graft
fabric damage, component separation, and resultant Type III endoleaks.
• The performance of the Aptus EndoAnchor has not been evaluated in vessels other than the aorta. Use
of the EndoAnchor to secure endografts to other vessels may result in adverse patient consequences
such as vascular perforation, bleeding, or damage to adjacent structures.
• The performance of the Aptus EndoAnchor has not been evaluated for securing multiple anatomical
structures together. Such use could result in adverse patient consequences such as vascular perforation,
bleeding, or embolic events.
MRI Safety and Compatibility
• The EndoAnchor implants have been determined to be MR Conditional at 3T or less when the scanner is
in Normal Operating Mode with whole body averaged SAR of 2 W/kg, or in First Level Controlled Mode
with a maximum whole body averaged SAR of 4 W/kg.
• Please refer to documentation provided by the endograft system manufacturer for MR safety status of
the endograft system with which the EndoAnchor implants are being used.
Potential Adverse Events
Possible adverse events associated with the Heli-FX EndoAnchor include, but are not limited to:
• Aneurysm rupture • Death • EndoAnchor embolization • Endoleaks (Type III) • Enteric fistula • Failure to
correct/prevent Type I endoleak • Failure to prevent endograft migration
• Infection • Renal complications (renal artery occlusion/dissection or contrast-induced AKI)
• Stroke • Surgical conversion to open repair • Vascular access complications, including infection, pain,
hematoma, pseudoaneurysm, arteriovenous fistula • Vessel damage, including dissection,
perforation, and spasm
Please reference product Instructions for Use for more information regarding indications, warnings,
precautions, contraindications and adverse events.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare
practitioner. See package inserts for full product information.
CAUTION: EndoAnchor implant locations should be based upon a detailed examination of the
preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zone(s).
EndoAnchor implants should be implanted only into areas of aortic tissue free of calcified plaque or
thrombus, or where such pathology is diffuse and less than 2mm in thickness. Attempting to place
EndoAnchor implants into more severe plaque or thrombus may be associated with implantation difficulty
and suboptimal endograft fixation and/or sealing.
FTSOP113326-33 Rev1C
Indications: The Endurant™ II/Endurant™ IIs bifurcated stent graft is indicated for the endovascular
treatment of infrarenal abdominal aortic or aorto-iliac aneurysms. The Endurant II aorto-uni-iliac (AUI)
stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac
aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/
Endurant IIs stent graft system is indicated for use in patients with the following characteristics:
• Adequate iliac/femoral access that is compatible with vascular access techniques, devices and/or
accessories • Proximal neck length of ≥10 mm • Infrarenal neck angulation of ≤60° • Aortic neck diameters
with a range of 19 to 32 mm • Distal fixation length(s) of ≥15 mm • Iliac diameters with a range of 8 to 25
mm • Morphology suitable for aneurysm repair
Contraindications: The Endurant II/Endurant IIs Stent Graft System is contraindicated in:
•P
 atients who have a condition that threatens to infect the graft.
•P
 atients with known sensitivities or allergies to the device materials.
Warnings and Precautions
•T
 he long-term safety and effectiveness of the Endurant II/Endurant IIs Stent Graft System has not been
established. All patients should be advised that endovascular treatment requires lifelong, regular
follow-up to assess the health and the performance of the implanted endovascular stent 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.
•P
 atients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent
endoleaks may be required to undergo secondary interventions or surgical procedures.
•T
 he Endurant II/Endurant IIs 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.
•R
 enal complications may occur: 1) From an excess use of contrast agents. 2) 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.
•S
 tudies indicate that the danger of micro-embolization increases with increased duration of the
procedure.
•T
 he safety and effectiveness of the Endurant II/Endurant IIs 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 Endurant II/Endurant IIs
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 (arranged in alphabetical 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, femoral-femoral artery thrombosis, 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
complications and subsequent attendant problems; renal complications and subsequent attendant
problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: 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; 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)
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.
FTSOP113326-06 Rev 1E

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