1. Aptus Heli-FX Overview
Physician Slide Deck
Developed by Aptus Endosystems, Inc.
MMA

2. Major Studies Show Higher 2nd Interventions in EVAR vs. Open Repair
DREAM
EVAR-1
ACE
De Bruin et al. N Engl J Med 2010;362:1881-9
R.M. Greenhalgh et al. N Engl J Med 2010, /NEJM
Becquemin JP et al. J Vasc Surg 2011;53(5):
Late ruptures in EVAR, none in open surgery
Unlike open repair, endoleaks and migration are major complications of EVAR
Predictors for rupture, and risks increase with time
Open surgery remains a ‘more durable option’
In ACE, 16% re-interventions in EVAR vs. 2.4% for open repair at 3 yr median f/u

3. Hostile Proximal Necks Further Challenge EVAR
Meta-Analysis of 7 major studies in EVAR by Antoniou et al1 compared outcomes in hostile vs. friendly neck anatomies (total patients N = 1559)
Study
Sample Size
Endografts
Torsello et al, 2011
177
Endurant
AbuRahma et al, 2010
238
AneuRx, Excluder, Zenith, Talent
Hoshina et al, 2010
129
Excluder, Zenith
Abbruzzese et al, 2008
565
AneuRx, Excluder, Zenith
Choke et al, 2006
147
Talent, Zenith, Excluder, AneuRx
Fulton et al, 2006 84
AneuRx
Fairman et al, 2004
219
Talent
Type I endoleaks 4.5x more likely at 1-year after endograft implantation in hostile proximal aortic neck anatomy (P = .010)
Aneurysm-related mortality risk 9x greater in hostile neck anatomy (P= .013)
1Antoniou GA et al. J Vasc Surg. 2013;57(2):

4. Hostile Proximal Necks Further Challenge EVAR
Another similar meta-analysis by Stather et al. of 16 major studies confirms higher risks in hostile necks
Total sample size: N=11,959 patients
Further substantiation that EVAR still faces significant challenges in hostile proximal neck anatomy
Stather PW et al. J Endovasc Ther. 2013;20:623–637

5. Influence of Multiple Hostile Neck Parameters
Speziale et al. shows greater proximal seal complication risks as the number of hostile neck parameters increases
Neck hostility
Intra-op adjunctive procedures
Intra-op endoleaks
All cause mortality
On label
9.9%
0.5%
1.1%
2 hostile neck parameters
26.7%
6.7%
13.3%
>2 hostile neck parameters
50%
16.7%
Greater than 1 hostile neck parameter substantially increases mortality, major adverse events, intra-op endoleaks and adjunctive procedures
Speziale F et al, Annals of Vascular Surgery (2014), doi: /j.avsg

6. Certain ‘on-label’ necks can be at-risk
Which Proximal Necks are Hostile?
Study by Jordan WD et al. assesses proximal neck anatomic criteria that are most predictive of success or failure after EVAR
Evaluated N=221 patients from ANCHOR post-market registry
Failure defined as:
Type Ia endoleak upon endograft implantation
Type Ia endoleak identified in post-op follow-up*
*In endografts without EndoAnchors
Identified proximal neck variables that independently predict type Ia endoleak:
Neck diameter
≥ 26 mm
P = .002
Neck length
≤ 17 mm
P = .017
Certain ‘on-label’ necks can be at-risk
Jordan WD et al. J Vasc Surg Feb 28. pii: S (15)

7. Multiple recent studies confirm neck dilatation in EVAR remains REAL
Neck Dilatation: A Cause for 2nd Intervention
Multiple recent studies confirm neck dilatation in EVAR remains REAL
Author
Follow-Up
Grafts studied
Proximal Neck Dilatation Rate
Outcomes in dilated necks
Oberhuber et al.1
39 mos average
Zenith (N=29), Talent (N=35), Excluder (N=39)
22%
(defined as >2mm diam increase)
31% re-interventions
Pintoux et al.2
57 mos average
Talent (N=33), AneuRx (N=25)
24%
(defined as >3mm diam increase)
5% late type Ia endoleak
16% migration
Bastos Gonçalves et al.3
5 yrs median
Excluder (N=144)
37% overall,
66% in pts >7 yrs f/u
Increased odds of migration (≥5mm) 5.5x
1Oberhuber A et al. J Vasc Surg 2012 April;55(4):
2Pintoux D et al. Ann Vasc Surg Nov;25(8):1012-9
3Bastos Goncalves F et al. J Vasc Surg Oct;56(4):920-8

8. Compromise of EVAR and Long-Term F/U
Standard follow-up imaging has shortcomings
Patient risk & contraindications
(radiation, contrast media)1,2
Patients lost to follow up
Quality of Life impact
Nordon IM et al. Eur J Vasc Endovasc Surg 2010;39(5):
Dias NV et al. Eur J Vasc Endovasc Surg 2009;37(4):

9. Image courtesy of National Institute of Health
Type I Endoleak? What Have Been Our Options…
TAA Classification
Possible TI EL TX Options
Ascending
Open surgical conversion
Aortic Arch
TEVAR Revision*, hybrid
Descending
TEVAR Revision*
AAA Classification
Possible TI EL TX Options
Infra-renal
EVAR Revision*, open surgical conversion, FEVAR conversion
Juxta-renal
Open surgical conversion, FEVAR conversion, CHIMPs
Supra-renal
*Ballooning, cuffs, Palmaz, coils, Onyx and/or CHIMPs may be considered in EVAR/TEVAR revision
What do we do when?
Standard revision techniques cannot be used or don’t seal endoleak?
Patients are unfit for FEVAR or open surgical conversion?
Image courtesy of National Institute of Health
Image courtesy of National Institute of Health

10. Tailored Seal and Fixation of EndoAnchors
Create the stability of A surgical anastomosis In EVAR and TEVAR
Surgical Anastomosis
EndoAnchoring
Displacement force in Newtons
Chart from data published in Melas N, et al. J Vasc Surg 2012;55(6):
Case images courtesy of John Aruny MD, Bart Edward Muhs, MD, PhD.

11. Long-Term Objectives of EndoAnchors in EVAR
Replicate surgical anastomosis
Prevent late term seal complications in primary setting
Treat seal complications & prevent recurrence in revision setting
Mitigate reinterventions in EVAR
Improve surveillance intervals by preventing type I leaks and sac growth
Legend: Status of clinical substantiation
Completed
In-process
Next phase

12. Heli-FX Indications for Use (FDA and CE Mark)
Intended to provide fixation and augment sealing between endovascular aortic grafts and the aorta
Indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications
The Aptus EndoAnchor and Heli-FX have been evaluated and determined to be compatible with the following endografts:
Cook Zenith
Gore Excluder
Medtronic AneuRx
Medtronic Endurant
Medtronic Talent
Jotec GmbH

13. Resolve proximal seal failures
How to Manage EVAR with EndoAnchors?
PROPHYLAXIS
TREATMENT
Hostile Anatomy
Overcoming concerns for implant stability
Challenging neck anatomies
(e.g. wide, short, conical, angulated)
Difficult landing
(e.g. birdbeaking, close to branched vessels)
Normal Anatomy
Mitigating risk of re-interventions
Severe comorbidities that preclude safe re-intervention
Patients potentially lost during F/U
Long remaining life expectancy (young pts)
Resolve proximal seal failures
Targeted sealing of acute type I endoleaks
Targeted sealing of late type I endoleaks
Augmented stability in migrated grafts
Case image from Gandhi RT, Katzen BT Treating a Type 1A Endoleak Using EndoAnchors. Endovascular Today March :26.

14. equivalent to 10 years in vivo
EndoAnchor Tailored Seal and Fixation
Performance
Verified equivalence to the strength of a surgical anastomosis 1
Designed to provide radial support and resist neck dilatation
Safety
In >4,000 cases and >23,000 EndoAnchors implanted to- date, no confirmed graft damage or late anchor fracture 3
No anchor dislocation after successful implantation in aortic tissue3
No unanticipated adverse device events in ANCHOR registry (N=319)2
Benefits
Customizable placement to target concerning anatomical areas and Type I endoleaks
Steerable guide for precise and accurate placement
Motorized controls for two-stage deployment with repositioning
No damage post 400M cycles,
equivalent to 10 years in vivo
1 Melas N et al, J Vasc Surg 2012;55:
2 Jordan WD et al, J Vasc Surg 2014 Jul 31. pii: S (14)00929-X. doi: /j.jvs
3 Based on data on file at Aptus as of May 2015
Images courtesy of Aptus Endosystems, Inc.

15. Heli-FX System: Applier + Guide + 10 EndoAnchors
Cross Bar
3 mm
1.0 mm
3.5 mm
Images courtesy of Aptus Endosystems, Inc.

16. Aptus Heli-FX Product Offerings
Aptus™ Heli-FX™ Thoracic
EndoAnchor ™System
18Fr OD,
90cm working length
Aptus™ Heli-FX™
EndoAnchor™ System
16Fr OD,
62cm working length
Images courtesy of National Institute of Health and Aptus Endosystems, Inc.

17. EndoAnchor Deployment Animation

18. ANCHOR Registry Capturing Real-World Usage
Registry Principal Investigators
Europe: Dr. Jean-Paul de Vries – Chief of Vascular Surgery, St. Antonius Hospital
US: Dr. William Jordan – Chief of Vascular Surgery/Endovascular Therapy, Univ. of Alabama
Registry Design
Prospective, observational, international, multi-center, dual-arm Registry
Treatment Arms
“Primary” – Up to 1000 pts, Prophylactic
“Revision” – Up to 1000 pts, Therapeutic
Duration
5 Years
Follow-up
Per Standard of Care at each center & discretion of Investigator
Over 570 Patients enrolled as of May 2015

19. 5 papers published since 2014
ANCHOR in the Scientific Literature
5 papers published since 2014
Rationale of EndoAnchors in abdominal aortic aneurysms with short or angulated necks
De Vries JP et al. J Cardiovasc Surg (Torino) Feb;55(1):103-7
Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy
Jordan WD et al. J Vasc Surg Oct;60(4): e2.
Analysis of EndoAnchors for endovascular aneurysm repair by indications for use
de Vries JP et al. J Vasc Surg Dec;60(6): e1
Outcome-based anatomic criteria for defining the hostile aortic neck
Jordan WD et al. J Vasc Surg Feb 28. pii: S (15)
Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy
Jordan WD et al. J Endovascular Therapy 2015; 22(2):163–170

20. ANCHOR Shows High Prophylactic Use
Indications for EndoAnchoring in Revision n=99
Indications for EndoAnchoring in Primary n=307
Jordan WD et al. J Vasc Surg. 2014;60:

21. ANCHOR Includes All Major Endografts
Complex AAA and complications have warranted EndoAnchor tailored seal and fixation with ALL major endografts
Confirms EndoAnchoring need is independent of endograft design, dependent on anatomical challenges and post-implant disease progression
Jordan WD et al. J Vasc Surg. 2014;60:

22. ANCHOR Parallels Commercial Experience1
Excellent Safety
No confirmed late EndoAnchor Fractures or Graft Damage in >23,000 anchors implanted to date
Usage patterns consistent with ANCHOR
In over 4,000 cases to-date, 71% in primary
In majority of primary EVAR cases, EndoAnchors address concerns for late complications
Consistency with ANCHOR
Demonstrates registry reflects real-world use of EndoAnchors
1Based on Aptus data on file as of April-15

23. High Ratio Hostile Neck Anatomy in ANCHOR
Proximal Neck Anatomical Characteristics (based on Corelab)
Primary
n=242*
Revision
n=77*
Max Aneurysm Diameter [mm], mean (+ SD)
Neck Length [mm], mean (+ SD)
Necks ≤ 10mm Length, N (%)
101 (41.7%)
36 (46.5%)
Necks ≤ 15mm Length, N (%)
141 (58.3%)
47 (60.5%)
Neck Diameter1 [mm], mean (+ SD)
26 + 4
29 + 5
Conical Necks2, %
41.7%
46.5%
Neck Thrombus ≥ 2mm
37%
21%
Neck Calcium ≥ 2mm
48%
12%
Hostile Neck3
53%
63%
(1) At most distal renal artery
≥10% diameter change over 10mm length
As determined by the investigator
*Note: Corelab sample sizes is different from total patients in ANCHOR. Corelab for all patients is still in-process. All above data is per Corelab except the ‘Hostile Neck’ line item which is investigator reported.
Jordan WD et al. J Vasc Surg. 2014;60:

24. Percentage Short Necks by Study
Among Major EVAR Studies, ANCHOR Has the Shortest Necks
GREAT4
(C3 Excluder) mean: 28mm
Mean Infra-Renal Neck Length
10mm
0mm
5mm
15mm
20mm
25mm
30mm
ZFEN8
(Cook)
mean: 8mm
ANCHOR3 (EndoAnchor) mean: 16mm
OVATION5 (Trivascular) mean: 23mm
ITER2 (Excluder) mean: 26mm
ENGAGE1 (Endurant) mean: 28mm
Percentage Short Necks by Study
Infra-Renal Neck Length*
ENGAGE
(Endurant)
GREAT4
(C3 Excluder)
ITER2
(Excluder)
OVATION5
(Trivascular)
FORWARD6
(Nellix)
ANCHOR3
(EndoAnchor)
≤10mm
2.2%
1.5%
N/A
15.5%
17%
41.7%
≤15mm
4.3%
9.5%
29%
58.3%
5. Mehta M et al. J Vasc Surg 2014;59:65-73
6. Presentation by Dr. Andrew Holden at VEITHsymposium 2014
Stokmans RA et al. Eur J Vasc Endovasc Surg Oct;44(4):369-75
Oderich GS et al. J Vasc Surg 2014;60:
*Cut-offs for neck length may be based on ≤xx mm or <xx mm
Pol RA et al. J Vasc Surg 2014;60:308-17
Pratesi C et al. J Vasc Surg 2014;59:52-7
Jordan WD et al. J Vasc Surg. 2014;60(4): e2
Verhoeven et al. Eur J Vasc Endovasc Surg Aug;48(2):131-7

25. Freedom from Type Ia Endoleak at Final Angio Remains Excellent
. . . Despite Hostile Proximal Neck Anatomy
Arm N
Success
% Successful
Primary
242
223
92.1%
Revision 77 67
87.0%
High success in treating type I endoleaks
83% for acute T1 ELs in primary
80% for late T1 ELs in revision
In majority of persisting type I endoleaks, standard adjuncts failed to treat or could not be administered
Reflects high ability for EndoAnchors to treat difficult endoleaks
Reasons for Unsuccessful Results:
Primary (N=3): 3 Unresolved type 1a endoleak at final angio – 1 F/U; 1 F/U; 1 Pt required a re-intervention 6-days post-op for a kink & Type I (Collapsed Gore Graft)
Revision (N=7): Persistent Type 1a endoleak at final angio
1 Pt w/Persistent Endoleak (Pre-existing Condition), 3 Pts outside Aptus IFU (significant Thrombus & Calcium)
Other Pts undergoing Corelab review
Jordan WD et al. J Vasc Surg. 2014;60:

26. Reason for Secondary Procedure
Re-Interventions Over 9-Mo Mean F/U
Seal Durability Exceeds Expectations from Standard EVAR in Hostile Proximal Neck Anatomy
Reason for Secondary Procedure
Primary Arm (242)
Revision Arm (77)
All (319)
Conversions (Open)
Type Ia Leak Repair
1 (0.4%)
7 (9.1%)
8 (2.5%)
Type II Leak Repair
4 (5.2%)
5 (1.6%)
Migration Treatment
Graft Limb Kinking Treatment
1 (1.3%)
2 (0.6%)
Graft Limb Occlusion
2 (0.8%)
3 (0.9%)
Access Vessel Injury Treatment
1 (0.3%)
Lower Extremity Revasc.
Total Secondary Procedures
7 (2.9%)
11 (14.3%)
18 (5.6%)
Total Patients w/Secondary Procedures
14 (4.4%)
Jordan WD et al. J Vasc Surg. 2014;60:

27. Excellent Outcomes as Prophylaxis in ANCHOR, Despite Majority Hostile Neck Anatomy
Midterm outcomes (14-month mean f/u) exceed expectations from standard EVAR
Shorter necks did NOT have significantly poorer outcomes
N = 1 related to proximal seal: endograft body collapse in area with no EndoAnchor penetration
N = 2 associated with significant thrombus/calcium and 4- 5mm length necks
Ruptures, migrations or open surgical conversions
0.0% (0/208)
Freedom from AAA-related re-interventions
96.2% (200/208)1
Freedom from type Ia endoleaks per Corelab
98.5% (128/130)2
Freedom from AAA expansion (>5 mm) per Corelab
98.4% (122/124)
Jordan WD et al. J Endovascular Therapy 2015; 22(2):163–170

28. Seal Durability in F/U Compares Favorably
ANCHOR Results vs. Antoniou et al. Meta-Analysis
Studies
Median
Follow-Up
Type 1 Endoleaks in Hostile Necks
Meta-analysis,
Antoniou et al1
12-Months
20/205*
(9.8%)
ANCHOR Registry2
14.3-Months
2/178**
(1.1%)
Antoniou GA et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2012
Podium presentation by W Jordan, “Benefit of EndoAnchors in Endovascular Aneurysm Repair,” 2014 Vascular Annual Meeting
* Hostile neck criteria: neck length <15 mm and neck angulation > 60 degrees
** Hostile as determined by physician in Primary Arm
No EndoAnchor Related SAEs or Re-Interventions Reported To-Date

29. STAPLE-2 Shows Promise to Prevent Failures
Aptus IDE Study: Highest sac regression, shortest average neck length
among all EVAR IDEs
Late durability data exceeds expectations2,3
Aptus has the highest sac regression among all EVAR IDEs at years 2 and 31
At year 3, 82% sacs regressed1
High sac regression predictor for lower complications4
Endpoint
Median 3.4 yr.
Type 1 Endoleak
0.0% (0/155)
Graft Migration (>1cm)
3.2% (5/155) [a]
AAA Ruptures
EndoAnchor-related safety adverse events
[a] No type I endoleak or EndoAnchor dislocation observed in migrations, no evidence of endograft movement relative to aortic wall
1Based on Aptus data on file as of January 2014
2Mehta M et al. STAPLE-2: The Pivotal Study of the Aptus Endovascular AAA Repair System - 24-Months Results. Abstract presented at SVS 2012
3Mehta M et al. J Vasc Surg 2014;60(2):
4Goncalves FB et al. Br J Surg Jun;101(7):802-10

30. EndoAnchoring to Target Acute Type I Endoleak
Short, reverse taper proximal neck
Intraoperative Type I post-implantation of Cook Zenith
6 EndoAnchors implanted - Type I endoleak resolved
Images from article: Gandi RT and Katzen BT, Treating a Type Ia Endoleak Using EndoAnchors, Endovascular Today, March 2012

31. EndoAnchoring to Re-Establish Seal in Migration
3 year F/U showed migrated Talent with type Ia endoleak
Endurant cuff and EndoAnchors implanted - endoleak resolved
Images from article: de Vries JP et al, Use of Endostaples to Secure Migrated Endografts and Proximal Cuffs after Failed Endovascular Abdominal Aortic Aneurysm Repair, J Vasc Surg 2011; 54:

32. Minimum 4 EndoAnchors Recommended
Tips for EndoAnchor implantation:
30º-45º RAO
30º-45º LAO
C-arm positioning critical for proper spacing, visualization & implantation
Min 4 EndoAnchors recommended
For prox neck dia. > 29mm, min 6 EndoAnchors recommended
Strive for even spacing around neck circumference
EndoAnchors should penetrate vessel wall
Select positions lacking excessive thrombus/calcium
EndoAnchors
# of C-arm positions
Recommended angular offset
4 EndoAnchors 2
~90°
6 EndoAnchors 3
~60°
Note: C-arm positions above show just one possible combination

33. C-Arm Positioning for 6 EndoAnchors
30º RAO
30º LAO
90º Lateral
Note: C-arm positions above show just one possible combination

34. C-Arm Positioning for T1 EL Treatment
Move C-Arm in degree increments
Identify leak channel and then create a “suture line” along wall.
Circumferential anchoring before/after T1 EL treatment is recommended: address concerns of long-term neck morphology changes

35. Conclusions Major EVAR studies highlight late durability limitations
e.g. ‘EVAR 1,’ ‘ACE,’ ‘DREAM’
Greater complications in more hostile proximal neck anatomies
Proximal seal stability remains key
EndoAnchors designed to bring long-term stability of surgical anastomosis to EVAR
Favorable safety profile
Maturing data supports hypothesis of prophylactic benefits
Clinical experience shows EndoAnchoring addresses clear needs in EVAR & TEVAR
Augment strength when concerns exist for late complications
Target and treat acute and late type I endoleaks

36. Appendix

37. Challenges in Treating Urgent Aneurysm Patients
Limited options
FEVAR lead times too excessive
CHIMPs outcomes not definitive
May be unfit for open repair
Logistical difficulties
Fast treatment needed to stop bleeding in rAAA
Time constraints often preclude proper case planning and graft sizing
Complex cases
Anatomical challenges: typically hostile anatomy with short or angulated infrarenal necks and durability risks
Type I endoleaks: can be lethal, highly critical to prevent onset or treat
Types of patients receiving urgent treatment:
Ruptured AAA
Symptomatic AAA
Rapid AAA expansion
Large AAA diameter
6.5cm diameter AAA
Ruptured AAA
Images courtesy of Nic Nelken MD, Kaiser Hawaii and ANCHOR investigators

38. Challenges in Treating Urgent Aneurysm Patients
Need for immediate effective treatment vs. inter-facility transfer
16% rAAA patients transferred to another facility die before receiving AAA repair1
Early benefits realized with EVAR vs. open repair in rAAA2
Lower 30-day mortality (24% vs. 40%)
Lower early major complications (58% vs. 76%)
However, durability after EVAR remains problematic3
Substantially higher late re-interventions after EVAR
25.8% vs. 4.7% for open repair
Endoleak highest cause of post-EVAR re-interventions
Constitute 43.8% of re-interventions
Whereas no endoleaks after open repair
Abstract presentation by Mell MW and colleagues of Stanford University at the 28th Annual WVS Meeting
von Meijenfeldt GC et al. Eu J Vasc Endovasc Surg May;47(5):479-86
Rollins KE et al. Br J Surg Feb;101(3):

39. Outcomes after Treating Urgent AAA1
EndoAnchors shown as a useful adjunct to optimize seal and address concerns for re-bleed or initial rupture
Rapid, high sealing performance in complex anatomy (N=39)
15 minutes average EndoAnchoring time with 100% implantation success
92% freedom from endoleaks at final angio despite >90% hostile proximal necks
Durability maintained in follow-up
0% ruptures, 0% rebleeds, 0% proximal seal re-interventions (14 month mean clinical f/u)
0% Type Ia endoleaks per Corelab (3 month mean imaging f/u)
Comparison with historical data shows EndoAnchors may reduce late type I endoleak risk
Substantially lower rates in ANCHOR vs. comparable studies in standard EVAR
1Based on abstract presentation at VIVA 2014 late breaking trials session by Dr. Peter Schneider: “EndoAnchors in Urgent Endovascular Aneurysm Repair: Results from the ANCHOR Global Registry”