1. The Aptus™ Endovascular Repair System: Independent Fixation and Implications
David H. Deaton, MD
Chief, Endovascular Surgery
Georgetown University Hospital

2. David H. Deaton, MD DISCLOSURES Consulting Fees Honoraria
Aptus Endosystems, Inc., ROX Medical
Honoraria
m2s, Inc.
Grants/Contracted Research
Boston Scientific Corporation, Terumo Medical Corporation
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference the published data from FDA sanctioned trials of devices that have not been approved yet. I will describe these devices and how they are physically different from current devices.

3. EVAR in 2010 Nearly 20 years of development
11 years of widespread use
A variety of grafts with different approaches to longitudinal graft fixation
No techniques for radial fixation (i.e. dilating disease)
Deficiencies
Migration
Long-term follow-up
Access and catheter crossing profile
Precision control and operator creativity

4. EVAR’s “Dirty Little Secrets”
Radial force (stents) in a dilating pathophysiology
No way to understand whether fixation elements (barbs, hooks) remain intact or are failing until the graft migrates (exception: Ancure, no longer available)
“Mandatory follow-up” necessary for success…but compliance highly variable

5. February
2009
April
2007
20 mm migration
Over 22 months

6. Long-Term Failure Modes
Disease related
Progression of aneurysmal disease
Device related
Acceleration of dilitation at attachment site
Longitudinal migration and loss of aneurysm exclusion (i.e. late Type I)
Late Type III – limb disjunction; stent fracture graft perforation

7. Aptus System Approach Separation of Endograft Exclusion and Fixation
Staples capable of reproducing “surgical” degree of fixation
Reduction in catheter crossing profile
Discrete fixation under physician control
EndoStaple augments endograft seal
Smaller crossing profile without compromises in:
Stent design to accommodate fixation elements
Material durability or deployment control to achieve lower crossing profile

8. Aptus™ Endovascular AAA Repair System
Aptus™ AAA Endograft
Highly flexible endograft
Short Neck Treatment Range
Modular Components
Positive-Interlocking Limbs
Aptus™ Endograft Delivery Systems
Lowest Crossing Profile Product Line in the Market (16Fr & 18Fr)
Aptus™ EndoStapling System
Proprietary technology
EndoStapling emulates surgical sutures
Discrete radial fixation enables Endograft design optimization – a system approach
Aptus Endograft
Aptus Endograft Delivery
Close up of endostaples in graft
18Fr
20Fr
14Fr
16Fr
Aptus EndoStapling System
Aptus Future
Aptus Current
Commercial Current

9. Irregular neck: Focal seal
Short proximal stent allows independence of adjacent aortic anatomy
Conformation of
unsupported body to
irregular aortic neck

11. Initial Phase Staple Implantation Completed Staple Implantation
Staple delivery withdrawal
Pressure felt and stent deflection seen as staple applier positioned for implantation

12. Aptus EndoStapling System
Aptus™ Endovascular Repair Kit (Strengthen and/or Repair of Commercial Products)
Aptus™ Aortic Cuff
Provides additional proximal length
Augments fixation and/or seal
Used in primary or secondary procedures
Aptus™ EndoStapling System
Aptus™ Steerable EndoGuide
Aptus™ EndoStaple Applier
EndoStaple Cassette
Aptus Aortic Cuff
Aptus EndoStapling System
Medtronic Talent
Gore Excluder

13. STAPLE-2 Clinical Primary Results
The STAPLE-2 clinical trial completed patient enrollment in Jan 2009
One year follow up to be completed in Feb 2010
Subject Accountability
Discharge
1 Mo
6 Mo
12 Mo
155
154
144
102*
Primary
Safety Endpoints
Goal: Less than 13% Major Adverse Event at 1 mo follow-up
Results: 1.9% (3 out of 154 patients)
Death (1), Myocardial Infarction (2)
Primary
Efficacy Endpoints
Goal: Greater than 80% composite success at 12 mo follow-up
Results: 96.1%* (4 patients out of 102 patients)
Delivery failure (2), Type I and III Endoleaks requiring intervention (1 Type I, 1 Type III), Conversion to open repair (1)
* 12 month follow has not been completed for all patients

14. STAPLE-2 Clinical Data Performance Comparisons
Technical and Performance
Success at 12 Mo*
Talent
Excluder
Zenith
Powerlink
Aptus
Migration (> 10 mm)
0.8%
2.3%
0.0%
0.7%
Migration (> 5 mm)** NA
2.5%
4.4%
Endoleak (I, III, IV)
6.6%
1.0%
1.4%
AAA Rupture
AAA Mortality
2.1%
0.5%
Device Integrity
2.7%
0.6%
2.0%
All data from core lab or SSE data sheets except were noted
EndoStapling System Delivery Success at 1 mo = 100%
EndoStaple Device Integrity at 12 mo* = 100%
*12 month follow has not been completed for all Aptus patients
** Internal data evaluation for Aptus

15. STAPLE-2 Clinical Data Performance Comparisons
Aneurysm Size Change at 12 Mo*
Talent
Excluder
Zenith
Powerlink
Aptus
Reduction (> 5 mm)
34%
14%
68%
62%
61%
Enlargement (> 5 mm) 2% 7% 1%
No Change (0 - 5 mm)
64%
79%
30%
36%
38%
All data from core lab or SSE data sheets
Pre-Op
Post-Op (30-days)
Post-Op (6-months)
Post-Op (1 Year)
* 12 month follow has not been completed for all Aptus patients

16. 12% STAPLE-2 patients with Proximal Neck lengths ≈ 12mm 17%
Proximal Neck Zone
STAPLE-2 patients with Proximal Neck lengths ≈ 12mm
17%
STAPLE-2 patients with Proximal Neck lengths ≈ 10mm
12%
Type I Endoleaks* 0%
* 12 month follow has not been completed for all Aptus patients

17. Radial Fixation: Case Example
STAPLE-1 Patient
12 mm neck
7.5 cm AAA
Post Op:
Type II endoleak
Refused treatment
AAA growth to 10 cm
No Migration
No Type I Endoleak
No Proximal Neck Dilation

18. STAPLE-2 Clinical Data: Thrombotic complications
Patients with Thromboembolic Events (12 mo)*
Talent
Excluder
Zenith
Powerlink
Aptus
Limb Occlusion
3.6%
1.0%
4.0%
1.3%
12%
Lower Limb Embolic Event
NA**
15%
Data from core lab and reported clinical studies
All studies had greater than 40 patients and minimum one-year follow-up
Patients that have experienced an event were treated via increased surveillance, anticoagulation and secondary interventions
The therapies used have been successful and to date no patient has experienced any tissue loss
*12 month follow has not been completed for all Aptus patients
** Clinical data on the number of patients with lower limb embolic events not reported

19. Where is the thrombus forming?
CT Images Show:
Irregular thrombus in the Main Body docking zone
Thrombus loosely connected and extending downstream
Small diameters and rough surface in the docking zone
Main Body
Docking Zone
CT Reconstruction and Image of Irregular Thrombus

20. Why is the thrombus forming?
Small Docking Lumens
Finished Main Body docking lumens were sewn undersized (2.3 mm)
Small and Rough Lumen Surface
Undersized Main Body docking lumens led to small and rough lumen surfaces
Thrombus Formation
Small and rough lumen surfaces led to high fluid shear stress and irregular thrombus

21. Shear Stress Induced Platelet Aggregation
Stagnant: Red blood thrombus may form at very low shear stress levels (0-5 dyne/cm2)
Physiologic: Neither coagulation nor intravascular thrombus normally forms ( dyne/cm2)
Pathologic: Excessive platelet activation and aggregation occurs ( dyne/cm2)
Platelets deposit rate as high as 10x greater than physiologic levels

22. Computational Fluid Dynamics (CFD):
Confirmed small docking lumens had high shear stresses
Confirmed comparable shear stress among competitors and Aptus device (nominal dimensions)
CFD Fluid Shear Results
CFD Analysis (Small Docking Lumens)

23. STAPLE-2 Device Explant:
One patient had a surgical conversion during the STAPLE-2 study for thrombus
Explanted device confirms the connection
Small Docking
Lumens
Small Rough Lumen Surface
Thrombus
Formation
Explanted Small Main Body Docking Lumens
Cast Model Small Main Body Docking Lumens

24. CFD Fluid Shear Results
Manufacturing and Quality Improvements:
Sewing procedures, operator training, manufacturing and inspection tooling
Design Improvements:
New sewing technique, optimize lumen flow characteristics
New Graft
Old Graft
CFD Fluid Shear Results
New Docking Lumen
Small Docking Lumen

25. Stapling ….a new Endovascular Capability
The ability to attach one object to another with a device independent of the objects being attached
Faithful reproduction of fundamental vascular reconstruction
Transmural interrupted suture
Fixation
Enhanced and scalable longitudinal fixation; potential equivalence to open sutured anastomosis
Radial – potential to resist aneurysmal degeneration
Discrete Control
Radial - location, concentration, number
Temporal - application of staple(s) at any time
Fixation - degree with number of staples
Sealing - Ability to use fixation to address seal in irregular anatomy

26. Thank you