1. Endurant: A New Generation Endograft
Jae Sung Cho, MD
Associate Professor, Division of Vascular Surgery
University of Pittsburgh School of Medicine

2. DISCLOSURES
Jae-Sung Cho, MD
Honoraria
W.L. Gore & Associates, Inc

3. Medtronic EVAR EndoGrafts
AneuRx Talent Endurant

4. The Endurant EndoGraft
Description
Modular Stent-Graft
Multi-filament Polyester Fabric
Electropolished Nitinol Stent
Active Suprarenal fixation
Bifurcated: 3 cm Overlap Zone
Aorto-Monoiliac Configuration
Pt-Ir and Gold Markers
Endurant

5. Endurant Theoretical Advantages
M-shaped proximal stent for improved neck conformability
Limbs stent geometry and spacing designed for flexibility
One-piece, laser-cut, nitinol suprarenal stent with anchoring pins

6. Endurant Delivery System Features
Accurate stepwise proximal deployment of the stentgraft
Thumb wheel for controlled release of the suprarenal anchoring pins

7. Endurant Radio-Opaque Markers
“e” marker assists with A/P view and identifies contralateral gate
Flow divider marker for accurate contralateral limb placement
Contralateral gate ring marker assists with cannulation

8. The Endurant EndoGraft: Size Chart
Configuration
(mm x mm)
Length
(mm)
Vessel Treated (mm)
Profile
OD (Fr.)
36x20
145, 170
29-32 20
36x16
32x20
120, 145, 170
26-28
32x16
28x20
23-25
28x16
28x13
25x16
21-22 18
25x13
23x16
19-20
23x13

9. The Endurant EndoGraft: Size Chart
Contralateral Iliac Limbs
Contralateral Limb
(mm x mm)
Limb Length (mm)
Vessel Treated (mm)
OD (Fr.)
16 x 28
80, 95, 120
23-25 16
16 x 24
19-22
16 x 20
15-18
16 x 16
12-14 14
16 x 13
10-11
16 x 10
8-9

10. The Endurant EndoGraft: Size Chart
Iliac Extenders
Aortic Extenders
Iliac Extension
(mm x mm)
Length (mm) OD
(Fr.)
28 x 28 80 18
24 x 24 16
20 x 20
13 x 13 14
10 x 10
Aortic Cuff
(mm x mm)
Length (mm) OD
(Fr.)
36 x 36 45 20
32 x 32
28 x 28
25 x 25 18
23 x 23

11. US FDA Trial PI: Michel Makaroun MD
Non Randomized, Multi-center study comparing Safety and Effectiveness to the TALENT IDE cohort
Safety endpoint: MAE 30 days
Effectiveness endpoint: Successful AAA 1 year

12. US FDA Trial AAA > 5 cm or increase in size > 0.5 cm in 6 months
Neck mm diameter
Neck > 10 mm in length
Neck angulation: < 45 ° suprarenal and < 65 ° infrarenal
Iliacs 8 – 25 mm and >1.5 cm landing zone

13. US FDA Trial 30 sites 150 patients Enrollment completed in 10 months
June 2008 to April 2009
Standard 5 year FU
44 patients planned for a separate AUI arm started enrolling June 2009

14. US FDA trial Treatment Range Neck Diameter: 19-32 mm
Iliac Diameter: mm
Anatomic Requirements
> 10 mm neck length
Infrarenal Angulation ≤ 60°
Suprarenal Angulation ≤ 45°
AAA > 5 cm or increase in size > 0.5 cm in 6 months

15. US FDA trial Demographics
91% male
Mean age yrs
Maximum aneurysm diameter (mm)
Mean 57.0 ± 8.3
87% hypertension
59% CAD
44% smokers
27% diabetes

16. US FDA trial Length of Procedure: 101.2 ± 46.6 min (range 15-318)
General anesthesia: 83%
Mean estimated Blood loss : 185 ±167.9 cc (range )
blood transfusion required in 1 patient
Length of Hospital Stay: 2.1±2.3 days (range 1-17)

17. US FDA Trial Results No reported deaths within 30 days
No deployment failures
No open conversions

18. US FDA trial (Events, site reported)
% (m/n)
Successful delivery and deployment1
100.0% (150/150)
All-cause mortality through 1 month1
0.0% (0/150)
Conversion to surgery through 1 month post-implant1
Stent graft patency through 1 month2
98.6% (143/145)
All endoleaks at 1-month visit3
11.7% (16/137)
Secondary procedures to correct type I endoleaks through 1 month1
Secondary procedures to correct type III endoleaks through 1 month1
Secondary procedures through 1 month1
2.0% (3/150)
1 n = number of all ITT subjects. 2 n = number of subjects who had readable scans through 1 month. 3 n = number of subjects who had readable scans at the visit.

19. US FDA trial Endoleaks (site reported)
Endoleaks 1 Month % (m/n1 )
Type I % (1/137)
Type II % (13/137)
Type III % (0/137)
Type IV % (0/137)
Indeterminate % (1/137)
Unknown % (1/137)
Subjects had endoleaks of any type % (16/137)
1 Denominator is the number of subjects who had readable images at the time of assessment. 2 A subject may have more than one type of endoleaks; hence, number of subjects who had endoleaks of any type may not be the sum of those in each type.

20. US FDA trial Complications
Pulmonary 4/150 (2.7%)
Renal 4/150 (2.7%)
No pt required dialysis
All Cr returned to baseline
Cardiac 10/150 (6.7%)
MI 1/150 (0.7%)

21. US FDA Trial RESULTS No audited reports so far
No reported deaths in first 30days
No deployment failures

23. Accurate Proximal Deployment
Allows for Slow Deliberate Deployment

24. Significant Sac Shrinkage in many patients
6 Months Follow-up
Significant Sac Shrinkage in many patients
1 Month Months

25. Endurant ENGAGE Registry
Multinational, Post market, Single arm registry with planned prospective 5 year Follow-up
Started March 2009
80 sites worldwide
1200 patients planned

26. The Endurant EndoGraft: Summary
New Device from Medtronic
Flexible
Low profile
Active fixation
Rx a wide range of anatomy
CE Mark in Europe
US approval about 1 year away