1. Precise and Durable Outcomes With the GORE® TIGRIS® Vascular Stent
Edward Woo, MD
Director, MedStar Vascular Program
Chairman, Department of Vascular Surgery
Professor of Surgery, Georgetown University

2. Disclosures
Gore SAB

3. Dual Component Design

4. Blood Loop Test Test Significance 6 mm x 80 mm stents.
Deploy in 5 mm tubing.
Circulate human blood at 37°C for two hours.
Significance
Less thrombus formation maximizes potential for clinical patency.

5. Blood Loop Testing
Lasting thromboresistance: CBAS Heparin Surface provides sustained bioactivity.*, **
GORE® TIGRIS® Vascular Stent
*Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda® BioActive Surface heparin immobilization. European Journal of Vascular & Endovascular Surgery 2003;25(5):
**Gore S, Andersson J, Biran R, Underwood C, Riesenfeld J. Heparin surfaces: impact of immobilization chemistry on hemocompatibility and protein adsorption. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2014;102(8):

6. Elongation Testing Test Significance 6 x 80 mm stents
Clamp with 70 mm exposed
Apply 70 grams force
Measure elongation
Significance
Less elongation provides deployment accuracy and decreased potential for stent fracture

7. Minimal Elongation Rate
Elongation Results
Minimal Elongation Rate
Competitive Stents
Increased diameter size up to 13mm

8. Longitudinal Compression
Test
6 x 80 mm stents
Compress 12 mm (15%)
Measure force of stent resisting compression
Significance
Less resistance to compression allows the stent to naturally conform to vessel shortening and decreases potential for stent fracture
GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

9. Longitudinal Compression Testing
GORE® TIGRIS® Vascular Stent

10. Flexibility Testing
GORE® TIGRIS® Vascular Stent

11. US IDE Study Design
Objective: evaluate the safety and effectiveness of the TIGRIS® Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤24 cm in length, in the SFA/PPA of patients with symptomatic Peripheral Artery Disease (PAD)
Primary Safety Endpoint: Freedom from Major Adverse Events (MAE)
Primary Efficacy Endpoint: Primary patency at 12 mo
LifeStent fracture rate at 1 year 27%, 2 years 33% (TIGRIS was 0% at both timepoints).
The majority of the fractures were high grade 4 or 5 fractures.

12. US IDE Study Design
Prospective, multi-center, randomized, non-inferiority, control clinical study
Patients were randomized 3:1 to treatment with either:
GORE® TIGRIS® Vascular Stent
Bard® LifeStent® Vascular Stent
33 sites in the US, 3 sites in the EU
LifeStent fracture rate at 1 year 27%, 2 years 33% (TIGRIS was 0% at both timepoints).
The majority of the fractures were high grade 4 or 5 fractures.

13. Patient Demographics GORE® TIGRIS® Vascular Stent BARD® LIFESTENT®
GORE® TIGRIS®
Vascular Stent
BARD® LIFESTENT®
p-value
Number of Subjects
197 70
Gender
0.878
Female
56 (28.4%)
21 (30.0%)
Male
141 (71.6%)
49 (70.0%)
Smoking History (current/former)
183/197 (91.4%)
60/70 (85.7%)
0.460
Diabetes Mellitus
79 (40.1%)
30 (42.9%)
0.777
Hypertension
171 (86.8%)
55 (78.6%)
0.122
Hyperlipidemia
137 (69.5%)
48 (68.6%)
0.881
Hypercholesterolemia
107 (54.3%)
40 (57.1%)
0.780
Coronary Artery Disease
98 (49.7%)
32 (45.7%)
0.580
Myocardial Infarction (MI)
36 (18.3%)
10 (14.3%)
0.581
Rutherford Clinical Category
0.772 2
62/197 (31.5%)
22/70 (31.4%) 3
125/197 (63.5%)
43/70 (61.4%) 4
10/197 (5.1%)
5/70 (7.1%)

14. Lesion Characteristics
GORE® TIGRIS®
Vascular Stent
BARD® LIFESTENT®
p-value
Number of Devices (Subjects)
335 (197)
100 (70)
Pre-treatment Lesion Length (mm)
107.6 ± 68.6
117.9 ± 75.4
0.292
Total Stented Length (mm)
129.0 ± 73.3
148.7 ± 75.4
0.057
Number of Stents Implanted to Cover Lesion
196 70
0.033 1
101 (51.5%)
44 (62.9%) 2
55 (28.1%)
22 (31.4%) 3
36 (18.4%)
4 (5.7%) 4+
4 (2.0%)
0 (0.0%)
Lesion Type
197
0.483
Occlusion
83 (42.1%)
26 (37.1%)
Stenosis
114 (57.9%)
Lesion Calcification
189 66
0.442
None/Mild
99 (52.4%)
28 (42.4%)
Moderate/Severe
90 (47.6%)
38 (57.6%)
Tibial Runoff Vessels
187 69
0.156
21 (11.2%)
11 (15.9%)
106 (56.7%)
30 (43.5%)
60 (32.1%)
28 (40.6%)

15. Procedural and Technical Success
GORE® TIGRIS®
Vascular Stent
BARD® LIFESTENT®
Device Success
196/197 (99.5%)
70/70 (100.0%)
Lesion Success
196/197 ( 99.5%)
68/70 (97.1%)

16. Safety and Efficacy Endpoints
Safety Endpoint: 30-day freedom from MAE
TIGRIS® Vascular Stent: 187/188 (99.5%)
LifeStent® Vascular Stent: 69/69 (100%)

17. Safety and Efficacy Endpoints
LifeStent fracture rate at 1 year 27%, 2 years 33% (TIGRIS was 0% at both timepoints).
The majority of the fractures were high grade 4 or 5 fractures.

18. US IDE Study: 24 month fracture rates

19. Published Literature Summary
Number of
patients
Lesion
Length (mm)
location
characteristics
12-month PP
fTLR
Battaglia 1, 2016 27
157 *
SFA/PA —
80%
n/a
Piorkowski 2, 2015 32 62
25% CLI
86%
90%
Thaveau 3, 2016 98 92
61% CLI
60% CTO
47% popliteal
72%
Sibé5, 2016
239 87
83% calcification
82%
Battaglia G, Turiano SA, Tringale R, Sabatino E, Monaca V. Short- and medium-term results in femoral-popliteal obstructive disease treated with Gore® Tigris® stent. Italian Journal of Vascular & Endovascular Surgery 2016;23(1):5-9.
Piorkowski M, Freitas B, Steiner S, et al. Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries. Journal of Cardiovascular Surgery 2015;56(1):89-95.
Thaveau F, Méteyer V, LeJay A, Chakfé N. Latest generation of conforming dual component stent. In: Greenhalgh RM, ed. Charing Cross 2016-Vascular & Endovascular Challenges Update ed. Fulham, London, United Kingdom: BIBA Publishing; 2016:
Sibé M, Kaladji A, Boirat C, et al. French multicenter experience with GORE® TIGRIS® Vascular Stent in superficial femoral and popliteal arteries. Journal of Vascular Surgery. In press.
* Stented length

20. Conclusion
The dual-component design of TIGRIS® matches stenting needs in high-flexion areas
CBAS technology may offer additional benefits
IDE study demonstrates favorable results