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

Disclosures Gore SAB

Dual Component Design

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.

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):432-437. **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):1817-1824

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

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

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.

Longitudinal Compression Testing GORE® TIGRIS® Vascular Stent

Flexibility Testing GORE® TIGRIS® Vascular Stent

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.

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.

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%)

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%)

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%)

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

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.

US IDE Study: 24 month fracture rates http://onlinelibrary.wiley.com/doi/10.1002/ccd.21240/epdf

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. 2016 ed. Fulham, London, United Kingdom: BIBA Publishing; 2016:423-428. 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

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