A new GORE TIGRIS Vascular Stent for the

Rajesh Malik MD I have no relevant financial relationships Some slides were provided by

GORE® TIGRIS® Vascular Stent: GORE®, TIGRIS®, and designs are trademarks of W. L. Gore

Indications for Use in the U. S. • FDA Approval July 2016 • Indications

Made from single-wire nitinol stent with flexible and biocompatible fluoroploymer interconnections GORE®, TIGRIS®, and

Dual Component Design GORE®, TIGRIS®, and designs are trademarks of W. L. Gore &

$Flexible Designed to: • Maximize flexibility while minimizing risk of stent fracture • Allow$

GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016

$Advantages? • 0 fractures in trials • No elongation • Resists thrombus formation$

Published Literature Summary and IDE Study Results GORE®, TIGRIS®, and designs are trademarks of

Published Literature Summary Number of patients Lesion length (average in mm) Lesion location Lesion

Conclusion • I’ve had some experience implanting tigris and overall I was satisfied •

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A new GORE® TIGRIS® Vascular Stent for the Treatment of Lower Extremity Occlusions Rajesh Malik MD, FACS Associate Professor of Surgery, Med. Star Georgetown University

Rajesh Malik MD I have no relevant financial relationships Some slides were provided by Gore

Indications for Use in the U. S. • FDA Approval July 2016 • Indications For Use – INDICATIONS FOR USE IN THE U. S. : The GORE® TIGRIS® Vascular Stent is intended to improve luminal diameter in patients with symptomatic de-novo or restenotic lesions or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA) with reference vessel diameters ranging from 4. 0 – 6. 5 mm and lesion lengths up to 240 mm. CONTRAINDICATIONS: The GORE® TIGRIS® Vascular Stent is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. The GORE ® TIGRIS® Vascular Stent is contraindicated in patients with contraindication to antiplatelet and/or anticoagulation therapy. DO NOT use the GORE ® TIGRIS® Vascular Stent in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016 W. L. Gore & Associates, Inc.

Made from single-wire nitinol stent with flexible and biocompatible fluoroploymer interconnections GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016 W. L. Gore & Associates, Inc.

$Flexible Designed to: • Maximize flexibility while minimizing risk of stent fracture • Allow$

Flexible Designed to: • Maximize flexibility while minimizing risk of stent fracture • Allow axial compression while resisting stent elongation • Naturally conforms and allows vessel movement GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016 W. L. Gore & Associates, Inc.

$Advantages? • 0 fractures in trials • No elongation • Resists thrombus formation$

Advantages? • 0 fractures in trials • No elongation • Resists thrombus formation

Published Literature Summary Number of patients Lesion length (average in mm) Lesion location Lesion characteristics 12 -month primary patency 12 -month f. TLR Battaglia 1, 2016 27 157 * SFA and PA — 80% n/a Piorkowski 2, 2015 32 62 SFA and PA 25% CLI 86% 90% 61% CLI 60% CTO 47% popliteal 72% n/a Thaveau , 2016 98 92 SFA and PA Parthipun 4, 2015 48 114* PA 70% CLI 74% CTO 100% popliteal 70% 86% Sibé 5, 2017 239 87 SFA and PA 83% calcification 82% n/a GORE® TIGRIS® Vascular Stent IDE Study 6, 2016 197 107 SFA and PA 42% CTO 63% 82% 3 1. 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. 2. 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. 3. Thaveau F, Méteyer V, Le. Jay 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. 4. Parthipun A, Diamantopoulos A, Kitrou P, et al. Use of a new hybrid heparin-bonded nitinol ring stent in the popliteal artery: procedural and mid-term clinical and anatomical outcomes. Cardiovascular & Interventional Radiology 2015; 38(4): 846 -854. ” 5. 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. 6. Laird JR. Novel nitinol stent for long lesions in the superficial femoral artery and proximal popliteal artery: 24 month results from the TIGRIS Randomized Trial. VIVA 2016: Vascular Interventional Advances Conference; September 18 -22, 2016; Las Vegas, NV. GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016 W. L. Gore & Associates, Inc. * Stented length

Published Literature Summary Number of patients Lesion length (average in mm) Lesion location Lesion characteristics 12 -month primary patency 12 -month f. TLR Battaglia 1, 2016 27 157 * SFA and PA — 80% n/a Piorkowski 2, 2015 32 62 SFA and PA 25% CLI 86% 90% 61% CLI 60% CTO 47% popliteal 72% n/a 70% 86% 82% n/a 63% 82% Thaveau , 2016 98 92 SFA and PA Parthipun 4, 2015 48 114* PA Sibé 5, 2017 239 87 GORE® TIGRIS® Vascular Stent IDE Study 6, 2016 197 107 3 1. 70% CLI 74% CTO 100% popliteal SFA and PA 83% calcification 2 year primary patency 67. 2% SFA and PA 42% CTO 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. 2. 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. 3. Thaveau F, Méteyer V, Le. Jay 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. 4. Parthipun A, Diamantopoulos A, Kitrou P, et al. Use of a new hybrid heparin-bonded nitinol ring stent in the popliteal artery: procedural and mid-term clinical and anatomical outcomes. Cardiovascular & Interventional Radiology 2015; 38(4): 846 -854. ” 5. 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. 6. Laird JR. Novel nitinol stent for long lesions in the superficial femoral artery and proximal popliteal artery: 24 month results from the TIGRIS Randomized Trial. VIVA 2016: Vascular Interventional Advances Conference; September 18 -22, 2016; Las Vegas, NV. GORE®, TIGRIS®, and designs are trademarks of W. L. Gore & Associates. © 2016 W. L. Gore & Associates, Inc. * Stented length

Conclusion • I’ve had some experience implanting tigris and overall I was satisfied • In the few patients I’ve treated (roughly 12 months), I have not had a thrombosis yet.