Medical Director of the Vascular Center My Choice for the 2 cm Uncomplicated Symptomatic Proximal Popliteal Stenosis John R. Laird, MD Professor of Medicine Medical Director of the Vascular Center UC Davis Health System

John R. Laird Jr. MD Consulting: Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Medtronic, Inc., Covidien and Abbott Vascular Grant Support: Atrium Medical Corporation and W. L. Gore and Associates, Inc Honoraria: Volcano Therapeutics, Inc. Stocks, Stock Options, other ownership interest: AngioSlide, NextGen Healthcare Information Systems, Inc., BioCardia, Inc., Endoluminal Sciences and Syntervention Reflow Medical Off-Label: Off-label use of stents

Popliteal Artery Direct extension of SFA as it passes through adductor canal Located between two heads of gastrocnemius muscle Anterior to popliteal vein Genicular and sural branches

Popliteal Artery Pathologic Conditions: Atherosclerosis Aneurysm Trauma Embolism Entrapment syndrome Cystic adventitial disease

The Uncomplicated, Symptomatic 2 cm Proximal Popliteal Artery Stenosis (Rare as Hen’s Teeth) Post PTA

Cystic Adventitial Disease Figure 14b. Case History 42 year old male runner Left lower extremity claudication Diagnosis? Treatment? Figure 14b. A 42-year-old male runner presented with acute claudication of the left lower extremity and was initially thought to have popliteal entrapment. (a, b) Stress (a) and nonstress (b) angiograms depict a similar hourglass-shaped stenosis. (c-e) Sequential axial T2-weighted MR images reveal extensive compression of the popliteal artery by CAD (arrow). Cystic Adventitial Disease

Case History 72 yo male CAD s/p CABG, HTN, Hyperlipidemia Lifestyle limiting claudication symptoms of right lower extremity Previous stenting of Left SFA Non-compressible arteries – ABI’s unreliable Duplex evidence of significant popliteal stenosis

Angiography

Treatment Options PTA Cutting/Scoring PTA Excisional atherectomy (TurboHawk Calcium Cutter) Orbital/Rotational atherectomy Stenting

Woven Nitinol Design

Leipzig Supera Popliteal Registry N = 101

Leipzig Supera Popliteal Registry N = 101

Post PTA

Diffuse Femoropopliteal Disease

5 x 120mm Supera Stents (x2) Final

Popliteal CTO: Interwoven Stents

Final Runoff Bent-Knee Angio

GORE® TIGRIS Vascular Stent Dual Component Stent Design Clinically Proven Stent Frame Nitinol wire ePTFE Interconnecting Structure CARMEDA Bioactive Surface

TIGRIS: Dual Component Stent Design Designed to: Maximize flexibility while minimizing risk of stent fracture Allow axial compression while resisting stent elongation Naturally conforms and allows vessel movement 23

ETAP Trial Multicenter, randomized trial of PTA vs. Stenting (LifeStent) for popliteal stenosis 1:1 Randomization 9 Centers in Europe, 246 patients Primary endpoint: restenosis rate at 24 months No restriction to lesion length

ETAP Trial Technical success 100% in both groups Stent fracture rate 3.8% at one year 12-Month Primary patency: LifeStent 67.4% PTA 44.9% 12-Month TLR Rate: LifeStent 15.4% PTA 50.4%

Case History 72 yo male (retired radiologist) Previous orbital atherectomy of popliteal artery calcified stenosis (over 2 years ago) Recurrent left calf claudication ABI: 0.80  0.60 Duplex: Popliteal PSV of 443 cm/sec (PSVR) > 3.5

Left Lower Extremity Angio

LEVANT 2 Study Procedural Technique Cross stenosis/occlusion with guidewire and predilate with balloon 1mm < reference vessel diameter If no flow limiting dissection or residual stenosis > 70%, randomize to DEB vs. POBA Dilate with DEB matched 1:1 to RVD Post dilate with standard balloon as necessary to treat recoil/dissection to avoid cross over stenting

DEFINITIVE LE Key Eligibility Criteria Inclusion Criteria RCC 1-6 ≥ 50% stenosis Lesion Length ≤ 20 cm Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm Exclusion Criteria Severe calcification In-stent restenosis Aneurysmal target vessel SilverHawkTM /TurboHawk™ Peripheral Plaque Excision Systems used in study

Study Design and Primary Endpoints 800 patients 47 centers Claudicants (RCC 1-3) 598 patients* Primary patency by Duplex US at 12 mos CLI (RCC 4-6) 201 patients Freedom from major unplanned amputation at 12 mos *1 censored due to informed consent violation

Baseline Demographics Claudication (RCC 1-3) (n=598) CLI (RCC 4-6) (n=201) All Subjects (RCC 1-6) (n=799) Age (yrs)* 69 72 70 Female 44% 50% 45% History and Risk Factors Angina 23% 18% 22% Diabetes* 47% 69% 52% Hypertension 92% Hyperlipidemia* 86% 76% 84% Renal Insufficiency* 17% Current/Previous Smoker* 54% 36% 49% * p<0.05, claudicant vs. CLI

Baseline Lesion Characteristics Core Lab Reported Claudication (RCC 1-3) CLI (RCC 4-6) All Subjects (RCC 1-6) Number of Patients 598 201 799 Number of Lesions 743 279 1022 Mean Length (cm) 7.5 7.2 7.4 Baseline Stenosis (%) 73 76 74 Occlusions (%) 17 30 21 Anatomic location based on proximal edge of lesion treatment, % (n) SFA 72% (536) 48% (135) 66% (671) Popliteal 15% (114) 17% (48) 16% (162) Infrapopliteal 13% (93) 34% (96) 18% (189)

Peri-procedural Outcomes Claudication (RCC 1-3) CLI (RCC 4-6) All Subjects (RCC 1-6) Device Success (≤30% stenosis after directional atherectomy) Investigator-Reported 87% Core Lab 76% 72% 75% Procedure Success (≤30% stenosis at end of procedure) 99% 98% 91% 83% 89% Therapy Pre-Directional Atherectomy PTA 9% Post-Directional Atherectomy PTA (no stent) 33% Mean pressure 6.6 atm Bail-Out Stent 3%

Stent-like Primary Patency Claudicant Cohort 743 Lesions 7.5 cm Mean lesion length 72.7% Mean baseline stenosis PSVR ≤ 3.5 82% PSVR ≤ 2.4 78% 36 |

Making Sense of it All For the uncomplicated 2 cm proximal popliteal stenosis – POBA is probably adequate Non-stent options reasonable – DCB, atherectomy Favorable early experience with newer, flexible nitinol stents (Supera stent for calcified/complicated lesions)