4/18/2015 Disclosure Statement of Financial Interest � Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Atherectomy: Where Do Atherectomy: Where Do Affiliation/Financial Relationship Company � We Stand After 12 Years We Stand After 12 Years Consulting Fees/Honoraria Boston Scientific, Medtronic, Abbott, Covidien, Since FDA Clearance Since FDA Clearance � Bard Peripheral Vascular, Volcano John R. Laird Research Support Atrium Medical, WL Gore � Professor of Medicine Medical Director of the Vascular Center Scientific Advisory board/stock options AngioScore, Angioslide, NexGen, Reflow, � Endoluminal Sciences, Syntervention, PQ Bypass, Shockwave Medical UC Davis Medical Center Board Member VIVA Physicians Device Evolution Where Do We Stand? � Continued evolution and improvement of devices � Niche applications (Calcium, thrombus containing lesions, instent restenosis, “non-stent zones”) � Limited data � Excellent reimbursement in US (outpatient labs) driving usage � Possibility of Atherectomy plus DCB 4 1
4/18/2015 Atherectomy Devices Excimer Laser Diamondback 360™, SilverHawk™, Turbo-Elite™ Jetstream™ Stealth 360™ TurboHawk™ Laser Atherectomy Atherectomy System Atherectomy System Plaque Excision Catheter Technical Improvements: (Boston Scientific) (Cardiovascular System (Spectranetics) Systems, Inc) (Covidien) Evolution of Catheter Designs – Extreme Front-Cutting � N/A Differential Cutting � � N/A – Optimally Spaced Active Aspiration � Concentric Lumens � – Point 9 Lesion Morphology: Calcium � � � (large vessel only) � – Turbo � � � Soft/Fibrotic Plaque – Turbo Elite Thrombus � (indicated for � thrombectomy and 2.3 mm and 2.5 mm peripheral atherectomy) – Turbo Tandem catheters FDA approved 2004 Sources: Endovascular Today Buyer’s Guide 2014. JETSTREAM System Brochure, Boston Scientific Website, 2014. Diamondback 360 product website, CSI, 2014. Covidien website, Directional Atherectomy products, 2014. Turbo-Elite Laser Atherectomy Catheter Instructions for Use, May 2014. Turbo Tandem Excimer Laser Technical Improvements: 2
4/18/2015 Angio Post 2 mm Pilot channel IVUS Post 2 mm Pilot channel 60 Fl/40 Hz Pretreatment Angio 100% Lt SFA 9 10 Angio Post 8 Fr TURBO-Booster Angio Post PTA using 5 mm x 8 cm with 2 mm catheter at 60 Fl/40 Hz IVUS Post PTA IVUS Post TURBO-Booster and 6 mm x 2 cm balloons @ 2 atm 4 passes/11,114 pulses 11 12 3
4/18/2015 Clinical Evidence Potential Applications � Peripheral Excimer Laser Angioplasty Trial (PELA) – Randomized trial of laser vs. PTA for long SFA occlusions � Debulking long occlusions � Laser Angioplasty for Critical Limb Ischemia Trial (LACI) � Instent restenosis – Multicenter registry of laser plus adjunctive therapies for CLI � Thrombus containing lesions � CELLO Trial – Multicenter registry of Turbo Booster/Tandem device � Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis (EXCITE ISR) – Randomized trial of laser vs. PTA for fem-pop ISR Laser debulking and PTA of Ant tibial and peroneal 15 16 4
4/18/2015 EXCITE Trial - Left SFA ISR Limb Salvage Rate = 93% EXCITE ISR Trial Primary Patency 11 Product-Limit Survival Estimates With number of subjects at risk p < 0.005 Survival Probability Days from Index Procedure Following Laser and PTA 5
4/18/2015 Occluded Viabahn Stent Graft STEALTH 360º PAD SYSTEM CLASSIC CROWN SOLID CROWN 6
4/18/2015 Clinical Application Clinical Evidence � Heavily calcified and non-dilatable lesions � OASIS Trial – Prospective multicenter registry � CONFIRM I and CONFIRM II – Post market registries � CALCIUM 360 ° – Post market registry 2.25 mm Crown Orbital Atherectomy Dealing with Calcification 7
4/18/2015 Post Atherectomy HawkOne™ Directional Atherectomy System Treat All Morphologies Treat all atherosclerotic plaque effectively, including severe calcium HawkOne™ Directional Atherectomy System Clinical Evidence � TALON Registry � 50% increase in rotational – Post market registry speed (8,000 – 12,000 RPM) � DEFINITIVE LE � More robust drive shaft – Large, prospective multicenter registry (claudication and CLI subgroups) � Modified blade design with 4 contoured blades � DEFINITIVE Calcium – Prospective multicenter registry of excisional atherectomy � Better crossing profile for calcified lesions � Simplified cleaning � DEFINITIVE AR – Small randomized trial of DCB vs. Atherectomy plus DCB 8
4/18/2015 Common Femoral Artery Potential Applications Common Femoral Artery � Ostial lesions � Common femoral lesions � Eccentric, bulky plaque � Calcified lesions � Instent restenosis TurboHawk Calcium Cutter Diffuse SFA Disease in Diabetic Patient 9
4/18/2015 JETSTREAM TM Systems • Rotational/differential cutting tips • Aspiration ports collect plaque & thrombus • .014GW / 7F sheath compatible XC 2.1/3.0mm SC 1.6mm SC 1.85mm XC 2.4/3.4 mm JETSTREAM SC (S ingle C utter) JETSTREAM XC (e X pandable System C utter) System � 145cm OTW � 135 cm OTW � Single Cutter technology for � Two sizing options in a single tortuosity device XC 2.1/3.0mm XC 2.4/3.4 mm SC 1.6mm SC 1.6mm SC 1.6mm SC 1.85mm SC 1.85mm SC 1.85mm What’s the quality of data supporting Jetstream Clinical Studies the use of atherectomy devices? Pathway PVD study Poor! 172 patients at 9 European centers � – 51% had lesions with moderate to high calcium, 31% total occlusions � 74% TLR-free at 12 months � Many were approved by the FDA using 510K pathway based on predicate device and little data Jetstream Calcium Study � After all these years - Only 3 randomized trials � Multicenter study of patients with moderately to severely calcified peripheral artery disease (N=21) � Results show that the JetStream Atherectomy System removes and remodels superficial calcium in – PELA Trial (Excimer Laser) moderately and severely calcified lesions, resulting in significant luminal gain – EXCITE ISR Trial (Excimer Laser) JET Post-market Registry – DEFINITIVE AR (Directional atherecomy plus DCB Ongoing registry to observe effects of Jetstream on various lesion types/morphologies � vs. DCB) Zeller et al. J Endovasc Ther 2009;16:653–662. Sixt et al. Ann Vasc Surg 2011; 25:520-529. Maehara et al. ISET 2013, Miami, FL. ClinicalTrials.gov NCT01436435 10
4/18/2015 Atherectomy and Drug-Coated Balloon Combination Therapy: Efficacy: Clinical Evidence Atherectomy Plus DCB � DEFINITIVE AR: directional atherectomy + DCB vs DCB alone – Third non-randomized arm for directional atherectomy + DCB for Best of Both Worlds? severely calcified lesions • Greater acute lumen � Results suggest that adjunctive atherectomy may improve procedural and clinical outcomes following DCB treatment of the gain of atherectomy SFA and/or popliteal artery, particularly for longer or severely calcified lesions without recoil/dissection Procedural Results 12-Month Results of PTA Lesions >10 cm All Severe Ca 2+ Atherectomy • DCB allows improved Atherectomy DCB + DCB 100% + DCB (Severe Ca 2+ ) 97% patency rates after 80% Technical 86% 60% 70% atherectomy 64.2% 89.6% 84.2% Success 40% 63% 50% Bail-out 31% 47% • Reduced need for stents 20% 3.7% 0% 5.3% Stent 37% 0% Flow- limiting DUS % DUS % 19% 2% 0% Dissection Patency Stenosis Patency Stenosis Zeller, VIVA 2014. Atherectomy + DCB DCB DCB, drug-coated balloon; DUS, duplex ultrasound; SFA, superficial femoral artery 11
4/18/2015 Where Do We Stand? Go Giants!! � Better atherectomy devices available � Device specific advantages for certain lesion subsets � More options for heavily calcified lesions But… � These are expensive devices � Limited good quality data � Usage driven by favorable reimbursement 12
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