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