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Atherectomy: Where Do We Stand After 12 Years

Since FDA ClearanceAtherectomy: Where Do We Stand After 12 Years

Since FDA ClearanceJohn R. Laird

Professor of MedicineMedical Director of the Vascular Center

UC Davis Medical Center

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.

� Affiliation/Financial Relationship Company

� Consulting Fees/Honoraria Boston Scientific, Medtronic, Abbott, Covidien, Bard Peripheral Vascular, Volcano

� Research Support Atrium Medical, WL Gore

� Scientific Advisory board/stock options AngioScore, Angioslide, NexGen, Reflow,Endoluminal Sciences, Syntervention, PQ Bypass, Shockwave Medical

Board Member VIVA Physicians

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

Device Evolution

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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)

Front-Cutting � N/ADifferential Cutting � � N/AActive Aspiration �Concentric Lumens �Lesion Morphology:

Calcium � � � (large vessel only) �

Soft/Fibrotic Plaque � � �

Thrombus � (indicated for thrombectomy and

atherectomy)

�

Atherectomy Devices

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.

Excimer Laser

Technical Improvements:Evolution of Catheter Designs

– Extreme

– Optimally Spaced

– Point 9

– Turbo

– Turbo Elite

– Turbo Tandem 2.3 mm and 2.5 mm peripheral catheters FDA approved 2004

Excimer LaserTechnical Improvements:

Turbo Tandem

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9

Pretreatment Angio 100% Lt SFA

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Angio Post 2 mm Pilot channel60 Fl/40 HzIVUS Post 2 mm Pilot channel

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Angio Post 8 Fr TURBO-Booster with 2 mm catheter at 60 Fl/40 Hz4 passes/11,114 pulsesIVUS Post TURBO-Booster

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Angio Post PTA using 5 mm x 8 cm and 6 mm x 2 cm balloons @ 2 atmIVUS Post PTA

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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

15 16Laser debulking and PTA of Ant tibial and peroneal

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Limb Salvage Rate = 93%

EXCITE Trial - Left SFA ISR

Following Laser and PTA

Sur

viva

l Pro

babi

lity

Product-Limit Survival EstimatesWith number of subjects at risk

EXCITE ISR TrialPrimary Patency11

Days from Index Procedure

p < 0.005

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Occluded Viabahn Stent Graft

STEALTH 360º PAD SYSTEM

CLASSIC CROWN SOLID CROWN

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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

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Post Atherectomy

Treat all atherosclerotic plaque effectively, including severe calcium

Treat All Morphologies

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

HawkOne™ Directional Atherectomy System 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

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Potential Applications�Ostial lesions�Common femoral lesions�Eccentric, bulky plaque�Calcified lesions� Instent restenosis

Common Femoral ArteryCommon Femoral Artery

TurboHawk Calcium Cutter

Diffuse SFA Disease in Diabetic Patient

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JETSTREAM XC (eXpandableCutter) System� 135 cm OTW � Two sizing options in a single device

JETSTREAM SC (Single Cutter) System� 145cm OTW � Single Cutter technology for tortuosity

XC 2.1/3.0mm XC 2.4/3.4 mm

JETSTREAMTM Systems• Rotational/differential cutting tips• Aspiration ports collect plaque & thrombus • .014GW / 7F sheath compatible

XC 2.1/3.0mm

XC 2.4/3.4 mm SC 1.85mm

SC 1.6mm

SC 1.6mmSC 1.6mmSC 1.6mm SC 1.85mmSC 1.85mmSC 1.85mm

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

Jetstream Clinical Studies

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

What’s the quality of data supporting the use of atherectomy devices?

� 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)

Poor!

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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

� 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

Atherectomy and Drug-Coated Balloon Efficacy: Clinical Evidence

Zeller, VIVA 2014.DCB, drug-coated balloon; DUS, duplex ultrasound; SFA, superficial femoral artery

97%

31%

70%50%

86%

37%

63%47%

0%20%40%60%80%

100%

DUSPatency

%Stenosis

DUSPatency

%Stenosis

Atherectomy + DCB DCB

DCB Atherectomy+ DCB

Atherectomy+ DCB

(Severe Ca2+)Technical Success 64.2% 89.6% 84.2%Bail-out Stent 3.7% 0% 5.3%Flow-limiting Dissection 19% 2% 0%

Lesions >10 cm All Severe Ca2+

Procedural Results 12-Month Results

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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!!