Device Evolution Where Do We Stand? Continued evolution and - - PowerPoint PPT Presentation

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Atherectomy: Where Do We Stand After 12 Years Since FDA Clearance Atherectomy: Where Do We Stand After 12 Years Since FDA Clearance

John R. Laird Professor of Medicine Medical 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

4

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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/A

Differential Cutting

• N/A

Active 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 Laser

Technical Improvements:

Turbo Tandem

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9

Pretreatment Angio 100% Lt SFA

10

Angio Post 2 mm Pilot channel 60 Fl/40 Hz IVUS Post 2 mm Pilot channel

11

Angio Post 8 Fr TURBO-Booster with 2 mm catheter at 60 Fl/40 Hz 4 passes/11,114 pulses IVUS Post TURBO-Booster

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Angio Post PTA using 5 mm x 8 cm and 6 mm x 2 cm balloons @ 2 atm IVUS 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 16 Laser 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

Survival Probability

Product-Limit Survival Estimates

With number of subjects at risk

EXCITE ISR Trial Primary 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 Artery Common Femoral Artery TurboHawk Calcium Cutter Diffuse SFA Disease in Diabetic Patient

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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

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

• f 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% DUS Patency % Stenosis DUS Patency % 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!!