Atherectomy: Jetstream and Directional. George S. Chrysant, M.D.

Transcription

1 Atherectomy: Jetstream and Directional George S. Chrysant, M.D.

2 Disclosures Abbott Vascular: MAB, consultant, proctor Abiomed: consultant Boston Scientific: MAB, consultant, proctor Medicines Company: MAB Spectranetics: consultant, proctor St. Jude Medical: consultant

3 Jetstream NXT Revascularization System Distal Tip Control Pod 2.1 mm 3.0 mm Differential cutting tip removes all plaque types Expandable blades offer single device solution Aspiration port collects plaque and thrombus Indications For Use: The Jetstream G2 System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries >3.0mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

4 Jetstream NXT Revascularization System Endovascular technology for complex lesion morphologies Differential cutting for plaque, calcium and thrombus Indicated for thrombus removal Single device solution for treatment from SFA to below the knee Expandable blade technology Active aspiration + front-end cutting Designed for efficiency and safety Reduced procedure time Minimized risk of distal embolization Indications For Use: The Jetstream G2 System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries >3.0mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

5 Overview PVD Study Purpose: A prospective, single arm, multi-center study to assess performance of the Pathway PV Atherectomy System during percutaneous peripheral vascular interventions Drs. Scheinert and Zeller - co-pis 172 patients at 9 European centers 100% data monitoring Angiographic core lab and CEC adjudicated

6 Pathway PVD Study Parameter Result Parameter Result Demographics (patients) Mean Age Female (n=88) Male (n=84) PVS Treatment Time 71.9 ± 8.4 years 51.2% 48.8% 3.5 ± 2.4 minutes Major Adverse Events (MAE) within 30 days Death Myocardial Infarction TVR (including TLR) Amputations 0/172 (0%) 0/172 (0%) 0/172 (0%) 2/172 (1.2%) ** Core Lab Analysis (lesions) Reference Vessel Diameter n=178 Target Lesion Length n=178 Pre - PVS Diameter Stenosis n=175 Post - PVS Diameter Stenosis n=175 Mean % reduction n=175 Ankle Brachial Index (patients) Baseline n= days n=149 6 months n= months n=109 Rutherford Score (patients) Baseline n= days n=142 6 months n= months n= ± 0.8 mm 35.4 ± 25.2 mm 79.1 ± 17.7% 35.6 ± 16.1% 43.5 ± 19.7% 0.59 ± ± ± ± ± ± 1.3 Other Device Related Serious Adverse Events within 30 days Emboli Dissection (C/D/E/F) Perforations Abrupt Closure Target Limb Re-intervention Target Lesion Revascularization (TLR) within 6 months Freedom from TLR at 6 months Freedom from TLR at 12 months 3/172 (1.7%) 1/172 (0.6%) 0/172 (0%) 1/172 (0.6%) 1/172 (0.6%) 25/172 (14.5%) 85% 74% * Abbreviations: PVS = Pathway PV System; TVR = Target vessel revascularization; TLR = Target lesion revascularization ** Amputations were planned for both patients prior to the revascularization procedure with the Pathway PV System Indications for use: The Pathway PV Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

7 Pre Treatment Lesion Location Pre treatment distal SFA, 60 mm CTO Jetstream G2 NXT Runtime: 10:34 mins Very stringy SFA, very fibrous lesions 60 mm CTO 2 passes blades down, 2 passes blades up Indications for use: The Jetstream G2 NXT System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries 3.0mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

8 Post Jetstream and PTA 4x120 balloon throughout SFA Console Indications for use: The Jetstream G2 NXT System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries 3.0mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. VS, IC or IR

9 Directional Atherectomy

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12 Directional Atherectomy MLD after atherectomy: 3.86, 3.76, 3.5 mm for de novo, restenosis and ISR respectively FINAL MLD: 4.58, 4.58, 4.38 mm PTA rates: 56%, 65%, 65% Stent rates: 2%, 7%, 9% Zeller T et al. JACC

13 Kaplan-Meier event-free survival curves for survival without target vessel revascularization Zeller, T. et al. J Am Coll Cardiol 2006;48: Copyright 2006 American College of Cardiology Foundation. Restrictions may apply.

14 Directional Atherectomy Primary patency: <50% stenosis by ultrasound at 18 months: 73%, 42%, 49% (p=0.008) TLR at 18 months: 22%, 56%, 49% (p=0.003) Amputation: 0, 1, 2 Zeller, T. et al. J Am Coll Cardiol 2006;48:

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19 Thank you