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12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director

12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director Baptist Cardiac & Vascular Institute. RESILIENT II: Trial Design. Lesions of SFA &/or Proximal Popliteal Artery Rutherford Category 1 - 3 Lesion Length: <150mm Edwards LifeStent + NT delivery system.

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12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director

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  1. 12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director Baptist Cardiac & Vascular Institute

  2. RESILIENT II: Trial Design • Lesions of SFA &/or Proximal Popliteal Artery • Rutherford Category 1 - 3 • Lesion Length: <150mm • Edwards LifeStent + NT delivery system 1:2 Randomization PTA Only Control Arm n=69 PTA + LifeStent Test Arm n=137 n=206 24 sites Clinical/MACE* 3yr 2yr 18mo 12mo 6mo 30d Duplex US Primary Endpoint: TLR and/or TVR at 6 months Secondary Endpoints: Patency; Lesion-, Procedure- & Clinical-Success; QOL measurements *MACE = Major Adverse Clinical Events

  3. Study Device LifeStent • Edwards LifeStent • Self-expanding Nitinol stent • Helically-designed • Stent Diameters: 6, 7mm • Stent Lengths: 40, 60, 80mm • Edwards LifeStent NT Delivery System LifeStent NT Delivery System

  4. 12-Month Results 100% PTA 87% 86% 86% PTA+LifeStent 80% 80% 72% 60% 46% p=.91 38% 40% 34% p<.0001 p<.0001 20% p<.0001 0% Freedom from Prim. Patency Freedom from TLR* Clinical success MACE* (duplex)* *Data from Kaplan-Meier Survival Analysis

  5. Quality of Life Assessment (LifeStent Arm) • Walking Impairment Questionnaire (WIQ) utilized for Disease-Specific Quality of Life assessment. • LifeStent arm demonstrated dramatic improvement over baseline at 6-months with sustained/improved benefit at 12-months. 70 60 50 40 30 20 10 0 WIQ - Pain WIQ - Stair WIQ - Distance WIQ - Speed Baseline 6 Months 12 Months

  6. Conclusions RESILIENT’s Level 1 evidence illustrates: • In claudicants with lesions shorter than 150 mm,a primarystenting strategy with the LifeStentis superior to a PTA alone strategy … • Peri-procedurally –as evidenced by a larger luminal diameter,lesion success and procedure success, and • at one year –as evidenced by primary patency and freedom from TLR • PTA + LifeStent did not lead to a higher rate of“Major Clinical Adverse Events” than PTA alone

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