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

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

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

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

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. 0 10 20 30 40 50 60 70 WIQ - PainWIQ - StairWIQ - DistanceWIQ - Speed Baseline6 Months12 Months

6. Conclusions RESILIENT’s Level 1 evidence illustrates: In claudicants with lesions shorter than 150 mm, a primary stenting strategy with the LifeStent is 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