1. Three-Year Results Gore VIBRANT Clinical Study
Gary Ansel, MD, FACC Clinical Director of Peripheral-Vascular Interventionists at
Midwest Cardiology Research Foundation, Columbus, OH
Assistant Clinical Professor of Medicine, Medical College at Toledo, OH

2. Gary M. Ansel, MD Honoraria: Consulting Fees: Cardiometrics
W.L. Gore and Associates,Inc./Embolitech
Consulting Fees:
Cardiometrics
Covidien/Ev3
Flexible Stenting Solutions
Nellix, Inc.

3. GORE® VIABAHN® Endoprosthesis
Polished nitinol support
Ultra-thin wall ePTFE tube
Unique, durable bonding film
Lengths: 2.5, 5, 10, and 15 cm
Diameters: 6 – 8 mm
Note: no heparin bioactive surface, 5mm diameter, or contoured proximal edge devices were used in the study

4. VIBRANT Take Home Messages
Toughest lesions ever studied in a controlled trial
Bare nitinol stent (BNS) fracture still a concern
Fractures increase with time
Longer stents = more fractures
Durable 3-year Results with Minimal Reinterventions for Long Lesions
85% of patients required ≤1 reintervention to maintain patency over 3 year period
No amputations
Stent grafts restenosed at edge; bare nitinol stents restenosed diffusely
Continued understanding of the VIABAHN stent graft technical considerations
Recent device (heparin-bonded surface, 5mm diameter) and manufacturing (proximal contoured edge) changes studied in VIPER and VIASTAR clinical studies

5. Gore VIBRANT Clinical Study Investigators
Co-PIs: Gary Ansel, MD; Mid-West Cardiology Research Foundation, Columbus, Ohio
Patrick Geraghty, MD; Washington University, St. Louis, Missouri
Mark Mewissen, MD; St. Luke’s Hospital, Milwaukee, Wisconsin
Core Lab: The Vascular Ultrasound Core Laboratory, Boston, MA
Dr. Michael R. Jaff, DO, RPVI, FACP, FACC
Site Investigators:
David Lasorda, DO, Allegheny General Hospital, Pittsburgh, Pennsylvania
Michael Rush, MD, Holy Cross Hospital, Ft Lauderdale, Florida
Jeffrey Goldstein, MD, St. Johns, Springfield, Illinois
Bob Smouse, MD, St. Francis, Peoria, Illinois
Manju Kalra, MD, Mayo Clinic, Rochester, Minnesota
Sean Lyden, MD, Cleveland Clinic, Cleveland, Ohio
R. Andrew, MD, Midwest Heart Foundation, Lombard, Illinois
Arun Chervu, MD, Vascular Surgical Associates, Austell, Georgia
William Gray, MD, Columbia University Medical Center, New York, New York
Romi Chopra, MD, Midwest Institute, Melrose Park, Illinois
Sam Money, MD, Mayo Clinic, Scottsdale, Arizona
David Mego, MD, Arkansas Heart, Little Rock, Arkansas
Mark Bates, MD, Charleston Medical Center, West Virginia
Richard Begg, MD, Heritage Valley Health System, Beaver Falls, Pennsylvania
Barry Katzen, MD, Baptist Cardiac & Vascular Institute, Miami, FL
W. Charles Sternbergh, MD, Ochsner Clinic, New Orleans, Louisiana 5

6. Enrollment by Site Study Site Enrolled
St. Luke’s Medical Center, Milwaukee, WI 26
Midwest Cardiology Research Foundation, Columbus, OH 21
Midwest Heart Foundation, Lombard, IL 20
Vascular Surgical Associates, Austell, GA 18
Midwest Institute, Melrose Park, IL 15
Holy Cross Hospital, Ft Lauderdale, FL 11
Prairie Heart (St. John's), Springfield, IL 8
St. Francis, Peoria, IL
Arkansas Heart, Little Rock, AK 7
Heritage Valley Health System, Beaver Falls, PA 6
Washington University Hospital, St. Louis, MO 3
Cleveland Clinic, Cleveland, OH 2
Allegheny General Hospital, Pittsburgh, PA
Ochsner Clinic, New Orleans, LA 1

7. Study Design 148 randomized patients enrolled
Test Group: GORE® VIABAHN® Endoprosthesis
FDA approved for SFA indication, June 14, 2005
Does NOT include Bioactive Heparin Surface
Does NOT include Contoured Edge Manufacturing Change
n=72
Control Group: Bare Nitinol Stent
Commercially available bare nitinol stent as determined by institutional standard of care when treating SFA occlusive disease and were not devices approved for SFA use
n=76
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates

8. Study Endpoints Primary Endpoints Secondary Endpoints
Three-year primary patency (duplex PSV ratio < 2.0 / core lab adjudicated)
Safety (30 day composite of major complications)
Secondary Endpoints
Primary assisted patency
Secondary patency
Technical success
Target vessel revascularization
Target lesion revascularization
Clinical success
Change in ABI from baseline
Alternate peak systolic velocity ratios of and 3.0 (core lab adjudicated)
Stent fracture on plain X-ray (core lab adjudicated)
Primary composite safety and efficacy endpoint
Quality of Life Questionnaires
Quantitative angiographic assessment of patterns of restenosis in the treated limb when control angiography is prompted 8

9. VIABAHN Endoprosthesis
Patient Demographics
VIABAHN Endoprosthesis
Bare
Nitinol Stent
p-value
RANDOMIZED SUBJECTS 72 76
Gender (% male)
62.5%
64.5%
0.87
Average Age (years) 69 64
0.01
SMOKING STATUS
0.36
Current / Previous Smoker
81.9%
88.2%
Never Smoked
18.1%
11.8%
GENERAL MEDICAL HISTORY
Diabetes
43.1%
44.7%
Myocardial Infarction
23.6%
25.0%
0.85
Hypertension
87.5%
76.3%
0.09
Dyslipidemia
72.2%
77.6%
0.46
Family History of CAD
60.0%
0.05
COPD
12.5%
7.9%
0.42
Prev. PTA on Study Limb (≥ 6 mo)
6.9%
5.3%
0.74

10. Lesion Characteristics
VIABAHN Endoprosthesis
Bare
Nitinol Stent
p-value
TREATED OCCLUSIONS
61.1%
56.6%
0.62
TARGET LESION LENGTH (cm)
0.87
Mean (Std Dev)
19 (8)
18 (7)
Median (Range)
20 (8 – 40)
16 (8 – 36)
LESION CALCIFICATION
0.01
None – Mild
37.5%
57.9%
Moderate – Severe
62.5%
42.1%
TIBIAL RUNOFF
0.10
1 Vessel
15.3%
22.4%
2 Vessel
50.0%
32.9%
3 Vessel
34.7%
44.7%
Technical success was 97% for the VIABAHN stent graft and 96% for Bare Stent (p=1.0)

11. VIABAHN Endoprosthesis
SAFETY Study Endpoint
30-DAY SAFETY OUTCOMES
VIABAHN Endoprosthesis
Bare
Nitinol Stent
NUMBER OF ENROLLED SUBJECTS 72 76
PROCEDURE-RELATED SAFETY ISSUES
Access / Treatment Site Complications 1*
OTHER SAFETY EVENTS
Death
Myocardial Infarction
Acute Renal Insufficiency
Study Limb Amputation
* The single access site complication was thrombosis in the non-treatment leg, that was resolved with subsequent treatment.
Major device-related adverse events at 3 years
Embolism (VIABAHN device) and Other (VIABAHN device)
No significant difference between arms (p=0.235)
No unexpected trends for disease-related Major Adverse Events at 3 years
No significant difference between arms (p=0.729)

12. Error bars = 95% confidence interval
VIBRANT 3 year Data
Error bars = 95% confidence interval
Comment on cross-over: Sixteen Bare Nitinol Stent patients received the VIABAHN Endoprosthesis during subsequent reinterventions, which complicates secondary endpoint comparisons.

13. Error bars = 95% confidence interval
Impact of PSVR Ratio
Error bars = 95% confidence interval

14. Treating In-Stent Restenosis Upon Initial Failure of BMS
Freedom from Target Lesion Revascularization
Error bars = 95% confidence interval
14 pts in each treatment arm

15. Error bars = standard deviation
Clinical Success
Quality of Life Questionnaires
Significant improvement in IC and SF-36 physical summary scores at three years
No significant difference between treatment groups
Error bars = standard deviation

16. Error bars = standard deviation
Clinical Success
ABI and Rutherford Category
Significant improvement in ABI and Rutherford Category at three years
No significant difference between treatment groups
Error bars = standard deviation

17. # Repeat Interventions / Subject Error bars = 95% confidence interval
Durable 3-year Results with Minimal Reinterventions for Long Lesions Treated Interventionally
No amputations in either study arm
# Repeat Interventions / Subject
VIABAHN
Stent Graft
Bare Nitinol
Stent
61%
65% 1
25%
22% 2 7% 8% 3+ 5%
Error bars = 95% confidence interval

18. Patterns of Restenosis at 1 year
VIABAHN Endoprosthesis
Focal edge stenosis comprised 87% of the VIABAHN Endoprostheses failures
50% isolated proximal edge
30% both proximal and distal edges
6% isolated distal edge
14% undetermined
Bare Nitinol Stent
Diffuse in-stent stenosis comprised 93% bare nitinol stent failures
Results are Core Lab-adjudicated

21. Restenosis Patterns Differ and Impact Patient Symptoms
Quality of life and ABI is maintained in failing VIABAHN stent graft limbs compared to Bare Nitinol Stents (through 36 month follow-up)
Effect of Stenosis (PSVR > 3) Clinical Outcomes
VIABAHN
Stent Graft
Bare Nitinol
Stent
p-value
Avg ICQ 20 33
< 0.05
Avg ABI
0.94
0.79
Avg Rutherford
0.8
1.2
0.11
ICQ: 0 = best, 100 = worst

22. Clinical Implications of Restenosis Patterns
Flow Dynamics Calculations*
Assuming 80% focal (5 mm) versus diffuse (10 cm) restenosis pattern
Pressure Drop in diffuse, in-stent stenosis is an order of magnitude higher than a focal edge stenosis
Flow Rate through diffuse, in-stent stenosis is reduced by 50% as compared to flow through an edge stenosis
*data on file

23. Stent Fractures for Bare Nitinol Stents are still a concern
Bare Nitinol Stents have a significantly higher fracture rate than the VIABAHN device (58% vs. 4.9%, respectively; p < 0.001)
Fracture incidence increases over time
Fractures are dependent on lesion length
Fractures not always associated with overlap
Bare Nitinol Stent Fractures at 36 Months
Lesion Length
Fracture
No Fracture
8-15 cm
11%
89%
16-25 cm
55%
45%
26+ cm
73%
27%
Error bars = 95% confidence interval

25. So if only we can limit stent graft edge restenosis the world will be a better place

26. VIBRANT Increases Our Understanding of the VIABAHN Stent Graft
Technical and Device Considerations
Newest Device Iteration
Demonstrated Efficacy
1000 Limbs in Literature
VIBRANT Study
VIPER, VIASTAR Studies
Technical Considerations
Healthy-to-healthy
Avoid extreme oversizing
Accurately measure vessel diameter
New Device Characteristics
Heparin Bonded Surface
5mm device SFA indication
6 Fr Profile
Manufacturing Change
Contoured proximal edge
VIPER: 90% patency when sized appropriately, 79% if not and 5 mm did the best.

27. VIBRANT Take Home Messages
Toughest lesions ever studied in a controlled trial
Bare nitinol stent (BNS) fracture still a concern
Fractures increase with time
Longer stents = more fractures
Durable 3-year Results with Minimal Reinterventions for Long Lesions
85% of patients required ≤1 reintervention to maintain patency over 3 year period
No amputations
Stent grafts restenosed at edge; bare nitinol stents restenosed diffusely
Continued understanding of the VIABAHN stent graft technical considerations
To see how educated engineering can be successful stay for the VIPER trial update shortly after this talk 27