1. Zilver PTX Trial Bhagat K. Reddy, MD, FACC
Director of Vascular Medicine & Endovascular Interventions
Piedmont Heart Institute
Atlanta, GA

2. Zilver® PTX™ Clinical Trials
Global Sponsor: Cook Incorporated
Physician Steering Committees:
Michael Dake, M.D. (Global Principal Investigator)
Randomized Study
Gary Ansel, M.D. (co-PI)
Michael Jaff, D.O.
Lindsay Machan, M.D.
Takao Ohki, M.D., Ph.D.
Richard Saxon, M.D.
H. Bob Smouse, M.D.
Registry Study
Gunnar Tepe, M.D.
Fabrizio Fanelli, M.D.
Dierk Scheinert, M.D.
Jöerg Tessarak, M.D. 2

3. Total Enrollment = 792 patients at 30 investigative sites
Registry Study Site
Enrolled
Herz-Zentrum (Bad Krozingen, Germany)
153
Seoul National University Hospital
(Seoul, Korea) 12
Heart Center Leipzig, Angiology
(Leipzig, Germany)
110
Hospital Universitario La Fe
(Valencia, Spain)
Gemeinschaftspraxis (Leipzig, Germany) 69
Samodzielny Publicczny (Lublin, Poland) 11
St. Blasius Hospital, Dendermonde
(Dendermonde, Belgium) 50
St. Francois (Quebec, Canada) 10
Imelda Hospital, Bonheiden
(Bonheiden, Belgium) 47
Samsung Medical Center (Seoul, Korea)
Endosurgery and Lithotripsy Center
(Moscow, Russian Federation) 45
Hospital Europeen Georges Pompidou
(Paris, France)
Universitat Klinik Tubingen
(Tubingen, Germany) 42
Centrum Medyczne (Katowice, Poland)
St. Franziskus Hospital Münster
(Münster, Germany) 34
Malmo Univeritetssjukhus
(Malmo, Sweden) 9
University Hospital Ostrava-Poruba
(Ostrava-Poruba, Czech Republic) 27
University Hospital Antwerp
(Edegem, Belgium) 7
Center for Cardiology & Vascular Intervention
Praxis (Hamburg, Germany) 24
Zurich University Hospital
(Zurich, Switzerland) 5
Careggi Hospital (Florence, Italy) 20
Catharina Hospital
(Eindhoven, The Netherlands)
University of Roma “La Sapienza”
(Rome, Italy) 15
Policlinico G. B. Rossi (Verona, Italy) 4
Amphia Hospital
(Breda, The Netherlands)
Hospital Clinic of Barcelona
(Barcelona, Spain)
Centre Hospitalier Universitaire de Sherbrooke
(Sherbrooke, Canada) 13
Hospital Jean Minjoz
(Besancon Cedex, France) 3
Asan Medical Center (Seoul, Korea)
Hospital Clinico Universitario
Total Enrollment = 792 patients at 30 investigative sites

4. Zilver® PTX™ Paclitaxel only Zilver®, self-expanding nitinol stent
No polymer or binder
3 µg/mm2 dose density
Zilver®, self-expanding nitinol stent
Flexible, durable platform
Uncoated
PTX™ Coated 4

5. Zilver® PTX™ Indication
Treatment of symptomatic disease of the above-the-knee femoropopliteal artery
Proximal: 1 cm below bifurcation
Distal: medial femoral epicondyle
Reference vessel diameter of mm 5

6. Clinical Trial Status Randomized Study (480 patients)
United States, Japan and Germany
Enrollment complete
Registry Study (792 patients)
Europe, Russia, Canada and Korea
Patients treated with Zilver® PTX™ stents 6

7. Registry Study Patients assigned to Zilver® PTX™ only
Includes complex SFA lesions (nearly “all comers”)
Rutherford category 2 or greater
No lesion length limitation
Up to 4 DES per patient - longest stent 8 cm
Multiple lesions per leg
Stenosis (≥ 50% DS), occlusion, re-stenosis, in-stent restenosis
Follow-up through 2 years
Currently available data
12-month follow-up for 592 patients (673 lesions)
24-month follow-up for 177 patients (221 lesions)

8. Demographics 12 Months 24 Months Overall Patients (n) 592 177
Age (years)
67 ± 9
66 ± 9
% Male
73%
76%
Height (cm)
170 ± 9
170 ± 8
Weight (kg)
79 ± 15
77 ± 15
Diabetes
35%
36%
High Cholesterol
59%
63%
Hypertension
82%
83%
Past/Current Smoker
80% 8

9. Baseline Angiographic Data
12 Months
24 Months
Overall Lesions (n)
673
221
Lesion Length (cm)
9.4 ± 7.8
9.3 ± 8.0
Proximal RVD (mm)
5.4 ± 0.8
Distal RVD (mm)
5.3 ± 0.8
MLD in Lesion (mm)
0.84 ± 0.88
0.76 ± 0.73
% Diameter Stenosis
84 ± 17
86 ± 14 9

10. Lesion Characteristics
12 Months
24 Months
Patients
592
177
Lesions
673
221
Lesion
Characteristics
TASC class *: A
28%
22% B
30%
36% C
25%
27% D
13%
> 7 cm
46%
Total Occlusion
33%
Restenosis (all)
37%
In-stent Restenosis
16%
24%
* TASC 2000

11. Results
Stent Integrity
Safety
Effectiveness 11

12. Stent Integrity Time Period † Potential Fractures * 6 Months
1.4% (21/1486)
12 Months
1.8% (21/1198)
* Pending core lab confirmation (rates may decrease)
† Zilver® PTX™ Registry did not include stent X-rays at 24-month follow-up
Integrity data for the Zilver® stent platform are also available for 96 stents implanted in the femoropopliteal arteries (above, behind and below the knee) of 34 patients, with a mean follow-up of 2.4 years, showing a 1% fracture rate (1/96, stents).
Ferriera, et al., Eur J Vasc Endovasc Surg 34, , 2007

13. Safety: Event-free Survival
Event-free survival defined as freedom from:
Death, amputation (toe, foot, or leg)
Revascularization
Clinically driven re-intervention for > 50% DS within treated segment (including ± 5 mm)
Surgical bypass of target vessel
Worsening of Rutherford Classification
(by two classes or to a Class 5 or 6)
12 Months
24 Months
Patients
596
181
Event-free Survival
87%
78% 13

14. Effectiveness: Freedom from TLR
TLR defined as:
Clinically driven re-intervention for > 50% DS within treated segment (including ± 5 mm)
12 Months
24 Months
Patients
593
177
Lesions
675
221
Freedom from TLR
89%
82% 14

15. Freedom from TLR Probability
Days after Procedure
Freedom from TLR Probability

16. Clinical Outcomes * p < 0.01 compared to pre-procedure
Clinical Measure
Pre-procedure
12 Months
24 Months
ABI
0.65 ± 0.26
(n = 686)
0.90 ± 0.24 *
(n = 582)
0.88 ± 0.21 *
(n = 161)
Most Common Rutherford Score 3
(n = 433/763)
0 *
(n = 290/563)
(n = 77/171)
Walking Distance Score
31 ± 26
(n = 659)
71 ± 32 *
(n = 565)
68 ± 33 *
(n = 158)
Walking
Speed Score
35 ± 28
(n = 643)
66 ± 31 *
(n = 553)
67 ± 31 *
(n = 156)
* p < 0.01 compared to pre-procedure

17. Freedom from TLR Subgroup 12 Months 24 Months Overall *TASC 2000
TASC C and D*
86% (n = 225)
75% (n = 87)
De novo
92% (n = 501)
88% (n = 139)
Restenosis (all)
81% (n = 170)
72% (n = 81)
Restenosis (not ISR)
86% (n = 64)
69% (n = 29)
In-stent Restenosis (ISR)
76% (n = 106)
73% (n = 52)
< 7cm Lesions
94% (n = 355)
91% (n = 116)
> 7 to 14 cm Lesions
89% (n = 158)
72% (n = 53)
> 14 cm Lesions
77% (n = 154)
73% (n = 49)
Occlusions
86% (n = 429)
78% (n = 72)
Stenosis
90% (n = 243)
85% (n = 149)
*TASC 2000

18. Literature Comparisons: TLR at 12 Months
Matching Registry Subset
Study
Inclusion Criteria
TLR
12 Months
Resilient:
(Katzen ISET 2008)
No in-stent restenosis
Lesion length < 15 cm
Rutherford 1-3
LifeStent
13%
(n = 153)
Zilver® PTX™ 5%
(n = 402)
Excluded: ISR, lesions > 15 cm
and Rutherford > 3
FAST:
(Krankenberg 2007)
De novo lesions
Length cm
Multiple lesions < 10 cm total
≥ 70% DS
Luminexx Stent
15%
(n = 127)
(n = 237)
Excluded: RS lesions and
lesions < 1 cm or > 10 cm
Durability:
(Scheinert TCT 2008)
Lesion length ≤ 14
Rutherford 2-4
Protégé
EverFlex Stent
21%
(n = 134) 6%
(n = 133)
Excluded: ISR, lesions >14, < 7 cm
and Rutherford < 2 or > 4

19. Literature Comparisons: TLR at 24 Months
Matching Registry Subset
Study
Inclusion Criteria
TLR
24 Months
Resilient:
(Katzen VEITH 2008)
No in-stent restenosis
Lesion length < 15 cm
Rutherford 1-3
LifeStent
20%
(n = 153)
Zilver® PTX™ 8%
(n = 115)
Excluded: ISR, lesions > 15 cm
and Rutherford > 3

20. Conclusions
The Zilver® stent platform appears to have excellent durability (i.e., fracture resistance) in the SFA
Results through 2 years with the Zilver® PTX™ stent show
No safety concerns apparent
Favorable effectiveness (TLR rates, clinical outcomes, comparison to literature)