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

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

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

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

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 4 - 9 mm 5

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

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)

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

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

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

Results Stent Integrity Safety Effectiveness 11

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, 707-708, 2007

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

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

Freedom from TLR Probability Days after Procedure Freedom from TLR Probability

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

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

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 1 - 10 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

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

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)