Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 24-Month Results

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1 Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 24-Month Results Hiroyoshi Yokoi, MD, Fukuoka Sannou Hospital Fukuoka, Japan On behalf of the Investigators

2 Disclosure Speaker name:...hiroyoshi Yokoi., M.D... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) Cook, Termo, BSJ, Medotoronic, Abott, Medicon I do not have any potential conflict of interest

3 Global Clinical Program Pre-Market Studies Post-Market Studies RCT Moderate lesions SAS More complex lesions China Similar lesions to RCT Japan PMS All-comers US PAS Similar lesions to RCT EU Longer Lesions PTA n=242 Optimal n=118 Suboptimal Enrolling Enrolling Zilver Flex n=56 n=63 n=787 n=175 n=907 n=200 n=45 More than 2400 patients to be included in current clinical program

4 Japan PMS Compared to RCT and SAS Key Study Criteria RCT SAS Japan PMS No significant untreated inflow tract stenosis At least one patent runoff vessel Maximum 2 stents Maximum 4 per lesion stents per patient Lesion length 14 cm One lesion per limb No exclusions No prior stent in SFA ISR included ALL patients treated with enrolled (up to enrollment limit), NO exclusion criteria Excluded if serum creatinine > 2.0, renal failure, or dialysis No exclusions Antiplatelets Clopidogrel or ticlopidine recommended for 60 days, aspirin indefinitely Follow-up 5 years 2 years 5 years Patency DUS core laboratory analysis DUS site analysis Stent Integrity X-ray core laboratory analysis Increasingly complex patients and lesions

5 Patient Demographics and Comorbidities RCT SAS Japan PMS Patients Age (years) 68 ± 10 * 67 ± 9 * 74 ± 9 Male 66% 73% 70% Diabetes 50% * 36% * 59% High cholesterol 76% * 58% 61% Hypertension 89% 80% * 85% Pulmonary disease 19% * 9% 8% Renal Failure (egfr< 60 and/or on Dialysis ) 0% (10% renal disease*) * p < 0.01 compared to Japan PMS Not assessed (11% renal disease*) 36% (44% renal disease) Japan PMS patients were older, more diabetic, and had more renal failure

6 Baseline Lesion Characteristics RCT Ziver PTX SAS Japan PMS Lesions Lesion length (cm) 6.6 ± 3.9 * 10.0 ± 8.2 * 14.7 ± 9.7 Diameter stenosis (%) 81 ± 17 * 85 ± 16 * 92 ± 11 Total occlusions 33% * 38% 42% In-stent restenosis 0% * 15%* 19% Patent runoff vessels 0 0% 0% 7% 1 22% 19% 32% * * 2 35% 35% 32% 3 42% 45% 29% * p < 0.05 compared to Japan PMS Japan PMS lesions were more complex (e.g., longer, more ISR, fewer patent runoff vessels)

7 Baseline Clinical Assessment Pre-procedure Clinical Assessment Rutherford 1-3 (Claudication) 4-6 (CLI) RCT SAS Japan PMS 91% 89% 78% * * 9% 11% 22% ABI 0.67 ± 0.19 * 0.64 ± ± 0.18 * p < 0.01 compared to Japan PMS Japan PMS had significantly more CLI patients 7

8 24-month Follow-up for Japan PMS 907 patients and 1075 lesions treated with 1861 stents 721 patients eligible for 24-month follow-up 85 deaths, 66 lost to follow-up, 27 withdrew, 8 not yet due 24-month follow-up currently available for 624 patients 86.5% follow-up compliance Patency assessed by ultrasound at sites where this was standard of care No significant differences in demographics, comorbidities, or lesion characteristics compared to patients who did not undergo ultrasound

9 Stent Integrity Next assessments at 3 and 5 years 1,135 stents evaluated at 1 year resulting in a 1.5% fracture rate Low fracture rate similar to the rates seen in the RCT (0.9%) and SAS (1.5%) at 1 year despite more complex lesions

10 Thrombosis/occlusion SFA stent thrombosis can be difficult to distinguish from total occlusion caused by restenosis No standardized classification Easier to distinguish thrombosis from restenosis at earlier timepoints (e.g., < 30 days), more difficult at later timepoints

11 Thrombosis/occlusion Time After Procedure Cumulative Occurrence Rate 12 months 3.0% 24 months 3.6% 3.6% rate of site-reported total occlusion of suspected thrombotic origin through 24 months Rate similar to in RCT (2.2%) and SAS (3.5%), bare Zilver in RCT (3.6%), and 30-day to 12- month BMS and PTA rates in literature (2-4%)

12 Freedom from TLR Months Freedom from TLR (n = patients) Japan PMS (n = 907) % %

13 Freedom from TLR Months Freedom from TLR (n = patients) RCT (n = 305) SAS (n = 787) Japan PMS (n = 907) % 89.5% 91.0% % 83.3% 85.0% Freedom from TLR rate in PMS remains high and consistent with both pre-market studies

14 Clinical Benefit Months Clinical Benefit (n = patients) Japan PMS (n = 907) % % Clinical benefit is defined as freedom from persistent or worsening claudication, rest pain, ulcer, or tissue loss

15 Clinical Benefit Months Clinical Benefit (n = patients) RCT (n = 301) SAS (n = 787) Japan PMS (n = 907) % 86.7% 87.7% % 78.6% 79.3% Clinical benefit in the Japan PMS is similar to both pre-market studies

16 Primary Patency by Duplex Ultrasound Months Primary Patency (n = lesions) Japan PMS (n = 702) % %

17 Primary Patency by Duplex Ultrasound Months Primary Patency (n = lesions) RCT (n = 318) SAS (n = 842) Japan PMS (n = 702) % 82.8% 86.4% % N/A 72.3% Primary patency rate in the Japan PMS is similar to both pre-market studies

18 Conclusions Large amount of clinical data ranging from carefully controlled Level I evidence to large, global, real-world experience As expected, patient population and lesion characteristics become more challenging in real-world, all-comer studies 24-month Japan PMS results are positive and confirm the long-term benefit of the technology Consistent results across studies provide added support for the established long-term performance of the technology Reaffirms long-term safety and effectiveness

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20 Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 24-Month Results Hiroyoshi Yokoi, MD, Fukuoka Sannou Hospital Fukuoka, Japan On behalf of the Investigators