BIOFLEX PEACE Registry

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1 BIOFLEX PEACE Registry Pulsar Efficacy: an All Comers Registry INTERIM ANALYSIS Michael K. W. Lichtenberg On behalf of the BIOFLEX-PEACE study group

2 Definition and understanding of various radial forces Radial force at expansion is also known as Chronic Outward Force (COF). COF Stent nominal diameter of 7mm 7mm stent expanding into a 6mm vessel Original plaque (post lesion preparation) 6mm vessel Radial force under compression is also known as Radial Resistive Force (RRF). RRF Simulating concentric restenosis Neointimal hyperplasia 6mm vessel Crush Resistance (CR) is also force under compression but at a focal point CR Simulating eccentric restenosis Neointimal hyperplasia 6mm vessel Source: Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol Jul;32(4):720-6

3 Correct chronic outward force (COF) Low COF = lower mechanical stress on vessel wall IIB(P)71/ test report, Institute fuer ImplantTechnologie und Biomaterialien e.v., Rostock-Warnemuende

4 Sufficient Crush resistance If too low = stent collapse 50 % 25 % 10 % IIB(P)71/ test report, Institute fuer ImplantTechnologie und Biomaterialien e.v., Rostock-Warnemuende

5 Link between scientific theory and proven clinical benefit: clinical trials Safety /Efficacy Required stent design /characteristics Long term patency Low TLR rate 4 F device w/o need of closure device Low compression time Ideal radial resistive force (RRF) Ideal chronic outward force (COF) Ideal crush resistance (CR)

6 4-EVER and PEACE Two Trials Looking Into 4F Self Expanding Stents in the SFA Primary Patency Baseline 12mt 24mt 4 EVER 100% 81.4% 72.3% PEACE 100% 79.5% N/A 4-EVER 1 (Savety and Efficacy) Prospective, Multicenter, non randomized trial, Belguim 120 pts 72.42mm Mean Lethion Lenght TASC (70% A, 22.5% B, 7.5% C, 0% D) Demographics (35.8% Diabethic, 41.7% current Smoker, 16.7%LI, 20.8%CTO) 89.3% ftlr at 12mth No closure device needed and short mean manual compression time of 8.1min PEACE 2 (Registry) Prospective, Multicenter, non randomized trial, Germany 148 pts 111.5mm Mean Lethion Lenght TASC (18.7% A, 23.6% B, 19.4% C, 32.2% D) Demographics (31%Diabethic, 37% current Smoker, 68.7% LI, 56.7% CTO) 81% ftlr at 12mth No significant patency difference at 12mth between TASC A/B vs. C/D or between patients with Rutherford <3 vs. >3 1.) Journal of Endovascular Therapy 2013;20: ) Journal of Endovascular Therapy 2014;21:

7 Study design and participating centers Objective: Evaluation of safety and performance of Pulsar-18 in treatment of subjects with atherosclerotic disease Design: Prospective, non-randomized, multi-centre All Comers Registry with follow-up investigations at 6, 12 and 24 months Indication: Subjects with infrainguinal atherosclerotic disease eligible for stent implantation Dr. Michael Lichtenberg (PI), Arnsberg Prof. Dr. Guenther Wittenberg (Bielefeld) Dr. Tessarek (Lingen) Prof. Holger Reinecke (Münster) Dr. Stefan Betge (Jena) Dr. Torsten Fuss (Suhl) Prof. Dr. Sigrid Nikol (Hamburg) Prof. Dr. Claus Nolte-Ernsting (Mülheim) Dr. Jawed Arjumand (Wuppertal) PD Dr. med. Ulrich Sunderdiek (Osnabrück) Prof. Dr. Birgit Hailer (Essen) Dr. Jawed Arjumand (Wuppertal) Up to 200 patients with SFA /APOP lesions in 12 clinical sites in Germany Enrollement startet 07/2014 BIOTRONIK 4F Pulsar - 18 SE Stent In combination with atherectomy, scoring and cutting balloon angioplasty, DCB 6 month follow up, clinical success, complications 12 month follow up, clinical success, complications 24 month follow up, clinical success, complications

8 Inclusion criteria: Registry design Rutherford 2-5 SFA APOP Seg. III stenosis > 50 % with clinical indication for treatment Target vessel reference diameter 2.5 to 6 mm No lesion length restriction No restriction of stent numbers Exclusion criteria: Treatment failure, subjects pregnant or planning to become pregnant, life expectancy < 1 year, subject enrolled in another study Primary / secondary endpoints Primary patency of the Pulsar-18 SE stent at 6,12 and 24 months: Defined as a binary duplex ultrasound ratio (PSVR) < 2,5 at the stented target lesion(s) No clinically driven re-intervention within the stented segment(s) (freedom from target lesion revascularization) Estimation of limb salvage

9 BIOFLEX PEACE Registry Subgroup analysis Type of stenosis (e.g. de novo, restenotic, etc.) Lesion length, location, degree of stenosis, calcification TASC classification Lesion preparation (e.g. scoring balloons, cutting balloons, atherectomy devices, etc.) Use of Drug eluting balloons for predilatation for postdilatation Stent characteristics (diameter, length, overlapping, etc.) Treatment approach (e.g. sub-intimal, intra-luminal, etc.) Stenting strategy (e.g. spot stenting, etc.) QoL (e.g. pain level, WIQ, SF-12)

10 Consort Chart of first 179 Patients First 179 consecutive subjects Jul Nov 2015 Upcoming 6mt FUP 16 Missed Visit 25 LTFU 0 Withdrawal 9 Patient Death Patients at 6 month FUP

11 Patients and lesions characteristics at baseline Patients N = 126 Lesion characteristics N = 144 Male 70 (55.6%) Age Median (Min/Max) 73 (47/89) Hypertension 114 (90.5%) Dyslipidemia 102 (81.0%) Current smoker 41 (32.5%) Diabetes 44 (34.9%) Renal Insufficiency 27 (21.4%) Rutherford* (1.6%) 55 (45.1%) 41 (33.6%) 12 (9.8%) 11 (9.0%) 1 (0.8%) Ankle brachial index (n=100) 0.65 ± 0.14 Walking capacity (m) (n=33) ± 90.0 Lesion length (mm) (n=143) ± TASC A lesion 34 (23.6%) TASC B lesion 48 (33.3%) TASC C lesion 27 (18.8%) TASC D lesion 35 (24.3%) Calcification 0 (no calcification) 1 (minimal) 2 (moderate) 3 (severe) Moderate & Severe 26 (18.1%) 60 (41.7%) 32 (22.2%) 26 (18.1%) 58 (40.3%) Femoral Artery 124 (86.1%) Popliteal Artery 19 (13.2%) PTA 1 (0.7%) * 4 patient without classification because of missing data

12 Freedom from MAE Subgroup Analysis (126 Subjects at 6 month) Freedom from MAE % (N/Ntot) (Target Lesion Restenosis or Target Lesion Revascularisation) MAE (first 126 subjects at 6mth) 91.3% (115/126) Diabetic patients MAE at 6mth FUP 93.2% (41/44) Non Diabetic patients MAE at 6mth FUP 90.2% (74/82) Lesion length > 100 mm MAE at 6mth FUP 85.5% (53/62)* Lesion length < 100 mm MAE at 6mth FUP 96.8% (61/63)* Popliteal segment (I III) MAE at 6mth FUP 82.4% (14/17) * p=0,02990 (Fisher exact, two sided)

13 Kaplan-Meier Estimation freedom MAE fmae 91.1% at 6 month Time (Month) MAE defined Target Lesion Restenosis or Target Lesion Revascularisation Patients at Risk Day 0 6 Month (interim)

14 Kaplan-Meier Estimation ftlr Freedom from TLR 91.9% at 6 month Time (Month) Patients at Risk Day 0 6 Month (interim)

15 Efficacy Analysis (125 subjects at 6 month) N Average lesion length Primary Patency ftlr Overall ± mm 115 (91.3%) 116 (92.1%) POBA -> Stent ± mm 13 (92.9%) 13 (92.2%) POBA -> Stent -> POBA ± 67.3 mm 44 (93.6%) 44 (93.6%) DCB -> Stent -> POBA ± 83.2mm 31 (86.1%) 31 (86.1%) POBA -> Stent -> DCB ± mm 18 (90.0%) 19 (95.0%) others (Artherectomy soring balloon, cutting balloon, etc.) SFA ± mm 100 (92.6%) 101 (93.5%) Popliteal Artery ± 58.8 mm 10 (83.3%) 10 (83.3%) other

16 Change in Rutherford Index at 6 Month 87.6% improved by one or more Rutherford classes Worsening Unchanged or more Improvement

17 Conclusions The preliminary 6 month results of the BIOFLEX-PEACE Registry shows a Kaplan Meier Estimate of 91.1% MAE and of 91.9% freedom from TLR, with clinical success of 87.6% (improvement in Rutherford class 1) in lesions of average length of 99.8mm Subgroup analysis shows no statistical significant difference in primary patency between diabetic and non diabetic patients. Statistical significant difference was shown for primary patency between long and short lesions with favourable outcome for lesions <100mm over lesion longer than 100mm. Further evaluation of the entire study population with a follow up of one year or more is needed to give more defined insight to the subject.

18 Thank you for your attention

19 Study DEVICE Mean lesion length Primary patency Freedom from TLR 4EVER Pulsar mm 73.4 % 85.2 % PEACE I Pulsar mm 79.5 % 81.5 % TASC D Trial (CLI patients) Long SFA Trial (non CLI patients) Pulsar mm 77.0 % 86.0 % Pulsar mm 85.4 % 89.6 % Supera Supera 90 mm 84.7 % NA Resilient Lifestent 62 mm 81.3 % 87.3 % Zilver PTX DES Zilver 63 mm 73.0 % 77.0 % Durability Everflex 96 mm 72.2 % 79.1 % Durability 200 Everflex 242 mm 64.8 % 68.2 % Viabahn 200 Viabahn 194 mm 78.0 % 85.0 % 6 F

20 BIOFLEX PEACE Registry Pulsar Efficacy: an All Comers Registry INTERIM ANALYSIS Michael K. W. Lichtenberg On behalf of the BIOFLEX-PEACE study group

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