BioMimics 3D in my Clinical Practice
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1 BioMimics 3D in my Clinical Practice M Lichtenberg M.D. Vascular Centre Arnsberg / German Venous Centre Arnsberg CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use PAM 178 Issue 00
2 1. Caro et al J R Soc Interface 10: Data on file at Veryan Medical A nitinol self-expanding stent with a 3D helical centreline Promotes swirling flow to increase wall shear 1, which is protective for atherosclerosis and intimal hyperplasia Enhances biomechanical performance 2
3 PAM 122 Issue 00
4 MIMICS Clinical Programme
5 MIMICS Clinical Programme
6 MIMICS Clinical Programme
7 MIMICS-3D Registry A Prospective, Multicentre Observational Study to Evaluate BioMimics 3D Stent in PAD PI: Michael Lichtenberg MD Primary Endpoints: Safety: composite of death, major amputation or CDTLR through 30 days Effectiveness: freedom from CDTLR through 12-months Minimum targeted enrolment: 500 subjects Follow-up: 3 years Current status: 21 European centres have rapidly enrolled 380/500+ subjects Target mid-2018 completion of enrolment 75 subjects enrolled at Vascular Centre Arnsberg
8 MIMICS-3D Registry Baseline Patient Demographics (interim: N=377 subjects; target >500) N= 377 Subjects Age Mean years ± SD (N) 70.0 ± 9.6 (377/377) Gender Male / Female 257 (68.2%) / 120 (31.8%) Diabetes Mellitus 37.5% (141/376) Risk Factors Hypertension 82.4% (310/376) Hypercholesterolemia 62.8% (236/376) Smoker Current / Former 67.0% (252/376) Coronary Revascularization Previous Percutaneous or 24.2% (91/376) Surgical 0 0.3% (1/373) 1 1.1% (4/373) % (71/373) Rutherford Category % (211/373) 4 7.5% (28/373) % (51/373) 6 1.9% (7/373) Ankle Brachial Index Mean ± SD (N) 0.59 ± 0.24 (299/377) 1. Data on file at Veryan Medical
9 MIMICS-3D Registry Baseline Lesion Characteristics (interim: N=377 subjects; target >500) N= 381 Lesions Treated target lesions (n= 373 subjects) % 1 target lesion 97.9% (365/373) % 2 target lesions 2.1% (8/373) Reference Vessel Diameter (mm) Mean ± SD 5.5 ± 0.7 (376) Lesion Type De novo 92.6% (351/379) Restenotic 7.4% (28/379) Prox SFA 18.5% (70/378) Mid SFA 34.9% (132/378) Lesion Location Distal SFA 30.4% (115/378) Prox. Pop 8.5% (32/378) Ostial SFA 5.6% (21/278) Other 2.1% (8/378) Diameter Stenosis (%) Mean ± SD 94.6 ± 7.8 (379) Lesion Length (mm) Mean ± SD ± 88.4 (379) Grade % (70/377) Grade % (120/377) Calcification (%) Grade % (88/377) Grade % (49/377) Grade % (50/377) Run-off (%) - 1 or more patent tibial artery (<50% stenosis) 97.6% (372/381) 1. Data on file at Veryan Medical
10 MIMICS-3D Registry Baseline Procedure Data (interim: N=377 subjects; target >500) N= 381 Lesions BioMimics 3D Stents placed # Stents / N 484 / stent 78.0% (297/381) 2 stents 17.8% (68/381) 3 stents 3.4% (13/381) 4 stents 0.8% (3/381) Stented Segment Length Mean ± SD (mm) ± 74.1 (377) Diameter Stenosis Pre-stent % ± SD 94.6 ± 7.8 (379) Post-stent % ± SD 6.5 ± 8.1 (379) Other target lesion treatments Drug coated balloon 50.4% (192/381) Pre-stenting 38.5% (74/192) Post-stenting 58.9% (113/192) Pre- and post-stenting 2.6% (5/192) Atherectomy 9.4% (36/381) Thrombectomy 5.8% (22/381) Cutting balloon 3.7% (14/381) Other BMS 1.3% (5/381) Covered stent 0.8% (3/381) DES 0.5% (2/381) Technical success 99.5% (377/379) 1. Data on file at Veryan Medical
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13 MIMICS-RCT vs. MIMICS-2 vs. MIMICS-3D Lesion and Stented Segment Length Mean ± SD (mm) (n/n) MIMICS-RCT MIMICS-2 MIMICS-3D Lesion Length 66 ± 29 (50/50) 81.2 ± 38.4 (269/271) ± 88.4 (379/380) Stented Segment Length 99 ± 30 (50/50) ± 36.3 (269/271) ± 74.1 (377/380) Core lab reported data for MIMICS and MIMICS-2, site-reported for MIMICS-3D MIMICS-3D in summary: Longer lesions, sicker patients, more calcium Large majority are stent+dcb; or DCB+stent Highly relevant population for a contemporary Registry 1. Data on file at Veryan Medical
14 BioMimics 3D Arnsberg single-centre registry Consort Chart of first 161 Patients Objective: Evaluation of safety and performance of BioMimics 3D in treatment of subjects with atherosclerotic disease Design: All Comers Registry with follow-up investigations at 6, 12 and 24 months Indication: Subjects with infrainguinal atherosclerotic disease eligible for stent implantation First 161 consecutive subjects August June patients at 6 month FUP 94 patients at 12 month FUP
15 Patient demographics at baseline Patient demographics N = 161 Male 118 (73%) Age Median (Min/Max) 72 (26/91) Hypertension 160 (99.1%) Dyslipidemia 158 (98.1%) Smoker (current or previous) 66 (47.5%) Diabetes 60 (37.5%) Renal Insufficiency 35 (21.8%) CLI (Rutherford 4/5/6) Rutherford (n=161) (22.3%) 0 (0.0%) 2 (1.2%) 58 (36.0%) 65 (40.3%) 20 (12.4%) 12 (8.5%) 4 (2.5%) Ankle brachial index (n=122) Ø 0.63 Walking capacity (m) (n=43) Ø 118.7
16 Lesion characteristics at baseline Lesion characteristics N = 161 Lesion length (mm) /- 107 SFA (prox distal) 121 Popliteal artery 44 TASC A lesion 28 (16.9%) TASC B lesion 44 (26.6%) TASC C lesion 46 (27.8%) TASC D lesion 47 (28.4%) Calcification 0 None 1 Mild 2 Moderate 3 Severe Moderate & Severe 32 (19.3%) 70 (42.4%) 40 (24.2%) 23 (13.9%) 63 (38.2%) De novo stenosis 150 (90.1%) Restenosis 15 (9,1%)
17 Treatment regime Patients N = 161 Stent only 78 (52%) 1 Stent 130 (80.7%) 2 Stents 25 (15.5%) 3 Stents 6 (3.7) Stent plus DCB 25 (15.5%) Stent plus rotational thrombectomy 18 (11.1%) Stent plus atherectomy 36 (22.6%) Stent plus cutting balloon 22 (13.6%)
18 6 and 12 months patency follow up data (DUS imaging cohort group, PSVR < 2.5) 6 months follow-up 12 months follow-up Patients (n) Primary Patency (%) Lesion length (mm) Patients Primary Patency (%) Lesion length (mm) SFA & POP (83,0 %) 127 ± (73,3 %) 116 ± 94 SFA (83,3 %) 132 ± (75,0 %) 119 ± 96 POP 10 8 (80,0 %) 72 ± (57,1 %) 86 ± 67
19 6 and 12 months ftlr follow-up 6 months follow-up 12 months follow-up Patients (n) Freedom From TLR (%) Lesion length (mm) Patients (n) Freedom from TLR (%) Lesion length (mm) SFA & POP (96,5 %) 126 ± (88,3%) 118 ± 96 SFA (96,9 %) 129 ± (89,7%) 121 ± 98 POP (92,3 %) 85 ± (71,4%) 94 ± 66
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21 12 months follow-up data in perspective STUDY NAME DEVICE A.L.L. PP FTLR ARNSBERG REGISTRY BioMimics 3D 12.7 cm 73.3% 88.3% BIOFLEX PEACE Pulsar cm 73.6% 96.2% 4EVER Pulsar cm 73.4% 85.2% PEACE Pulsar cm 79.5% 81.0% RESILIENT Lifestent 6.2 cm 81.3% 87.3% ZILVER FLEX (PTX study) Zilver Flex 6.3 cm 73.0% 77.0% ZILVER PTX Zilver PTX (DES) 6.6 cm 83.1% 90.5% DURABILITY II EverFlex 8.9 cm 77.2% N/A SUPERA Supera 9.0 cm 84.7% N/A DURABILITY EverFlex 9.6 cm 72.2% 79.1% ABSOLUTE Absolute 10.1 cm 63.0% N/A
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23 Conclusions The preliminary results of the Arnsberg BioMimics All Comers Registry with a mean lesion length of 127 mm shows: TASC C and D lesions: 56.2% of patients treated Moderate/severe calcification: 38.2% of patients treated Very promising overall primary patency and freedom from TLR data in patients with SFA and POP lesions, including complex lesions In perspective to other nitinol stent studies the swirling flow stent seems to have additional benefits in terms of clinical outcome Further evaluation of the entire study population with continued follow up is on-going to give more detailed and longer term insight especially in combination with DCBs and extensive lesion preparation
24 BioMimics 3D in my Clinical Practice M Lichtenberg M.D. Vascular Centre Arnsberg / German Venous Centre Arnsberg CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use PAM 178 Issue 00
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