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

• Promotes swirling flow® to increase wall shear1, which is protective for atherosclerosis and intimal hyperplasia

• Enhances biomechanical performance2

1. Caro et al. 2013 J R Soc Interface 10: 201305782. Data on file at Veryan Medical

A nitinol self-expanding stent with a 3D helical centreline

PAM 122 Issue 00

MIMICS Clinical Programme

MIMICS Clinical Programme

MIMICS Clinical Programme

MIMICS-3D RegistryA 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

N= 377 Subjects

Age Mean years ± SD (N) 70.0 ± 9.6 (377/377)Gender Male / Female 257 (68.2%) / 120 (31.8%)

Risk Factors

Diabetes Mellitus 37.5% (141/376)Hypertension 82.4% (310/376)

Hypercholesterolemia 62.8% (236/376)Smoker Current / Former 67.0% (252/376)

Coronary RevascularizationPrevious Percutaneous or

Surgical 24.2% (91/376)

Rutherford Category

0 0.3% (1/373)1 1.1% (4/373)2 19.0% (71/373)3 56.6% (211/373)4 7.5% (28/373)5 13.7% (51/373)6 1.9% (7/373)

Ankle Brachial Index Mean ± SD (N) 0.59 ± 0.24 (299/377)

MIMICS-3D RegistryBaseline Patient Demographics (interim: N=377 subjects; target >500)

1. Data on file at Veryan Medical

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 TypeDe novo 92.6% (351/379)

Restenotic 7.4% (28/379)

Lesion Location

Prox SFA 18.5% (70/378)Mid SFA 34.9% (132/378)

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 118.8 ± 88.4 (379)

Calcification (%)

Grade 0 18.6% (70/377)Grade 1 31.8% (120/377)Grade 2 23.3% (88/377)Grade 3 13.0% (49/377)Grade 4 13.3% (50/377)

Run-off (%) - 1 or more patent tibial artery (<50% stenosis)

97.6% (372/381)

MIMICS-3D RegistryBaseline Lesion Characteristics (interim: N=377 subjects; target >500)

1. Data on file at Veryan Medical

N= 381 LesionsBioMimics 3D Stents placed # Stents / N 484 / 381

1 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) 125.2 ± 74.1 (377)

Diameter StenosisPre-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)

Baseline Procedure Data (interim: N=377 subjects; target >500)

MIMICS-3D Registry

1. Data on file at Veryan Medical

Lesion and Stented Segment Length

MIMICS-RCT vs. MIMICS-2 vs. MIMICS-3D

Mean ± SD (mm) (n/N) MIMICS-RCT MIMICS-2 MIMICS-3D

Lesion Length 66 ± 29 (50/50) 81.2 ± 38.4 (269/271) 118.8 ± 88.4 (379/380)

Stented Segment Length 99 ± 30 (50/50) 112.3 ± 36.3 (269/271) 125.2 ± 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

First 161 consecutive subjectsAugust 2015 - June 2016

144 patients at 6 month FUP94 patients at 12 month FUP

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 monthsIndication: Subjects with infrainguinal atherosclerotic disease eligible for stent implantation

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)

0

1

2

3

4

5

6

36 (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

Lesion characteristics at baseline

Lesion characteristics N = 161

Lesion length (mm) 127.2 +/- 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%)

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%)

6 and 12 months patencyfollow 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 100 83 (83,0 %) 127 ± 107 75 55 (73,3 %) 116 ± 94

SFA 90 75 (83,3 %) 132 ± 109 68 51 (75,0 %) 119 ± 96

POP 10 8 (80,0 %) 72 ± 60 7 4 (57,1 %) 86 ± 67

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 144 139 (96,5 %) 126 ± 106 94 83 (88,3%) 118 ± 96

SFA 131 127 (96,9 %) 129 ± 109 87 78 (89,7%) 121 ± 98

POP 13 12 (92,3 %) 85 ± 57 7 5 (71,4%) 94 ± 66

STUDY NAME DEVICE A.L.L. PP FTLR

ARNSBERG REGISTRY BioMimics 3D 12.7 cm 73.3% 88.3%

BIOFLEX PEACE Pulsar-18 11.9 cm 73.6% 96.2%

4EVER Pulsar-18 10.8 cm 73.4% 85.2%

PEACE Pulsar-18 11.2 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

12 months follow-up data in perspective

• 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

Conclusions

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