MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Veryan Medical Ltd.

MIMICS-2 IDE Study Protocol 
CID 100 Issue 09 Date: 20 July 2017 
Veryan Medical Limited / Confidential 
 
Page 1 of 69 
 
 
 
Evaluation of Safety and Effectiveness of the 
BioMimics 3DTM Stent System in the 
Femoropopliteal Arteries of Patients with 
Symptomatic Peripheral Arterial Disease 
 
 
Protocol Number:  CID-100 
 
Issue: 09 
Date:  July 20, 2017 
 
 
Sponsor: 
 
 
 
 
Veryan Medical Ltd 
Block 11, Galway Technology Park 
Parkmore, Galway, 
Co. Galway, Ireland 
Telephone:  +353 (91) 750 040 
Facsimile:   +353 (91) 750 031 
CONFIDENTIAL 
DO NOT COPY 
This investigational Protocol contains confidential information for use by the principal investigators 
and their designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. It should not be copied or made available for 
review by any unauthorized person or firm. 
 

MIMICS-2 IDE Study Protocol 
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Investigator’s Signature Page 
 
STUDY TITLE: 
MIMICS-2: Evaluation of the Safety and Effectiveness of the BioMimics 3DTM 
Stent System in the Femoropopliteal Arteries of Patients with Symptomatic 
Peripheral Arterial Disease 
PROTOCOL NUMBER 
& ISSUE: 
CID 100 Issue 09 
STUDY CENTER: 
_____________________________________________ 
(Print name of study center) 
 
I, the undersigned, have read and understand the Protocol specified above and agree with its content. 
I agree to perform and conduct the Study as described in the Protocol. In addition, when applicable, I 
agree to enlist sub-investigators who also agree to perform and conduct the Study as described in the 
Protocol. I will provide copies of this Protocol and all pertinent information to the Study personnel 
under my supervision and my hospital Institutional Review Board/Ethics Committee. I will discuss this 
material with them and ensure they are fully informed regarding the BioMimics 3D investigational 
device and the conduct of the Study according to Good Clinical Practice (GCP), Declaration of Helsinki, 
21 CFR Parts 50, 54, 56 and 812, ISO 14155:2011, and any local regulations. 
 
 
___________________________________________________________________ 
SITE PI – Print Name 
 
 
___________________________________________________________________ 
SITE PI – Signature 
 
 
_______________________ 
DATE 
 
 
 

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TABLE OF CONTENTS 
CONTENTS 
PROTOCOL SUMMARY ................................................................................................................. 6 
1.0 
INTRODUCTION AND BACKGROUND ................................................................................ 11 
1.1 
Introduction .......................................................................................................................... 11 
1.2 
Literature Summary .............................................................................................................. 11 
1.3 
Novel Technology .................................................................................................................. 13 
1.4 
Report of Prior Investigations ............................................................................................... 13 
1.5 
Results from Prior Clinical Investigation: Mimics Study ....................................................... 14 
1.5.1 
Clinical Investigation Title ..................................................................................... 14 
1.5.2 
Introduction .......................................................................................................... 14 
1.5.3 
Purpose of the Clinical Investigation ..................................................................... 14 
1.5.4 
Description of the Clinical Investigation Population ............................................. 14 
1.5.5 
Clinical Investigation Methodology ....................................................................... 15 
1.5.6 
Phase 2 Clinical Investigation Results ................................................................... 15 
1.5.7 
Conclusion ............................................................................................................. 20 
2.0 
DEVICE INDICATION FOR USE AND DEVICE DESCRIPTION .................................................. 21 
2.1 
Intended Use ......................................................................................................................... 21 
2.2 
Device Description ................................................................................................................ 21 
2.3 
Device Preparation and Deployment Procedure .................................................................. 22 
3.0 
INVESTIGATIONAL PLAN .................................................................................................. 23 
3.1 
Study Objective ..................................................................................................................... 23 
3.1.1 
Study Design .......................................................................................................... 23 
3.1.2 
Enrollment ............................................................................................................. 23 
3.1.3 
Study Population ................................................................................................... 23 
3.2 
Study Duration and Follow-Up .............................................................................................. 23 
4.0 
STUDY ENDPOINTS AND SUBJECT POPULATION ............................................................... 24 
4.1 
Primary Outcome Measures ................................................................................................. 24 
4.1.1 
Primary safety endpoint:....................................................................................... 24 
4.1.2 
Primary effectiveness endpoint: ........................................................................... 24 
4.2 
Secondary Outcome Measures ............................................................................................. 25 
4.3 
Exploratory Outcomes .......................................................................................................... 25 
4.4 
Eligibility Criteria ................................................................................................................... 25 
4.4.1 
Inclusion Criteria ................................................................................................... 25 
4.4.2 
Angiographic Inclusion Criteria: ............................................................................ 26 
4.4.3 
Exclusion Criteria: .................................................................................................. 26 
4.4.4 
Angiographic Exclusion Criteria: ........................................................................... 27 
5.0 
STUDY SCREENING AND ENROLLMENT ............................................................................ 28 
5.1 
Subject Screening .................................................................................................................. 28 
5.2 
Informed Consent ................................................................................................................. 28 
5.3 
Subject Enrollment ................................................................................................................ 28 
5.4 
Subject Withdrawal ............................................................................................................... 29 
5.5 
Anticipated Total Enrollment ................................................................................................ 29 
6.0 
STUDY PROCEDURES ....................................................................................................... 30 
6.1 
Visit Schedule ........................................................................................................................ 30 
6.2 
Baseline ................................................................................................................................. 32 
6.3 
Medications .......................................................................................................................... 32 

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6.4 
Index Procedure .................................................................................................................... 32 
6.4.1 
Pretreatment of Lesion / Vessel............................................................................ 33 
6.4.2 
Implant Procedure ................................................................................................ 33 
6.4.3 
Stenting ................................................................................................................. 33 
6.4.4 
Additional Stenting / Bailout Procedures.............................................................. 33 
6.4.5 
Post-Treatment of Lesion / Vessel ........................................................................ 34 
6.5 
Day 30 Follow-Up .................................................................................................................. 34 
6.6 
Month 12 Follow-Up ............................................................................................................. 34 
6.7 
Month 24 Follow-Up (Long-Term Follow-Up Phase of the Study) ........................................ 34 
6.8 
Month 36 Follow-up (Post-Market Surveillance Phase of the Study)................................... 35 
7.0 
ADVERSE EVENTS ............................................................................................................ 36 
7.1 
Adverse Event ....................................................................................................................... 36 
7.2 
Serious Adverse Event (SAE) ................................................................................................. 38 
7.3 
Major Adverse Event (MAE) .................................................................................................. 38 
7.4 
Adverse Event Reporting Requirements ............................................................................... 38 
7.4.1 
General Reporting Requirements ......................................................................... 38 
7.4.2 
Reporting Requirements for Serious and Major Adverse Events ......................... 39 
7.4.3 
Device Failures and Malfunctions ......................................................................... 39 
8.0 
RISK/BENEFIT ASSESSMENT ............................................................................................. 40 
8.1 
Risks to the Subject ............................................................................................................... 40 
8.1.1 
Risk Analysis .......................................................................................................... 40 
8.1.2 
Risk Minimization .................................................................................................. 41 
8.2 
Potential Benefits .................................................................................................................. 41 
9.0 
STATISTICAL ANALYSIS PLAN ........................................................................................... 42 
9.1 
Analysis Populations ............................................................................................................. 42 
9.2 
Population Demographics ..................................................................................................... 42 
9.3 
Primary Endpoint Analysis .................................................................................................... 42 
9.3.1 
Primary safety endpoint:....................................................................................... 42 
9.3.2 
Primary effectiveness endpoint: ........................................................................... 42 
9.4 
Secondary Endpoint Analysis ................................................................................................ 43 
9.5 
Exploratory Endpoint Analysis .............................................................................................. 43 
9.6 
Other Safety Data .................................................................................................................. 43 
9.7 
Site Poolability and Subgroup Analyses ................................................................................ 43 
9.8 
Sample Size ........................................................................................................................... 44 
9.9 
Handling of Missing Data ...................................................................................................... 46 
9.10 
Interim Analysis ..................................................................................................................... 47 
10.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS & REPORTS .................................................. 48 
10.1 
Informed Consent & Institutional Review Board / Ethics Committee .................................. 48 
10.2 
Withdrawal of Approval ........................................................................................................ 48 
10.3 
Clinical Data Collection ......................................................................................................... 48 
10.4 
Device Accountability ............................................................................................................ 48 
10.5 
Investigator Reports .............................................................................................................. 49 
10.5.1 
Serious Adverse Events & Major Adverse Events ................................................. 49 
10.5.2 
Device Malfunctions or Failures ............................................................................ 49 
10.5.3 
Deviations from the Investigational Plan .............................................................. 49 
10.5.4 
Investigator Final Report ....................................................................................... 49 
10.6 
Publication Policies ............................................................................................................... 50 
11.0 
SPONSOR RESPONSIBILITIES ............................................................................................ 51 
11.1 
General Duties ...................................................................................................................... 51 

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11.2 
Selection of Clinical Sites & Investigators ............................................................................. 51 
11.3 
Monitoring ............................................................................................................................ 51 
11.3.1 
Investigational Site Termination ........................................................................... 52 
11.4 
Informed Consent & Institutional Review Board / Ethics Committee .................................. 52 
11.5 
Records & Record Retention ................................................................................................. 52 
11.6 
Study Reports ........................................................................................................................ 53 
11.7 
Supplemental Applications ................................................................................................... 53 
12.0 
QUALITY ASSURANCE & ETHICAL STANDARDS ................................................................. 54 
12.1 
Institutional Review Boards / Ethics Committees ................................................................. 54 
12.2 
Informed Consent ................................................................................................................. 54 
12.3 
Protocol Amendments .......................................................................................................... 54 
12.4 
Emergency Actions ................................................................................................................ 55 
12.5 
Protocol Compliance ............................................................................................................. 55 
12.6 
Investigator & Staff Training ................................................................................................. 55 
12.7 
Audits and Inspections .......................................................................................................... 56 
12.8 
Monitoring Procedures ......................................................................................................... 56 
12.8.1 
Monitoring ............................................................................................................ 56 
12.9 
Investigational Device Distribution and Accountability ........................................................ 57 
12.9.1 
Investigational Device Distribution ....................................................................... 57 
12.9.2 
Device Accountability ............................................................................................ 57 
12.9.3 
Return of Study Materials at Study Termination / Completion ............................ 57 
12.10 
Clinical Events Committee .................................................................................................... 57 
12.11 
Data Management ................................................................................................................ 57 
12.12 
Central Core Labs – Angiography, Duplex Ultrasound, X-Ray ............................................... 58 
12.13 
Subject Compensation .......................................................................................................... 58 
12.14 
Confidentiality ....................................................................................................................... 58 
13.0 
STUDY DEFINITIONS ........................................................................................................ 59 
14.0 
REFERENCES ................................................................................................................... 66 
APPENDIX A – CORE LABORATORIES ........................................................................................... 69 
 
Table 1: Core lab reported baseline angiographic data for BioMimics 3D and Control ....................... 16 
Table 2: Summary of subject disposition in the randomized phase of the Mimics study (N=76) ........ 17 
Table 3: Summary of adjudicated Major Adverse Events during Mimics study ................................... 17 
Table 4: Primary stent patency for BioMimics 3D and Control ............................................................ 18 
Table 5: Patients experiencing an improvement in Rutherford category from baseline ..................... 19 
Table 6: BioMimics 3D stent and delivery system size matrix .............................................................. 22 
Table 7: MIMICS-2 study schedule ........................................................................................................ 31 
Table 8: Summary of Protocol-required medications for MIMICS-2 Study .......................................... 32 
Table 9: MIMICS-2 investigator reporting timelines ............................................................................. 50 
 
Figure 1: Forces on the femoropopliteal artery during lower limb movement .................................... 12 
Figure 2: BioMimics 3D Stent ................................................................................................................ 13 
Figure 3: Collinear transition zones and 3D helical centerline ............................................................. 13 
Figure 4: X-ray image of implanted BioMimics 3D Stent ...................................................................... 13 
Figure 5: Kaplan Meier survival estimate of freedom from CDTLR at 12 & 24 months ....................... 18 
Figure 6: Kaplan Meier survival estimate of primary patency at 12 and 24 months ............................ 19 
Figure 7: BioMimics 3D stent delivery system components ................................................................. 21 
Figure 8: Location of eligible target lesions .......................................................................................... 28 
 

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PROTOCOL SUMMARY 
Study Title: 
MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3DTM 
Stent System in the Femoropopliteal Arteries of Patients with 
Symptomatic Peripheral Arterial Disease 
Study Objective:  
To demonstrate that the BioMimics 3D Stent System meets the 
performance goals defined by VIVA Physicians, Inc. for the safety and 
effectiveness of Nitinol stents used in the treatment of symptomatic 
disease of the femoropopliteal artery. 
Study Device: 
BioMimics 3D™ Stent System 
Intended Use:  
The BioMimics 3D stent is intended to improve luminal diameter in the 
treatment of symptomatic de-novo, obstructive or occlusive lesions up 
to 140 mm in length in native femoropopliteal arteries with reference 
vessel diameters ranging from 4.0 – 6.0 mm 
Study Design: 
Prospective, single-arm, multicenter clinical trial 
Device Regulatory Status: 
United States 
Class III investigational device 
 
Europe 
CE Mark approval (Class IIb) 
 
Japan  
Class III investigational device 
 
BioMimics 3D Stent System has been designed and is manufactured by 
Veryan Medical Limited under the control of Veryan’s Quality 
Management System. Veryan is ISO 13485 certified. 
Estimated Enrollment: 
280 subjects.  
Up to 40% (112 subjects) of total study population may be enrolled 
outside the United States 
 
No site may enroll more than 35 subjects.  
Subject Population: 
Subjects 
with 
symptomatic 
atherosclerotic 
disease 
of 
the 
femoropopliteal artery who comply with all study eligibility criteria. 
Clinical Sites: 
Up to 40 centers in the United States. Up to 13 centers in Japan and 
Europe. 
Study Follow-Up:  
After the index procedure on Day 0, subjects will be evaluated within 30 
days, then at Months 12, 24 and 36. 
Study Duration: 
First subject enrolled: 
June, 2015 
Last subject enrolled: 
October, 2016 
Last subject completes Month 12 Visit: 
December, 2017 
Last subject completes Month 24 Visit: 
December, 2018 
Long-term surveillance completed (Month 36): 
December, 2019 
 
Primary Outcome Measures: Primary safety endpoint: 
A composite of major adverse events (MAE) comprising death, any major 
amputation performed on the target limb or clinically-driven target 
lesion revascularization (TLR) through 30 days.  

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Primary effectiveness endpoint: 
Primary stent patency rate at 12 months. Patency is defined as no 
significant reduction in luminal diameter (i.e. < 50% diameter stenosis) 
since the index procedure. Luminal diameter is assessed by core lab 
using angiography or duplex ultrasound imaging. Loss of primary stent 
patency is deemed when peak systolic velocity ratio (PSVR) is >2.0*, or 
where angiography reveals >50% diameter stenosis, or where the 
subject undergoes clinically-driven TLR. When both imaging modalities 
are available, angiography takes precedence.  
 
*In cases where PSVR cannot be determined, or where the independent 
core lab deems the PSVR as discrepant from correlating factors1, these 
correlating factors will be primarily considered in the determination of 
patency. 
Secondary Outcome 
Measures: 
1. Contribution of individual MAE rates for death, major amputation 
performed on the target limb and clinically-driven target lesion 
revascularization to the overall MAE rate at 30 days. 
2. Long-term safety assessment – overall MAE rate at Month 12 and 
contribution of individual event rates to the overall MAE. 
3. Overall rate and incidence of type of serious adverse events from 
Day 0 through completion of Study follow-up at Month 36. 
4. Technical success reported by the core lab as the percentage of 
treated lesions in which a final result of ≤50% residual diameter 
stenosis (in-stent) was achieved at index procedure. 
5. Primary stent patency rate: determined at Months-12 and 24 using 
values of: PSVR >2.0; >2.4; >2.5; and >3.5, each to indicate loss of 
patency on duplex ultrasound or where angiography reveals >50% 
diameter stenosis or where the subject undergoes clinically-driven 
TLR. When both imaging modalities are available, angiography takes 
precedence. 2   
6. Clinical outcome: comparison of Rutherford Clinical Category 
measured at Baseline, Day 30, Months 12 and 24. Worsening of 
Rutherford Clinical Category is defined as an increase by one or more 
categories compared to Baseline or unexpected major amputation 
of the target limb. 
7. Clinical outcome: comparison of Six-Minute Walk Test measured at 
Baseline, Day 30, Months 12 and 24 (subgroup of US investigational 
sites only). 
                                                          
1 The core lab uses the following secondary criteria in the determination of patency:  
• 
Focal increase in the absolute PSV at the area of visible plaque 
• 
Spectral broadening of the waveform at the area of stenosis 
• 
Post-stenotic turbulence and/or change in the waveform shape and/or drop in velocity distal to the 
stenosis 
• 
Review of the B-mode images for plaque burden 
 
2 In cases where PSVR cannot be determined, or where the independent core lab deems the PSVR as discrepant 
from correlating factors, these correlating factors will be primarily considered in the determination of patency. 

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8. Functional outcome: comparison of the ankle brachial index (ABI) 
measurement at Baseline, within 30 days after index procedure, 
then at Months 12 and 24. 
9. Functional outcome: comparison of the Walking Impairment 
Questionnaire at Baseline, within 30 days after index procedure, 
then at Months 12 and 24. 
10. Stent integrity measured as freedom from stent fracture, defined as 
clear interruption of a stent strut observed in a minimum of two 
projections, determined by core lab examination of X-rays taken 
with the leg in extension at 12, 24 and 36 Months. 
Exploratory Outcomes 
1. Presence and quantification of swirling blood flow in the stented 
segment (using computational fluid dynamic modeling of duplex 
ultrasound data and bent knee X-ray measurements) taken at 12 
Months (sub-group of US investigational sites only). 
Inclusion Criteria: 
1. Subject is male or female, with age >18 and ≤85 years at date of 
enrollment. 
2. Subject or authorized representative provides written informed 
consent before any study-specific investigations or procedures. 
3. Subject is willing to undergo all follow-up assessments according to 
the specified schedule over 36 months. 
4. Subject is a suitable candidate for angiography and endovascular 
intervention and, if required, is eligible for standard surgical repair. 
5. Subject has symptomatic peripheral arterial disease (PAD) of the 
lower extremities requiring intervention to relieve de novo 
obstruction or occlusion of the native femoropopliteal artery. 
6. Subject has PAD classified as Rutherford clinical category 2, 3 or 4. 
7. Subject has documented PAD by either (i) a resting ankle-brachial 
index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb). 
Resting toe brachial index (TBI) is performed only if unable to reliably 
assess ABI. TBI must be <0.70; or (ii) Normal ABI with angiographic 
or ultrasound evidence of ≥60% diameter stenosis. 
Angiographic Inclusion 
Criteria: 
8. Subject has single or multiple stenotic or occlusive lesions within the 
native femoropopliteal artery (“target lesions”) that can be crossed 
with a guidewire and fully dilated. (Note: multiple target lesions 
must be treated as a single lesion.) 
9. Single or multiple target lesions must be covered by a single stent or 
two overlapping stents. In the case of tandem lesions, the gap 
between lesions must be ≤ 3 cm. 
10. Target lesion(s) eligible for treatment under the Protocol are at least 
1 cm distal to the origin of the deep femoral artery and at least 3 cm 
above the bottom of the femur.  
11. Target lesion(s) reference vessel diameter is between 4.0 mm and 
6.0 mm by operator’s visual estimate. 
12. Single or multiple target lesions measure ≥40 mm to ≤140 mm in 
overall length, with ≥60% diameter stenosis by operator’s visual 
estimate. 
13. Subject has a patent popliteal artery (no stenosis ≥50%) distal to the 
treated segment.  
14. Subject has at least one patent infrapopliteal vessel (<50% stenosis) 
with run-off to the ankle. 

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Exclusion Criteria: 
1. Subject is unable or is unwilling to comply with the procedural 
requirements of the study Protocol or will have difficulty in 
complying with the requirements for attending follow-up visits. 
2. Subject has a comorbidity that in the investigator’s opinion would 
limit life expectancy to less than 36 months. 
3. Subject has iliac stent in target limb that has required re-
intervention within 12 months prior to index. 
4. Subject has any planned major surgical procedure (including any 
amputation of the target limb) within 30 days after the index 
procedure for this Study. 
5. Subject has a target vessel that has been treated with any type of 
surgical or endovascular procedure prior to enrollment. 
6. Subject has a target vessel that has been treated with bypass 
surgery. 
7. Subject has PAD classified as Rutherford clinical category 0, 1, 5 or 6. 
8. Subject has known or suspected active systemic infection at the time 
of enrollment. 
9. Subject has a known coagulopathy or has bleeding diatheses, 
thrombocytopenia with platelet count less than 100,000/microliter 
or INR >1.8. 
10. Subject has a stroke diagnosis within 3 months prior to enrollment. 
11. Subject has a history of unstable angina or myocardial infarction 
within 60 days prior to enrollment. 
12. Subject has a contraindication to antiplatelet, anticoagulant, or 
thrombolytic therapies. 
13. Subject has known allergy to contrast agents or medications used to 
perform endovascular intervention that cannot be adequately pre-
medicated. 
14. Subject has known allergy to titanium, nickel or tantalum. 
15. Subject has received thrombolysis within 72 hours prior to the index 
procedure.  
16. Subject has acute or chronic renal disease (e.g., as measured by a 
serum creatinine of >2.5 mg/dL or >220 umol/L), or on peritoneal or 
hemodialysis.  
17. Subject requiring coronary intervention within 7 days prior to 
enrollment. 
18. Subject is pregnant or breast-feeding. 
19. Subject is participating in another research study involving an 
investigational product (pharmaceutical, biologic, or medical 
device). 
20. Subject has other medical, social or psychological problems that, in 
the opinion of the investigator, preclude them from receiving this 
treatment, and the procedures and evaluations pre- and post-
treatment. 
Angiographic Exclusion 
Criteria: 
21. Subject has significant disease or obstruction (≥50%) of the inflow 
tract that has not been successfully treated at the time of the index 
procedure (success measured as ≤30% residual stenosis, without 
complication). 
22. Subject has a lesion in the contralateral limb requiring intervention 
during index procedure or within next 30 days. 

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23. Subject has no patent (≥50% stenosis) outflow vessel providing run-
off to the ankle. 
24. There is a lack of full expansion in the predilatation balloon. 
25. Target lesion(s) requires percutaneous interventional treatment, 
beyond standard balloon angioplasty alone, prior to placement of 
the study stent. 
26. Evidence of aneurysm or acute thrombus in target vessel. 
Sponsor 
Veryan Medical Limited, Block 11, Galway Technology Park, Parkmore, 
Galway, Co. Galway, Ireland 
Co-Principal Investigators: 
European Co-PI: Professor Thomas Zeller (Bad Krozingen, Germany) 
US Co-PI: Professor Timothy Sullivan (Minneapolis, MN) 
Japan Co-PI: Prof. Masato Nakamura (Tokyo, Japan) 
Safety Monitoring: 
Yale Cardiovascular Research Group, New Haven CT 06510, USA 
Study Management: 
Veryan Medical Ltd., Galway, Ireland 
US Agent: 
CardioMed LLC, Baltimore, MD, USA 
Japanese In-Country 
Caretaker: 
Medico’s Hirata, Nishu-Ku, Osaka, Japan 
Monitoring (CRO): 
Clinlogix LLC, Ambler, PA, USA 
Data Management: 
Veryan Medical Ltd., Galway, Ireland 
EDC Provider: 
DataTrak International Inc., Mayfield Heights, OH, USA 
Image Data Transfer: 
AG Mednet, Boston MA, USA 
Angiographic Core Lab: 
Yale Cardiovascular Research Group, New Haven CT, USA 
X-Ray Core Lab: 
Yale Cardiovascular Research Group, New Haven CT, USA 
Duplex Ultrasound Core Lab: VasCore, Boston MA, USA 
 

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1.0 
INTRODUCTION AND BACKGROUND  
1.1 
Introduction 
Veryan intends to conduct a prospective, single arm, multicenter trial (MIMICS-2) to demonstrate the 
safety and effectiveness of Veryan’s BioMimics 3D Stent System. The BioMimics 3D self-expanding 
Nitinol stent is intended to improve luminal diameter in the treatment of symptomatic de-novo 
obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters 
ranging from 4.0 – 6.0 mm. Up to 280 subjects will be enrolled into MIMICS-2 and treated with the 
BioMimics 3D Stent System. Safety and effectiveness outcomes in the MIMICS-2 study will be 
compared to established performance goals defined by VIVA Physicians, Inc. for the clinical evaluation 
of safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the 
femoropopliteal artery. 
1.2 
Literature Summary 
Atherosclerosis is a chronic vascular disease that can manifest itself in the coronary, neurovascular 
and peripheral vascular beds with end organ and distal extremity vascular impact. Specifically, 
peripheral arterial disease (PAD) is a common manifestation of atherosclerosis and is a chronic 
occlusive arterial disease caused by plaque buildup in the arterial lumen that leads to diminished blood 
flow. The rising prevalence of PAD with increasing age, and within a population increasingly at risk 
from obesity and diabetes, is a major international health care issue with substantial economic 
ramifications. In the United States alone, Medicare-funded, in-patient costs for PAD have been 
estimated to total $4 billion annually [1]. A recent estimate concluded that the global prevalence of 
PAD presently exceeds a quarter of a billion and that this number grew by more than 20% in the period 
2000 to 2010 [2]. Patients with PAD have an increased risk of myocardial infarction, stroke, and death 
[2]. Major risk factors for the development of PAD include family history, age, hypertension, cigarette 
smoking, diabetes, and dyslipidemia; the greatest risk factors being diabetes and smoking [2]. The 
treatment of PAD is initially directed at a combination of lifestyle or behavioral modification and 
medical management to hopefully slow the disease and symptom progression. When these methods 
fail to provide symptomatic relief, revascularization may be achieved through endovascular or surgical 
approach [2]. 
Anatomically, 70% of PAD lesions are present in the femoropopliteal and tibial arteries with more than 
50% of all PAD interventions involving the superficial femoral and popliteal arteries [3]. 
Femoropopliteal disease is characterized by long, diffuse obstructive or occlusive lesions that create a 
unique slow-flow and high resistance environment [3]. The treatment of the femoropopliteal arteries 
using endovascular treatments has gained popularity with patients and physicians alike due to these 
procedures being less invasive, and potentially with fewer complications, than the surgical options [4], 
[5]. 
The immediate treatment goal for patients with PAD is relief of symptoms arising from intermittent 
claudication. The ultimate long-term goal is preservation of tissue or limb salvage. When lifestyle or 
behavioral modification and conservative medical therapy fail, surgical intervention may be a 
consideration for these patients [6].  An open surgical procedure continues to be a standard treatment 
modality but is associated with longer recovery, greater costs and potential complications (i.e., general 
surgical and anesthesia-related complications, thrombosis of the bypass graft, infection, etc.). As 
endovascular interventional techniques have advanced in both treatment success and long-term 
durability, endovascular therapy is increasingly the preferred option to treat patients with PAD whose 
symptoms are refractory to optimal exercise programs and medical therapy [3]. 
Percutaneous transluminal angioplasty (PTA) is one of the simplest endovascular methods to treat 
PAD, but the acute success of the technique is often dependent on the lesion morphology [7]. The 
effectiveness of PTA in the femoropopliteal artery may be compromised by calcium deposition in the 
arterial wall that may contribute to elastic recoil and suboptimal outcome [8]. Acute failure of PTA in 

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moderate length lesions (<10 cm) was reported as 40% in the Resilient trial [9] and at 50% in the Zilver 
PTX trial [10]. A number of non-randomized studies have demonstrated that PTA can yield acceptable 
long term results in focal lesions [11]–[13]; however, success of the technique in longer lesions is 
hampered by a high incidence of restenosis [14], [15]. A recent study which reviewed the safety and 
effectiveness of PTA for the treatment of femoropopliteal lesions up to 15 cm in length (mean 8.7 cm) 
revealed a 12-month primary patency rate of 33% [16].  
Nitinol stents were developed as an adjunctive endovascular therapy to provide scaffolding to the 
arterial wall, thus preventing elastic recoil, and treating intimal injuries post-angioplasty [17]. 
Endovascular stenting is frequently used to recanalize the peripheral vessels [18]–[20].  However, 
despite improvements in stent design, restenosis is a limiting factor as a result of intimal hyperplasia 
following stent placement [21]. The mechanism for the development of restenosis is multi-factorial 
but may include vessel injury during angioplasty, stent implantation, sub-optimal flow conditions and 
mechanical factors. Recently, the STELLA study reported a 12 month fracture rate of 17.7% in patients 
with long lesions (mean lesion length 220mm) [22]. Iida et al. reported a fracture rate of 14% and 
noted that stent fracture was more prevalent in longer lesions [23]. In a review by Rits et al. the highest 
stent fracture rate reported was 65%, with the highest occurrence in the superficial femoral artery 
(SFA) [24]. Ansel et al. reported a fracture rate of 31% at 12 months in the Nitinol stent study arm and 
observed that fractures predominantly occurred in longer lesions (>150mm) [25]. Allie et al. reported 
that stent fractures were linked to restenosis in 77% of stent fractures [26].  Scheinert et al. reported 
that over two-thirds of cases of stent fracture were associated with restenosis or reocclusion [27]. 
These data have underscored the need for a new approach to the design of stents for the peripheral 
vessels in general and the SFA in particular. 
Given that the SFA and popliteal arteries are under continuous 
mobility during knee flexion the resultant mechanical forces on 
the vessel include compression, flexion, extension, torsion and 
pulsatile distension (see Figure 1). Stents deployed in these 
vessels are also subjected to these forces [28]. The suitability of 
a stent for the femoropopliteal artery may therefore depend on 
its ability to shorten in a controlled manner, without inducing 
strains which lead to fatigue fracture [29]. The inability of long 
and /or multiple straight stent segments to shorten or "take up 
the slack" during motion, leads to large strains, kinking and 
fatigue fractures [28], [30]. In addition, if the stent is unable to 
shorten, it may create biomechanical incompatibilities leading 
to acute and chronic injury to adjacent vessel segments 
subjected to substantial deformation where knee flexion may 
induce acute vascular angulation (kinking) [30]–[32]. A stent 
which can shorten naturally in order to reduce focal 
deformation and provide longitudinal flexibility may therefore provide a favorable solution for 
recanalization of the SFA.  
Local hemodynamics are strongly influenced by vessel morphology and the vascular endothelium is 
constantly exposed, and highly sensitive to, the prevailing wall shear stress. Shear stress of 
physiological arterial magnitudes (>1.5 pascals) is reported to produce an atheroprotective 
endothelial phenotype that renders the endothelium less susceptible to pathogenic stimuli [33]. 
Deleterious flow modifications resulting in low wall-shear stress in an artery (< 0.4 Pa) are both pro-
atherogenic and a focus for intimal hyperplasia [34], [35]. It has been shown that endovascular 
stenting not only physically damages the endothelium but also disturbs blood flow, creating regions 
of low wall shear stress leading to endothelial activation and initiation and progression of intimal 
hyperplasia [36]. The stimulation of endothelial cells by arterial wall shear stress therefore plays a 
central role in the restenotic process. Any tendency for a stent in the distal part of the long SFA to 
Figure 1: Forces on the 
femoropopliteal artery during 
lower limb movement 

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straighten natural vessel geometry in this longest of arteries may jeopardize protective swirling blood 
flow imparted by the helically curved common iliac arteries [data on file]. In summary, the design 
hypothesis for Veryan’s BioMimics 3D stent is that by imparting 3D geometry to the vessel it will help 
to maintain normal physiological swirling flow and normal wall shear stress levels and, in conjunction 
with improved biomechanical performance, there is the prospect of improved outcomes. 
1.3 
Novel Technology  
The BioMimics 3D stent (see Figure 2) is a permanently implanted, self-
expanding Nitinol stent designed to maintain luminal patency in the 
endovascular treatment of patients with symptomatic peripheral arterial 
disease of the superficial femoral and/or popliteal (femoropopliteal) arteries.  
The design of the BioMimics 3D stent is built on the principles underlying the 
latest generation of Nitinol stent technology for use in the femoropopliteal 
artery: an appropriate level of mechanical radial support and plaque coverage; 
good flexibility; durability against fracture; clear visualization and delivery 
accuracy. However, the BioMimics 3D stent has unique 3D helical geometry 
permanently imposed on the laser-cut Nitinol stent through a shape-setting 
heat treatment process during manufacture. Specific pitch and amplitudes are 
set in the stent according to stent diameter. 
Patterns of short and long 
connectors between the 
crowns 
respectively 
support the stent’s 3D 
helical 
geometry 
and 
flexibility. BioMimics 3D 
stents 
also 
feature 
a 
transition zone within the 
last three crowns at each 
end of the stent (see Figure 3). Each of these transition zone crowns are increased in length, which 
slightly reduces the outward radial force of the end of the stent on the vessel, to avoid flow 
disturbance that might arise from a step-change between stent and vessel. 
The stent ends are also formed to be collinear with the vessel to ensure 
good apposition and optimal blood flow into and from the BioMimics 3D 
stent. 
During a standard percutaneous procedure where the leg is extended, the 
femoropopliteal artery is in tension [37]. The implanted BioMimics 3D 
stent is delivered using a 6F over-the-wire delivery system and is deployed 
using a standard pin-and-pull technique (see Instructions for Use). After 
deployment, the stent may appear straightened (with respect to its 
unconstrained shape) with gentle curvature evident on fluoroscopy or X-
ray (see Figure 4), indicating its adaptation to the anatomy of the native 
vessel. As the knee is bent, tension on the femoropopliteal artery is eased         
and the stent is axially compressed. Under this compression, the stent 
physically assumes the 3D geometry inherent in the Nitinol shape memory 
and the stent centerline curvature increases. 
1.4 
Report of Prior Investigations 
Refer to the Investigator’s Brochure for a detailed description of the pre-clinical (bench, animal and 
cadaver) testing performed with the BioMimics 3D Stent and Stent Delivery System and full details on 
Figure 4: X-ray image of 
implanted BioMimics 3D 
Stent 
Figure 2: BioMimics 
3D Stent 
Figure 3: Collinear transition zones and 3D helical centerline 

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the Mimics clinical study. Summary details on the Mimics clinical investigation are provided in 
Section1.5. 
1.5 
Results from Prior Clinical Investigation: Mimics Study 
1.5.1 
Clinical Investigation Title 
“BioMimics 3D Stent Clinical Investigation: The Mimics Study” 
1.5.2 
Introduction 
Veryan developed the BioMimics 3D Stent System for use in the endovascular treatment of patients 
with de novo or restenotic, obstructive or occlusive disease of the femoropopliteal artery.  
Based on preclinical studies, including a cadaveric study, that demonstrated the BioMimics 3D stent 
could be placed with standard stent delivery technique, and that 3D geometry was safely imposed on 
the target arterial segment, Veryan conducted the Mimics study as the first clinical investigation of 
the BioMimics 3D Stent System to obtain safety and performance data in subjects representative of 
the intended patient population.  
1.5.3 
Purpose of the Clinical Investigation 
The Mimics study, conducted in accordance with ISO 14155:2003 and Good Clinical Practice (GCP) 
guidelines, was a prospective, multicenter, randomized (2:1 BioMimics 3D vs. Control stent), 
evaluation of safety and effectiveness in patients with symptomatic peripheral arterial disease 
undergoing femoropopliteal intervention. The comparator arm was enrolled specifically to provide a 
point of anatomical, mechanical and hemodynamic reference for analysis of exploratory outcomes 
including vascular curvature and swirling flow. 
The primary objective of the Mimics study was to provide data to support an application for approval 
to apply the CE Mark to the BioMimics 3D Stent System.  
• 
Safety at 30 days: with reference to the goal for femoropopliteal Nitinol stents that was 
published by VIVA Physicians in 2007 that has been widely adopted as the primary safety 
endpoint for clinical evaluation of Nitinol stents for femoropopliteal use[38]. The goal for 
safety in the Mimics study defined that 88% of subjects should be free from major adverse 
events through 30 days (MAE: defined in the Mimics study Protocol as death, amputation and 
target lesion revascularization). 
• 
Performance at 6 months: with reference to a goal pre-specified by Veryan on the results of 
a literature review and a quantitative risk analysis. The goal for clinical effectiveness in the 
Mimics study defined that 67% of subjects treated with BioMimics 3D should be free from 
clinically-driven target lesion revascularization (CDTLR) at 6 months. 
The Mimics study Protocol was subsequently amended, and subjects were re-consented, to enable 
the Phase 2 randomized populations to be followed, via assessments at 12 and 24 months to obtain 
information on the longer term clinical safety and effectiveness of the BioMimics 3D Stent System. 
1.5.4 
Description of the Clinical Investigation Population 
The eligible population for the Mimics study comprised patients with intermittent claudication 
(Rutherford Clinical Classification 1-4) due to a single occlusive or de novo and/or restenotic lesion of 
the femoropopliteal artery of ≥ 4.0 cm and ≤ 10.0 cm in length, treatable with a single stent. Patients 
with previous stenting of the superficial femoropopliteal, popliteal or tibial arteries of the target limb 
were ineligible for participation in the Study, as were those who had inadequate distal run-off from 
the target vessel to the lower leg.   

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1.5.5 
Clinical Investigation Methodology 
Professor Dr. Thomas Zeller, Chief Physician in the Dept. of Angiology at Universitäts-Herzzentrum 
Freiburg-Bad Krozingen in Bad Krozingen, Germany, was the Principal Investigator for the Mimics 
study. 
The Study comprised a Phase I lead-in registry of 10 subjects each treated with the BioMimics 3D Stent 
System, followed by a Phase 2 evaluation in which subjects were prospectively randomized on a 2:1 
basis to treatment with either BioMimics 3D Stent System or Control Stent System (LifeStent, CR Bard). 
A core lab (coreLab Bad Krozingen GmbH, Germany) provided blinded, independent analysis of 
imaging data from all subjects. Safety reporting was monitored by an independent physician and all 
adverse events potentially qualifying as Major Adverse Events per Protocol definition were clinically 
adjudicated. 
The Phase I lead-in registry of 10 subjects receiving treatment with the BioMimics 3D Stent System 
was enrolled at Prof. Zeller’s investigational site in Bad Krozingen. The Phase I registry was used to 
provide initial safety and performance assessment of the stent deployment procedure and to refine 
subject eligibility criteria and the follow-up assessment schedule for Phase 2.  
Enrollment into the randomized Phase 2 part of the Mimics study was initiated at the Bad Krozingen 
site and progressively expanded to a total of eight investigational sites in Germany. During the period 
30-Jun-2010 to 14-Mar-2012, 76 subjects were enrolled into Phase 2 using 2:1 randomization, to 
either BioMimics 3D Stent System or Control. Two subjects out of 26 randomized to receive the 
Control were treated with an alternative device due to LifeStent inventory issues. One subject received 
a Misago (Terumo) stent and a second subject received a Pulsar-18 (Biotronik) stent. In total, 61 
BioMimics 3D stents were placed in 60 subjects (Phase 1=10 subjects; Phase 2=50 subjects). One Phase 
2 subject who received a BioMimics 3D stent during the index procedure received a second stent 
(S.M.A.R.T.) due to incomplete target lesion coverage. 
The analyses reported in the following sections are on an intention-to-treat basis, according to the 
initial randomization. 
1.5.6 
Phase 2 Clinical Investigation Results 
Baseline 
Subjects (66% male) receiving BioMimics 3D stents were 68 ± 10 years old, 76% were smokers and 
26% had diabetes. No significant differences were noted in subject demographics between those 
treated with BioMimics 3D or Control. Clinical symptoms of ischemia were present in all subjects and 
76 % of BioMimics 3D subjects were Rutherford category 3 or greater. 
Index Procedure 
Table 1 presents the angiographic baseline data for BioMimics 3D and Control subjects reported by 
the independent core lab: 

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Table 1: Core lab reported baseline angiographic data for BioMimics 3D and Control 
 
BioMimics 3D 
Control 
P value 
Mean lesion length (mm; Range: Min – Max) 
65.8 (13.7 – 153.8) 
63.3 (7.6 – 115.8) 
0.715 
Mean vessel reference diameter (mm) 
4.7 
4.7 
1.0 
Mean pre-procedural stenosis (%; Range: Min – 
Max) 
84 (51 – 100) 
88 (53.6 – 100) 
0.329 
Mean stented segment length (mm; Range: 
Min – Max) 
101.1 (51.9 – 
162.3) 
87.8 (33.8 – 128.6) 
0.026 
Subjects with totally occluded lesions (%) 
44 
46 
1.0 
Subjects with moderately to severely calcified 
lesions (%) 
52 
57 
0.809 
Subjects with target lesions located in distal 
segment of SFA or popliteal artery (% of 
subjects) 
74 
69 
0.788 
 
The overall deployment success for 51 BioMimics 3D stents placed during the index procedure in 50 
subjects was 94.1% (48/51). Based on operator judgment at the conclusion of the index procedure, 
acute procedural success defined as the proportion of subjects with ≤30% diameter residual stenosis 
after revascularization with a BioMimics 3D stent, was 100% (51/51 stents placed). Independent Core 
Lab review of the index procedure angiograms confirmed ≤30% diameter residual stenosis in 44 out 
of 51 BioMimics 3D stent placements (86%) compared with 85% (22/26 subjects) for the Control 
(p=0.846). 
Follow-up at 30 days and 6 months 
In conjunction with an accredited Notified Body in the European Union, a pre-defined analysis of the 
safety and performance of BioMimics 3D Stent System was undertaken for CE Mark submission after 
the final 6 month assessment visit. This analysis, to provide data to support an application for CE Mark 
approval, was conducted according to the primary endpoints described in Section 1.5.3, after the last 
subject enrolled into the Mimics study (Phase 1 and 2) had completed 6 months’ follow-up.  
• 
Clinical safety at 30 days:  
Based on the independently reviewed analysis of all adverse events reported, all 60 subjects 
enrolled who were treated with the BioMimics 3D Stent System (10 subjects in Phase 1 and 
50 in Phase 2) remained free from MAE at 30 days (60/60; 100%). The primary safety endpoint 
in the Mimics Study was successfully achieved. 
• 
Clinical effectiveness at 6 months: 
At the interim analysis data cut-off for CE Marking application, 55 subjects (Phase I, 10 
subjects; Phase II, 45 subjects) who received BioMimics 3D stents had reached the 6-month 
follow-up milestone. All subjects were free from CDTLR at 6 months (55/55; 100%). The 
primary effectiveness endpoint in the Mimics Study was successfully achieved. 
Veryan’s application for CE Mark approval was approved in November 2012. 
Longer-term follow-up to 12 and 24 months 
Analyses at 12 and 24 months take account of all subjects in Phase 2 that re-consented for longer-
term follow-up – see Table 2.  

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Table 2: Summary of subject disposition in the randomized phase of the Mimics study (N=76) 
BioMimics 3D (N=50) 
Control (N=26) 
12-Month Assessment 
(N=44/44) 
Death (1); Withdrawn 
consent (3); Lost to 
follow-up (2) 
12-Month Assessment 
(N=24/25) 
Lost to follow-up (1); 
Missed 12-month visit 
(1) 
24-Month Assessment 
(N=41/41) 
Withdrawn consent (1); 
Did not re-consent to 
24-month follow-up (2) 
24-Month Assessment 
(N=22/22) 
Death (1); Withdrawn 
consent (1); Lost to 
follow-up (1) 
 
12-Month and 24-Month Safety 
The BioMimics 3D stent was well tolerated with no significant differences noted in the overall 
incidence of adverse events between the cohorts over the 24 month study period (107 events in 50 
subjects for BioMimics 3D vs. 77 events in 26 subjects for the Control) or in the type of adverse events 
reported. No stent fractures were observed in core lab review of X-ray imaging at any time point in 
either cohort. 
A summary of the incidence of clinically adjudicated Major Adverse Events occurring in the 12 and 24 
month follow-up windows is presented in Table 3. 
Table 3: Summary of adjudicated Major Adverse Events during Mimics study 
Clinical Events 
Adjudicated 
6-months 
12-months 
24-months 
Day 0 to 182 
Day 0 to 365 
Day 0 to study end 
BioMimics 3D 
Control 
P- 
value‡ 
BioMimics 3D 
Control 
P- 
value‡ 
BioMimics 3D 
Control 
P- 
value‡ 
N=49* 
N=26* 
N=47* 
N=26* 
N=44* 
N=23* 
Death 
0% 
(0/49) 
[0] 
0% 
(0/26) 
[0] 
 
1.0 
2.1% 
(1/47) 
[1] 
0% 
(0/26) 
[0] 
 
1.0 
4.5% 
(2/44) 
[2] 
4.3% 
(1/23) 
[1] 
 
1.0 
% (No. of subjects 
with events / N) 
[No. of events†] 
Amputation 
0% 
(0/49) 
[0] 
0% 
(0/26) 
[0] 
 
1.0 
0% 
(0/47) 
[0] 
0.0% 
(0/26) 
[0] 
 
1.0 
0.0% 
(0/44) 
[0] 
0.0% 
(0/23) 
[0] 
 
1.0 
% (No. of subjects 
with events / N) 
[No. of events†] 
CDTLR 
0% 
(0/49) 
[0] 
0% 
(0/26) 
[0] 
 
1.0 
8.5% 
(4/47) 
[4] 
7.7% 
(2/26) 
[2] 
 
1.0 
11.4% 
(5/44) 
[6] 
30.4% 
(7/23) 
[8] 
 
0.09 
% (No. of subjects 
with events / N) 
[No. of events†] 
Total MAE Rate 
0% 
(0/49) 
[0] 
0% 
(0/26) 
[0] 
 
1.0 
10.6% 
(5/47) 
[5] 
7.7% 
(2/26) 
[2] 
 
1.0 
15.9% 
(7/44) 
[8] 
34.8% 
(8/23) 
[9] 
 
0.12 
% (No. of subjects 
with events / N) 
[No. of events†] 
* Denominator is the number of subjects who completed a scheduled assessment visit at that time point PLUS those who were in the study 
on the last day of the follow-up window but without completing the assessment within the due time PLUS those subjects who had an adverse 
event in the time period shown but did not complete the assessment follow-up window. 
† This variable quantifies the total number events irrespective of the number of subjects affected. The number of subjects treated with a 
BioMimics 3D Stent who underwent CDTLR by the 24 month time point is 5 of 44, but one subject suffered two clinically-driven TLRs on Days 
289 and 450 post index procedure.   
‡ Fishers exact test used to detect differences between proportions 
Freedom from CDTLR in both the randomized Phase 2 cohorts was also evaluated by Kaplan Meier 
survival analysis (see Figure 5). The difference between the BioMimics 3D and Control arms’ Kaplan 
Meier estimates of freedom from CDTLR did not reach significance over the 24 month period (log rank 
test; p=0.135). However, between Day 365 and Day 730 the survival estimate for the BioMimics 3D 
cohort was maintained at 91% whereas this reduced from 92% to 76% in the Control arm during the 
same time interval. 

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Figure 5: Kaplan Meier survival estimate of freedom from CDTLR at 12 & 24 months 
12-Month and 24-Month Efficacy 
Loss of primary patency in the target lesion was evaluable through core-lab analyzed diagnostic duplex 
ultrasound imaging of the stented arterial segment or through the adjudicated occurrence of CDTLR, 
through 12 and 24 months of follow-up. Duplex ultrasound was acquired at 30 days, 6, 12 and 24 
months in the Mimics study. Loss of primary patency was deemed when peak systolic velocity ratio 
was > 2.0. Primary stent patency in the BioMimics 3D and Control cohorts is presented for both time 
points in Table 4 
Table 4: Primary stent patency for BioMimics 3D and Control 
 
12-Month Assessment 
24-Month Assessment 
 
Primary Patency % 
(No. Patent / No. Evaluable) 
P value* 
Primary Patency % 
(No. Patent / No. Evaluable) 
P value* 
BioMimics 3D 
75% (33/44) 
0.404 
72% (31/43) 
0.04 
Control 
72% (15/24) 
46% (11/24) 
*Fishers exact test used to detect differences between proportions 
 
Freedom from loss of primary patency was also evaluated by Kaplan Meier survival analysis. For this 
analysis the time to loss of patency was measured without reference to the timing of follow-up 
assessment visits. Figure 6 is a plot of the survival estimate for BioMimics 3D and Control groups 
through 24 month follow-up. The difference between groups achieves a significant level over the 24 
month period (log rank test; p=0.0497). 

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Figure 6: Kaplan Meier survival estimate of primary patency at 12 and 24 months 
A decrease by one or more Rutherford category from the baseline value is a measure of clinical 
improvement. The percentage of subjects that experienced a clinical improvement of one or more 
Rutherford category is summarized in Table 5. There was a sustained improvement of at least 1 
Rutherford category in 88% (36/41) of BioMimics 3D subjects and 86% (19/22) of Control subjects over 
the 24-month follow-up period. There were no statistical differences in Rutherford category 
performance between the randomized cohorts. 
Table 5: Patients experiencing an improvement in Rutherford category from baseline 
 
1 month 
6 months 
12 months 
24 months 
BioMimics 3D 
92% (44/48) 
87% (41/47) 
86% (38/44) 
88% (36/41) 
Control 
92% (23/25) 
75% (18/24) 
82% (18/24) 
86% (19/22) 
P-value* 
1.0 
0.315 
0.72 
1.0 
*Fishers exact test used to detect differences between proportions 
 
There was a sustained improvement in mean ABI throughout the 24-month follow-up period in both 
study cohorts. The mean ABI at baseline and 24 months for subjects treated with the BioMimics 3D 
stent was 0.58 ± 0.24 and 0.87 ± 0.19 respectively. The mean ABI at baseline and 24 months for 
subjects treated with the Control stent was 0.59 ± 0.17 and 0.94 ± 0.19 respectively. The difference 
between the groups at 24 months was not statistically significant.  
Exploratory outcomes 
Analysis of anterior/posterior and lateral view X-rays taken with knee flexed provided a basis from 
which to compute stent curvature in three dimensions for each subject in the BioMimics 3D and 
control cohorts. The introduction of these virtual stented segments into a computational fluid 
dynamics environment, together with duplex ultrasound velocity measurements, enabled predictions 
of blood flow patterns and resulting wall shear maps in the stented segment of each subject. 
 

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Computational fluid dynamic analysis3 predicted a statistically significant increase in swirling flow4 
being generated within the BioMimics 3D stented segments, than in Controls (1.57 x 10-5 m4s-2 (N=42) 
vs. 1.01 x 10-5 m4s-2 (N=23); p=0.017) and increased levels of averaged wall shear stress (1.13 Pa (N=42) 
vs. 1.06 Pa (N=23); p=0.054). 
1.5.7 
Conclusion 
The Mimics multicenter, randomized clinical trial has provided preliminary confirmation of the safety 
and effectiveness of the BioMimics 3D Stent System in subjects undergoing femoropopliteal 
intervention for treatment of symptomatic peripheral arterial disease. 
Performance goals defined for the primary study endpoints of safety (rate of freedom from MAE at 30 
days) and effectiveness (rate of freedom from CDTLR at 6 months) were both successfully achieved, 
leading to approval of Veryan’s CE Mark application. 
In analysis of data from the longer term follow-up of subjects to 24 months, a Kaplan Meier (KM) 
survival estimate indicates no change in the rate of CDTLR in subjects treated with BioMimics 3D 
between 12 and 24 months (9% at both time-points) whereas there was a three-fold increase (8% at 
12 months and 24% at 24 months) in the rate of CDTLR in subjects treated with the Control stent. 
Although this difference did not reach statistical significance (p=0.135), a statistically significant 
difference was observed between the two Study arms in the KM survival estimate of freedom from 
loss of primary patency in the target lesion through 24 months (log rank test; p=0.0497). 
 
 
                                                          
3 This CFD analysis is based on the assumptions that (i) blood acts as a Newtonian fluid, is steady and laminar; 
(ii) the stented vessel has constant circular cross-section; (iii) the stent strut pattern can be omitted from the 
analysis, and (iv) the inlet velocity for each case can be scaled off the peak systolic velocity proximal to the 
stented segment. 
4 Steady state adaptation of helical flow defined by Gallo et al.[39] 

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2.0 
DEVICE INDICATION FOR USE AND DEVICE DESCRIPTION 
2.1 
Intended Use 
The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-
novo obstructive or occlusive lesions up to 140 mm in length in native femoropopliteal arteries with 
reference vessel diameters ranging from 4.0 – 6.0 mm. 
2.2 
Device Description 
The BioMimics 3D Stent System consists of: 
• 
A Nitinol stent with a three dimensional (3D) helical profile in a range of lengths and diameters  
• 
An over-the-wire (OTW) stent delivery system. 
Stent 
The BioMimics 3D stent is a peripheral self-expanding nickel-titanium alloy (Nitinol) stent with 3D 
helical centerline geometry. The stent is laser cut from a straight Nitinol tube and 3D helical geometry 
is stored in the Nitinol shape memory. Three tantalum radiopaque markers are located at both ends 
of the stent. 
Stent Delivery System 
The BioMimics 3D stent is mounted on a 6F over-the-wire stent delivery system (SDS) for use with a 
0.035” guidewire. The SDS is shown in Figure 7 and consists of the inner shaft (8) and outer braided 
stainless steel sheath (9) secured together via the Tuohy Borst valve (3). The operating length of the 
SDS, comprising proximal (5), middle (6) and distal (7) sections, is 1128 ±8 mm. 
 
1. 
Luer Hub 
8. 
Inner Shaft 
2. 
Support Shaft 
9. 
Outer Braided Sheath 
3. 
Tuohy Borst Valve 
10. 
Inner Shaft Marker 
4. 
Bifurcated Luer 
11. 
BioMimics 3D Stent 
5. 
Proximal Section 
12. 
Inner Liner 
6. 
Middle Section 
13. 
Outer Sheath Marker 
7. 
Distal Section 
14. 
SDS Tip 
 
The inner shaft consists of a luer hub (1), bonded to a stainless steel support shaft (2) and inner shaft 
(8) assembly. A radiopaque inner shaft marker band (10) is located at the assembly distal end. An inner 
liner (12) runs the length of the device and is the lumen through which the guidewire passes. The 
radiopaque tip (14) is attached to the inner liner distal end. 
Figure 7: BioMimics 3D stent delivery system components 

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The outer sheath consists of a Tuohy Borst valve (3), bonded to the bifurcated luer (4) which attaches 
to the outer braided sheath (9). A radiopaque marker (13) is located at the distal end of the outer 
sheath. 
The stent (11) is crimped and loaded into the space between the inner shaft and the outer sheath at 
the distal end of the SDS immediately proximal to the radiopaque tip. 
Table 6 provides information on the dimensions of the BioMimics 3D stent and stent delivery system. 
Table 6: BioMimics 3D stent and delivery system size matrix 
Unconstrained 
Stent Internal 
Diameter 
(mm) 
Stent Length 
(mm) 
Minimum-
Maximum 
Reference 
Vessel 
Diameter 
(mm) 
Stent 
Delivery 
System 
Operating 
Length 
(cm) 
Stent 
Delivery 
System 
Outer 
Diameter 
Minimum 
Sheath 
Inner 
Diameter 
Guide Wire 
Compatibility 
5 
60, 80, 100, 125, 
150 
3.51 – 4.0 
 
0.079” 
0.088” 
0.035” 
6 
4.0 - 5.0 
112.8 
7 
5.0 - 6.0 
 
1Although the 5mm stent is indicated for vessels with a reference vessel diameter of 3.5 mm to 4.0mm, the Protocol only allows for reference 
vessel diameters 4.0 mm to 6.0mm for MIMICS-2 Study inclusion. 
 
2.3 
Device Preparation and Deployment Procedure 
The BioMimics 3D Stent will be prepared and deployed as described in the "Instructions for Use" that 
accompanies each device. The standard of care for subject preparation and follow-up, including 
medication and vascular access, will be followed according to the requirements of this Protocol and 
hospital / institutional standards of care. 
 

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3.0 
INVESTIGATIONAL PLAN 
3.1 
Study Objective 
The Primary Objective is to demonstrate that the BioMimics 3D Stent System meets the performance 
goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the 
treatment of symptomatic disease of the femoropopliteal artery. 
3.1.1 
Study Design 
Prospective, single arm, multi-center trial in which study subjects will receive treatment with Veryan’s 
BioMimics 3D Stent System. 
3.1.2 
Enrollment 
A total of 280 subjects will be enrolled into the MIMICS-2 Study to provide 230 subjects for evaluation 
at 12 months. This study will be conducted in up to 40 centers in the US and up to 13 centers in Europe 
and Japan. Up to 40% of total study population may be enrolled outside the US. A minimum of 30 
evaluable subjects is required in Japan for the 12 month assessment time point. No site may enroll 
more than 35 subjects. 
3.1.3 
Study Population  
Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery that comply with all 
study eligibility criteria. 
3.2 
Study Duration and Follow-Up 
The Study commenced enrollment in June, 2015. Enrollment was closed in October, 2016. Study 
subjects will be required to return for clinic visits post-procedure at Day 30 (± 7 days), Month 12 (365 
days ± 30 days), and Month 24 (730 days ± 60 days). A final study visit at Month 36 (1095 days ± 60 
days) is required as well; however, this visit may be completed either as a clinic visit or telephone visit. 
The 36 month visit is expected to be in the post-market surveillance phase of the study. All subjects 
will be followed with duplex ultrasound and X-ray evaluation according to the Schedule in Table 7. The 
last follow-up visit is expected to be completed by December, 2019, at the last subject’s 36 month 
follow-up visit. 
 
 

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4.0 
STUDY ENDPOINTS AND SUBJECT POPULATION 
4.1 
Primary Outcome Measures 
4.1.1 
Primary safety endpoint: 
The primary outcome measure for safety in the MIMICS-2 Study is a composite of major adverse 
events (MAE) comprising death, any major amputation performed on the index limb or CDTLR through 
30 days. The outcome will be compared to the safety performance goal of 88% for bare Nitinol stenting 
as defined by VIVA Physicians.  
4.1.2 
Primary effectiveness endpoint: 
The primary outcome measure for effectiveness in the MIMICS-2 Study is primary stent patency rate at 
12 months. Patency is defined as no significant reduction in luminal diameter (i.e., < 50% diameter 
stenosis) since the index procedure. Luminal diameter is the value determined by the independent core 
lab. Loss of primary stent patency is deemed when PSVR >2.0*, or where angiography reveals >50% 
diameter stenosis, or where the subject undergoes CDTLR. When both imaging modalities are available, 
angiography takes precedence. 
*In cases where PSVR cannot be determined, or where the independent core lab deems the PSVR as 
discrepant from correlating factors5, these correlating factors will be primarily considered in the 
determination of patency. 
  
                                                          
5 The core lab uses the following secondary criteria in the determination of patency:  
• 
Focal increase in the absolute PSV at the area of visible plaque 
• 
Spectral broadening of the waveform at the area of stenosis 
• 
Post-stenotic turbulence and/or change in the waveform shape and/or drop in velocity distal to the 
stenosis 
• 
Review of the B-mode images for plaque burden 

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4.2 
Secondary Outcome Measures 
1. 
Contribution of individual MAE rates for death, major amputation performed on the target limb 
and CDTLR to the overall MAE rate at 30 days. 
2. 
Long-term safety assessment – overall MAE rate at Month 12 and contribution of individual event 
rates to the overall MAE. 
3. 
Overall rate and incidence of type of serious adverse events from Day 0 through completion of 
Study follow-up at Month 36. 
4. 
Technical success reported by the core lab as the percentage of treated lesions in which a final 
result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure. 
5. 
Primary stent patency rate: determined at Months 12 and 24 using values of: PSVR >2.0; >2.4; 
>2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography 
reveals >50% diameter stenosis or where the subject undergoes CDTLR. When both imaging 
modalities are available, angiography takes precedence. 6 
6. 
Clinical outcome: comparison of Rutherford Clinical Category measured at Baseline, Day 30, 
Months 12 and 24. Worsening of Rutherford Clinical Category is defined as an increase by one or 
more categories compared to Baseline or unexpected major amputation of the target limb. 
7. 
Clinical outcome:  comparison of Six-Minute Walk Test measured at Baseline, Day 30, Months 12 
and 24 (sub-group of investigational sites). 
8. 
Functional outcome: comparison of the ankle brachial index (ABI) measurement at Baseline, 
within 30 days after index procedure, then at Months 12 and 24. 
9. 
Functional outcome: comparison of the Walking Impairment Questionnaire at Baseline, within 
30 days after index procedure, then at Months 12 and 24. 
10. Stent integrity measured as freedom from stent fracture, defined as clear interruption of a stent 
strut observed in a minimum of two projections, determined by core lab examination of X-rays 
taken with the leg in extension at 12, 24 and 36 Months. 
4.3 
Exploratory Outcomes 
1. 
Presence and quantification of swirling blood flow in the stented segment (using computational 
fluid dynamic modeling of duplex ultrasound data and bent knee X-ray measurements) taken at 
12 Months (sub-group of US investigational sites only). 
4.4 
Eligibility Criteria  
Subjects are required to meet ALL the following criteria in order to be included in this clinical trial: 
4.4.1 
Inclusion Criteria 
1. 
Subject is male or female, with age >18 and ≤85 years at date of enrollment. 
2. 
Subject or authorized representative provides written informed consent before any study-
specific investigations or procedures. 
3. 
Subject is willing to undergo all follow-up assessments according to the specified schedule over 
36 months. 
4. 
Subject is a suitable candidate for angiography and endovascular intervention and, if required, 
is eligible for standard surgical repair. 
5. 
Subject has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring 
intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery. 
6. 
Subject has PAD classified as Rutherford clinical category 2, 3 or 4. 
7. 
Subject has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 
after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to 
                                                          
6 In cases where PSVR cannot be determined, or where the independent core lab deems the PSVR as discrepant 
from correlating factors, these correlating factors will be primarily considered in the determination of patency. 

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reliably assess ABI. TBI must be <0.70; or (ii) Normal ABI with angiographic or ultrasound 
evidence of ≥60% diameter stenosis. 
4.4.2 
Angiographic Inclusion Criteria: 
8. 
Subject has single or multiple stenotic or occlusive lesions within the native femoropopliteal 
artery (“target lesions”) that can be crossed successfully with a guidewire and fully dilated. 
(Note: multiple target lesions must be treated as a single lesion.) 
9. 
Single or multiple target lesions must be covered by a single stent or two overlapping stents. In 
the case of tandem lesions, the gap between lesions must be ≤ 3 cm. 
10. 
Target lesion(s) eligible for treatment under the Protocol are at least 1 cm distal to the origin of 
the deep femoral artery and at least 3 cm above the bottom of the femur.  
11. 
Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm by operator’s visual 
estimate. 
12. 
Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% 
diameter stenosis by operator’s visual estimate.   
13. 
Subject has a patent popliteal artery (no stenosis ≥50%) distal to the treated segment.  
14. 
Subject has at least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle. 
4.4.3 
Exclusion Criteria: 
1. 
Subject is unable or is unwilling to comply with the procedural requirements of the study 
Protocol or will have difficulty in complying with the requirements for attending follow-up visits. 
2. 
Subject has comorbidity that in the investigator’s opinion would limit life expectancy to less 
than 36 months. 
3. 
Subject has iliac stent in target leg that has required re-intervention within 12 months prior to 
index. 
4. 
Subject has any planned major surgical procedure (including any amputation of the target leg) 
within 30 days after the index procedure for this Study. 
5. 
Subject has a target vessel that has been treated with any type of surgical or endovascular 
procedure prior to enrollment. 
6. 
Subject has a target vessel that has been treated with bypass surgery. 
7. 
Subject has PAD classified as Rutherford clinical category 0, 1, 5 or 6.  
8. 
Subject has known or suspected active systemic infection at the time of enrollment. 
9. 
Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet 
count less than 100,000/microliter or INR > 1.8. 
10. 
Subject has a stroke diagnosis within 3 months prior to enrollment. 
11. 
Subject has history of unstable angina or myocardial infarction within 60 days prior to 
enrollment. 
12. 
Subject has a contraindication to antiplatelet, anticoagulant, or thrombolytic therapies. 
13. 
Subject has known allergy to contrast agents or medications used to perform endovascular 
intervention that cannot be adequately pre-medicated. 
14. 
Subject has known allergy to titanium, nickel or tantalum. 
15. 
Subject has received thrombolysis within 72 hours prior to the index procedure.  
16. 
Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 
mg/dL or >220 umol/L), or on peritoneal or hemodialysis.  
17. 
Subject requiring coronary intervention within 7 days prior to enrollment. 
18. 
Subject is pregnant or breast-feeding. 
19. 
Subject is participating in another research study involving an investigational product 
(pharmaceutical, biologic, or medical device). 
20. 
Subject has other medical, social or psychological problems that, in the opinion of the 
investigator, preclude them from receiving this treatment, and the procedures and evaluations 
pre- and post-treatment. 

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4.4.4 
Angiographic Exclusion Criteria: 
21. 
Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been 
successfully treated at the time of the index procedure (success measured as ≤30% residual 
stenosis, without complication). 
22. 
Subject has a lesion in the contralateral limb requiring intervention during index procedure or 
within next 30 days. 
23. 
Subject has no patent (≥50% stenosis) outflow vessel providing run-off to the ankle. 
24. 
There is a lack of full expansion in the predilatation balloon. 
25. 
Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon 
angioplasty alone, prior to placement of the study stent. 
26. 
Evidence of aneurysm or acute thrombus in target vessel. 
 
 
 

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5.0 
STUDY SCREENING AND ENROLLMENT 
5.1 
Subject Screening 
All patients presenting to the institution with known superficial femoral and 
proximal popliteal artery disease requiring an interventional procedure shall be 
evaluated for eligibility and participation in the study. Target Lesion(s) are at 
least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above 
the bottom end of the femur – see Figure 8. A member of the research team 
shall perform a preliminary evaluation of the potential subject’s medical history 
and previously performed examinations to assess for initial eligibility. If the 
patient is willing to participate in the study, a written consent will be obtained. 
No study-specific requirements will be performed prior to obtaining informed 
consent.  
5.2 
Informed Consent 
Written Informed Consent with the Institutional Review Board (IRB) or Ethics 
Committee (EC) approved consent form will be obtained for all subjects prior 
to any study-specific screening/baseline tests or procedures being performed. 
This does not include those procedures or tests that are obtained in the normal 
course of the patient’s non-study related care and prior to undergoing the 
study procedure. The patient shall be given adequate time to read the informed consent form, have 
the study procedures explained, including the risks, benefits and follow-up requirements prior to 
signing the Informed Consent documents. All subjects providing informed consent are to receive 
copies of their signed informed consent documentation. The consent process may be obtained up to 
14 days prior to index / treatment procedure. 
5.3 
Subject Enrollment 
All patients requiring angioplasty due to reasons detailed in this Protocol are potential study 
candidates and shall be screened for eligibility. Every effort will be made to ensure eligibility prior to 
enrollment. According to ISO 14155:2011, enrollment in the study occurs at the time of informed 
consent; however, for the purposes of this study, only subjects who are consented and meet all the 
study inclusion criteria and none of the study exclusion criteria and are treated or treatment is 
attempted with the study device will be considered enrolled into the study. Therefore, the enrollment 
date (Day 0) will be the date of the study index procedure; the enrollment date will not be the date of 
informed consent for this study. Subjects who do not meet all inclusion and exclusion criteria (e.g., 
including: (i) operator is unable to successfully cross the target lesion with a guidewire or successfully 
dilate the lesion; (ii) either target reference vessel diameter or target lesion length are outside the 
eligible parameters; (iii) lack of patent popliteal and tibioperoneal arteries in the target limb, etc.) will 
be considered an angiographic screen failure and will not be followed in the study (no data will be 
collected on these subjects). Subjects in whom the BioMimics 3D Stent System is inserted into the 
vasculature and the treatment of the target lesion is attempted, but the procedure is aborted without 
delivery of a stent, will be followed for 30 days after the attempted index procedure. At the 30-day 
follow-up visit, these subjects will be assessed for safety only and the subject will be allowed to exit 
the study. No additional study required assessments shall be collected. 
Subjects who are enrolled and treated, but who are later discovered to not meet all of the study 
criteria will remain in the study and complete all of the study testing and follow-up requirements. A 
Protocol Deviation will be completed for study subjects who are found to be ineligible after 
enrollment. 
Figure 8: Location of 
eligible target lesions 

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5.4 
Subject Withdrawal 
Subjects may withdraw at any time from the clinical trial without jeopardy or prejudice. If a subject 
prematurely terminates from the study, the reason for study termination will be recorded and the 
results will be tabulated by number and percent for each category. If termination is a result of an 
adverse event or death, an Adverse Event Form will also be completed. Subjects who withdraw 
consent after treatment will have their data evaluated until the time of their withdrawal. 
The Investigator should follow all unresolved serious adverse events until the events are resolved, the 
subject is lost to follow-up, the subject has withdrawn consent, the subject completes the study, or 
the adverse event is otherwise explained. 
All reasonable efforts will be made to obtain complete data for all subjects; however, missing 
observations will occur due to loss to follow-up, withdrawal, or non-adherence with required 
assessments. Three attempts shall be made to contact subjects who do not return for study follow-up 
visits. The final attempt shall include a certified letter to the subject regarding study participation. If 
these subjects cannot be located, they will be considered lost to follow-up. If they are contacted but 
refuse to return for visits, they will be considered withdrawals. If they actively request to withdraw 
from the study, they will be considered withdrawals. Subjects shall be encouraged to complete a final 
study exit visit at the time of withdrawal to assess for safety. Data collected up to the time of loss to 
follow-up or withdrawal will be maintained in the study database and used for analysis purposes, as 
appropriate. These subjects will not be replaced. 
5.5 
Anticipated Total Enrollment 
Two hundred eighty (280) subjects will be enrolled, anticipating 230 subjects evaluable at 12 month 
assessment time point. Up to 40% of total study population may be enrolled outside the United States. 
A minimum of 30 evaluable subjects is required in Japan for the 12 month assessment time point. No 
site may enroll more than 35 subjects. 
 
 

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6.0 
STUDY PROCEDURES 
6.1 
Visit Schedule 
Study participation will last for a total of 36 months (± 60 days). Subjects will be enrolled in the acute 
phase of the study. Study visits and data collection during the acute phase will be completed at index 
hospitalization, 30 days (± 7 days), and 12 months (365 days ± 30 days). A long-term follow-up visit 
will be performed at 24 months (730 days ± 60 days). A final post-market surveillance follow-up visit 
will be performed at 36-months (1095 days ± 60 days). 
A summary schedule of the required study tests and evaluations is in Table 7. 
 
 
 
 

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Table 7: MIMICS-2 study schedule 
Assessment 
Baseline1 
Day 0 
Index 
Procedure 
(Enrollment /  
Treatment) 
Day 30 
(± 7 days) 
Month 12 
(365 days 
± 30 days) 
Month 24 
(730 days 
± 60 days) 
Month 36 
(1095 days 
± 60 days)8 
Informed Consent 
X2 
 
 
 
 
 
Medical History / 
Physical Exam3 
X 
 
X 
X 
X 
 
Laboratory 
Assessments: 
Creatinine, platelets 
X 
 
 
 
 
 
Coagulation Studies: 
PT/ INR4 
X 
 
 
 
 
 
Urine pregnancy test if 
female5 
X 
 
 
 
 
 
Ankle Brachial Index 
(ABI) [or Toe Brachial 
Index (TBI), if indicated] 
X 
 
X 
X 
X 
 
Rutherford Clinical 
Category (RCC) 
X 
 
X 
X 
X 
 
Walking Impairment 
Questionnaire (WIQ)10 
X 
 
X 
X 
X 
 
Six-Minute Walk Test 
(6MWT) (subgroup 
only) 
X 
 
X 
X 
X 
 
Index Angiogram / 
Stent Deployment 
 
X 
 
 
 
 
Medications:  Aspirin / 
Clopidogrel6 
 
X 
X6 
X6 
X6 
X6 
Duplex scan 
 
X7 
X 
X 
X7 
X-rays of treatment 
area 
 
 
 
X 
X 
X9 
Adverse Event 
Assessment 
X 
X 
X 
X 
X 
X 
1 Standard of care evaluations may be done up to 30 days before the procedure. Protocol-specific exams that are non-
standard of care cannot be obtained until after informed consent. 
2  Consent to be obtained within 14 days prior to enrollment. 
3  Medical History is required at baseline only. Refer to applicable Protocol section for physical exam requirements. 
4  PT/INR to be obtained only if subject is on chronic warfarin therapy. 
5  Negative pregnancy test within 14 days of enrollment for women of childbearing potential. 
6 Dual anti-platelet therapy is required through 30 days and then continued per physician / institutional standards of care. 
Aspirin therapy is to be continued indefinitely. 
7 Post-procedure duplex ultrasound will be obtained post-procedure through Day 30 (+7 days). Duplex ultrasound at 36 
months only if clinical signs or symptoms are present suggestive of worsening claudication. 
8  36-Month surveillance visit may be completed via clinic or telephone visit. 
9 The requirement for X-ray imaging may be fulfilled at a facility remote to the investigational site. 
10 WIQ may be obtained 30 days prior to index procedure through the peri-procedural period (e.g., within 24 hours of index 
procedure.) 
 

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6.2 
Baseline 
The following examinations and tests will be performed. For those study procedures that are not 
considered standard of care (performed only for study participation), they will be performed after the 
subject signs the informed consent form in order to meet all inclusion and no exclusion criteria. These 
examinations and tests will be used both to screen eligible subjects and provide baseline information 
for those subjects that meet study eligibility criteria. 
All tests must be completed within the 30 days prior to undergoing the index / study procedure, except 
for the urine pregnancy test which must be completed within 14 days of the procedure. 
• 
Demographic information and medical history including risk factors  
• 
Physical examination  
o Height and weight 
o Ankle Brachial Index (ABI) or Toe Brachial Index (TBI) 
o Rutherford Clinical Category 
o Target review of symptoms, including distal pulse assessment on the target limb 
• 
Walking Impairment Questionnaire (may be obtained 30 days prior to index procedure 
through the peri-procedural period, e.g., within 24 hours of index procedure) 
• 
Six-Minute Walk Test (subgroup of US investigational sites only) 
• 
Laboratory Assessments:   
o Platelets and creatinine 
o Coagulation profile: PT & INR if subject on chronic warfarin therapy 
o Urine pregnancy test if female of child-bearing age (within 14 days of procedure) 
6.3 
Medications 
Table 8 provides a summary of the Study required medications, dosage and timing: 
Table 8: Summary of Protocol-required medications for MIMICS-2 Study 
Medication 
Peri-Procedure 
(± 24 hours of Index Procedure) 
Intra-Procedure 
Post-Procedure 
Aspirin 
Minimum loading dose of 75 mg 
required, if not on chronic aspirin 
therapy 
N/A 
A minimum of 75 mg per day 
indefinitely 
Clopidogrel 
(or similar 
antiplatelet 
agent) 
Minimum loading dose of 300 
mg required, if not on chronic 
clopidogrel therapy 
N/A 
Clopidogrel 75 mg per day for 
a minimum of 30 days (or per 
prescribing dose if other 
similar antiplatelet agent) 
Heparin / 
Bivalirudin 
N/A 
Maintain anticoagulation 
per hospital / institution 
standard of care 
N/A 
6.4 
Index Procedure 
At the index procedure, a radiopaque ruler is to be placed directly on the subject’s leg under the sterile 
drapes. The end of the ruler is placed at the tibial tubercle. The ruler will serve as a location marker 
for the target lesion(s) being treated at both the index procedure and as a reference point for follow-
up examinations, including follow-up duplex evaluations. All other measurements are referenced back 
to this angiographic measurement. 
Angiography for final anatomic eligibility will be obtained at time of index procedure prior to opening 
the stent package and inserting into the vasculature. The baseline index procedure angiogram is to be 
performed as per guidelines established by the core lab. 

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Reminder: Subjects that do not meet the angiographic eligibility criteria will be documented as an 
angiographic screen failure and will not be considered enrolled into the study; no data collection will 
be obtained on these subjects. Only subjects that meet eligibility criteria will be enrolled into the study 
and will undergo stent placement. All consented, screen failed, and enrolled and treated subjects will 
be recorded on the Screening & Enrollment Log. 
6.4.1 
Pretreatment of Lesion / Vessel  
The Target Lesion must be successfully crossed and fully pre-dilated with standard percutaneous 
transluminal balloon angioplasty. This Protocol does not allow for direct stenting. In general, a gentle 
pre-dilatation with a fully-expanded balloon catheter that is the same size as the reference vessel 
diameter (RVD) (i.e., 1:1 balloon to artery ratio) is required. Pre-treatment therapies other than PTA 
(such as, but not limited to, drug-eluting balloon therapy, directional atherectomy, excimer laser, 
rotational atherectomy, etc.) are not permitted in this trial. 
6.4.2 
Implant Procedure 
Refer to the Instructions for Use (IFU) for a description of the implant procedure. Additional data 
captured during the procedure include, but may not be limited to: 
• 
Baseline angiographic criteria assessment, i.e., inflow disease, outflow disease, patent tibial, 
etc. 
• 
Location of stent placement using angiographic radiopaque ruler during index procedure 
• 
Assessment of post-stent implantation lumen patency via angiogram at the conclusion of the 
index procedure (percent angiographic stenosis and angiographic patency of ≤50% stenosis at 
target site) 
• 
Evaluation of total procedure time 
• 
Determination of blood loss and replacement 
• 
Identification of technical difficulties 
• 
Adverse event observation, evaluation, and treatment 
• 
At the conclusion of the index procedure, an angiographic cine showing the stent with 
reproducible landmarks for follow-up evaluation and assessment. In addition, a final distal 
run-off cine to the ankle shall be performed (per Angiographic Core Lab Protocol) to assess for 
procedural- and/or device-related complications. 
6.4.3 
Stenting  
The stenting procedure should be performed according to the Instructions for Use. Lesion length per 
inclusion criteria is between 40 mm and 140 mm. This can be a single lesion or multiple tandem 
lesions; however, the total lesion length may not exceed 140mm. No more than two (2) study stents 
may be used to treat the lesion(s) as stated in the inclusion and exclusion criteria. If the total lesion 
length is less than or equal to 140 mm, then a single primary study stent should be used (maximum 
stent length is 150 mm).  
6.4.4 
Additional Stenting / Bailout Procedures  
If the first BioMimics 3D stent does not cover the entire lesion and an additional stent is needed (e.g., 
due to lesion length, geographic miss, inaccurate visual assessment of lesion length), a second 
BioMimics 3D stent of appropriate size and length must be used to cover the lesion. No other 
investigational or commercially available stents may be used. Overlapping of stents should be limited 
to no greater than 10 mm. 
If a study subject experiences a major edge dissection or an occlusive complication manifested as 
decreased target vessel flow or ischemic changes which do not respond to repeat balloon inflations, 
intra-arterial vasodilators (nitroglycerin, verapamil) or fibrinolytic agents, the investigator shall 

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perform a prolonged balloon inflation of at least 3 minutes. If the additional prolonged balloon 
inflation is not successful in treating the complication and an additional stent is warranted (bail-out 
stent), a BioMimics 3D stent of appropriate size and length should be used. No other investigational 
or commercially available stents may be used. Overlapping of stents should be limited to no greater 
than 10mm. 
6.4.5 
Post-Treatment of Lesion / Vessel 
The target lesion must be post-dilated with standard percutaneous transluminal balloon angioplasty. 
In general, a post-dilatation ratio of 1:1 between the balloon and the reference vessel diameter is 
required. Caution should be employed to ensure post-dilatation is accomplished within the stented 
region to minimize tissue injury outside of the stent margins. 
6.5 
Day 30 Follow-Up 
The following evaluations will be scheduled for Day 30 (± 7 days) post procedure: 
• 
Physical examination 
 
o Rutherford Clinical Category 
o ABI or TBI  
o Target review of symptoms, including distal pulse assessment on the target limb 
• 
Walking Impairment Questionnaire 
• 
Six-Minute Walk Test (subgroup of US investigational sites only) 
• 
Duplex ultrasound (may be performed anytime following the index procedure through the 
Day 30 visit) 
• 
Adverse event assessment 
6.6 
Month 12 Follow-Up 
The following evaluations will be scheduled for Month 12 (365 days ± 30 days) post procedure: 
• 
Physical examination 
o Rutherford Clinical Category 
o ABI or TBI 
o Target review of symptoms, including distal pulse assessment on the target limb 
• 
Walking Impairment Questionnaire 
• 
Six-Minute Walk Test (subgroup of investigational sites only) 
• 
Duplex ultrasound 
• 
X-rays of the target limb in extension (those US sub-study sites participating in the Exploratory 
Outcome study into swirling flow will also conduct bent-knee X-ray imaging) 
• 
Adverse event assessment 
6.7 
Month 24 Follow-Up (Long-Term Follow-Up Phase of the Study) 
The following evaluations will be scheduled for Month 24 (730 days ± 60 days) post procedure: 
• 
Physical examination 
o Rutherford Clinical Category 
o ABI or TBI 
o Target review of symptoms, including distal pulse assessment on the target limb 
• 
Walking Impairment Questionnaire 
• 
Six-Minute Walk Test (subgroup of investigational sites only) 
• 
Duplex ultrasound  
• 
X-rays of the target limb in extension 
• 
Adverse event assessment 

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6.8 
Month 36 Follow-up (Post-Market Surveillance Phase of the Study) 
This visit may be conducted as a telephone or clinic visit as long as the subject is able to obtain the 
final follow-up X-rays per the study requirements. The final X-ray imaging may be fulfilled at a facility 
remote to the investigational site as long as the study and core lab instructions and requirements are 
followed. The following evaluations will be scheduled for Month 36 (1095 days ± 60 days) post 
procedure: 
• 
X-rays of the target limb in extension 
• 
Duplex ultrasound (required only if clinical signs or symptoms are present suggestive of 
worsening claudication) 
• 
Adverse event assessment 
 

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7.0 
ADVERSE EVENTS  
All adverse events will be recorded and documented throughout the 12-month visit. Following the 12-
month visit, only major adverse events (MAE), serious adverse events (SAE), revascularizations in 
target leg, and unanticipated adverse device effects (UADE) will be recorded and documented through 
the 36-month follow-up visit.   
The Investigator at each participating center is ultimately responsible for reporting adverse events to 
the Sponsor. The adverse event electronic case report form (eCRF) provides a venue for the 
Investigator to record any adverse event data. The Investigator should follow all unresolved serious 
adverse events until the events are resolved, the subject is lost to follow-up, the subject has 
withdrawn consent, the subject completes the study, or the adverse event is otherwise explained.   
The Sponsor shall review all adverse events for their relationship to the study device(s) and/or 
procedures and comparative anticipated safety event rates. The Sponsor will conduct evaluations of 
any unanticipated device-related event per standard operating procedures.   
7.1 
Adverse Event 
For the purposes of this study, an adverse event (AE) is any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational 
device or procedure. In addition, the definition of AE applies to any event with an onset during 
enrollment / index procedure or to any underlying diseases, present at baseline, that exacerbate in 
severity post study procedure. Therefore, an underlying disease that was present at the time of 
enrollment is not reported as an AE, but any increase in the severity of the underlying disease is to be 
reported as an AE. This definition includes events occurring during the follow-up period. 
All reported AEs through 12 months must be recorded in the electronic database. Following the 12 
month visit, only SAEs, MAEs, revascularizations in target leg, and UADEs will be recorded in the 
electronic database. A description of the event, including the start date, resolution date, action taken, 
and the outcome should be provided, along with the Investigator’s assessment of the relationship 
between the AE, the study device and the study procedure. 
The following definitions for rating severity of adverse events will be used: 
Mild: 
Awareness of signs or symptoms, but easily tolerated; are of minor irritant type; causing 
no loss of time from normal activities; symptoms would not require medication or a 
medical evaluation; signs or symptoms are transient. 
Moderate: 
Interferes with the subject’s usual activity and/or requires symptomatic treatment. 
Severe: 
Symptom(s) causing severe discomfort and significant impact of the subject’s usual 
activity and requires treatment. 
Adverse Device Effect (ADE) / Device-Related Adverse Event: an adverse device effect (or device-
related adverse event) is defined as any untoward adverse effect when, in the judgment of the 
Investigator, the clinical event has a reasonable time sequence associated with use of the 
investigational device and is unlikely to be attributed to concurrent disease or other procedures or 
medications. It is reasonable to believe that the device directly caused or contributed to the adverse 
event. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
Instructions for Use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.  
NOTE 2: This definition includes any event resulting from user error or from intentional misuse 
of the investigational medical device. 

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Major Adverse Vascular Event (MAVE):  a major adverse vascular event is an adverse event that could 
possibly be procedure- or device-related. MAVE is defined as the following: 
• 
Abrupt occlusion 
• 
Access site complication requiring surgery or transfusion 
• 
Arterial perforation or rupture 
• 
Dissection (Grade C or greater) in target vessel requiring intervention 
• 
Embolization, distal 
• 
Limb ischemia 
• 
Necrosis, target limb 
• 
Pseudoaneurysm, access site 
• 
Pseudoaneurysm, target limb 
• 
Restenosis, target lesion 
• 
Restenosis, target vessel 
• 
Thrombosis 
Procedure-Related Adverse Event: an adverse event is considered to be procedure-related when, in 
the judgment of the Investigator, it is reasonable to believe that the event is associated with the 
assigned study procedure and is not specific to the investigational device (i.e., BioMimics 3D Stent 
System) used. Other products, surgical techniques, or medications required specifically for the 
procedure are likely to have contributed to the occurrence of the event. 
Concomitant Medication-Related Adverse Event: an adverse event is considered to be concomitant 
medication-related when, in the judgment of the Investigator, it is reasonable to believe that the event 
is associated with concomitant medications used in conjunction with the investigational device and is 
not otherwise specific to the investigational device (e.g., bleeding associated with anticoagulation 
medication). 
Pre-Existing Condition-Related Adverse Event: an adverse event is considered to be related to a pre-
existing condition when, in the judgment of the Investigator, it is reasonable to believe that the event 
is associated with the subject’s pre-existing condition and is not specific to the investigational device 
or procedure. Pre-existing conditions that are aggravated or become more severe during or after the 
procedure should be evaluated on a case-by-case basis to determine if the event may be more 
appropriately classified as device-related or procedure-related. 
Unanticipated Adverse Device Effect (UADE): any serious adverse effect on health or safety, any life-
threatening problem or death caused by, or associated with a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the application; or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects. 
Veryan or its designee, in cooperation with the Investigator, will assess all adverse events considered 
to be device-related for potential reportability to the FDA and other regulatory authorities (as 
applicable) as an UADE. 
Events Not Considered Adverse Events 
For purposes of this study, the following events are not considered adverse events, because they are 
normally expected to occur in conjunction with endovascular procedures / post-procedure, or are 
associated with customary, standard care of subjects undergoing these procedures: 
• 
Early post-operative pain (within 24 hours post-index procedure) at the access site and/or 
related to position on procedure table 
• 
Post-anesthesia/conscious sedation emesis, nausea, or headache (within  24  hours post-index 
procedure) 
• 
Chest pain without associated ECG changes 

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• 
Hematocrit decrease from baseline not associated with hemodynamic changes, remaining 
above 26% and not requiring transfusion 
• 
Electrolyte imbalance without clinical sequelae following endovascular procedure, even if 
requiring correction 
• 
Low grade temperature increase (≤38.3 °C/≤101 °F) 
• 
Sinus bradycardia/tachycardia that does not require treatment or intervention 
• 
Systolic or diastolic blood pressure changes that do not require treatment or intervention 
• 
Any pre-planned surgical procedures 
This listing of events is intended to provide guidance to the investigational sites for purposes of 
adverse event reporting. The Investigator at the investigational site should utilize his/her own clinical 
judgment in evaluating adverse experiences, and may decide that the above events should be 
reported as adverse events. 
7.2 
Serious Adverse Event (SAE) 
A serious adverse event is defined as an adverse event that: 
• 
Led to death,  
• 
Led to a serious deterioration in the health of the subject, that either resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization 
o medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function, or 
• 
Led to fetal distress, fetal death or a congenital abnormality or birth defect.  
All Serious Adverse Events will be reported throughout the study. 
NOTE: Planned hospitalization for a pre-existing condition or elective cosmetic procedures, or a 
procedure required by the investigational plan without serious deterioration in health, is not 
considered a serious adverse event. 
All SAEs must be reported to the IRB / EC in accordance with IRB / EC reporting requirements and 
institutional policies. The Investigator will note whether the adverse event was device-related or 
procedure-related and the severity of the event. All SAEs must be reported by the Investigator (or 
designee) to the Sponsor within 24 hours of knowledge of the event, or by the end of the next working 
day. 
7.3 
Major Adverse Event (MAE) 
For the purposes of this study, the definition of a major adverse event includes: 
• 
Death 
• 
Any major amputation performed on the target limb  
• 
Clinically-driven target lesion revascularization 
All MAEs and suspected MAEs must be reported by the Investigator (or designee) to the Sponsor 
within 24 hours of knowledge of the event, or by the end of the next working day, and will be reviewed 
by the Clinical Events Committee. Those events confirmed by adjudication as MAEs will comprise the 
composite safety endpoint for major device-related adverse events. 
7.4 
Adverse Event Reporting Requirements 
7.4.1 
General Reporting Requirements 
All serious and potentially device- and/or procedure-related adverse events must be recorded on the 
Adverse Event electronic CRF by the Investigator (or designee). The report should include: severity, 

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duration, action taken, treatment outcome and relationship of the adverse experience to the study 
device, procedure, concomitant medications, pre-existing condition, (i.e., unrelated, related or 
relationship unknown). 
In the case of serious adverse events, procedure- and /or device-related adverse events, and device 
malfunctions and failures, medical record documentation (e.g., procedure notes, operative notes, 
discharge summary, relevant progress notes, imaging, or lab studies) must be provided to the Sponsor 
or its designee. 
7.4.2 
Reporting Requirements for Serious and Major Adverse Events 
All serious and major adverse events must be reported by the Investigator (or designee) to the Sponsor 
within 24 hours of knowledge of the event or by the end of the next working day. This may be done 
via phone, fax, email or electronic data capture for the clinical database. 
The Investigator (or designee) shall send a written report including a narrative description of the 
serious or major adverse event to the Sponsor or their designee within five (5) working days of the 
initial report. This can also be in the form of the AE eCRF. 
Any serious or major adverse events and all deaths regardless of cause must also be reported to the 
IRB / EC per local IRB / EC requirements. It is the responsibility of the Investigator to inform their IRB 
/ EC of these serious adverse events as required by their IRB / EC procedures and in conformance with 
FDA and local regulatory requirements. In addition, the investigator shall provide documentation of 
the IRB / EC report to Veryan or its designee. 
All adverse events (AE) will be monitored from the time of enrollment through the 12-month 
assessment. SAEs, MAEs, revascularizations in target leg, and UADEs will be monitored from the time 
of enrollment through the follow-up period for this trial. A description of the event, including the start 
date, resolution (or date of final outcome assessment) date, action taken, and the outcome should be 
provided, along with the Investigator’s assessment of the relationship between the AE, SAE or MAE 
and the study treatment. Pain, neurological status and functional impairment should be considered 
AEs when a subject’s complaint for any of these symptoms is outside the normal pattern for the illness 
treated. 
All AEs should be followed until the event is resolved or judged to be chronically stable. The clinical 
site should plan to provide relevant AE follow-up information to the Sponsor upon request. 
The Sponsor or its designee will report all applicable serious adverse events as vigilance reports per 
MEDDEV 2.12.1, Rev 8 (2013) "Guidelines on a Medical Devices Vigilance System” and as clinical study 
reportable events per MEDDEV 2.7/3 “Clinical Investigations: Serious Adverse Event Reporting”.   The 
Sponsor will determine whether all of the local Investigators need to be informed immediately of an 
SAE or UADE, or whether this can be postponed until the next regularly scheduled study update. 
7.4.3 
Device Failures and Malfunctions 
All reported device observations / performance issues, malfunctions or failures of the Veryan 
BioMimics 3D stent are required to be documented in the eCRF. In the event of a suspected 
observation or device problem, the investigational device shall be returned to the Sponsor for analysis. 
Device failures and malfunctions should also be documented in the subject’s medical record. 
Instructions for returning the investigational device are included in the Manual of Operations 
Binder. 
NOTE: Device failures or malfunctions are NOT to be reported as adverse events. However, if there 
is an adverse event that results from a device failure or malfunction, that specific event would be 
recorded in the usual manner on the AE eCRF. 
 

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8.0 
RISK/BENEFIT ASSESSMENT 
8.1 
Risks to the Subject 
8.1.1 
Risk Analysis 
The BioMimics 3D Stent System or the MIMICS-2 Study treatment procedure may result in failures or 
complications similar to other peripheral stents with similar indications for use. Prior human use and 
preclinical studies of the BioMimics 3D Stent System have not shown any additional risks. Documented 
risks of peripheral stents and/or the treatment procedure include, but are not limited to (potential 
risks are listed in alphabetical order and not per risk level): 
• 
Access-site complications 
• 
Allergic reaction to contrast media / medications 
• 
Aneurysm 
• 
Arterial dissection 
• 
Arterial perforation 
• 
Arterial rupture 
• 
Arterial spasm 
• 
Arteriovenous fistula 
• 
Bleeding complications 
• 
Cardiac arrest 
• 
Cardiac arrhythmia  
• 
Death 
• 
Device embolization 
• 
Device malfunction 
• 
Embolism and/or arterial thrombosis 
• 
Emergency or non-emergency arterial bypass surgery 
• 
Extravasation of contrast media 
• 
Fracture of the guide wire or any component of the device that may or may not lead to device 
embolism, serious injury or surgical intervention 
• 
Gastrointestinal bleed 
• 
Hematoma 
• 
Hypotension 
• 
Infection or fever 
• 
Ischemia 
• 
Myocardial infarction or coronary ischemia 
• 
Neurological deficit 
• 
Placement of a bailout stent 
• 
Pseudoaneurysm 
• 
Radiation exposure 
• 
Reaction to contrast media / medication 
• 
Renal insufficiency or failure 
• 
Respiratory distress or failure 
• 
Restenosis of the treated segment 
• 
Serious injury requiring surgical intervention 
• 
Stent strut fracture(s) 
• 
Stroke or TIA 
• 
Thrombosis 
• 
Transfusion 
• 
Total occlusion of the peripheral artery 

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• 
Vascular complications which may require surgical repair (conversion to open surgery) 
• 
Worsening of peripheral arterial disease 
 
These risks are present in any endovascular treatment procedure for which the study subjects would 
be indicated because of their disease, and the subject’s physician will review these risks with the 
subject. Standard of care practice should be followed for preparing a subject for endovascular 
intervention, including medication and vascular access. 
8.1.2 
Risk Minimization 
As with any endovascular procedure, appropriate safety precautions will be followed. In addition, this 
Protocol provides additional steps to minimize risk to study subjects. These include the following: 
• 
Investigator Selection: The Investigators in this study are selected based on their 
experience in treating subjects with peripheral arterial disease (PAD) and performing 
peripheral endovascular treatment procedures, including stent placement and peripheral 
balloon angioplasty. 
• 
Investigator Training: Investigators will be trained in proper device operation prior to 
study start. Training will include didactic and hands-on training with the Veryan BioMimics 
3D Stent System (e.g., bench-top model). 
• 
Subject Screening: This Protocol includes appropriate precautions in subject selection. For 
example, subjects with known sensitivity to contrast or other agents used in the study 
with significant co-morbidities or uncontrolled cardiovascular or other disease will be 
excluded. 
Subjects with excessive tortuous vascular anatomy, known allergy to nickel, and/or unable to take 
standard medications used for interventional procedures (e.g., anticoagulants, contrast agents, and 
antiplatelet therapy) will be excluded from this Protocol per IFU Contraindications for Use. 
8.2 
Potential Benefits 
Prior human clinical experience in a population of 60 subjects has validated that the Veryan device 
can be used to safely and effectively stent the femoropopliteal arteries, resulting in acute and long 
term luminal patency. The MIMICS-2 trial is intended to evaluate the safety and effectiveness of the 
BioMimics 3D Stent System in a larger clinical population. 
 
 

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9.0 
STATISTICAL ANALYSIS PLAN 
9.1 
Analysis Populations  
• 
Intention-to-Treat (ITT) Analysis Set: includes all enrolled subjects. 
• 
Modified Intention-to-Treat (mITT) Analysis Set: includes all enrolled subjects in whom the 
BioMimics 3D Stent is implanted. Those subjects in whom the procedure is aborted without 
deployment (implantation) of a stent are excluded in this analysis set. This is the primary 
analysis set for the primary safety and effectiveness endpoints, as well as secondary and 
exploratory endpoints. 
o While mITT is intended as the primary analysis set for all safety and effectiveness 
endpoints, the primary safety and effectiveness endpoints will additionally be 
evaluated in the ITT analysis set as supportive information. All subjects excluded from 
mITT analysis set will be described in the final study report and the reasons for 
aborted procedures, if any, detailed. 
9.2 
Population Demographics 
The demographics and medical history will be presented in tabular form for all subjects enrolled in 
this study (ITT analysis set). Means, standard deviations, and sample size will be used to summarize 
continuous characteristics such as age. Percentages, raw number of subjects exhibiting a 
characteristic, and sample size will be used to summarize categorical characteristics such as gender. 
Demographic and medical history data will be additionally tabulated for the mITT analysis set. 
9.3 
Primary Endpoint Analysis 
Endpoints will be analyzed using the modified intention-to-treat analysis set as described below. The 
study will be considered successful if both primary safety and efficacy endpoints have been met. An 
additional supportive analysis will be conducted in the ITT analysis set for the primary safety and 
effectiveness endpoints. 
9.3.1 
Primary safety endpoint: 
The primary outcome measure for safety is the composite of MAE as adjudicated by the CEC including 
death, any major amputation performed on the target limb or CDTLR through 30 days. The one-sided 
lower 97.5% Agresti-Coull confidence bound will be computed for the composite and compared to the 
safety performance goal of 88% for bare Nitinol stenting as defined by the VIVA Physicians Inc. [38]. 
The performance goal will have been met if the lower bound is greater than 88%. This analysis will be 
conducted in the mITT analysis population. Only subjects with sufficient follow-up data will be 
included. That is, only subjects with ascertainment of status past the lower window for the 30-day visit 
(with any ascertainment of status post 23 days on study) and/or subjects who experienced an MAE at 
any time prior to and including 30 days will be considered eligible for this analysis. Any ascertainment 
of status post 23 days includes subjects who may have had missing safety status at 30 days, but are 
found to be free of MAE at a later out-of-window date. This subject will be considered MAE-free at 30 
days. It is not expected that there will be notable loss to follow-up at this time point, however, if any 
loss to follow-up is present, sensitivity analyses for excluding these data will be conducted as described 
in Section 9.9 below. 
9.3.2 
Primary effectiveness endpoint: 
The primary outcome measure for effectiveness is primary stent patency rate at 12 months as defined 
in 4.1.2. The one-sided lower 97.5% Agresti-Coull confidence bound will be computed for patency and 
this lower bound will be compared to the effectiveness performance goal of 66% for bare Nitinol 
stenting as defined by the VIVA Physicians, Inc.[38]. The performance goal will be met if the lower 

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bound is greater than 66%. The mITT analysis population will be used for this endpoint; however, only 
subjects with valid endpoint data without imputation will be included. This includes all subjects with 
imaging data at 12 months and/or subjects without imaging data who experienced a CDTLR. 
Additionally, if a subject is missing stent patency status at the 12 month visit but is found to be patent 
at a later out-of-window date, the subject will be considered patent at 12 months. Sensitivity analyses 
for excluding missing data will be conducted as described in Section 9.9 below. 
9.4 
Secondary Endpoint Analysis 
All secondary endpoints as described in Section 4.2 will be tabulated. Means, standard deviations and 
sample size will be used to summarize continuous characteristics. Distributions of continuous data will 
be examined and if non-normality is exhibited, medians and interquartile ranges will be presented. 
Percentages, raw number of subjects exhibiting a characteristic, and sample size will be used to 
summarize categorical characteristics. Measures collected serially over time (for example, ABI) will be 
presented at each time point, and the measure at each time point will be compared to the baseline 
measure as well as tested for trends. All available data will be used for each endpoint and no 
imputations will be done. The mITT analysis set will be used for these analyses. 
9.5 
Exploratory Endpoint Analysis 
The exploratory endpoints as described in Section 4.3 will be tabulated. In general, means, standard 
deviations and sample size will be used to summarize continuous characteristics. Distributions of 
continuous data will be examined and if non-normality is exhibited, medians and interquartile ranges 
will be presented. Percentages, raw number of subjects exhibiting a characteristic, and sample size 
will be used to summarize categorical characteristics. All available data will be used for each endpoint 
and no imputations will be done. The mITT analysis set will be used for these analyses. 
9.6 
Other Safety Data 
All adverse events, serious adverse events, major adverse events, and UADEs will be tabulated for the 
ITT analysis set and provided in listings. Device failures and malfunctions will be provided in a separate 
listing. Relevant concomitant medications will be tabulated at each study time point and all collected 
medications will be provided in listings. 
9.7 
Site Poolability and Subgroup Analyses 
Poolability of study subjects across investigational sites will be explored by comparing the primary 
outcome measure across site. Initially, testing of the primary outcomes will be conducted across site 
at a two-sided alpha=0.15 level using a chi-square test, unadjusted for covariates. If differences 
between sites exist at the alpha=0.15 level, further analysis will compare prognostic factors, protocol 
violations and study outcomes across sites using a chi-square test for categorical data and t-test for 
continuous data. For these analyses, any sites with fewer than 10 subjects will be pooled by country. 
Within the US, sites will be pooled by region (Northeast, Southeast, Midwest and West). If a 
country/region has fewer than 10 subjects, that country/region will be pooled with its nearest 
neighboring country/region. Regardless of these findings, if differences between sites exist at the 
alpha=0.15 level, summary statistics will be presented for each site. Any differences by study site will 
be discussed in the study report. If substantial differences emerge, a sensitivity analysis of the primary 
outcomes may be performed by excluding outlying sites from the analysis. 
Additionally, an analysis by region (US vs. OUS) will be conducted for the primary endpoints. 
Heterogeneity of region will be tested via a chi-square test. If no statistically significant difference 
exists for the primary endpoints at alpha=0.15, the data will be considered poolable by region. If a 
statistically significant difference exists for the primary endpoints at alpha=0.15, the primary 
endpoints will be presented by region along with 95% confidence intervals. If difference between 
region exist but can be explained by baseline covariates, then the data will be considered poolable by 

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region, however, descriptive statistics will be presented by region as noted above and discussed in the 
study report. 
Heterogeneity of the primary endpoints will also be explored for the subgroup sex (Male vs. Female). 
Outcomes will be reported separately for each group along with 95% confidence intervals. A chi-
square test will be conducted to determine if a statistically significant difference (at alpha=0.15) exists 
between the groups. If no statistically significant difference exists, then the results will be considered 
poolable by sex. If difference between sexes exist but can be explained by baseline covariates, then 
the data will be considered poolable by sex, however, descriptive statistics will be presented by sex as 
noted above and discussed in the study report.  
The results of the subgroup analyses for region (US vs. OUS) and sex will be presented in the final study 
report regardless of the findings above. Descriptive statistics will be presented by subgroup including 
frequency and percent. The study is not powered for these subgroups, however, so these analyses are 
considered exploratory. While it is expected that some differences between these groups will exist, 
any statistically significant (at alpha=0.15) and/or clinically meaningful (or clinically unexpected) 
differences between subgroups will be reported along with the primary results. No formal statistical 
inference will be made within subgroups with respect to the performance goal for labeling purposes, 
only descriptive statistics will be presented. As no formal inference regarding subgroups will be made, 
no adjustment for multiplicity is indicated. 
Primary endpoints will be reported separately for the following subgroups:  
• 
subjects who are taking cilostazol (vs. not taking cilostazol), 
• 
Japan versus rest of world (ROW) and versus the overall study cohort, 
• 
Japan versus US versus Germany, 
• 
subjects implanted with a 5 mm stent diameter versus > 5 mm stent diameter. 
In addition, the effect of overlapping stents will be explored by looking at patients with single versus 
multiple stents. 
While these subgroups are not powered statistically to detect meaningful differences, the data will be 
presented and any perceived differences will be described in the final study report. 
 
9.8 
Sample Size 
Using Percutaneous Transluminal Angioplasty (PTA) data from a series of clinical studies, VIVA 
Physicians Inc., developed performance goals that may be used as standards of comparison for safety 
and effectiveness in the treatment of claudication associated with femoropopliteal disease. The safety 
and effectiveness of the BioMimics 3D stent will be compared to the VIVA Physicians’ defined objective 
performance goals (OPGs).[38] 
• 
VIVA Physicians’ primary safety endpoint is freedom from major adverse events (MAE), 
defined as all-cause death, index limb amputation and target lesion revascularization (TLR), 
through 30 days. The lower limit of the one-sided 95% confidence interval of the true 
femoropopliteal PTA rate for freedom from MAE was 88%, which was established as the 
primary safety OPG.  
• 
The VIVA Physicians Inc. primary effectiveness endpoint is the primary stent patency rate at 
12 months, where patency is defined as freedom from more than 50% restenosis based on 
DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the 
proximal normal arterial segment. A PSVR > 2.0 is indicative of the loss of patency. The primary 
effectiveness OPG of 66% was established as two times the observed PTA freedom from loss 
of patency rate of 33%. 

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Sample size estimation for the MIMICS-2 Study was performed using VIVA OPGs and outcomes from 
the Mimics Study, a first-in-man study of the safety and effectiveness of the BioMimics 3D Stent 
System conducted at eight investigational sites in Germany in which patients were followed for 24 
months after the index procedure. 
There are two primary endpoints in the MIMICS-2 Study, one safety and one effectiveness. In order 
for the trial to be considered successful, both primary endpoint hypotheses must be satisfied, thus no 
adjustment for alpha is necessary. The size of the study will be driven by the primary effectiveness 
endpoint as detailed below. Initially, powers of 95% and 85% are considered for primary safety and 
effectiveness, respectively, in order to preserve an overall power greater than 80%. 
Primary Safety Endpoint and Hypothesis Test 
The primary safety endpoint in the MIMICS-2 Study is a composite of Major Adverse Events (MAE) 
including all-cause death, any major amputation performed on the target limb, or CDTLR through 30 
days. 
The primary safety objective is to demonstrate that the freedom from MAE rate for treatment with 
the BioMimics 3D Stent System meets the VIVA OPG of 88%. The null and alternative hypotheses are 
as follows: 
H0: π ≤ 88% 
HA: π > 88% 
where π is the population proportion of subjects treated with BioMimics 3D who are free from MAE 
through 30 days. Hypothesis testing will be conducted using the confidence interval approach. Success 
on the primary safety objective will be established if the one-sided lower 97.5% Agresti-Coull 
confidence limit [40] for the proportion of subjects treated with BioMimics 3D who are free from an 
MAE through 30 days is greater than 88%. 
Sample size implications for Primary Safety Objective 
The sample size for the primary safety objective was determined using the method presented in 
Agresti-Coull [40]. The freedom from MAE rate in the Mimics Study was 100% at 30 days, so a 
conservative estimate of 98% freedom from MAE in the MIMICS-2 Study was used for sample size 
calculations. 
The following assumptions were used for sample size: 
• 
95% statistical power. 
• 
Confidence interval approach to hypothesis testing with one-sided 97.5% lower Agresti-Coull 
confidence limit (one-sided type-I error rate of 2.5%). 
• 
VIVA freedom from MAE OPG of 88%. 
• 
Estimated 98% freedom from MAE in MIMICS-2. 
The conclusion was that 83 evaluable subjects would be required to statistically power the primary 
safety endpoint at the 95% level.  
Primary Efficacy Endpoint and Hypothesis Test 
The primary effectiveness endpoint in the MIMICS-2 Study is primary stent patency rate at 12 months. 
Patency is defined as no significant reduction in luminal diameter (i.e. < 50% diameter stenosis) since 
the index procedure. Luminal diameter is assessed by core lab using angiography or duplex ultrasound 
imaging. Loss of primary stent patency is deemed when peak systolic velocity ratio (PSVR) is >2.0*, or 
where angiography reveals >50% diameter stenosis, or where the subject undergoes clinically-driven 
TLR. When both imaging modalities are available, angiography takes precedence.  
 

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*In cases where PSVR cannot be determined, or where the independent core lab deems the PSVR as 
discrepant from correlating factors7, these correlating factors will be primarily considered in the 
determination of patency. 
The primary effectiveness objective is to demonstrate that the 12-month primary stent patency rate 
after use of the BioMimics 3D Stent System is statistically superior to the VIVA OPG of 66%. The null 
and alternative hypotheses are as follows: 
H0: π ≤ 66% 
HA: π > 66% 
where π is the population BioMimics 3D patency at 12 months. Hypothesis testing will be conducted 
using the confidence interval approach. Success in the primary effectiveness objective will be 
established if the one-sided lower 97.5% Agresti-Coull confidence limit for the proportion of subjects 
treated with BioMimics 3D that continue to have treated segment patency through 12 months is 
greater than 66%. 
Sample size implications for Primary Efficacy Objective 
The sample size for the primary effectiveness objective was determined using the method presented 
in Agresti-Coull. The 12-month patency rate for those subjects who received BioMimics 3D stents in 
the randomized portion of the MIMICS Study was 75% (PSVR ≤ 2.0) with no CDTLR in the interim, and 
this value was used as the estimate of BioMimics 3D performance in the MIMICS-2 Study. 
The following assumptions were used for the primary effectiveness objective sample size calculation: 
• 
85% statistical power. 
• 
Confidence interval approach to hypothesis testing with one-sided 97.5% lower Agresti-Coull 
confidence limit (one-sided type-I error rate of 2.5%). 
• 
VIVA 12-month patency OPG of 66%. 
• 
Estimated 12-month primary stent patency rate in the MIMICS-2 Study of 75%. 
The conclusion was that 230 evaluable subjects would be required to statistically power the primary 
effectiveness endpoint at the 85% level. 
Final sample size determination 
In order to statistically power both of the primary endpoints simultaneously, 230 evaluable subjects 
at 12 months are required. In order to allow for attrition, a sample size of 280 subjects should be 
enrolled in the MIMICS-2 Study. Thus the power for the primary safety endpoint is actually >99%, 
keeping the overall study power at approximately 85%. 
9.9 
Handling of Missing Data 
For all primary, secondary and exploratory analyses, no imputation of missing data is planned. Subjects 
who have ascertainment of status at a later out-of-window date (for example, subjects who are known 
to be free of MAE past 30 days but missed the 30 day visit) are not considered missing as their status 
is known and their data will be used as noted previously. A sensitivity analysis, specifically a tipping 
                                                          
7 The core lab uses the following secondary criteria in the determination of patency:  
• 
Focal increase in the absolute PSV at the area of visible plaque 
• 
Spectral broadening of the waveform at the area of stenosis 
• 
Post-stenotic turbulence and/or change in the waveform shape and/or drop in velocity distal to the 
stenosis 
• 
Review of the B-mode images for plaque burden 

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point analysis, will be used to assess the impact of missing data on the study conclusions for the 
primary endpoints. This sensitivity analysis will be performed on the ITT analysis set. 
9.10 
Interim Analysis 
There is no interim analysis planned with the purpose of altering the Protocol or planned statistical 
analyses. When all data have been collected and imaging completed for the co-primary endpoints 
(through 12 months), the database will be cleaned and the primary study analysis conducted. All data 
available at that time will be summarized for reporting and regulatory filing purposes (PMA submission 
on primary data set). 
 
 

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10.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS & REPORTS  
The Investigators are responsible for signing the Investigator Agreement prior to the commencement 
of the study and for ensuring that this trial is conducted according to this study Protocol, GCPs, 
Declaration of Helsinki, 21 CFR Parts 50, 54, 56 and 812, ISO 14155:2011 (Section 9) and any other 
local, national or IRB / EC requirements that apply to Clinical Investigations at their center. 
It is also the Investigator’s responsibility to ensure that all sub-investigators and staff assisting with 
this study have the appropriate qualifications and that they complete training on the Protocol, 
investigational devices and study procedures, and that subject confidentiality is respected. 
10.1 
Informed Consent & Institutional Review Board / Ethics Committee 
(21 CFR Parts 50 & 56; ISO 14155: 2011 Section 4) 
Because this study is collecting medical data from subjects providing written informed consent, the 
Investigator at each site is responsible for securing IRB / EC approval for this study Protocol and the 
Informed Consent documents. The local IRB / EC for each specific institution must review and approve 
this study Protocol and the specific Informed Consent form to be used at that site prior to enrollment 
of the first subject. The Sponsor must also review and approve the final Informed Consent documents 
prior to their use. The Sponsor must receive a copy of any IRB / EC correspondence as well as the final 
approval letter and the final approved Informed Consent from each IRB / EC. 
The Investigator is responsible for ensuring that all applicable local and national (21 CFR Part 50, ISO 
14155:2011) requirements, and Declaration of Helsinki are met when completing the informed 
consent process. Written, informed consent is to be obtained for all subjects prior to enrollment. 
The Investigator or clinical site staff will not make amendments to this Protocol or the Informed 
Consent form without PRIOR written approval from the Sponsor. All approved amendments must then 
be submitted to the local IRB / EC and national authorities, as appropriate for approval. 
10.2 
Withdrawal of Approval 
If the Investigator’s IRB or EC withdraws their approval to conduct this study for any reason, the 
Investigator must notify the Sponsor as soon as possible, but in no event later than five working days 
after the withdrawal of the approval. 
10.3 
Clinical Data Collection 
Standardized electronic case report forms (eCRF) will be used to collect complete and accurate records 
of the clinical data from the MIMICS-2 trial according to the GCPs requirements. The Investigator 
and/or study staff under his/her direction is responsible for accurately recording the clinical data for 
this study and submitting it to the Sponsor in a timely manner. 
10.4 
Device Accountability 
The Sponsor will ship investigational devices to the designated Investigators participating in this study 
following IRB / EC approval. All Investigators will be responsible for providing a secure storage location 
for the devices, supervising device use, and the disposal and/or return of the devices as instructed by 
the Sponsor. In addition, all Investigators will maintain records to document the receipt, use and 
disposition of all devices received by their site intended for this study. The Sponsor and/or designee 
will also maintain records of all shipments and disposition of the investigational devices. The Sponsor 
and/or their authorized Contract Research Organization (CRO) will routinely inspect the clinical site 
inventory records for device accountability at the clinical sites participating in this study. 

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10.5 
Investigator Reports 
10.5.1 
Serious Adverse Events & Major Adverse Events 
The Investigator will report to the Sponsor by telephone, email, fax, or electronic CRF submission any 
SAE or MAE as soon as possible (within 24 hours of the Investigator becoming aware of the event or 
by the end of the next working day). Additionally, SAEs and MAEs should be reported to the IRB / EC, 
if required per the clinical site guidelines or as directed by the Sponsor. The Adverse Event eCRF is to 
be completed and submitted to the Sponsor within five (5) working days of the event. The contact 
information for reporting SAEs and MAEs is provided in the study contact section of this Protocol. 
10.5.2 
Device Malfunctions or Failures 
The Investigators will report any Device Malfunctions or Failures that occur, to the Sponsor within 24 
hours of the Investigator becoming aware of the device malfunction or failure or by the end of the 
next working day. The report may be made by or within 24 hours via telephone, email or fax. The 
Investigator or study staff are to return the devices per the Instructions for Use for investigation. The 
Device Performance eCRF is to be completed and submitted to the Sponsor within five (5) working 
days of the event. The contact information for reporting Device Performance issues is provided in the 
study contact section of this Protocol. 
10.5.3 
Deviations from the Investigational Plan 
The Investigator must notify the Sponsor of any deviation from the Investigational Plan. The 
Investigator should also notify the IRB / EC as required per their local requirements or as directed by 
the Sponsor. This notice must occur as soon as possible, but in no case longer than five (5) working 
days after the Investigator becomes aware of a major deviation. Major deviations include, but is not 
limited to, those that involve the informed consent process, the inclusion/exclusion criteria of the 
study, SAE/MAE reporting, device misuse or device accountability discrepancies, or any deviation that 
involves or leads to a serious adverse event in a study participant. 
10.5.4 
Investigator Final Report 
The Investigator will report information and events according to the timelines in Table 9. Within three 
(3) months of Study completion, the Investigator will provide a final study report that summarizes 
their enrollment and study participation. This report should include a summary of enrollment, AEs, 
MAEs, SAEs, UADEs and Device Malfunctions and Failures. This report will be forwarded to the IRB / 
EC and the Sponsor after all of the enrolled subjects have completed their final follow-up visit or have 
exited the study and the study close-out visit has been completed, but no later than three (3) months 
following completion of the last follow-up visit. 
 
 

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Table 9: MIMICS-2 investigator reporting timelines 
Form/Report 
Submission Timeframe 
Enrollment notification  
Completion of Enrollment eCRF within 24 hours of enrollment, or by 
the end of the next working day. 
Electronic CRFs 
Completion within 3 working days of study visit. 
Angiographic, X-Ray and 
Duplex Ultrasound Images 
Submit to Core Lab within 3 working days of completion. 
Adverse Events  
(non-serious) 
Complete eCRF within 14 days of the Investigator becoming aware 
of the event. 
SAEs & MAEs 
Submit notification to Sponsor within 24 hours of the site becoming 
aware of the event, or by the end of the next working day; submit 
to the local IRB / EC as required or as directed by the Sponsor. 
Study Progress Reports 
As required by the local IRB / EC (minimum annually). 
Final Report to the IRB / EC 
Within 3 months of Study completion. 
 
10.6 
Publication Policies 
At the conclusion of the MIMICS-2 Study, a multi-center manuscript will be prepared for publication 
in a reputable scientific journal. The publication of the principal results from any single center 
experience within the trial is not allowed until the preparation and publication of the multi-center 
results. Exceptions to this rule require the prior approval of Veryan. The analysis of other pre-specified 
and non-pre-specified endpoints will be performed by Veryan and will require pre-approval by Veryan. 
For the purposes of timely abstract presentation and publication, such secondary publications will be 
delegated to the appropriate principal authors, and final analyses and manuscript review for all multi-
center data and/or single-center experience reports will require approval from Veryan. 
This study will be registered with www.clinicaltrials.gov. 
 
 

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11.0 
SPONSOR RESPONSIBILITIES 
As the Sponsor of this clinical study, Veryan has the overall responsibility for the conduct of the study, 
including assurance that the study meets the regulatory requirements of the Food and Drug 
Administration (FDA) and ISO 14155:2011 (Section 8). In this study, Veryan will have certain direct 
responsibilities and will delegate other responsibilities to Independent Contractors. Together, both 
Veryan and its Independent Contractors will ensure adherence to the sponsor’s general duties (21 CFR 
812.40; ISO 14155:2011 Section 8), selection of Investigators (21 CFR 812.43; ISO 14155:2011 Section 
8.2.1), monitoring (21 CFR 812.46; ISO 14155:2011 Section 8.2.4.2), supplemental applications (21 CFR 
812.35 (a) and (b)), record maintenance (21 CFR 812.140 (b)), and report submissions (21 CFR 812.150 
(b)). 
11.1 
General Duties  
(21 CFR 812.40; ISO 14155:2011 Section 8) 
The Sponsor’s general duties consist of submitting the IDE application to FDA, submitting the 
Investigational Plan to other applicable national regulatory agencies (as applicable), obtaining FDA, 
other national regulatory (as applicable) and IRB / EC approvals prior to shipping the devices, selecting 
qualified Investigators, and shipping devices only to those qualified Investigators. As the sponsor, 
Veryan is also required to obtain signed study agreements, to provide the Investigators with the 
information necessary to conduct the study and adequate on-site training to conduct the trial, to 
ensure proper clinical site monitoring, and to provide the required reports to the Investigators, IRBs / 
ECs, other national regulatory agencies (as applicable), and FDA. 
Veryan will be responsible for providing quality data that satisfies federal regulations and informing 
about serious unanticipated adverse events and deviations from the Protocol. Written progress 
reports and a final report will be prepared in coordination with the Ultrasound, Angiographic and X-
Ray Core Laboratories. 
11.2 
Selection of Clinical Sites & Investigators 
(21 CFR 812.43; ISO 14155:2011 Section 8.2.1) 
Veryan will select qualified clinical sites and Investigators who are experienced with percutaneous 
transluminal angioplasty and peripheral stenting. The Investigator must work with a qualified IRB / EC 
to oversee the rights, safety and welfare of the study participants. The clinical site must also have an 
adequate subject population and the appropriate staffing and equipment to meet the requirements 
of the study Protocol and the expected enrollment time frames. 
11.3 
Monitoring 
(21 CFR 812.46; ISO 14155:2011 Section 8.2.4.2) 
Veryan will designate a CRO to monitor and oversee the conduct of the MIMICS-2 study. The Sponsor 
and/or CRO designee will conduct investigational site monitoring to ensure that all Investigators are 
in compliance with the Protocol and the Investigators’ agreements. The Sponsor and/or CRO 
designee will monitor the sites to ensure that the completed eCRFs are in agreement with the 
source documentation and other records, and resolve any differences. Periodic phone contacts and 
site visits will be conducted to ensure that the Protocol is being followed. 
For record verification purposes, the clinical monitor and/or authorized Sponsor representative will 
be provided access to hospital records, original laboratory data, and other records and data as they 
relate to the study and as agreed to with the Investigator prior to the initiation of the trial. The 
Investigator will also make available to the clinical monitor all regulatory documents, all completed 
eCRFs, informed consent documents, source documentation and other relevant records for all 

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enrolled subjects at the site. It is important that the Investigator and other relevant site personnel are 
available for consultation with the clinical monitor during the monitoring visits and that sufficient time 
is devoted at the site to the monitoring process. 
If the Sponsor and/or their authorized representative become aware that an Investigator is not 
complying with the study Protocol, the Investigator Agreement, the Declaration of Helsinki, applicable 
privacy standards, or any condition of the study imposed by the IRB / EC, the Sponsor or their 
authorized representative may immediately secure compliance or discontinue further shipments of 
the study devices. An inability to secure compliance and/or to complete an investigation into the 
factors that are inhibiting compliance may result in the Investigator’s termination from the study by 
the Sponsor. 
The Sponsor will review significant new information, including unanticipated serious adverse events 
and ensure that such information is provided to the FDA, other national regulatory agencies (as 
applicable), the Investigators, and to all reviewing IRBs / ECs. 
Study close-out visits will be conducted after the final follow-up visit is completed at each site 
following the resolution of any outstanding data discrepancies and adverse events. The remaining 
study devices will be the collected and returned to the Sponsor on or before the close out visit. A final 
study report will be generated and submitted to the Investigator and the appropriate study oversight 
authorities. Study document retention requirements will be reviewed with each site during the close-
out visit. 
11.3.1 
Investigational Site Termination 
The Sponsor reserves the right to terminate an investigational site from the Study for any of the 
following reasons: 
• 
Failure to obtain Informed Consent. 
• 
Failure to report Serious Adverse Events within 48 hours of knowledge. 
• 
Loss of or unaccountable device inventory. 
• 
Repeated Protocol violations or safety concerns. 
• 
Repeated failure to complete Case Report Forms. 
• 
Failure to enroll an adequate number of subjects. 
11.4 
Informed Consent & Institutional Review Board / Ethics Committee 
(21 CFR Parts 50 & 56; ISO 14155:2011 Section 4) 
All subjects must provide written informed consent in accordance with the local clinical site’s IRB / EC. 
A copy of the consent form from each center must be forwarded to the Sponsor for review and 
approval prior to submitting it to the IRB / EC. Each site must provide the Sponsor with a copy of the 
clinical site’s IRB / EC approval letter and the informed consent. Continuing review (e.g., institutional 
annual review) approvals for the continuation of the trial at each clinical site must also be forwarded 
to the Sponsor, as applicable. 
All Protected Health Information (PHI) to be collected in the study will be described in the informed 
consent form, and all study data will be managed in accordance with the Privacy Law (HIPAA) or 
international privacy regulations, as applicable. 
11.5 
Records & Record Retention 
(21 CFR 812.140 (b) & (d)) 
The Sponsor and/or their designated CRO will maintain copies of correspondence, data, device 
shipments, clinical events (AEs, SAEs, MAEs) and supporting documentation and other records and 
reports related to this clinical study. 

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The Sponsor, core laboratories and clinical sites will maintain the MIMICS-2 study records until two 
(2) years after the final study report is completed, or longer if required by local, national or 
international regulatory agencies. The Sponsor will notify each site regarding the regulatory 
requirements for record retention during the study close-out visit. 
11.6 
Study Reports 
(21 CFR 812.150 (b)) 
All information and data generated in association with the study will be held in strict confidence and 
remains the sole property of the Sponsor. The Investigator agrees to use this information for the sole 
purpose of completing the study and for no other purpose without prior approval of the Sponsor. 
The Sponsor will submit the required FDA reports identified in this section of the regulation. This 
includes unanticipated serious adverse device effects, withdrawal of IRB / EC or FDA approval, current 
6-month Investigators list, annual progress reports, recall information, final reports, investigators that 
use the device without obtaining informed consent, and significant risk device determinations. 
Upon receipt of the final study data and the final reports from each center, the Sponsor will complete 
a final study report. Copies of the final report will be provided to each Investigator.  
11.7 
Supplemental Applications 
(21 CFR 812.35) 
As appropriate, the Sponsor will submit changes to the study Protocol for national approval and 
subsequently to the Investigators to obtain IRB / EC approval. 
 
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12.0 
QUALITY ASSURANCE & ETHICAL STANDARDS 
The study will be conducted according to the Declaration of Helsinki, GCPs, 21 CFR parts 50, 54, 56 
and 812, ISO 14155:2011, and any additional IRB / EC, local (site and/or state requirements) and/or 
national requirements that apply to clinical studies of medical devices. As the study Sponsor, Veryan, 
has the overall responsibility for the conduct of the study, including the assurance that the study is in 
compliance with these guidelines, standards and requirements. 
12.1 
Institutional Review Boards / Ethics Committees 
A copy of the study Protocol, proposed Informed Consent form, other written patient information and 
any proposed advertising material must be submitted to the IRB / EC for written approval. A copy of 
the written IRB / EC approval of the Protocol and Informed Consent form must be received by Veryan 
before recruitment of subjects into the study and shipment of investigational product. 
The Investigator must submit and, where necessary, obtain approval from the IRB / EC as well as the 
FDA, for all subsequent significant Protocol amendments and significant changes to the Informed 
Consent form. The Investigator should notify the IRB / EC of deviations from the Protocol or SAEs and 
UADEs occurring at the site and other SAE/UADE reports received from Veryan in accordance with 
local procedures. 
The Investigator will be responsible for obtaining annual IRB / EC approval and renewal throughout 
the duration of the study. Copies of the Investigator’s reports and the IRB / EC continuance of approval 
must be sent to Veryan. 
12.2 
Informed Consent  
A sample Informed Consent form template shall be provided to the Investigator to use to prepare for 
use at his/her site. The written Informed Consent documents should be prepared in the language(s) 
of the potential patient population. 
The reviewing IRB / EC and the sponsor must first approve the Informed Consent forms that are used. 
The Informed Consent forms that are used should be in accordance with the current guidelines as 
outlined by the FDA Regulations, GCP guidelines, Declaration of Helsinki, and ISO Standards. 
Prior to participation in the clinical trial, each patient must give written Informed Consent after the 
context of the study has been fully explained to the patient in language that is easily understood by 
the patient. The patients must also be given the opportunity to read the consent, ask questions, and 
have those questions answered to their satisfaction. 
Written Informed Consent must be recorded appropriately by means of the subject’s, or their legal 
representative’s dated signature. The subject will receive a copy of the Informed Consent form. 
12.3 
Protocol Amendments 
An Investigator may not make changes to this Protocol without prior approval by the Sponsor. All 
significant changes to the Protocol that may affect the following must be submitted and approved by 
the FDA before initiating the change: 
• 
Validity of the data or information resulting from the completion of the approved Protocol. 
• 
Relationship of the likely subject risk to benefit relied upon to approve the Protocol. 
• 
Scientific soundness of the investigational plan. 
• 
Rights, safety, or welfare of the human subjects involved in the investigation. 
Any such change to the Protocol must be approved by the FDA and submitted and subsequently 
approved by the site IRB / EC. Veryan will submit a copy of the Protocol amendment to all Investigators 
for their IRBs / ECs to review and ensure the study continues to be conducted consistently across all 

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sites. The investigative sites must send Veryan a copy of the IRB / EC approval letter for the Protocol 
amendment. 
Veryan may make certain administrative changes to the Protocol without prior approval of the FDA or 
IRB / EC. Veryan will notify all investigative sites of such changes to ensure the study continues to be 
conducted consistently across all sites. The site IRBs / ECs will be notified of these changes. 
12.4 
Emergency Actions 
Veryan accepts the right of the Investigator to deviate from the Protocol in an emergency when 
necessary to safeguard the life or the physical well-being of a study subject. The Investigator must give 
notice of any emergency deviations and justification for the deviation to Veryan and the IRB / EC as 
quickly as possible after the episode, in any event no later than 24 hours after the emergency. 
Emergency Use of the investigational device is not permitted in this study. 
12.5 
Protocol Compliance 
A Protocol deviation is defined as an event where the Clinical Investigator or site personnel did not 
conduct the study according to the Protocol. 
Investigators shall be required to obtain prior approval from the Sponsor’s clinical study 
management before initiating deviations from the Protocol, except where necessary to protect the 
life or physical well-being of a subject in an emergency. Such approval shall be documented in 
writing and maintained in clinical study management and Investigator files. Prior approval is generally 
not expected in situations where unforeseen circumstances are beyond the Investigator’s control 
(e.g., subject was not available for scheduled follow-up office visit, blood sample lost by 
laboratory, etc.); however, the event is still considered a deviation and will be reported via the 
appropriate eCRF. 
Deviations must be reported to the Sponsor regardless of whether medically justifiable, pre-approved 
by the Sponsor or taken to protect the subject in an emergency. Subject specific deviations will be 
reported on the Protocol Deviation case report form. Non-subject specific deviations, (e.g., 
unauthorized use of an investigational device outside the study, unauthorized use of an 
investigational device by a physician who has not signed an Investigator agreement or not been 
trained in the use of the device, etc.), will be reported to the Sponsor reported via the applicable site 
monitoring visit report. Investigators will also adhere to procedures for reporting study deviations 
to their IRB / EC in accordance with their specific IRB / EC reporting policies and procedures. 
Regulations require that Investigators maintain accurate, complete and current records, including 
documents showing the dates of and reasons for each deviation from the Protocol. For reporting 
purposes, the Sponsor classifies study deviations as major and minor: 
Major deviation: Any deviation from subject inclusion and exclusion criteria, subject 
informed 
consent 
procedures, 
SAE/MAE 
reporting, 
device 
accountability 
discrepancies, or unauthorized device use. 
Minor 
deviation: 
Deviation 
from 
a 
Protocol 
requirement 
such 
as 
incomplete/inadequate subject testing procedures, follow-ups performed outside 
specified time windows, etc. Minor Deviations that continue to occur at an 
investigational site may be classified as Major Deviations if corrective action is 
not taken to secure future compliance to the Protocol. 
12.6 
Investigator & Staff Training 
Training of the Investigators and clinical study staff is the responsibility of the Sponsor and their 
designee. Training may be conducted during an Investigator meeting, a site initiation visit, or 
appropriate training venues. Investigators and study staff will undergo training on the study devices 

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and study Protocol, eligibility criteria, device accountability, and proper storage of the equipment and 
supplies, prior to participating in the study. Training may encompass didactic information regarding 
the study devices and system, as well as hands-on practice with the device. Procedural technique and 
experience with the BioMimics 3D Stent System may be assessed by clinical/engineering personnel. 
Observations during the cases will also be discussed with the Investigator and study staff. 
12.7 
Audits and Inspections 
The Principal Investigator for the site will also allow representatives of the governing IRB or EC, the 
United States Food and Drug Administration (FDA), and other applicable regulatory agencies to inspect 
all trial records, eCRFs, and corresponding portions of the subject’s office and/or hospital medical 
records at regular intervals throughout the trial. These inspections are for the purpose of verifying 
adherence to the Protocol, completeness and exactness of the data being transcribed into the eCRF, 
and compliance with FDA or other regulatory agency regulations. 
The Principal Investigator for the site will inform the Sponsor or the Sponsor’s designee in advance if 
they are to be audited or inspected by any regulatory agencies. The Sponsor or the Sponsor’s designee 
will also inform the site if they are made aware of a pending audit or inspection by a regulatory agency. 
The Investigator and/or designees must be available to respond to reasonable requests by authorized 
Sponsor, CRO and regulatory agency representatives during the monitoring and inspection process. 
The Investigator must provide the Sponsor with copies of all correspondence that may affect the 
review of the current study (i.e., Inspection Observations) or their qualification as an Investigator in 
clinical studies conducted by the Sponsor. The Sponsor will provide any needed assistance to the 
clinical site for regulatory audits, if any. 
12.8 
Monitoring Procedures 
12.8.1 
Monitoring 
Monitoring visits to the clinical sites will be made periodically during the study, to ensure that all 
aspects of the current, approved Protocol/amendment(s) are followed. Original source documents 
shall be reviewed for verification of data in the electronic database according to the defined 
monitoring plan. The Investigator/institution shall make all attempts to grant direct access to original 
source documents by Veryan personnel, their designees, and appropriate regulatory authorities. It is 
recognized that all participating institutions may not have procedures for providing access to 
electronic health records to non-institutional employees. In such situations, the Sponsor and/or 
designee shall collaborate with the investigator and institution to ensure alternative access to the 
complete medical record for enrolled subjects. In the event that the original medical records cannot 
be obtained for a patient that is seen by a non-study physician at a non-study institution, photocopies 
of the original source documents must be made available for review. 
Site visits will be conducted to ensure that the Protocol is being followed and that any Protocol 
deviations are properly documented. Additionally, telephone and/or e-mail contact will be conducted 
on a regular basis with the investigator and the site staff to ensure that the Protocol is being followed 
and to address any issues that may occur during the course of the trial. Clinical monitoring will include 
a verification that Informed Consent was properly obtained for all enrolled trial participants, a review 
of clinical records for accuracy and completeness, resolution of missing or inconsistent results and a 
review of source documents. The clinical monitor will verify that the eCRFs are in agreement with the 
source documentation and other records. The investigator will make available to the clinical monitor 
for review all Informed Consent documents, Internet access to completed eCRFs, source 
documentation, original laboratory data and other relevant records for all enrolled subjects at the site. 
It is important that the investigator and other relevant site personnel are available for consultation 
with the clinical monitors during the monitoring visits and that sufficient time is devoted at the site to 
the monitoring process. 

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If a deficiency is noted during an on-site visit (or at any other time during the course of the trial), the 
clinical monitor is required to discuss the situation with the investigator and the Sponsor (if required) 
to secure compliance. 
12.9 
Investigational Device Distribution and Accountability 
12.9.1 
Investigational Device Distribution  
Veryan will control the distribution of the investigational devices. Each investigational site will be 
responsible for ordering the investigational devices for the study. The Investigator is responsible for 
ensuring that the devices are ordered for shipment to arrive at the hospital before the procedure date. 
Devices will be shipped with an Investigational Device Shipment Record. This form is to be used by 
Veryan, or distribution designee, and the investigational site to record any shipments of the 
investigational device. A copy is to be retained by the shipper and the recipient. 
12.9.2 
Device Accountability 
The Investigator shall maintain adequate records of the receipt and disposition of all investigational 
devices. The Investigator is responsible for ensuring that the investigational devices are used only 
under the Investigator’s supervision and are only used according to this Protocol and any approved 
amendments. The Investigator will not supply an investigational device to any person not authorized 
to participate in the MIMICS-2 Study. The Investigator shall document in the operative notes and 
eCRFs the lot/device numbers of the devices used during an index procedure. In addition, the 
Investigator shall keep complete and accurate records of all devices used or unused that have been 
returned to the Sponsor in a Device Accountability Log provided by Veryan. 
12.9.3 
Return of Study Materials at Study Termination / Completion 
After enrollment is completed, all unused devices must be accounted for and shipped back to the 
Sponsor. Instructions for device return to the Sponsor will be reviewed at the site initiation visit as 
well as following study enrollment closure. 
IMPORTANT: Please note that the devices must be labeled with a “BIOHAZARD” sticker if there is 
reasonable belief that the device has come in contact with blood or infectious substances that are 
known or are believed to cause disease in animals or humans. 
12.10 Clinical Events Committee  
An independent Clinical Events Committee (CEC) will be responsible for systematic review and 
adjudication of all major adverse events including death, and all potentially device- or procedure-
related adverse events. In the case of an MAE with associated imaging, the CEC may review imaging 
assessments to assess the reported event. 
At a minimum, the CEC shall consist of at least three (3) independent physicians, with experience in 
interventional peripheral endovascular procedures. 
In order to enhance objectivity and reduce the potential for bias, the CEC members shall be 
independent of the Sponsor as well as the investigational sites and investigators. The methodology for 
performing these responsibilities shall be developed and outlined in the Safety Charter. Operational 
provisions shall be established to minimize potential bias. 
12.11 Data Management 
Standardized eCRFs will be utilized by all participating sites. Investigators are responsible for the 
accurate completion and timely submission of the data collected during the trial. All data from the 
trial will be entered into eCRFs via a secure, web-based system with password protection. Incoming 
data will be automatically reviewed to identify inconsistent or missing data and any adverse events. 

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Any data issues are to be promptly addressed with the investigator by the CRO, the Sponsor designee 
and/or data manager. Quality assurance procedures will be established to ensure that complete, 
accurate and timely data are submitted, that Protocol requirements are followed and that 
complications, adverse events and adverse device effects are correctly reported and investigated, as 
appropriate. Investigators are to maintain all source documents as required by the Protocol, including 
laboratory results, supporting medical records, and signed Informed Consent forms. The source 
documents will be used during the regular monitoring visits to verify information from the database 
against data contained on the completed eCRFs. 
The Investigator must maintain detailed records on all subjects who sign the Informed Consent and 
begin the pre-procedure evaluation. Only subjects who are enrolled and treatment is attempted or 
completed will have data entered into the eCRFs provided by the Sponsor. All data should be entered 
completely and promptly. For source documents, corrections should be made in a manner that does 
not obscure or eliminate the original error, by striking through the original data with one line, and 
initialing and dating the change, along with the reason for the change (if not obvious). 
Study Exit eCRFs are completed for all enrolled and treated subjects, regardless if they did or did not 
complete the trial (e.g., subject discontinuation, trial termination). 
12.12 Central Core Labs – Angiography, Duplex Ultrasound, X-Ray 
In order to ensure that the clinical data and images are analyzed in a controlled, non-biased manner 
and that the results are analyzed using a standardized process, all angiograms, duplex ultrasound 
studies and X-rays obtained during this study per study requirements will be submitted to central core 
labs for analysis. 
The core labs will be responsible for analyzing the angiograms and ultrasound images according to the 
study eligibility criteria, the study endpoints and this study Protocol. In addition, they will provide 
feedback to the sites and Sponsor regarding the quality of the tracings and images. The X-ray core lab 
will be assessing for stent fracture at the applicable study time points. Final written summary reports 
of all angiograms, X-rays, and duplex ultrasounds will be provided to the study Sponsor. 
12.13 Subject Compensation 
The treated subjects will not be reimbursed or compensated for participating in the trial. Travel 
expenses may be reimbursed by the Sponsor subject to approval by Sponsor and/or IRB/EC. 
12.14 Confidentiality  
Confidentiality of subjects will be maintained throughout the MIMICS-2 Study. A unique identification 
code will be assigned to each subject participating in this trial. Any data that may be published in 
abstracts, scientific journals, or presented at medical meetings will reference a unique subject code 
and will not reveal the subject’s identity. The Sponsor and their representatives will make every 
reasonable effort to protect the confidentiality of the subjects participating in the MIMICS-2 Study. 

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13.0 
STUDY DEFINITIONS 
Access Site Hemorrhage: Bleeding from the access site which requires transfusion, hospitalization 
(either admission or extended stay), or further treatment for management. Hemorrhage needing ≥ 1 
unit RBCs will be considered a serious adverse event. 
Access Site Infection: Culture-proven wound infection or presumptive treatment with antibiotics for 
clinically diagnosed wound infection. 
Acute Renal Failure:  Acute post-operative renal insufficiency resulting in one or more of the following: 
(a) increase of > 1.0 mg/dl in serum creatinine from most recent prior measured level, and current 
measured absolute value is > 2.0 mg/dl; (b) a new requirement for dialysis. 
Allergic Reaction: An allergic reaction characterized by rash, upper respiratory congestion, urticaria, 
shortness-of-breath, or general collapse (anaphylaxis). 
Amputation:  
 
Major: any requirement for amputation of the target limb above the ankle. 
 
Minor: any requirement for amputation of the of the target limb below the ankle. 
Anemia:  Decrease from baseline in red blood cells, hemoglobin, or total blood volume that is 
associated with hemodynamic changes or requires transfusion, or a drop in hematocrit to below 26%. 
Any documented anemic event requiring ≥2 units PRBCs will be considered an SAE. 
Angina, unstable:  Angina that increases in frequency, intensity, or duration, which occurs at rest, or 
which is new in onset. Unstable angina is a syndrome that is intermediate between stable angina and 
myocardial infarction: it is characterized by an accelerating or "crescendo" pattern of chest pain that 
lasts longer than stable angina, occurs at rest or with less exertion than stable angina, or is less 
responsive to medication. Unstable angina and myocardial infarction are considered acute coronary 
syndromes. 
Ankle Brachial Index (ABI):  The ratio of systolic blood pressure measured at the ankle to systolic blood 
pressure measured at the brachial artery. It is used to predict the severity of peripheral arterial disease 
(PAD). ABIs >0.9-1.2 = normal, ≤ 0.9 = peripheral arterial disease, < 0.4 = severe peripheral arterial 
disease (ischemic pain and ulceration). ABI > 1.2 is likely due to incompressible arteries and is 
commonly observed in association with long-standing diabetes mellitus, extreme old age, or 
calcinosis. 
Instructions for ABI Calculations: 
1. Obtain systolic blood pressures (SBP) for both arms (brachials) and both ankles [posterior 
tibials (PT) & dorsalis pedals (DP)]. 
2. Divide the higher of the two SBPs for each leg (highest between the PT and DP) by the 
higher of the two arm pressures to get the right and left ABIs. 
Arterial Occlusion / Thrombosis at Groin Puncture Site:  Angiographic or ultrasonographic evidence 
of occlusion at the puncture site limiting antegrade flow to the distal limb. 
Arterial Perforation/Rupture/Puncture of an Arterial Wall:  Classified as follows: 
Angiographic perforation: Perforation detected by the clinical site at any point during the 
procedure. 
Clinical perforation: Perforation requiring additional treatment (including efforts to seal the 
perforation), or resulting in significant extravasation of blood from the site, abrupt closure, 
limb ischemia or death. 
Arterial Pseudoaneurysm: Disruption of arterial wall confirmed by imaging study and requiring 
intervention. 

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Arteriovenous Fistula (AVF): An abnormal passage or communication between an artery and a vein 
which may be due to the percutaneous introduction of ancillary devices (e.g., needles, catheters, guide 
wires) confirmed by imaging studies. 
Bleeding Complication (Major): Bleeding resulting in ≥3 g/dl decrease in hemoglobin (if hemoglobin 
level not available, a decrease in hematocrit of ≥ 10%), or necessitating transfusion of >1 unit of PRBC’s 
/whole blood, or necessitates surgery/endoscopic intervention. 
Access site: Bleeding from the arteriotomy site which requires transfusion, hospitalization 
(either admission or extended stay), or further treatment for management. 
Cardiac Arrhythmia: Electrical disruption of the heart rhythm requiring specific medication, DC shock, 
or pacemaker insertion to address condition. 
Cardiogenic Shock: Subject presents with SBP < 80 mm Hg for more than 30 minutes unresponsive to 
fluids or requiring intravenous vasopressor agent or an intra-aortic balloon pump (IABP). 
Cerebral Vascular Accident (CVA): See Stroke. 
Classification of Calcification: Intimal and medial vessel wall calcification at the target lesion site as 
assessed by high intensity fluoroscopy and digital subtraction angiography (DSA) assessed in the AP 
projection [41]. 
Peripheral Arterial Calcium Scoring System (PACSS): 
Grade 0: No visible calcium at the target lesion site. 
Grade 1: Unilateral calcification <5cm: a) intimal calcification; b) medial calcification; c) mixed 
type. 
Grade 2: Unilateral calcification ≥5cm: a) intimal calcification; b) medial calcification; c) mixed 
type. 
Grade 3: Bilateral calcification <5cm: a) intimal calcification; b) medial calcification; c) mixed 
type. 
Grade 4: Bilateral calcification ≥5cm: a) intimal calcification; b) medial calcification; c) mixed 
type. 
Classification of Lesion Morphology (TASC II) [42] 
TASC II type A lesions:  
• 
Single stenosis ≤ 10 cm in length 
• 
Single occlusion ≤ 5 cm in length 
TASC II type B lesions: 
• 
Multiple lesions (stenosis or occlusions), each ≤ 5 cm  
• 
Single stenosis or occlusion ≤ 15 cm not involving the infrageniculate popliteal artery  
• 
Single or multiple lesions in the absence of continuous tibial vessels to improve inflow 
for a distal bypass 
• 
Heavily calcified occlusions ≤ 5 cm in length 
• 
Single popliteal stenosis 
TASC II type C lesions: 
• 
Multiple stenosis or occlusions totaling > 15 cm, with or without heavy calcification 
• 
Recurrent stenosis or occlusions that need treatment after two endovascular 
interventions 
TASC II type D lesions: 

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• 
Chronic total occlusion of the common or superficial femoral arteries (> 20 cm, 
involving the popliteal artery) 
• 
Chronic total occlusion of the popliteal artery and proximal trifurcation vessels 
Closure, Abrupt: Occurrence of new (during the index procedure), persistent slow, reduced, or loss of 
flow within the target vessel that requires intervention other than the index or adjunct treatment. 
Abrupt closure may also be referred to as acute occlusion if there is a total loss of flow.  
Closure, Late: Target lesion site occlusion that occurs greater than 30 days after the index procedure 
is completed (e.g., the subject has left the treatment area). 
Closure, Subacute: Target lesion site occlusion that occurs after the index procedure is completed 
(e.g., the subject has left the treatment area) and within 30 days of procedure. 
Contrast-Induced Nephropathy: Associated with contrast agent resulting in > 25% increase in serum 
creatinine or an absolute value of > 0.5 mg/dl. 
Contrast Media Reaction: An allergic reaction, immediate or delayed, associated with the 
intravascular administration of contrast media that results in symptoms (e.g. itching, hives) or 
physiologic changes requiring treatment (e.g. anaphylactic reaction) or death. 
Critical Limb Ischemia (CLI): Clinical manifestation of peripheral arterial disease characterized by 
Rutherford Clinical Scale Category of 4-6. For the purposes of this study, only subjects with Rutherford 
Clinical Scale Category of 2, 3, and 4, are eligible for enrollment. 
Death:  Death is divided into 2 categories:  
Cardiovascular death is defined as death due to any of the following: 
1. Acute myocardial infarction. 
2. Sudden cardiac death. 
3. Death due to heart failure. 
4. Death due to stroke. 
5. Death due to other cardiovascular causes. 
6. Death not attributable to any other cause (e.g., undetermined cause of death). 
Non-cardiovascular death is defined as a death not due to cardiovascular causes (as listed 
above). 
Deep Vein Thrombosis (DVT): Thrombosis of a deep vein, as confirmed by imaging study or direct 
visualization. 
Femoropopliteal: DVT involvement limited to the superficial femoral or popliteal veins, with 
or without distal (e.g. toward foot) DVT involvement, based on duplex ultrasound exam. 
Iliofemoral: DVT involvement of the common or external iliac veins or the common femoral 
vein, with or without distal (e.g. toward foot) DVT involvement, based on duplex ultrasound 
exam. 
De Novo Lesion: An obstructive or occlusive lesion without previous endovascular or surgical 
intervention 
Device Failure: A device that is used in accordance with the Instructions for Use, but does not perform 
according to the Instructions for Use and negatively impacts the treatment. 
Device Malfunction: A malfunction of a device is an unexpected change to the device that is 
contradictory to the Instructions for Use and may or may not affect device performance. 
Dissection: Disruption of an arterial wall resulting in separation of the intimal layer. May or may not 
be flow limiting. 

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Dissection Classifications (National Heart, Lung and Blood Institute – NHLBI) 
Type A: Small radiolucent area within the lumen of the vessel disappearing with the passage 
of the contrast material. 
Type B: Appearance of contrast medium parallel to the lumen of the vessel disappearing 
within a few cardiac cycles. 
Type C: Dissection protruding outside the lumen of the vessel persisting after passage of the 
contrast material. 
Type D: Spiral shaped filling defect with our without delayed run-off of the contrast material 
in the antegrade flow. 
Type E: Persistent luminal filling defect with delayed run-off of the contrast material in the 
distal lumen. 
Type F: Filling defect accompanied by total coronary occlusion. 
Embolization, Distal: Any distal emboli confirmed by imaging. 
Embolization, Symptomatic: Clinical signs or symptoms of distal emboli detected in the treated limb 
distal to the treated lesion after the index procedure or noted angiographically and requiring 
mechanical or pharmacologic means to improve flow. This includes new abrupt occlusions or filling 
defects. 
Enrollment: Subjects who are consented and meet all the study inclusion criteria and none of the 
study exclusion criteria and are treated or treatment is attempted with the study device will be 
considered enrolled into the study. Subjects who do not meet all inclusion and exclusion criteria (e.g., 
including ability to cross the lesion with a guidewire, target reference vessel diameter, target lesion 
length, calcification exclusion, patent popliteal and tibioperoneal artery in the target limb, etc.) will be 
considered an angiographic screen failure and will not be followed in the study (no data will be 
collected on these subjects). 
Hematoma: Collection of blood (or its degradation products) which exceeds 5 cm in diameter, requires 
treatment, or prolongs hospitalization. 
Hypertension: Systolic BP >140 mmHg, or diastolic >90 mmHg requiring specific medical therapy. 
Hypotension: Any prolonged systolic blood pressure <80 mmHg associated with symptoms and 
requiring intravenous vasopressor medications. 
Infection, access site: Infection at the vascular access site, documented by lab culture or clinical 
evidence requiring medical treatment (irrigation, debridement, antibiotics, etc.) to resolve.  
Infection, systemic: Systemic infection documented by positive lab culture or clinical evidence, 
requiring medical treatment to treat and resolve. 
Intention to Treat (ITT): The principle of including outcomes of all subjects in the analysis who are 
enrolled and treated (attempted or completed) into the study, regardless of noncompliance, Protocol 
deviations, or withdrawal. 
Limb Ischemia: Deficient supply of oxygenated blood to the tissues in the limbs that is due to 
obstruction of the inflow of arterial blood characterized by pain and/or discoloration of the limb 
and/or tissue loss. 
Luminal Patency: Restenosis <50% as determined by angiography or duplex ultrasound. 
Major Adverse Event (MAE):  An MAE comprises all-cause death, any major amputation performed 
on the target limb or clinically-driven target lesion revascularization. 
Myocardial Infarction (MI): Evidence of myocardial necrosis in a clinical setting consistent with 
myocardial ischemia. 

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Patency, Primary Stent: Patency is defined as no significant reduction in luminal diameter (i.e. < 50% 
diameter stenosis) since the index procedure. Luminal diameter is assessed by core lab using 
angiography or duplex ultrasound imaging. Loss of primary stent patency is deemed when peak 
systolic velocity ratio (PSVR) is >2.0*, or where angiography reveals >50% diameter stenosis, or where 
the subject undergoes clinically-driven TLR. When both imaging modalities are available, angiography 
takes precedence.  
*In cases where PSVR cannot be determined, or where the independent core lab deems the PSVR as 
discrepant from correlating factors8, these correlating factors will be primarily considered in the 
determination of patency.  
Patency, Tibioperoneal Run-Off: Subject has at least one patent tibioperoneal run-off vessel with 
<50% stenosis confirmed by angiography at time of enrollment. 
Perforation: Puncture of an arterial wall. 
Pseudoaneurysm: Disruption of the arterial wall characterized by an out-pouching or pocket with 
swirling, flowing blood outside of the confines of the arterial lumen. 
Recurrent Occlusion: Occlusion (i.e. total obstruction of vessel lumen) after a successful canalization.   
Recurrent Thrombosis: Thrombosis (i.e. sub-total obstruction of vessel lumen) following successful 
treatment. 
Reference Vessel Diameter, Proximal (RVDprox): Diameter of normal vessel immediately proximal to 
the treated segment. 
Reference Vessel Diameter, Distal (RVDdist): Diameter of normal vessel immediately distal to the 
treated segment. 
Renal Failure (Acute): Acute post-operative renal insufficiency resulting in one or more of the 
following: (a) increase of > 1.0 mg/dl in serum creatinine from most recent prior measured level, and 
current measured absolute value is > 2.0 mg/dl; (b) a new requirement for dialysis. 
Renal Insufficiency: An increase in serum creatinine of ≥ 1.0 mg/dl over previous value requiring 
medical treatment but which does not require dialysis to resolve. 
Respiratory Failure: New onset of respiratory insufficiency that requires placement of endotracheal 
tube and/or pneumothorax with or without chest tube. 
Respiratory Insufficiency: Deterioration of subject’s respiratory efforts that require supportive or 
medical treatment. 
Restenosis: Reoccurrence of narrowing or blockage or target lesion. Recurrence of ≥ 50% diameter 
stenosis within ± 5 mm proximal and/or distal to the target lesion as measured by duplex ultrasound 
(PSV ≥ 2.0) or angiography (note: in cases where both imaging modalities are available, the 
angiography will take precedence). 
Retroperitoneal Bleed: Bleeding into the back of the abdomen from a vascular access or puncture 
site. 
                                                          
8 The core lab uses the following secondary criteria in the determination of patency [43]–[45]:  
• 
Focal increase in the absolute PSV at the area of visible plaque 
• 
Spectral broadening of the waveform at the area of stenosis 
• 
Post-stenotic turbulence and/or change in the waveform shape and/or drop in velocity distal to the 
stenosis 
• 
Review of the B-mode images for plaque burden 
 

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Rutherford Clinical Category Scale: Clinical scale identifying three grades of claudication and three 
grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss [46].  
Category 
Clinical Description 
0 
Asymptomatic 
1 
Mild claudication 
2 
Moderate claudication 
3 
Severe claudication 
4 
Ischemic rest pain 
5 
Minor tissue loss 
6 
Ulceration or gangrene 
Stent Fracture: Defined as clear interruption of stent strut observed in a minimum of two projections, 
determined by core lab examination of X-ray images. 
Stent Strut Fracture Types: [26], [47] 
Type 0: 
No strut fractures.  
Type I: 
Single strut fracture only. 
Type II: 
Multiple single strut fractures that can occur at different sites.  
Type III: Multiple strut fractures resulting in complete transection of the stent, without 
displacement of the stent segments. 
Type IV:  Multiple strut fractures resulting in displacement of segments of the stent. 
Type V: Spiral strut fracture. 
Stroke: Any neurological deficit lasting 24 hours or longer, or lasting less than 24 hours with a brain 
imaging study showing infarction consistent with deficit. May be further categorized as:  
• 
Ischemic Stroke: neurologic deficit meeting the study definition for Stroke that is attributed 
to thromboembolic event. 
• 
Hemorrhagic Stroke: neurologic deficit meeting the study definition for Stroke that is 
attributed to bleeding into brain tissue, epidural, subdural, or subarachnoid space; or a 
combination of these sites. 
Target Lesion Revascularization, Clinically-driven (CDTLR): Revascularization of the target lesion with 
objective evidence of recurrent symptoms associated with an angiographic determination of ≥50% 
stenosis and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated 
with the index limb); or ≥70% diameter stenosis in the absence of objective evidence of recurrent 
symptoms. 
Target Vessel Revascularization, Clinically-driven (CDTVR): Revascularization of the target vessel with 
objective evidence of recurrent symptoms associated with an angiographic determination of ≥50% 
stenosis and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated 
with the index limb); or ≥70% diameter stenosis in the absence of objective evidence of recurrent 
symptoms. 
Thrombocytopenia: A persistent decrease in the number of blood platelets to subnormal levels. 
Toe Brachial Index (TBI): A Toe Brachial Index (TBI) is performed when the ABI or Ankle Brachial Index 
is abnormally high due to plaque and calcification of the arteries in the leg; this is caused by 
atherosclerosis and is most often found in diabetic patients. The abnormally high ABI is >1.3. 
Instructions for TBI Calculations: 
1. Obtain systolic blood pressures (SBP) for both arms (brachials) and both great toes. 
2. Divide the higher of the two SBPs for each leg (highest between the PT and DP) by the great 
toe pressure to get the right and left TBIs. 

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Thrombus: Blood clot that obstructs a blood vessel. 
Transient Ischemic Attack: A neurological event where symptoms last for less than 24 hours, with no 
evident permanent functional impairment. 
Walking Impairment Questionnaire (WIQ): A measure of subject-perceived walking performance for 
patients with PAD and/or intermittent claudication. This questionnaire estimates walking distance, 
walking speed, and stair climbing. Improvement is defined as an increase of walking distance 
 
 

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14.0 
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APPENDIX A – CORE LABORATORIES 
In order to ensure that the clinical data and images are analyzed in a controlled, non-biased manner 
and that the results are analyzed using a standardized process, all angiograms, duplex ultrasound, and 
X-ray studies obtained during this study will be submitted to a central core lab for analysis. 
The core labs will be responsible for analyzing the angiograms, ultrasound, and X-ray images according 
to the study eligibility criteria, the study endpoints and this study Protocol, for providing feedback to 
the sites and Sponsor regarding the quality of the tracings and images and for providing a written 
summary report of all angiograms and duplex ultrasound results to the study Sponsor. 
Core lab identification: 
 
Angiography and X-ray: 
Alexandra Lansky, MD 
Yale Cardiovascular Research Group 
1 Church Street, Suite 330 
New Haven, CT 06510, USA 
 
Ultrasound: 
Ido Weinberg, MD 
Vascore Laboratory, 
Massachusetts General Physicians Organization, Inc. 
62 Staniford Street, 
Boston MA 02144, USA