FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
Phase: NA
Conditions: Pulmonary Embolism
Sponsor: Inari Medical

FlowTriever Pulmonary Embolectomy Clinical 
Study-FlowTriever2 (FLARE-FT2)
Device
FlowTriever2 Catheter
Protocol Number
21-001
Version
4.0
11-Aug-2023
Sponsor
Inari Medical
6001 Oak Canyon, Suite 100
Irvine, CA 92618
USA
CONFIDENTIALITY STATEMENT
This Clinical Investigation Plan and all attachments are considered confidential information. The contents must not be 
disclosed, unless authorized in writing by Inari Medical, except that this document may be disclosed to the appropriate 
Institutional Review Board (IRB) and other authorized regulatory bodies with similar requests for maintenance of 
confidentiality. All data and study results are similarly subjected to the same disclosure restrictions as the investigational 
plan, as stated above. All copies of this investigational plan remain the property of Inari Medical.

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CONTENTS 
PROTOCOL SYNOPSIS .................................................................................................................................... 6 
ABBREVIATIONS ............................................................................................................................................ 9 
1 
INTRODUCTION AND BACKGROUND .................................................................................................. 10 
1.1 Incidence and Fatality Rate for Pulmonary Embolism ........................................................................ 10 
1.2 Diagnosis of Pulmonary Embolism ...................................................................................................... 11 
1.3 Pulmonary Embolism Treatment & Risk Stratification ....................................................................... 11 
1.4 Classification Schema for Pulmonary Embolism ................................................................................. 12 
1.5 Risk-Based Treatment of Pulmonary Embolism .................................................................................. 13 
1.6 Treatment Options for Pulmonary Embolism ..................................................................................... 14 
1.6.1 
Anticoagulation ........................................................................................................................... 14 
1.6.2 
Open Surgical Thromboembolectomy ........................................................................................ 14 
1.6.3 
Systemic Thrombolysis ................................................................................................................ 14 
1.6.4 
Catheter Directed Thrombolysis ................................................................................................. 15 
1.6.5 
Percutaneous Pulmonary Artery Thromboembolectomy ........................................................... 15 
1.6.6 
Limitations of Currently Approved Therapy................................................................................ 15 
2 
INVESTIGATIONAL DEVICE .................................................................................................................. 17 
2.1 Device Description .............................................................................................................................. 17 
2.2 Operating Principle ............................................................................................................................. 17 
2.3 Device Construction/Operation .......................................................................................................... 17 
2.4 Manufacturer ...................................................................................................................................... 20 
2.5 Indications for Use .............................................................................................................................. 20 
3 
PRIOR INVESTIGATIONS ...................................................................................................................... 21 
3.1 FLARE Study ......................................................................................................................................... 21 
3.2 FLARE Study Results ............................................................................................................................ 22 
3.3 Design of the FLASH Study .................................................................................................................. 23 
3.4 FLASH Interim Study Results ............................................................................................................... 23 
4 
FLARE-FT2 STUDY OBJECTIVES ............................................................................................................ 25 
4.1 Primary Endpoint - Effectiveness ........................................................................................................ 25 
4.2 Primary Endpoint - Safety ................................................................................................................... 25 
4.3 Secondary Endpoints - Effectiveness .................................................................................................. 25 
4.4 Secondary Endpoints - Safety ............................................................................................................. 25 
5 
STUDY DESIGN ..................................................................................................................................... 26 

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5.1 Number of Sites and Subjects ............................................................................................................. 26 
5.2 Study Duration .................................................................................................................................... 26 
5.3 Study Population ................................................................................................................................. 26 
5.4 Study Enrollment Criteria .................................................................................................................... 27 
5.5 Inclusion Criteria ................................................................................................................................. 27 
5.6 Exclusion Criteria ................................................................................................................................. 27 
6 
FLARE-FT2 STUDY PROCEDURES ......................................................................................................... 29 
6.1 Overview of Study Flow ...................................................................................................................... 29 
6.1.1 
Subject Screening ........................................................................................................................ 29 
6.1.2 
Informed Consent ....................................................................................................................... 30 
6.1.3 
Numbering of Study Subjects ...................................................................................................... 30 
6.1.4 
Imaging and Invasive Pressure .................................................................................................... 30 
6.2 Examinations ....................................................................................................................................... 30 
6.2.1 
Baseline ....................................................................................................................................... 31 
6.2.2 
Endovascular Treatment/Procedure ........................................................................................... 32 
6.2.3 
48-Hour Follow Up (+36 hours, or at time of discharge, whichever comes first) ....................... 33 
6.2.4 
30-Day Visit (-5 to + 15 Days) ...................................................................................................... 33 
6.2.5 
Unscheduled Visits ...................................................................................................................... 33 
6.3 Handling of Lost to Follow-up Subjects ............................................................................................... 34 
6.4 Study Discontinuation ......................................................................................................................... 34 
6.5 Withdrawal/Premature Discontinuation of Study Subjects................................................................ 34 
7 
RISK AND BENEFIT ANALYSIS ............................................................................................................... 36 
7.1 Anticipated Risks ................................................................................................................................. 36 
7.1.1 
Risks During the Interventional Procedure ................................................................................. 36 
7.1.2 
Device Warnings ......................................................................................................................... 37 
7.1.3 
Risks of CT ................................................................................................................................... 37 
7.1.4 
Potential Risks of the Proposed Investigation ............................................................................ 37 
7.2 Risk Mitigation .................................................................................................................................... 38 
7.3 Potential Benefits ................................................................................................................................ 38 
7.3.1 
Potential Benefits of the Proposed Investigation ....................................................................... 39 
7.3.2 
Assessment of Uncertainty ......................................................................................................... 39 
7.4 Alternative Treatments ....................................................................................................................... 39 
8 
ADVERSE EVENT AND PRODUCT COMPLAINT RECORDING/REPORTING ........................................... 39 
8.1 Complications ...................................................................................................................................... 39 

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8.2 Adverse Events (AE) ............................................................................................................................ 40 
8.2.1 
Adverse Device Effect (ADE) ....................................................................................................... 40 
8.2.2 
Serious Adverse Event (SAE) ....................................................................................................... 40 
8.2.2.1 
Serious Adverse Device Effect (SADE) ......................................................................................... 41 
8.2.3 
Anticipated Serious Adverse Device Effect (ASADE) ................................................................... 41 
8.2.4 
Unanticipated Adverse Device Effect (UADE) ............................................................................. 41 
8.3 Event Severity ..................................................................................................................................... 41 
8.4 Event Relationship .............................................................................................................................. 41 
8.5 Adverse Event Reporting..................................................................................................................... 42 
8.6 Device Deficiency (DD) ........................................................................................................................ 42 
8.7 Clinical Events Committee .................................................................................................................. 43 
9 
STATISTICS & DATA ANALYSIS ............................................................................................................. 44 
9.1 Sample Size Calculations ..................................................................................................................... 44 
9.2 Primary Endpoint - Effectiveness ........................................................................................................ 44 
9.3 Primary Endpoint - Safety ................................................................................................................... 44 
9.4 Secondary Endpoints - Effectiveness .................................................................................................. 44 
9.5 Secondary Endpoints - Safety ............................................................................................................. 44 
10 STUDY MANAGEMENT CONSIDERATIONS .......................................................................................... 45 
10.1 Quality Control and Quality Assurance ............................................................................................... 45 
10.1.1 
Sponsor Compliance ................................................................................................................... 45 
10.1.2 
Investigator Compliance ............................................................................................................. 45 
10.1.3 
Compliance to the Protocol ........................................................................................................ 46 
10.1.4 
Protocol Deviations ..................................................................................................................... 46 
10.2 Site Selection ....................................................................................................................................... 46 
10.3 Study Training ..................................................................................................................................... 47 
10.4 Physician Device Training .................................................................................................................... 47 
10.5 Device Accountability .......................................................................................................................... 47 
10.6 Site Initiation and Addition of Site Personnel ..................................................................................... 48 
10.7 Site Close-out ...................................................................................................................................... 48 
10.8 Data Collection and Electronic Case Report Forms (eCRF) ................................................................. 48 
10.9 Study Monitoring ................................................................................................................................ 49 
10.9.1 
Monitoring Reports ..................................................................................................................... 49 
10.10 
Direct Access to Source Documents ........................................................................................... 49 
10.11 
On-Site Audits ............................................................................................................................. 50 

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10.12 
Record Storage and Retention .................................................................................................... 50 
10.12.1 Investigator Record Retention .................................................................................................... 50 
10.12.2 Sponsor Record Retention .......................................................................................................... 50 
11 ETHICS AND CONFIDENTIALITY ........................................................................................................... 51 
11.1 Ethical Conduct of the Study ............................................................................................................... 51 
11.2 Institutional Review Boards (IRB) ........................................................................................................ 51 
11.3 Study Patient Confidentiality .............................................................................................................. 51 
11.4 Investigator Responsibilities ............................................................................................................... 52 
11.5 Publication Policy ................................................................................................................................ 52 
12 TERMS AND DEFINITIONS ................................................................................................................... 53 
13 REFERENCES ........................................................................................................................................ 56 
SIGNATURE APPROVAL PAGE ...................................................................................................................... 60 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
Protocol Number  
21-001 
Study Title 
FlowTriever Pulmonary Embolectomy Clinical Study-FlowTriever2 (FLARE-FT2) 
Study Device 
FlowTriever2 Catheter 
Regulatory Status 
Under US Regulations 510(k) number K201541, the FlowTriever2 Catheter is 
indicated for: 
x 
The non-surgical removal of emboli and thrombi from peripheral blood 
vessels. 
x 
Injection, infusion, and/or aspiration of contrast media and other fluids into 
or from a blood vessel.  
 
The FlowTriever2 Catheter is intended for use in the peripheral vasculature. 
Sponsor 
Inari Medical 
6001 Oak Canyon Road, Suite 100 
Irvine, CA 92618 USA 
Study Objective 
The primary study objective is to evaluate the safety and effectiveness of the 
FlowTriever2 Catheter for the treatment of pulmonary embolism (PE). 
Study Population 
This study will enroll 50 subjects 
Number of Sites 
Five to twelve (5-12) sites will participate in the study  
Study Design 
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of 
the FlowTriever2 Catheter 
Safety Endpoints 
The study’s primary safety endpoint is incidence of adjudicated Serious Adverse 
Events (SAE), which is a composite of: 
x 
Mortality through 48 hours after the index procedure related to FlowTriever2 
Catheter 
x 
Major bleeding through 48 hours after the index procedure related to 
FlowTriever2 Catheter 
x 
Intra-procedural device or procedure-related adverse events, including: 
o 
Clinical deterioration defined by hemodynamic or respiratory worsening  
o 
Pulmonary vascular injury related to FlowTriever2 Catheter 
o 
Cardiac injury related to FlowTriever2 Catheter 
The study’s secondary safety endpoints will include incidence of adjudicated Adverse 
events, including: 
x 
All-cause mortality through the 30-day visit (visit window = 30 days from 
procedure -5 / +15 days) 
x 
Device-related SAE through the 30-day visit (visit window = 30 days from 
procedure -5 / +15 days) 
x 
Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit 
window = 30 days from procedure -5 / +15 days) 

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Effectiveness Endpoints 
The study’s primary effectiveness endpoint is the change in mean pulmonary arterial 
pressure from baseline pre-procedure and post-procedure 
 
The study’s secondary effectiveness endpoints are:  
x 
The change in systolic pulmonary arterial pressure from baseline pre-procedure 
to post-procedure 
x 
Incidence of adjunctive thrombolytic use 
Inclusion Criteria 
Patients must meet each of the following criteria to be included in the study: 
1. ŐĞшϭϴĂŶĚчϳϱǇĞĂƌƐ 
2. Clinical signs and symptoms consistent with acute PE 
3. PE ƐǇŵƉƚŽŵĚƵƌĂƚŝŽŶчϭϰĚĂǇƐ 
4. CTA evidence of proximal PE (filling defect in at least one main or lobar 
pulmonary artery) 
5. Zsͬ>sƌĂƚŝŽŽĨшϬ͘ϵ;EKd͗ŶƌŽůůŵĞŶƚƋƵĂůŝĨŝĐĂƚŝŽŶĂƐƐĞƐƐŵĞŶƚďĂƐĞĚŽŶ
Investigator’s interpretation    of RV/LV ratio) 
6. Systolic blood ƉƌĞƐƐƵƌĞшϵϬŵŵ,Ő;ŝŶŝƚŝĂů^WŵĂǇďĞшϴϬŵŵ,ŐŝĨƚŚĞ
ƉƌĞƐƐƵƌĞƌĞĐŽǀĞƌƐƚŽшϵϬŵŵ,ŐǁŝƚŚĨůƵŝĚƐͿ 
7. Stable heart rate < 130 BPM prior to procedure 
8. Patient is deemed medically eligible for interventional procedure(s), per 
institutional guidelines and/or clinical judgment. 
9. FlowTriever2 Catheter enters the vasculature 
Exclusion Criteria 
Patients will be excluded from the study for any of the following criteria: 
1. Thrombolytic use within 30 days of baseline CTA 
2. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg 
by right heart catheterization 
3. sĂƐŽƉƌĞƐƐŽƌƌĞƋƵŝƌĞŵĞŶƚĂĨƚĞƌĨůƵŝĚƐƚŽŬĞĞƉƉƌĞƐƐƵƌĞшϵϬŵŵ,Ő 
4. &ŝKϮƌĞƋƵŝƌĞŵĞŶƚхϰϬйŽƌхϲ>WDƚŽŬĞĞƉŽǆǇŐĞŶƐĂƚƵƌĂƚŝŽŶхϵϬй 
5. ,ĞŵĂƚŽĐƌŝƚ ф Ϯϴй ;EKd͗ ŚĞŵĂƚŽĐƌŝƚ ƌĞƋƵŝƌĞĚ ǁŝƚŚŝŶ ϲ ŚŽƵƌƐ ŽĨ ŝŶĚĞǆ
procedure) 
6. Platelets < 100,000/μL 
7. Serum creatinine > 1.8 mg/dL 
8. INR > 3 
9. Major trauma Injury Severity Score (ISS) > 15 
10. Presence of intracardiac lead in the right ventricle or right atrium placed 
within 6 months 
11. Cardiovascular or pulmonary surgery within last 7 days 
12. Actively progressing cancer 
13. Known bleeding diathesis or coagulation disorder 
14. Left bundle branch block 
15. History of severe or chronic pulmonary arterial hypertension 
16. ,ŝƐƚŽƌǇŽĨĐŚƌŽŶŝĐůĞĨƚŚĞĂƌƚĚŝƐĞĂƐĞǁŝƚŚůĞĨƚǀĞŶƚƌŝĐƵůĂƌĞũĞĐƚŝŽŶĨƌĂĐƚŝŽŶч
ϯϬй 
17. History of uncompensated heart failure 
18. History of underlying lung disease that is oxygen dependent 
19. History of chest irradiation 
20. History of heparin-induced thrombocytopenia (HIT) 

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21. Any contraindication to systemic or therapeutic doses heparin or 
anticoagulants 
22. Known anaphylactic reaction to radiographic contrast agents that cannot 
be pretreated 
23. Imaging evidence or other evidence that suggests, in the opinion of the 
Investigator, the Subject is not appropriate for mechanical thrombectomy 
intervention (e.g., inability to navigate to target location, predominately 
chronic clot, or non-clot embolus) 
24. Life expectancy of < 90 days, as determined by Investigator 
25. Female who is pregnant or nursing 
26. Current participation in another investigational drug or device treatment 
study 
Follow-up Schedule 
Subjects will have follow-up evaluations after the index procedure at:  
x 
48 hours (+ 36 hours or at time of discharge, whichever comes first) 
x 
30 days (-5 to +15 days) 
Safety Monitoring 
Safety events will be adjudicated by an external Clinical Events Committee (CEC). 

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ABBREVIATIONS 
Abbreviation 
Term 
AC 
Anticoagulation 
ADE 
Adverse Device Effect 
AE 
Adverse event 
AHA 
American Heart Association 
BARC 
Bleeding Academic Research Consortium 
BNP 
B-type natriuretic peptide 
CDT 
Catheter-directed thrombolysis 
CRO 
Contract research organization 
CTED 
Chronic thromboembolic disease 
CTEPH 
Chronic thromboembolic pulmonary hypertension 
CTPA 
Computed tomographic pulmonary angiography 
DD  
Device Deficiency 
DOAC 
Direct oral anticoagulant 
DVT 
Deep venous thrombosis 
ECMO 
Extracorporeal membrane oxygenation 
eCRFs 
Electronic case report forms 
ESC 
European Society of Cardiology 
FDA 
Food and Drug Administration 
FLARE 
FlowTriever Clinical Embolectomy Clinical Study 
FLASH 
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics 
FT 
FlowTriever 
H-FABP 
Heart type fatty acid binding protein 
HGB 
Hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
HIT 
Heparin-induced thrombocytopenia 
ICF 
Informed consent form 
IFU 
Instructions for use 
INR 
International normalized ratio 
IRB 
Institutional review board 
LV 
Left ventricle 
MAE 
Major adverse event 
mMRC  
Modified Medical Research Council Dyspnea Scale 
NT-proBNP 
N-terminal pro B-type natriuretic peptide 
PAPi 
Pulmonary Artery Pulsatility Index 
PE 
Pulmonary embolism 
PERT 
Pulmonary Embolism Response Team 
PESI 
Pulmonary Embolism Severity Index 
PHI 
Protected Health Information 
PMT 
Percutaneous mechanical thrombectomy 

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Abbreviation 
Term 
Post-PES 
Post-pulmonary embolism syndrome 
RV 
Right ventricle 
RV/LV 
Right ventricular to left ventricular diameter ratio 
RVSWI 
Right ventricular stroke work index 
SADE 
Serious Adverse Device Effect 
SAE 
Serious adverse event 
SIV 
Site initiation visit 
sPESI 
Simplified Pulmonary Embolism Severity Index 
TLF 
Tables, lists, and figures 
TNK 
Tenecteplase 
TPVR 
Total pulmonary vascular resistance 
TTE 
Transthoracic echocardiogram 
SVI 
Stroke volume index 
UAT 
Ultrasound-accelerated thrombolysis 
USADE 
Unanticipated Serious Adverse Device Effect 
VTE 
Venous thromboembolism 
 
1 
INTRODUCTION AND BACKGROUND 
Pulmonary embolism (PE) comprises one element of venous thromboembolism (VTE), an entity that includes DVT and PE. 
PE occurs when venous thrombi travel from the peripheral veins, through the heart, and lodge in the pulmonary arterial 
circulation. The emboli arise from peripheral locations, usually the large deep veins of the leg and pelvis, but sometimes 
from the large veins of the upper extremities. While small PE may remain asymptomatic and go unnoticed, larger emboli 
may result in significant pulmonary artery obstruction, right heart decompensation, and mortality. Some PE are 
immediately fatal, particularly large PE that lodge at the bifurcation of the main pulmonary artery into its right and left 
branches; the so-called “saddle embolus.” On the other hand, PE may occur in a repeated fashion, often over months or 
even years, insidiously obliterating the pulmonary arterial outflow to culminate in debilitating pulmonary hypertension 
and the syndrome known as chronic thromboembolic pulmonary hypertension, or “CTEPH.” 
1.1 
INCIDENCE AND FATALITY RATE FOR PULMONARY EMBOLISM 
Estimates of VTE incidence range from 75 and 269 cases per 100,000 population.1 While the actual incidence of reported 
VTE differs by global geography, the VTE increases with age, rising to 700 cases per 100,000 population in patients aged 70 
and older. PE itself occurs at differing rates in different countries; at least as reported. For instance, the rate of PE as a 
primary diagnosis of hospitalization in the United States is among the highest of the countries (Figure 1).2 The rate of PE in 
the US rose from approximately 40 to approximately 60 per 100,000 population between 1998 and 2006. These findings 
are likely attributable to an increase in the use of computed tomographic pulmonary angiography (CTPA) over the years of 
ƐƚƵĚǇ͘ƚƚŚĞƐĂŵĞƚŝŵĞ͕ƚŚĞĐĂƐĞĨĂƚĂůŝƚǇƌĂƚĞĚƌŽƉƉĞĚĨƌŽŵĂƉƉƌŽǆŝŵĂƚĞůǇϳйƚŽϰйŽǀĞƌƚŚĞƐĂŵĞǇĞĂƌƐŝŶƚŚĞh^͘Ǉ
ĐŽŶƚƌĂƐƚ͕ƚŚĞĨĂƚĂůŝƚǇƌĂƚĞŝŶŚŝŶĂĚĞĐƌĞĂƐĞĚĨƌŽŵϮϱйŝŶϭϵϵϳƚŽůĞƐƐƚŚĂŶϭϬйŝŶϮϬϬϴ; a change likely accounted for by 
an increase in the rate of diagnosis of smaller PE and, possibly, improved treatment after recognition.2 
 
 

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Figure 1. Incidence and Case-Fatality Rate for Pulmonary Embolism by Country 
Incidence is displayed on the left and fatality rate on the right. From Konstantinides et al.2 
*PE as the primary diagnosis 
†PE as any diagnosis, primary or secondary, during hospitalization 
  
1.2 
DIAGNOSIS OF PULMONARY EMBOLISM 
Traditionally, clinical prediction rules have been utilized to guide appropriate patients toward imaging analyses. Patients 
can be subcategorized using, for instance, the Geneva or Wells prediction models. When using a 3-level classification, the 
ƉƌŽďĂďŝůŝƚǇŽĨĐŽŶĨŝƌŵĞĚWŝƐϭϬй͕ϯϬй͕ĂŶĚϲϱйŝŶƚŚĞůŽǁ͕ŝŶƚĞƌŵĞĚŝĂƚĞ͕ĂŶĚŚŝŐŚ-probability categories.3 Patients in the 
latter two categories should undergo imaging such as CTPA, while patients in the low-probability category should undergo 
D-dimer testing.4 The sensitivity of the D-dimer test is high, but the specificity is low.5 For this reason, a negative test safely 
excludes PE, but further imaging is necessary when the D-dimer test is positive. 
CTPA imaging is performed in most centers today.6 Except for the evaluation of CTEPH, CTPA has replaced V/Q scan as the 
imaging test of choice. The accuracy of CTPA, however, is not uniform. Respiratory motion, reconstruction artifacts (e.g., 
“stair-step” artifact), or beam-hardening artifacts from high-density structures such as a contrast-filled superior vena cava 
may be responsible for errors.7 As well, CTPA can over-ĚŝĂŐŶŽƐĞƐŵĂůů͕ƐƵďƐĞŐŵĞŶƚĂůĞŵďŽůŝŽĨůŝƚƚůĞĐůŝŶŝĐĂůĐŽŶƐĞƋƵĞŶĐĞ͘8 
Irrespective of the clinical implications of small, subsegmental emboli on CTPA, these can be false-positive findings, and 
duplex ultrasonography of the lower extremity veins can be helpful in these cases.7, 9 
1.3 
PULMONARY EMBOLISM TREATMENT & RISK STRATIFICATION 
The treatment of PE depends on its severity. The severity is defined by the risk of mortality; a risk tightly correlated with 
ƚŚĞ ŚĞŵŽĚǇŶĂŵŝĐ ĐŽŶƐĞƋƵĞŶĐĞƐ ŽĨ ƚŚĞ ĞŵďŽůŝƐŵ͕ ŶĂŵĞůǇ͕ ĂĐƵƚĞ ƌŝŐŚƚ ǀĞŶƚƌŝĐƵůĂƌ ĚǇƐĨƵŶĐƚŝŽŶ͘ ZŝŐŚƚ ǀĞŶƚƌŝĐƵůĂƌ ;ZsͿ
dysfunction is the principal determinant of a patient’s clinical course.4, 10 The risk of hemodynamic compromise is related 
to the interplay between the size of the embolus and the baseline cardiorespiratory state of the patient. For instance, a PE 
of moderate size in a healthy patient may be unassociated with hemodynamic compromise while the same embolus in an 
elderly patient with preexisting cardiac disease may result in fulminant right heart decompensation and mortality. In this 
regard, the severity of pulmonary embolism is only partially represented by the presenting hemodynamic condition of the 
patient, and baseline comorbidities should be considered. 

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A variety of indices have been used in the prediction of outcome after PE. One, the Pulmonary Embolism Severity Index 
(PESI), has been well-validated.11 PESI risk strata I and II patients have a low risk of 30-day mortality. A simplified PESI score, 
sPESI, was also developed and validated.12-14 Patients with a sPESI score of 0 have a very low risk of adverse early outcome. 
Adding the combination of a negative cardiac troponin further increases the negative predictive value of the scores.13 It 
should be noted, however, that the PESI and sPESI risk stratifications were developed as epidemiologic tools and were not 
designed to guide the management of PE. 
1.4 
CLASSIFICATION SCHEMA FOR PULMONARY EMBOLISM 
American Heart Association. The 2019 American Heart Association (AHA) Scientific Statement on Pulmonary Embolism 
reiterates the established classification of PE into three traditional categories utilized in the literature: massive, submassive, 
and low-risk.15 The AHA document included definitions for each category. Massive PE is defined as hypotension with 
ƐǇƐƚŽůŝĐďůŽŽĚƉƌĞƐƐƵƌĞфϵϬŵŵ,ŐůĂƐƚŝŶŐŵŽƌĞƚŚĂŶϭϱŵŝŶƵƚĞƐŽƌƌĞƋƵŝƌŝŶŐŝŽŶŽƚropic support, or persistent bradycardia 
to <40 bpm with shock. Submassive PE is defined as PE without hypotension, and either RV dysfunction or myocardial 
necrosis. RV dysfunction is identified when at least one of the following is present: RV/LV ratio >0.9, RV systolic dysfunction 
on echocardiography, elevation of BNP >90 pg/mL, elevation on N-terminal pro-BNP >500 pg/mL, electrocardiographic 
changes of new right bundle-branch block, anteroseptal ST elevation or depression, or anteroseptal T-wave inversion. 
Myocardial necrosis is defined by elevation of troponin I >0.4 mg/mL or troponin T >0.1 ng/mL. Low-risk PE is a PE that falls 
short of the criteria for submassive PE; in other words, a PE without RV dysfunction or elevation of biomarkers. 
While these categories correlate roughly with the risk of mortality, the AHA document stresses that concurrent 
comorbidities must be accounted for in the prediction of mortality. For instance, a non-massive PE in a patient with 
preexisting chronic obstructive lung disease or congestive heart failure. That said, the short-term mortality approximates 
25-ϱϬйĨŽƌŵĂƐƐŝǀĞW͕ϭйĨŽƌůŽǁ-risk PE, and somewhere in between for submassive PE. 
European Society of Cardiology. The 2019 European Society of Cardiology (ESC) guidelines for the diagnosis and 
management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS) 
specified combinations of clinical presentation, imaging, biomarkers to better risk-classify patients (Figure 2).4 The ESC risk 
stratification scheme utilizes four criteria to classify PE patients into four grades of mortality risk; high, intermediate-high, 
intermediate-low, and low. 
 
 

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Figure 2: European Society of Cardiology Risk Stratification 
From Konstantinides et al4 
 
 
High-risk patients include those with all four criteria positive. These patients present in shock, PESI scores III or greater or 
sPESI scores greater than 0, RV dysfunction on imaging, and positive cardiac biomarkers indicative of myocardial necrosis. 
An intermediate-risk category is defined by the ESC guidelines, analogous to the submassive category in the literature. The 
intermediate-risk subgroup is divided into intermediate high-risk and intermediate low-risk subcategories, depending on 
whether both RV dysfunction and positive cardiac biomarkers are present (intermediate high-risk) or only one of the two 
are present (intermediate low-risk). The last category is the low-risk group and is similar to the AHA low-risk category. 
These patients present without hemodynamic compromise, have low PESI/sPESI scores, and normal imaging or laboratory 
assessments when they are performed. 
While validation of the ESC risk scale has been studied in only one large randomized clinical trial, the scale is one method 
on which to guide treatment options.16 
1.5 
 RISK-BASED TREATMENT OF PULMONARY EMBOLISM 
High-risk (massive) PE is defined as when a patient presents with shock from acute right ventricular decompensation. Early, 
definitive treatment is necessary to prevent the rapid, downhill spiral that culminates in a patient’s demise. Anticoagulation 
with the removal of the occluding pulmonary artery thrombus is indicated, either by pharmacologic, pharmacomechanical, 
or mechanical means. In certain cases, open surgical pulmonary embolectomy and even extracorporeal membrane 
oxygenation (ECMO) may be necessary. Fortunately, high-risk ƉƵůŵŽŶĂƌǇĞŵďŽůŝƐŵŽĐĐƵƌƐŝŶůĞƐƐƚŚĂŶϭϬйŽĨĐĂƐĞƐ͘17 

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The treatment of high-risk patients is clear; definitive intervention is indicated, up to and including open surgical 
thrombectomy with or without ECMO.18 Treatment of low-ƌŝƐŬƉĂƚŝĞŶƚƐŝƐĞƋƵĂůůǇĐůĞĂƌ͖ĂŶƚŝĐŽĂŐƵůĂƚŝŽŶĂůŽne is all that is 
necessary; sometimes even on an outpatient basis.19 More controversial and less well-defined, however, is the treatment 
of intermediate -risk patients – analogous to the “submassive” category of PE. Currently, there is scant data on which to 
base therapeutic decisions for the intermediate-risk group. There has been recent enthusiasm for endovascular 
interventional treatment modalities, however, utilizing catheter-directed thrombolysis, ultrasound-accelerated 
thrombolysis, or mechanical thrombectomy.20-25 
1.6 
TREATMENT OPTIONS FOR PULMONARY EMBOLISM 
1.6.1 
ANTICOAGULATION 
Anticoagulation is the mainstay of therapy for VTE, directed at decreasing the risk of recurrent embolic events and 
propagation of existing thrombi. Traditionally, unfractionated heparin followed by 3 months of oral vitamin K antagonists 
such as warfarin.26 Longer treatment with oral agents has been controversial, but individualized therapy must balance the 
risk of hemorrhage and VTE recurrence.26-28 
Some Investigators have studied low molecular weight heparin in place of unfractionated heparin and warfarin, with 
satisfactory results.29 More recently, direct oral anticoagulants (DOACs) have been employed as alternatives to warfarin in 
the setting of PE.30-32 
1.6.2 
OPEN SURGICAL THROMBOEMBOLECTOMY 
Open surgical thromboembolectomy is perhaps the first definitive interventional treatment for PE. Surgical 
ƚŚƌŽŵďŽĞŵďŽůĞĐƚŽŵǇǁĂƐĨŝƌƐƚĐŽŶĐĞŝǀĞĚďǇdƌĞŶĚĞůĞŶďƵƌŐŝŶϭϵϬϴ͖ǁŚŝůĞ<ŝƌƐĐŚŶĞƌǁĂƐƚŚĞĨŝƌƐƚƚŽƉƵďůŝƐŚƚŚĞƚĞĐŚŶŝƋƵĞ
in a 1924 report.33 Open surgical thromboembolectomy can result in rapid, life-saving hemodynamic improvement in 
patients with significant PE.18, 34 However, open surgical thromboembolectomy is a major invasive procedure, fraught with 
complications in unstable patients. The in-hospital mortalitǇƌĂƚĞŝƐŵŽƌĞƚŚĂŶϮϱй͕ĂůƚŚŽƵŐŚƚŚŝƐĨŝŐƵƌĞŵƵƐƚbe considered 
in the context of alternative therapies in this high-risk group. No randomized trials have been performed to compare the 
outcome with alternate therapies in similar patient populations. For these reasons, AHA and ESC guidelines suggest that 
open surgical intervention be reserved for hemodynamically-unstable patients with contraindications to thrombolysis.4, 15 
However, selected indications remain appropriate for open thromboembolectomy; for example, emboli in transit such as 
within the right heart or a patent foramen ovale. In this regard, the American College of Chest Physicians advocates open 
surgical intervention for patients who are severely compromised such that mortality is likely to occur before thrombolytic 
therapies can improve the patient’s hemodynamic state.35  
1.6.3 
SYSTEMIC THROMBOLYSIS 
While anticoagulation is effective in preventing recurrent PE, it does little to treat existing emboli. Treatment of obstructing 
pulmonary artery thromboembolism attains relevance in patients with intermediate-risk (submassive) and high-risk 
(massive) PE, where normalization of right heart function and reduction in mortality is important. Initially, intravenous, 
systemic thrombolysis was used for PE. After initial anecdotal success with intravenous urokinase for PE reported in 1968 
by Sasahara,36 the landmark randomized clinical trials upon which the initial US Food and Drug Administration (FDA) 
approval for urokinase was based demonstrated improved outcome with thrombolysis versus anticoagulation for 
submassive and massive PE.37-42 The benefits were limited to short-term improvement in cardiac function, but the studies 
were not powered to detect mortality differences. For the first time, however, removal of pulmonary artery thrombus was 
demonstrated to be safe, effective, and appeared advantageous compared to anticoagulation alone. 
Over the next five decades, intravenous, systemic thrombolysis was demonstrated to be effective in reducing the thrombus 
load after PE. However, this outcome was achieved at the cost of a five-fold increase in major bleeding, which in some 

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cases included intracranial hemorrhage.16, 43, 44 These findings remained unchanged despite newer agents and better 
periprocedural patient management over the years. 
1.6.4 
CATHETER DIRECTED THROMBOLYSIS 
Noting the hemorrhagic complications associated with systemic thrombolysis for PE, lower-dose, catheter-directed 
thrombolytic approaches were studied. Catheter-directed thrombolysis for PE was the subject of a meta-analysis published 
in 2009.45 In sum, catheter-directed thrombolysis appeared effective and probably safer than the systemic approach. The 
authors recommended that catheter-directed thrombolysis be considered as a first-line therapy for acute, high-risk PE. 
However, recent work suggests that even a catheter-directed approach may be associated with significant bleeding 
complications,46 although possibly at a lower rate than with systemic treatment.47 
After demonstrating the possibilities of more effective thrombolysis using ultrasound to accelerate the process, catheter-
directed, ultrasound-accelerated thrombolysis (UAT) was studied for submassive and massive PE. Two multicenter, 
prospective studies were completed, ULTIMA and SEATTLE-II. ULTIMA was a randomized analysis of UAT vs. anticoagulation 
alone in 59 subjects with submassive PE.48 UAT was more effective than anticoagulation in normalizing RV function. No 
intracranial bleeding was observed. The SEATTLE-II trial evaluated differing doses of rt-PA PAT infused over varying 
timeframes in 150 subjects with submassive and massive PE.49 These studies concluded that catheter-directed pulmonary 
artery thrombolysis with rt-PA was safe and effective in the treatment of submassive (intermediate-risk) PE, at least with 
respect to reductions in RV/LV ratio without intracranial hemorrhage. This conclusion, however, has not been without 
controversy. A 2017 review of 23 studies and 700 subjects found no difference in the rate of bleeding complications 
between UAT and standard, catheter-ĚŝƌĞĐƚĞĚ ƚŚƌŽŵďŽůǇƐŝƐ͕ ϭϮй ǁŝƚŚ hd ǀƐ͘ ϭϬй ǁŝƚŚ ƐƚĂŶĚĂƌĚ ĐĂƚŚĞƚĞƌ-directed 
thrombolysis.21 dŚĞƌĞǀŝĞǁ͕ŚŽǁĞǀĞƌ͕ĚŽĐƵŵĞŶƚĞĚĂƚƌĞŶĚƚŽǁĂƌĚŝŵƉƌŽǀĞĚƐƵƌǀŝǀĂůǁŝƚŚhd͖ϰйǀƐ͘ϵйŝŶƚŚĞhdĂŶĚ
standard thrombolytic subjects, respectively. 
1.6.5 
PERCUTANEOUS PULMONARY ARTERY THROMBOEMBOLECTOMY 
Interest in percutaneous pulmonary artery thromboembolectomy flourished on a clinical landscape of effective but 
relatively slow thrombolytic treatment of PE and risk of thrombolytic-related bleeding complications even when drugs 
were administered with a lower-dose, catheter-directed approach. Direct pulmonary arterial thromboembolectomy 
offered the opportunity for rapid removal of thrombus while limiting hemorrhagic, thrombolytic-related complications in 
those cases where thrombectomy could be utilized as a sole therapy, without pharmacologic thrombolysis. 
Historically, percutaneous thromboembolectomy for PE predated catheter-directed thrombolysis. The therapy began with 
the Greenfield suction catheter, first reported in 1969.50 After that, other technologies were attempted, including 
fragmentation of proximal emboli,51, 52 rheolytic thrombectomy,53-57 and the use of various pulmonary artery 
thromboembolectomy devices.58-60 To the extent that the percutaneous thromboembolectomy devices removed 
obstructing thromboembolism without the need for thrombolytic therapy, such devices presented the potential for 
normalization of pulmonary arterial flow without the hemorrhagic complications associated with thrombolytic agents.  This 
is the rationale for FlowTriever as it has the advantages of a percutaneous procedure, with expectation that the bleeding 
complications of thrombolysis will be minimized. 
1.6.6 
LIMITATIONS OF CURRENTLY APPROVED THERAPY 
Generally, the guidelines agree that the mainstay of treatment for massive and submassive PE is anticoagulation and that 
thrombolysis should be offered to unstable patients.4, 15, 61They further suggest that thrombolytics not be routinely used to 
treat submassive PE but should instead be considered on a per patient basis. The benefit of thrombolysis for patients with 
submassive PE is not clear and treatment may cause more harm than benefit for many patients; lytic therapy must be 
weighed against the risk of major bleeding, including the risk of intracranial hemorrhage. 

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The goal of a successful interventional procedure is to restore RV outflow through the pulmonary artery, thereby 
disrupting the potentially lethal cascade towards hemodynamic collapse. There is a strong clinical need to develop a 
reliable, rapid, percutaneous method of clot removal for the treatment of clinically significant acute PE. The need is 
especially strong for a mechanical method that does not rely on the use of thrombolytics, as physicians are reluctant 
to administer lytics given the high bleeding risk and because many patients cannot tolerate lytics. The FlowTriever 
System was developed to meet this need to rapidly restore blood flow through the pulmonary vasculature in patients 
experiencing acute submassive pulmonary embolism. Once the immediate clot burden is removed, the blood flow is 
restored and the acute physiological effects from pressure overload should begin to dissipate.  
The FlowTriever System including use of the FlowTriever Catheter was designed to remove emboli and restore blood 
flow through the pulmonary arteries. The goal in using this device is not ϭϬϬй removal of clot, but rather to remove 
enough clot to make a clinically significant difference in the patient by reducing the patient’s risk level for further 
complications and enable the endogenous thrombolysis mechanism to further reduce any residual clot. Should there 
be any residual or distal clot that is not part of the immediate emergent issue it should be treated according to the 
medical judgment of the Investigator on a case-by-case basis. 
 
 

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2 
INVESTIGATIONAL DEVICE 
2.1 
DEVICE DESCRIPTION 
The FlowTriever Retrieval/Aspiration System (“FlowTriever System”) is comprised of the FlowTriever2 Catheter and Triever 
Catheter. 
2.2 
OPERATING PRINCIPLE 
The FlowTriever2 Catheter provides a mechanical means for the retrieval of blood clots, which can then be aspirated using 
the Triever Catheter, from the vasculature. These features facilitate the reperfusion of vasculature obstructed by acute 
clot. 
The system is designed for use with a 0.035" guidewire. The outside diameter of the Triever Catheter is available in 16 Fr, 
20 Fr, and 24 Fr sizes. The outside diameter of the FlowTriever2 Catheter is 17 mm. 
An introducer sheath is used to access the appropriate vessel and place the 0.035” guidewire through and past the clot 
under fluoroscopic guidance. The Triever Catheter with dilator is then introduced over the guidewire and situated on the 
ƉƌŽǆŝŵĂů ƐŝĚĞ ŽĨ ƚŚĞ ĐůŽƚ͘ dŚĞ ƚŝƉ ŽĨ ƚŚĞ ĚŝůĂƚŽƌ ĂŶĚ dƌŝĞǀĞƌ ĂƚŚĞƚĞƌ ĐŽŶƚĂŝŶ ƌĂĚŝŽƉĂƋƵĞ ŵĂƌŬĞƌƐ ĨŽƌ ĨůƵŽƌŽƐĐŽƉŝĐ
positioning. The dilator is removed from the Triever Catheter, and the FlowTriever2 Catheter is placed over the guidewire, 
through the Triever Catheter, and is passed through the clot. The delivery catheter component of the FlowTriever2 
Catheter is retracted, causing the self-expanding wireform component of the FlowTriever2 Catheter to expand within the 
blood vessel distal to, and within, some portion of the clot. Expansion of the device may allow some blood flow to be 
restored. The proximal end of the self-ĞǆƉĂŶĚŝŶŐǁŝƌĞĨŽƌŵĐŽŶƚĂŝŶƐĂƌĂĚŝŽƉĂƋƵĞŵĂƌŬĞƌƚŽĂŝĚŝŶŵĂŝŶƚĂŝŶŝŶŐƉƌŽƉĞƌ
position. The FlowTriever2 Catheter can be manually retracted into the Triever Catheter, and simultaneous aspiration of 
fluid and clot can be performed through the Triever Catheter using a provided large-bore syringe. The device with captured 
clot is removed from the body. 
Pulmonary embolisms are caused by clots that typically originate in the leg in the form of a cast of the vessel from which 
they broke loose. The clots tend not to be the same diameter of the pulmonary artery. They travel en masse and often fold 
upon themselves, and/or collect together in the pulmonary artery, giving the appearance of a large clot. Retrieving the clot 
is similar to grabbing the head of the snake and pulling in the rest of the clot (body) as with retraction and aspiration. The 
elasticity of the clot, depending on its age, and various other factors, make it soft enough to deform during the retrieval 
process and fit into the Triever Catheter. 
2.3 
DEVICE CONSTRUCTION/OPERATION 
FlowTriever2 Catheter 

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The FlowTriever2 Catheter is comprised of a FlowTriever2 Catheter, delivery catheter, a hemostasis valve Y connector and 
one-way stopcock. The FlowTriever2 Catheter is preloaded into the delivery catheter and provided to the user in an 
assembled state (Figure 3.1).
Figure 3.1: FlowTriever2 Catheter
The outer diameter of the FlowTriever2 Catheter is 17 mm. The FlowTriever2 Catheter shaft is fabricated from stainless
ƐƚĞĞů͕WĞďĂǆ͕ĂŶĚWd&ͬ&WͬƉŽůǇŝŵŝĚĞďůĞŶĚ͘ZĂĚŝŽƉĂƋƵĞƉůĂƚŝŶƵŵŵĂƌŬĞƌďĂŶĚƐĂƌĞƉŽƐŝƚŝŽŶĞĚĂƚƚŚĞƉƌŽǆŝŵĂůĞŶĚŽĨƚŚĞ
FT2 element to aid with fluoroscopic visualization (Figure 3.2).
Figure 3.2 FlowTriever2 Catheter Model, Sizes and Dimensions
The delivery catheter is a single lumen catheter comprised of a stainless-steel braid reinforced Pebax shaft with a 
polyethylene terephthalate (PTFE) liner with a proximal Luer fitting to connect to a “Y” connector with a rotatable 
ŚĞŵŽƐƚĂƚŝĐǀĂůǀĞĂŶĚƐƚŽƉĐŽĐŬ͘ƌĂĚŝŽƉĂƋƵĞƉůĂƚŝŶƵŵŵĂƌŬĞƌŝƐƉŽƐŝƚŝŽŶĞĚŶĞĂƌƚŚĞĚŝƐƚĂůƚŝƉƚŽĂŝĚǁŝth fluoroscopic 
visualization (Figure 3.3).
Figure 3.3: Delivery Catheter

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Triever Catheter
The single-lumen Triever Catheter is available in three sizes: 16F, 20F, and 24F. The Triever Catheter and dilator are 
introduced together over a previously placed 0.035” exchange length guidewire (not provided). The Triever Catheter shaft 
is constructed from Pebax embedded with a stainless-steel coil and braid to prevent lumen collapse and provide flexibility, 
pushability, and strength. The shaft lumen is lined with PTFE. There is a Pebax/silicone hemostasis valve with a side-port 
terminating in a stopcock bonded to the proximal end of the Triever Catheter shaft. The dilator is constructed of low-
density polyethylene (LDPE) with a Luer fitting at the proximal end to accommodate a “Y” connector with a rotatable 
hemostatic valve and stopcock. The dilator is compatible with the 0.035” guidewire and is provided to facilitate Triever 
ĂƚŚĞƚĞƌĂĚǀĂŶĐĞŵĞŶƚ͘dŚĞƚŝƉŽĨƚŚĞĚŝůĂƚŽƌŝƐƌĂĚŝŽƉĂƋƵĞ͕ĂŶĚĂƌĂĚŝŽƉĂƋƵĞƉůĂƚŝŶƵŵŵĂrker is positioned near the distal 
tip of the Triever Catheter to aid with fluoroscopic visualization. A large-bore, 60 cc VacLok Vacuum Syringe is used to 
ĂƐƉŝƌĂƚĞĐůŽƚĨƌŽŵƚŚĞdƌŝĞǀĞƌĂƚŚĞƚĞƌ͘dŚĞƐǇƌŝŶŐĞŝƐĨŝƚƚĞĚǁŝƚŚĂƋƵŝĐŬ-release connector compatible with the Triever 
Catheter’s side port connector to establish an airtight seal. (Figure 3.4).
Figure 3.4: Triever Catheter Accessories and Model Dimensions

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2.4 
MANUFACTURER 
Inari Medical 
6001 Oak Canyon Road, Suite 100 
Irvine, CA 92618 USA 
2.5 
INDICATIONS FOR USE 
Under US Regulations 510(k) number K201541, the FlowTriever2 Catheter is indicated for: 
x 
The non-surgical removal of emboli and thrombi from peripheral blood vessels. 
x 
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.  
The FlowTriever2 Catheter is intended for use in the peripheral vasculature. 
 
The FLARE-FT2 study is an IDE confirmatory study evaluating the FlowTriever2 Catheter for the treatment of pulmonary 
embolism. 
At present, the FlowTriever2 Catheter is not cleared for the specific indication for which it is being tested (e.g., treatment 
of pulmonary embolism) and, thus, is not commercially available for this indication. The FlowTriever2 Catheter used to 
treat PE will be under clinical investigation at sites where the responsible Institutional Review Board (IRB) has approved 
the FlowTriever Pulmonary Embolectomy Clinical Study-FlowTriever2 (FLARE-FT2) protocol. 
Neither Inari Medical nor the Investigator may represent the investigational device as safe or effective for the purpose for 
which it is under clinical study or otherwise promote the product for this indication. 
 
 

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3 
PRIOR INVESTIGATIONS 
The FlowTriever System was first evaluated in a US pivotal Investigational Device Exemption trial, the FlowTriever Clinical 
Embolectomy Clinical Study (FLARE) study, in subjects with submassive (i.e., intermediate-risk) PE. The study was a 
prospective, multicenter study to evaluate the safety and effectiveness of the FlowTriever System in subjects eligible for 
endovascular treatment of acute PE.  The FLARE study was completed in 2017 and resulted in the FlowTriever System 
cleared indication for use in the peripheral vascular and for the treatment of PE.   
&ŽůůŽǁŝŶŐƚŚŝƐ&ĐůĞĂƌĂŶĐĞ͕ĂƐƵďƐĞƋƵĞŶƚƉŽƐƚ-market registry (FlowTriever All-Comer Registry for Patient Safety and 
Hemodynamics (FLASH)) was initiated to continue to evaluate the safety and effectiveness of the FlowTriever System for 
use in the removal of emboli from the pulmonary arteries in a real-world patient population. The all-comer nature of the 
registry allows for the evaluation of FlowTriever outcomes in a real-world population including both intermediate-risk 
and high-risk PE patients, and enrollment in the study is ongoing. 
3.1 
FLARE STUDY 
The FLARE study, IDE # G160002, was a prospective, single-arm, multicenter study conducted at 18 sites across the United 
States from April 2016 to November 2017. The study evaluated the treatment of 106 patients with intermediate risk PE 
using the FlowTriever System. The study met both of its primary endpoints, which demonstrated safety and effectiveness 
and represented a successful treatment of PE. Data from the study supported FDA 510(k) clearance (K180466) for the 
FlowTriever System. 
 
All patients enrolled in the study were symptomatic for 14 days or less, with clinical signs and presentation consistent with 
PE, including documented proximal PE by computed tomography, or CT, angiography, and a site-reported right 
ventricle/left ventricle, or RV/LV, ratio of 0.9 or greater by CT. 
 
The primary effectiveness endpoint was a reduction in core laboratory-assessed RV/LV ratio. The average RV/LV ratio 
decreased from 1.53 (n = 104) at baseline assessment to 1.15 (n = 101) in the 48 hours after treatment using the 
FlowTriever, representing a statistically significant reduction in RV/LV ratio of 0͘ϯϴŽŶĂǀĞƌĂŐĞ;Ϯϱ͘ϭй͖ƉфϬ͘ϬϬϬϭͿ͘ 
 
The primary safety endpoint was measured by device-related death, major bleeding, treatment-related clinical 
deterioration, pulmonary vascular injury or cardiac injury in the 48 hours after treatment using the FlowTriever. Four 
ƉĂƚŝĞŶƚƐ;ϯ͘ϴйͿĞǆƉĞƌŝĞŶĐĞĚƐŝǆŵĂũŽƌĂĚǀĞƌƐĞĞǀĞŶƚƐŝŶƚŚĞϰϴŚŽƵƌƐĂĨƚĞƌƚƌĞĂƚŵĞŶƚ͘ůůŵĂũŽƌĂĚǀĞƌƐĞĞǀĞŶƚƐǁĞƌĞ
determined to be procedure related, with no device-ƌĞůĂƚĞĚŵĂũŽƌĂĚǀĞƌƐĞĞǀĞŶƚƐ͘ůůĨŽƵƌ;ϯ͘ϴйͿƉĂƚŝĞŶƚƐĞǆŚŝďŝƚĞĚĐůŝŶŝĐĂů
deteriŽƌĂƚŝŽŶ͘dŚĞƌĞǁĂƐŽŶĞŵĂũŽƌďůĞĞĚŝŶŐĞǀĞŶƚ;Ϭ͘ϵйͿĂŶĚŽŶĞƉƵůŵŽŶĂƌǇǀĂƐĐƵůĂƌŝŶũƵƌǇ͘dŚĞŵĂũŽƌďůĞĞĚŝŶŐĞǀĞŶƚ
experienced by one patient was also classified as a pulmonary vascular injury and as clinical deterioration. 
 
dǁŽ ƉĂƚŝĞŶƚƐ ;ϭ͘ϵйͿ ĞǆƉĞƌŝĞŶĐĞĚ ƌĞƐƉŝƌĂƚŽƌǇ ĚĞƚĞƌŝŽƌĂƚŝŽŶ ĚƵƌŝŶŐ Žƌ ŝŵŵĞĚŝĂƚĞůǇ ĂĨƚĞƌ ƚŚĞ ƉƌŽĐĞĚƵƌĞ ƚŚĂƚ ƌĞƋƵŝƌĞĚ
ĞŵĞƌŐĞŶƚŝŶƚƵďĂƚŝŽŶ͘KŶĞƉĂƚŝĞŶƚ;Ϭ͘ϵйͿďĞĐĂŵĞĂŐŝƚĂƚĞĚĚƵƌŝŶŐƚŚĞƉƌŽĐĞĚƵƌĞ͕ƌĞƋƵŝƌŝŶŐŝŶĐƌĞĂƐĞĚƐĞĚĂƚŝŽŶ͕ĂŶĚŚĂĚĂ
ǀĞŶƚƌŝĐƵůĂƌĨŝďƌŝůůĂƚŝŽŶĞǀĞŶƚƚŚĂƚƌĞƋƵŝƌĞĚĐĂƌĚŝŽǀĞƌƐŝŽŶand emergent intubation. An additional 10 patients experienced 
serious adverse events within 30 days after treatment, none of which were determined to be procedure- or device-related. 
/ŶƚŽƚĂů͕ϭϰƉĂƚŝĞŶƚƐ;ϭϯ͘ϮйͿĞǆƉĞƌŝĞŶĐĞĚϮϲƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚƐǁŝƚŚŝŶϯϬĚĂǇƐ͕ǁŝƚŚĨŝǀĞƉĂƚŝĞŶƚƐ;ϰ͘ϳйͿĞǆƉĞƌŝĞŶĐŝŶŐ
ŵƵůƚŝƉůĞƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚƐ͘KŶĞƉĂƚŝĞŶƚ;Ϭ͘ϵйͿĚŝĞĚǁŝƚŚŝŶϯϬĚĂǇƐŽĨƚƌĞĂƚŵĞŶƚďĞĐĂƵƐĞŽĨƌĞƐƉŝƌĂƚŽƌǇĨĂŝůƵƌĞĨƌŽŵ
undiagnosed metastatic breast cancer. 
 
FLARE Study results were published in Tu T, et al. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed 
Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv 
2019.62 

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3.2
FLARE STUDY RESULTS
A total of 106 subjects that met the eligibility criteria were consecutively enrolled and treated with the FlowTriever System 
comprising the full Intent-To-Treat (“ITT”) population. Of these 106 subjects, two (2) subjects received thrombolytics during 
their index procedure and were therefore not included in the modified Intent-To-Treat (mITT) population. The mITT 
population was defined as all subjects in the “ITT Population” with no thrombolytics administered during the operative 
procedure. The primary effectiveness and safety analyses were done using the mITT population.
The disposition of subjects in the FLARE trial is depicted in Figure 4. In all, 106 subjects were enrolled and treated with the 
study device; 104 without thrombolytics. Among these, 101 had evaluable CTPA studies suitable for the primary 
effectiveness endpoint. There were also 101 subjects that had 48-hour data suitable for the primary safety endpoint. The 
mean baseline RV/LV ratio was 1.5 ± 0.4, and the mean 48-hour RV/LV ratio was 1.2 ± 0.3. Three subjects had missing 
values for the primary effectiveness endpoint at the 48-hour visit resulting in 101 subjects with both a pre-and post- RV/LV 
ratio for comparison. For these paired subjects, the mean change (reduction) in RV/LV ratio from pre- to post- was 0.38 ± 
0.3, with a range from an increase of 0.4 to a decrease of 1.4. This mean change in RV/LV ratio was 0.38 and the p-value < 
0.0001, indicating that the null hypothesis was rejected and the FlowTriever device met the performance goal.a
Figure 4. Disposition of Subjects in the FLARE Trial
For the primary safety endpoint, 4 subjects ;ϯ͘ϴйͿŝŶƚŚĞŵ/ddƉŽƉƵůĂƚŝŽŶĞǆƉĞƌŝĞŶĐĞĚŽŶĞŽƌŵŽƌĞDƐ͘dŚĞĐŽŵƉŽƐŝƚĞ
ĞŶĚƉŽŝŶƚŽĨϯ͘ϴйǁĂƐƐƚĂƚŝƐƚŝĐĂůůǇůŽǁĞƌƚŚĂŶƚŚĞƉĞƌĨŽƌŵĂŶĐĞŐŽĂůŽĨϮϱй;Ɖ-value <0.0001), with an upper one-ƐŝĚĞĚϵϱй
ĐŽŶĨŝĚĞŶĐĞůŝŵŝƚŽĨϴ͘ϲй͘dŚĞƵƉƉĞƌŽŶĞ-ƐŝĚĞĚϵϱйĐŽŶĨŝĚĞŶĐĞ ůŝŵŝƚĨŽƌƚŚĞ/ddƉŽƉƵůĂƚŝŽŶǁĂƐϴ͘ϰй͕ǁŚŝĐŚǁĂƐƐŝŐŶŝĨŝĐĂŶƚůǇ
ůĞƐƐƚŚĂŶƚŚĞƉĞƌĨŽƌŵĂŶĐĞŐŽĂůŽĨϮϱй͘
In summary, the FLARE trial met its primary safety and effectiveness endpoints. This trial was the basis for the US FDA 
510(k) clearance of the device in May 2018.
a The p-value is from a one-sided t-test (Wald statistic) from the multiple imputation analysis, testing the null hypothesis that the mean change is not 
greater than the performance goal of 0.12. 

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3.3 
DESIGN OF THE FLASH STUDY 
The primary study objective of FLASH is to evaluate the safety and effectiveness of the next-generation FlowTriever System 
for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use 
of the device is being assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical 
practice.  
The FLASH Study is a prospective, single-arm, multicenter all-comer registry of the FlowTriever System for intermediate-
risk (submassive) and high-risk (massive) PE. While originally designed to enroll up to 500 subjects at up to 50 registry sites 
in the United States, the study has been expanded to enroll up to 1,000 subjects treated with FlowTriever, including up to 
800 subjects in up to 70 US sites and up to 200 in up to 30 Europe sites. The study will also include an additional 300 
subjects with anticoagulation treatment as the initial planned primary treatment strategy for intermediate-risk PE. 
Enrollment in the FLASH registry is ongoing.  
The primary endpoint is the rate of Major Adverse Events (MAE). MAEs are defined as a composite, when one or more of 
the following events occur:  
x 
Device-related mortality through 48 hours after the index procedure, or  
x 
Major bleeding through 48 hours after the index procedure, or  
x 
Intra-procedural device or procedure-related adverse events, including: 
o 
Clinic deterioration defined by hemodynamic or respiratory worsening, or  
o 
Device-related pulmonary vascular injury, or 
o 
Device-related cardiac injury 
Secondary safety endpoints include individual components of the MAE composite endpoint, major access-site 
ĐŽŵƉůŝĐĂƚŝŽŶƐƌĞƋƵŝƌŝŶŐŽƉĞŶƐƵƌŐŝĐĂůŽƌĞŶĚŽǀĂƐĐƵůĂƌŝŶƚĞƌǀĞŶƚŝŽŶŽƌďůŽŽĚƚƌĂŶƐĨƵƐŝŽŶ͕Ăůů-cause mortality through 30 
days, and device-related serious adverse events within 30 days. Secondary effectiveness endpoints include reduction in 
pulmonary artery pressure (PAP) and other hemodynamic improvements during the procedure, and reduction in RV/LV 
ratio from baseline to 30 days and 6 months. 
3.4 
FLASH INTERIM STUDY RESULTS 
An interim analysis of outcomes out to 30 days on the first 250 subjects was recently published.63 These subjects (60.9 ± 
13.9 years, 52͘ϰйŵĂůĞͿǁĞƌĞĞŶƌŽůůĞĚĂĐƌŽƐƐϭϵƐŝƚĞƐ͕ǁŝƚŚϵϯ͘ϮйŚĂǀŝŶŐŝŶƚĞƌŵĞĚŝĂƚĞ-ƌŝƐŬWĂŶĚϲ͘ϴйŚŝŐŚ-risk PE. The 
ĂǀĞƌĂŐĞďĂƐĞůŝŶĞZsͬ>sƌĂƚŝŽǁĂƐϭ͘ϱцϬ͘ϱĂŶĚƐW^/ǁĂƐϭ͘ϲцϭ͘ϭ͘ůĞǀĂƚĞĚďŝŽŵĂƌŬĞƌƐǁĞƌĞƉƌĞƐĞŶƚŝŶϵϲ͘ϮйŽĨ
ƐƵďũĞĐƚƐ͕ĂŶĚϲϴ͘ϰйŽĨƐƵďũĞĐƚƐŚĂĚĐŽŶĐŽŵŝƚĂŶƚsd͘dŚĞƉƌŝŵĂƌǇĞŶĚƉŽŝŶƚŽĨĐŽŵƉŽƐŝƚĞDƐŽĐĐƵƌƌĞĚŝŶƚŚƌĞĞ;ϭ͘ϮйͿ
subjects, all of which were non-/,ŵĂũŽƌďůĞĞĚƐ͕ĂŶĚŶŽĚĞĂƚŚƐ;Ϭ͘ϬйͿŽĐĐƵƌƌĞĚǁŝƚŚŝŶϰϴŚŽƵƌƐ͘ 
In-hospital outcomes demonstrated significant improvements across several acute parameters. Subjects experienced 
significant on-ƚĂďůĞŚĞŵŽĚǇŶĂŵŝĐŝŵƉƌŽǀĞŵĞŶƚƐ͕ŝŶĐůƵĚŝŶŐĂϮϮ͘ϮйĚĞĐƌĞĂƐĞŝŶŵĞĂŶƉƵůŵŽŶĂƌǇĂƌƚĞƌǇƉƌĞƐƐƵƌĞ;ϯϭ͘ϵ
mmHg to 24.8 mmHg, P фϬ͘ϬϬϭͿĂŶĚĂϭϯ͘ϯйŝŶĐƌĞĂƐĞŝŶĐĂƌĚŝĂĐŝŶĚĞǆŝŶƐƵďũĞĐƚƐǁŝƚŚĂůŽǁďĂƐĞůŝŶĞĐĂƌĚŝĂc index (1.7 
to 1.9 l/min/m2, P сϬ͘ϬϬϱͿ͘dŚĞƌĞǁĂƐŽŶůǇŽŶĞ;Ϭ͘ϰйͿĂĐĐĞƐƐƐŝƚĞĐŽŵƉůŝĐĂƚŝŽŶ͘dŚĞŵĞĚŝĂŶƉŽƐƚ-procedure hospital 
length of stay was 3.0 [2.0 – 5.0] days and ICU length of stay was 0.0 [0.0 – 1.0] days.  
Thirty day follow up data was availabůĞĨŽƌϮϰϮƐƵďũĞĐƚƐŝŶƚŚŝƐĂŶĂůǇƐŝƐ͘/ŶƚŚŝƐƉŽƉƵůĂƚŝŽŶ͕ƚŚĞƌĞǁĂƐŽŶĞĚĞĂƚŚ;Ϭ͘ϰйall-
cause mortality), which was unrelated to the device, and there were 13 hospital readmissions, only one of which was 
related to the patient’s acute PE. The average RV/LV ƌĂƚŝŽŝŵƉƌŽǀĞĚďǇϮϴ͘ϯйĂƚĨŽůůŽǁƵƉ;P < 0.001) and subjects with 
confirmed baseline dyspnea had a significant improvement from baseline to 30 days (Modified Medical Research Council 
Dyspnea Scale, 2.9 ± 1.1 to 0.8 ± 1.1, P < 0.001).  

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These interim results of the FLASH all-comer registry demonstrate both safety and efficacy of the FlowTriever System, 
with a low all-ĐĂƵƐĞŵŽƌƚĂůŝƚǇƌĂƚĞ;Ϭ͘ϬйĂƚϰϴŚŽƵƌƐ͕Ϭ͘ϰйĂƚϯϬĚĂǇƐ͖ŶŽĚĞǀŝĐĞ-related deaths), along with significant 
and immediate hemodynamic improvements and continued improvements in RV/LV ratio and dyspnea out to 30 days. 
 
 
 

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4 
FLARE-FT2 STUDY OBJECTIVES  
The FlowTriever2 Catheter is a catheter-based mechanical thrombectomy device for percutaneous endovascular retrieval 
of emboli from vasculature and is intended for use in the peripheral vasculature. The FlowTriever2 Catheter is designed to 
mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing PE. 
4.1 
PRIMARY ENDPOINT - EFFECTIVENESS 
The study’s primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure 
to post-procedure.   
4.2 
PRIMARY ENDPOINT - SAFETY 
The study’s primary safety endpoint is incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: 
x 
Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter 
x 
Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter 
x 
Intra-procedural device or procedure-related adverse events, including: 
x 
Clinical deterioration defined by hemodynamic or respiratory worsening 
x 
Pulmonary vascular injury related to FlowTriever2 Catheter 
x 
Cardiac injury related to FlowTriever2 Catheter 
4.3 
SECONDARY ENDPOINTS - EFFECTIVENESS 
The study’s secondary effectiveness endpoints are:  
x 
The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure 
x 
Incidence of adjunctive thrombolytic use 
4.4 
SECONDARY ENDPOINTS - SAFETY 
The study’s secondary safety endpoints will include incidence of adjudicated Adverse events, including: 
x 
All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) 
x 
Device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) 
x 
Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure 
-5 / +15 days) 
 
 
 

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5 
STUDY DESIGN 
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 
Catheter in patients eligible for endovascular treatment of acute PE. 
5.1 
NUMBER OF SITES AND SUBJECTS 
Five to twelve (5-12) sites will participate in the Study. The total population for the Study is 50 subjects with no more than 
ϮϬйĞŶƌŽůůŵĞŶƚĂƚĂŶǇŽŶĞƐŝƚĞ. Sites are selected based on a variety of factors including, but not limited to, experience 
ǁŝƚŚĞŶĚŽǀĂƐĐƵůĂƌƚĞĐŚŶŝƋƵĞƐ͕ĂĐĐĞƐƐƚŽƌĞƋƵŝƌĞĚĨĂĐŝůŝƚŝĞƐĂŶĚĞƋƵŝƉŵĞŶƚ͕ƐƵĨĨŝĐŝĞŶĐǇĂŶĚĂĚĞƋƵĂƚĞůǇƚƌĂŝŶĞĚ personnel, 
and availability of potential subjects. The criteria used for determination will be documented. 
5.2 
STUDY DURATION 
The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is expected to 
last over a period of approximately 12 months. Each study subject will actively participate for up to 30 days (-5 / +15 days) 
following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. 
5.3 
STUDY POPULATION 
The study population consists of subjects that have a PE. Subject eligibility is to be determined based on data available to 
the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the 
study. Waivers will not be granted by the Sponsor regarding enrollment criteria. All subjects that complete the procedure 
and the follow-ups will be included in the analysis. 
In this study, subjects will be categorized as follows: 
Screen Failure: Any screened patient who does not meet the inclusion and exclusion criteria. No case report forms 
;Z&ƐͿĂƌĞƌĞƋƵŝƌĞĚĨŽƌƚŚĞƐĞƉĂƚŝĞŶƚƐ͘ůůƉĂƚŝĞŶƚƐƐĐƌĞĞŶĞĚǁŝůůďĞĚŽĐƵŵĞŶƚĞĚŽŶƚŚĞ^ĐƌĞĞŶŝŶŐͬŶƌŽůůŵĞŶƚ>ŽŐ͘ 
Enrolled Subject: All patients who met the inclusion/exclusion criteria and in whom the FlowTriever2 Catheter is  
inserted into the vasculature. These subjects will comprise the “Enrollment Population.” 
Intent-To-Treat (ITT): All “Enrolled Subjects” in whom the procedure was attempted and the FlowTriever2 
Catheter was deployed, whether successful or not. 
Modified Intent-To-Treat (mITT): All subjects in the “ITT Population” who have no thrombolytics administered 
during the procedure. 
Full Analysis Set (FAS): All subjects in the “mITT Population” that have successfully received the procedure and 
have completed the 48-hour post- procedure follow-up (+36 hours or discharge, whichever comes first) per study 
protocol. 
Completed Cases (CC): All subjects in the “mITT Population” that have successfully received the procedure and 
have completed all follow-up visits. 

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5.4 
STUDY ENROLLMENT CRITERIA 
Only patients who meet all inclusion criteria and none of the exclusion criteria are considered eligible for enrollment. 
The decision to use the FlowTriever2 Catheter will occur prior to the procedure and written informed consent will be 
obtained prior to all study-specific procedures. 
If the FlowTriever2 Catheter is not inserted into the vasculature, the subject is considered a screen failure (not meeting 
inclusion criteria for use of FT2) and is not enrolled nor entered into the EDC. 
5.5 
INCLUSION CRITERIA 
Subjects must meet all the inclusion criteria to be considered eligible for enrollment including: 
1. Age ш 18 and ч 75 years 
2. Clinical signs and symptoms consistent with acute PE 
3. PE symptom duration чϭϰ days 
4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) 
5. Zsͬ>sƌĂƚŝŽŽĨш 0.9 (NOTE͗ŶƌŽůůŵĞŶƚƋƵĂůŝĨŝĐĂƚŝŽŶĂƐƐĞƐƐŵĞŶƚďĂƐĞĚŽŶInvestigator’s interpretation  of RV/LV 
ratio) 
6. ^ǇƐƚŽůŝĐďůŽŽĚƉƌĞƐƐƵƌĞшϵϬŵŵ,Ő;ŝŶŝƚŝĂů^WŵĂǇďĞшϴϬŵŵ,ŐŝĨƚŚĞƉƌĞƐƐƵƌĞƌĞĐŽǀĞƌƐƚŽшϵϬ mmHg with 
fluids) 
7. Stable heart rate < 130 BPM prior to procedure 
8. Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical 
judgment. 
9. FlowTriever2 Catheter enters the vasculature 
5.6 
EXCLUSION CRITERIA 
Subjects must not meet any of the following general exclusion criteria: 
1. Thrombolytic use within 30 days of baseline CTA 
2. Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization 
3. Vasopressor ƌĞƋƵŝƌĞŵĞŶƚ after fluids to keep pressure ш 90 mmHg 
4. FiO2 ƌĞƋƵŝƌĞŵĞŶƚ > ϰϬйŽƌ > 6 LPM to keep oxygen saturation > ϵϬй 
5. Hematocrit < Ϯϴй (NOTE: hematocrit ƌĞƋƵŝƌĞĚ within 6 hours of index procedure) 
6. Platelets < 100,000/μL 
7. Serum creatinine > 1.8 mg/dL 
8. INR > 3 
9. Major trauma Injury Severity Score (ISS) > 15 
10. Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months 
11. Cardiovascular or pulmonary surgery within last 7 days 
12. Actively progressing cancer 
13. Known bleeding diathesis or coagulation disorder 
14. Left bundle branch block 
15. History of severe or chronic pulmonary arterial hypertension 
16. History of chronic left heart disease with left ventricular ejection fraction ч ϯϬй 
17. History of uncompensated heart failure 
18. History of underlying lung disease that is oxygen dependent 
19. History of chest irradiation 
20. History of heparin-induced thrombocytopenia (HIT) 
21. Any contraindication to systemic or therapeutic doses heparin or anticoagulants 

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22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 
23. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate 
for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic 
clot, or non-clot embolus) 
24. Life expectancy of < 90 days, as determined by Investigator 
25. Female who is pregnant or nursing 
26. Current participation in another investigational drug or device treatment study 
 
 

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6 
FLARE-FT2 STUDY PROCEDURES
6.1 
OVERVIEW OF STUDY FLOW 
Subjects presenting with PE will be evaluated by the Investigator, in accordance with their institutional practices, to 
establish an appropriate treatment plan based on the patient’s medical condition and available diagnostic screening 
procedures prior to recruitment in the FLARE-FT2 Clinical Study. A representative overview of the study flow is shown 
in Figure 5. 
 
FIGURE 5. Representative Study Flow from Screening to Discharge 
 
6.1.1 
SUBJECT SCREENING 
Patients will be screened to determine their initial eligibility and interest in the study. Informed consent will be 
obtained once a patient has satisfied screening criteria and prior to any study-specific procedures not part of 
standard of care. All patients screened will be documented on the Screening/Enrollment Log. 

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6.1.2 
INFORMED CONSENT  
Written, study-specific informed consent will be obtained from each patient via the current IRB-approved 
Informed Consent Form (ICF) prior to the patient’s de-identified medical record or personal health information 
(PHI) being shared with any study representative. The Investigator will keep the original ICF and a copy will be 
given to the patient. The patients will be informed that they are free to refuse entry into the study and free to 
withdraw from the study at any time without prejudice to future treatment. The patients will also be informed 
about study purpose, alternative treatments, potential risks/benefits, and study assessment schedule. 
6.1.3 
NUMBERING OF STUDY SUBJECTS 
Each site will be assigned a site number at the beginning of the Study and each enrolled Subject will be assigned 
ĂƐĞƋƵĞŶƚŝĂůƐƵďũĞĐƚŶƵŵďĞƌ͘ůů^ƵďũĞĐƚƐǁŚŽƉƌŽǀŝĚĞŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚĂŶĚŚĂǀĞƚŚĞƐƚƵĚǇƉƌŽĐĞĚƵƌĞǁŝůůďĞ
ŐŝǀĞŶĂƵŶŝƋƵĞƐƵďũĞĐƚŶƵŵďĞƌĂŶĚƚŚĞƐƵďũĞĐƚŶƵŵďĞƌǁŝůůďĞƌĞĐŽƌĚĞĚŽŶƚŚĞ^ĐƌĞĞŶŝŶŐͬŶƌŽůůŵĞŶƚ>ŽŐ͘dŚĞ
subject numbĞƌǁŝůůĐŽŶƐŝƐƚŽĨƚŚĞƐŝƚĞŶƵŵďĞƌĨŽůůŽǁĞĚďǇĂƐĞƋƵĞŶƚŝĂůŶƵŵďĞƌƚŚĂƚďĞŐŝŶƐǁŝƚŚ͞ϬϬϭ͘͟ 
6.1.4 
IMAGING AND INVASIVE PRESSURE 
Computed Tomography Angiography (CTA) 
dŚĞ^ƚƵĚǇƌĞƋƵŝƌĞƐĂdďĞŽďƚĂŝŶĞĚĨŽƌƐƵďũĞĐƚƐĐƌĞĞŶŝŶŐƚŽĐŽŶĨŝƌŵƉƵůŵŽŶĂƌǇĞŵďŽůŝƐŵĂŶĚǀĞƌŝĨǇZsͬ>s
ratio for inclusion. 
Invasive Pulmonary Artery (PA) Systolic Pressure 
Once access is achieved, a pre-procedure invasive PA systolic pressure will be obtained prior to beginning the 
FlowTriever part of the procedure. After the FlowTriever System has been removed, a post-procedure invasive 
PA systolic pressure will be obtained to assess change between end mean and pulmonary arterial pressures and 
baseline.  
6.2 
EXAMINATIONS 
dŚĞĨŽůůŽǁŝŶŐƚĂďůĞĚĞƚĂŝůƐƚŚĞĐůŝŶŝĐĂůĂŶĚůĂďŽƌĂƚŽƌǇƉƌŽĐĞĚƵƌĞƐƌĞƋƵŝƌĞĚĨƌŽŵ^ĐƌĞĞŶŝng through the 30-day follow-
up visit. The majority of these tests and procedures are considered standard of care for all patients under treatment 
of clinically significant PE. 
All scheduled exams listed in Table 1 must be performed at the designated time point and the results documented. 
 
 

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Table 1: Schedule of Assessments
Assessment/Method
Baseline
Procedure
(Day 0**)
48-Hr Visit
(+36 hours, or time 
of discharge, 
whichever comes
first****)
30-Day Visit
(-5 to +15 days)
Verification of
inclusion/exclusion
criteria
Medical/Surgical History
Physical
Examination/Vitals
Blood Labs
CT Angiography
Invasive PA Pressure
(x2)*
Concomitant
Medications***
Adverse Events
*Invasive PA pressures ƌĞƋƵŝƌĞĚ pre- and post-procedure
**Day 0 is the date of the FlowTriever procedure, Time 0 is when the FlowTriever2 Catheter enters the
vasculature
*** Anticoagulation and Thrombolytics
****If discharged prior to 48 hours from Index Procedure, phone call to subject will be conducted to 
confirm if any SAEs occurred between time of discharge and 48 hours.
6.2.1
BASELINE 
Baseline assessments will include the following:
x
Verification of inclusion/exclusion criteria
x
Medical history
x
Physical examination/vitals
x
Blood labs
x
CT angiography to confirm PE and RV/LV ratio for inclusion
x
Concomitant medications
Medical/Surgical History: Relevant medical and surgical history will be collected from all consented subjects 
at the time of enrollment.
Blood Labs: The following blood values must be available to assess Subject eligibility for the study and for 
baseline data collection: hematocrit, hemoglobin, platelet count, serum creatinine, and International
Normalized Ratio (INR).
Concomitant Medications: /ƚŝƐƌĞƋƵŝƌĞĚƚŚĂƚƚŚĞƐƵďũĞĐƚ͛ƐƌĞůĞǀĂŶƚĐŽŶĐŽŵŝƚĂŶƚŵĞĚŝĐĂƚŝŽŶƵƐĞĚƵƌŝŶŐƚŚĞ
study be documented at pre-procedure, procedure, and follow- up visits.

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As part of the routine care to treat PE, anticoagulation medication is administered to impede blood clotting 
and thrombolytic medication may be administered to dissolve blood clots. The specific dose and course of 
administration is at the discretion of the Investigator and will be recorded on the case report form (CRF). 
6.2.2 
ENDOVASCULAR TREATMENT/PROCEDURE 
Once all inclusion/exclusion criteria have been satisfied, including imaging assessments, the subject will 
proceed with the mechanical thrombectomy procedure using the FlowTriever2 Catheter. 
Sites will complete the procedure per standard institutional guidelines and physician discretion. The 
ƉƌŽĐĞĚƵƌĞƌĞƋƵŝƌĞŵĞŶƚƐĨƌŽŵƚŚĞ/-specific IFU for the use of the FlowTriever 2 Catheter are listed 
below. Refer to the IDE-specific IFU for more information on the appropriate use of the device for this 
study. 
x 
Administer IV sedation or general anesthesia, as appropriate, to assure subject comfort and safety. 
x 
Administer/continue to administer anticoagulation medications per standard institutional guidelines. 
x 
Access the target area via femoral or jugular vein per standard institutional guidelines for thrombectomy 
procedures. 
For use in Pulmonary Arteries: 
o 
Place an exchange length 0.035” guidewire into the target vessel through the right atrium and into 
the target pulmonary artery. 
o 
Using angiographic radiography, determine the location and size of the area to be treated. 
o 
Verify that the guidewire extends beyond the treatment area. 
WARNING: Do not treat vessels smaller than 6 mm diameter. 
x 
Refer to the respective Instructions for Use (IFU) for Triever Preparation. Prepare and insert the Triever20 
or Triever24.Attach the “Y” connector to the proximal Luer connector by sliding over the FlowTriever2 
Catheter shaft. 
x 
Flush the Delivery Catheter through the stopcock with sterile saline to remove all air. Tighten the rotatable 
hemostatic valve. Close stopcock. 
x 
Place the FlowTriever2 Delivery Catheter containing the collapsed FlowTriever2 element over the 
guidewire, through the Triever Catheter, and advance through the target clot. 
WARNING: Avoid using excessive force to advance or retract against resistance. If excessive resistance 
occurs, retract, and collapse the distal element into the catheter and remove the device. Excessive force 
against resistance may result in damage to the device or vessel perforation. 
x 
Pin the guidewire. While maintaining the Triever Catheter and FlowTriever2 Catheter position, manually 
retract the FlowTriever2 Delivery Catheter enough to allow the self-expanding element to expand within or 
beyond some portion of the clot. 
o 
dŚĞƉƌŽǆŝŵĂůĂŶĚĚŝƐƚĂůĞŶĚƐŽĨƚŚĞĞůĞŵĞŶƚĐŽŶƚĂŝŶĂƌĂĚŝŽƉĂƋƵĞŵĂƌŬĞƌƚŽĂŝĚŝŶŵĂŝŶƚĂŝŶŝŶŐ 
proper position as the FlowTriever2 Delivery Catheter is retracted. 
x 
Lock the FlowTriever2 Catheter and the Delivery Catheter together by tightening the Tuohy-Borst 
connector. 
x 
Manually retract the FlowTriever2 Catheter inside the Triever Catheter to capture the targeted thrombus. 
x 
Remove the FlowTriever2 Catheter from the Triever Catheter while maintaining the position of the Triever 
Catheter and guidewire. Depress the buttons on the Triever Catheter hemostasis valve as the FlowTriever2 
element passes through the valve septum. 
x 
Perform aspiration via the Triever Catheter side port using the 60-cc syringe provided in the package to 
capture additional thrombus. This step can be performed before and/or after the manual FlowTriever2 
Catheter retraction. 
x 
If thrombus remains, repeat steps 4-9. 
Caution: If the same FlowTriever2 Catheter device is used for another pass, the FlowTriever2 Catheter 
device and element should be thoroughly examined for damage and rinsed to prevent the introduction of 
thrombus to the patient. 

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x 
After the procedure is complete, remove the Triever Catheter and FlowTriever2 Catheter from the patient. 
x 
Complete the procedure per standard institutional guidelines for thrombectomy procedures. 
The FlowTriever System, including the FlowTriever2 Catheter, must be the only device used for 
thrombectomy. Additional adjunctive drugs may be used at the discretion of the Investigator. Post-
procedure, the Investigator will review all images, clinically assessing the PE status and looking for evidence 
of vessel injury (perforation/dissection). An Inari Medical representative may be present during the 
thrombectomy procedure. 
Procedure assessments will include the following: 
x 
Invasive PA pressure (pre- and post-procedure) 
x 
Record concomitant medications 
x 
Record adverse events, as applicable 
6.2.3 
48-HOUR FOLLOW UP (+36 HOURS, OR AT TIME OF DISCHARGE, WHICHEVER COMES FIRST) 
The sites will complete the following assessments on the subjects at the 48-hour visit or at time of discharge, 
whichever comes first: 
x 
Physical examination and vitals 
x 
Record adverse events, as applicable 
x 
Record concomitant medications 
 
*Note: If discharged prior to 48 hours from Index Procedure, phone call to subject will be conducted to confirm if 
any SAEs occurred between time of discharge and 48 hours. 
6.2.4 
30-DAY VISIT (-5 TO + 15 DAYS) 
The sites will complete the following assessments either remotely or in-person on the subjects at the 30-Day Visit 
(visit window = 30 days from procedure -5 days / +15 days): 
x 
Physical examination and vitals 
x 
Record adverse events, as applicable 
x 
Record concomitant medications 
x 
Complete Study Exit form 
If the 30-Day Visit is ĐŽŵƉůĞƚĞůǇƌĞŵŽƚĞůǇ͕ƚŚĞƉŚǇƐŝĐĂůĞǆĂŵŝŶĂƚŝŽŶĂŶĚǀŝƚĂůƐĂƌĞŶŽƚƌĞƋƵŝƌĞĚ͘ 
Subjects who expire during their participation will be documented on an Adverse Event form and Study Exit form. 
Sites will fill out the Study Exit form for all enrolled subjects, regardless of reason, at the 30-Day Visit. 
6.2.5 
UNSCHEDULED VISITS 
The unscheduled assessments should be done as clinically indicated and corresponding data must be documented 
on the case report forms and submitted to the Sponsor. The study will only record patient visits during the follow-
up period that are related to the patient’s PE condition and treatment including: 
• 
Physical examination/vitals 
• 
Concomitant medications 
• 
Adverse events 

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6.3 
HANDLING OF LOST TO FOLLOW-UP SUBJECTS 
Every attempt must be made to have all subjects complete the follow-up visit schedule. A subject will be considered 
lost-to-follow-up when all efforts to obtain compliance are unsuccessful. At a minimum, the effort to obtain follow-
up information must include two attempts to make contact and must be documented in the subject’s medical 
records and appropriate study records.   
6.4 
STUDY DISCONTINUATION 
The Sponsor and applicable regulatory authorities have the right to terminate the entire study or study activities at 
an individual site at any time. The circumstances which may warrant study termination include, but are not limited 
to: 
• 
Increased incidence of adverse experiences and/or the severity of such, suggestive of a potential, 
device-related health hazard, or 
• 
Insufficient subject enrollment rates, or 
• 
Recurrent protocol deviations or other non-compliances, or 
• 
Inaccurate, incomplete, and/or untimely data recording on a recurrent basis, or 
• 
>ĂĐŬŽĨĐŽŽƉĞƌĂƚŝŽŶǁŝƚŚŵŽŶŝƚŽƌŝŶŐǀŝƐŝƚƐ;Ğ͘Ő͕͘ĨĂŝůƵƌĞƚŽĂĚĞƋƵĂƚĞůǇƉƌĞƉĂƌĞĨŽƌǀŝƐŝƚƐ͕ĂĚĚƌĞƐƐĂĐƚŝŽŶ
items from one visit to the next, or provide access to medical records) 
Study Discontinuation by IRB 
The IRB may choose to discontinue the Study at any center(s) for which they granted approval if the: 
• 
Research study is not conducted in accordance with the IZ͛ƐƌĞƋƵŝƌĞŵĞŶƚƐ 
• 
Research study indicates unexpected serious harm to subjects 
Study Discontinuation by Sponsor 
The Sponsor may choose to discontinue the Study should the Sponsor discover additional information during the 
Study that may cause harm to subject safety. If the Study is terminated or suspended, the Sponsor will promptly 
inform all Investigators of the termination or suspension and the reason(s) for this. The IRB will also be informed, 
either by the Sponsor or Investigator if a local IRB is utilized, promptly and provided with the reason(s) for the 
termination or suspension. If applicable, regulatory authorities will be informed. 
6.5 
WITHDRAWAL/PREMATURE DISCONTINUATION OF STUDY SUBJECTS 
^ƵďũĞĐƚƐŵĂǇǁŝƚŚĚƌĂǁĨƌŽŵƚŚĞ^ƚƵĚǇĂƚĂŶǇƚŝŵĞƵƉŽŶǁƌŝƚƚĞŶƌĞƋƵĞƐƚ͕ŽƌƚŚĞǇŵĂǇďĞǁŝƚŚĚƌĂǁŶĂƚĂŶǇƚŝŵĞĂƚ
the discretion of the Investigator or Sponsor for safety or administration reasons. 
Subject Discontinuation by Investigator 
An Investigator may discontinue a Subject from the Study, with or without the Subject’s consent, for any reason that 
may, in the Investigator’s opinion, negatively affect the well- being of the Subject. 
Withdrawal by Subject 
If a Subject chooses to withdraw from the Study and also withdraws consent for disclosure of future information, no 
further evaluation(s) will be performed, and no additional data will be collected. The Sponsor may retain and 

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continue to use any data collected prior to the withdrawal of consent, unless specified by the Subject or legally 
authorized representative. 
The reason for, and date of, withdrawal must be recorded on the patient’s Study Exit CRF. If the reason for the 
withdrawal is a device-related or procedure-related AE, the event must be reported to the Sponsor and recorded in 
the CRF. 
 
 

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7 
RISK AND BENEFIT ANALYSIS 
A risk analysis according to ISO 14971 (Application of Risk Management to Medical Devices) has been 
conducted. Risks have been minimized or eliminate through appropriate design and confirmed by pre-clinical 
bench, laboratory, and animal testing. 
The FlowTriever2 Catheter provides a means for the removal of pulmonary emboli to facilitate the restoration 
of circulation to the pulmonary vasculature by minimally invasive means. Alternative therapies to endovascular 
clot retrieval in the treatment of pulmonary embolism include anticoagulation, thrombolytic therapy (systemic 
or catheter-directed), pharmacomechanical catheter-directed thrombolysis, catheter intervention, and surgical 
thrombectomy. 
Anticoagulation therapy has bleeding risks and a slow onset of action. Thrombolytic therapy has a risk of major 
hemorrhage, including the risk of hemorrhagic stroke, that may negate the potential benefit derived from this 
therapy and is not available to patients with absolute and relative contraindications to its use. As with 
anticoagulation therapy, thrombolytics’ onset of action is prolonged. 
Pharmacomechanical catheter-directed devices may allow lower dosages of thrombolytics but are nevertheless 
not appropriate or effective in certain patient populations. Catheter interventions have not been studied in a 
trial with anticoagulation alone and are often used in combination with thrombolytics. Open surgical 
embolectomy is a highly invasive suƌŐŝĐĂůƚĞĐŚŶŝƋƵĞǁŝƚŚĂƐŝŐŶŝĨŝĐĂŶƚŵŽƌƚĂůŝƚǇƌĂƚĞ͘ 
The goal of the FlowTriever2 Catheter is the safe and expeditious removal of the obstructing thrombi from the 
pulmonary arteries to facilitate right ventricular recovery. 
7.1 
ANTICIPATED RISKS 
A risk analysis according to ISO 14971 (Application of Risk Management to Medical Devices) has been 
conducted. Risks have been minimized or eliminated through appropriate design control, and confirmed by 
pre-clinical bench, laboratory and animal testing. 
7.1.1 
RISKS DURING THE INTERVENTIONAL PROCEDURE 
Possible complications may occur during an interventional procedure. These complications include but are not 
limited to the following: 
 • 
Access site hematoma 
• 
Adverse reaction to device materials 
• 
Aneurysm 
• 
Angina 
• 
Air embolism 
• 
Arrhythmias 
• 
Arteriovenous fistula 
• 
Bradycardia 
• 
Cardiac tamponade 
• 
Cardiogenic shock 
x 
 
Cardiac Perforation 
• 
Death 
• 
Distal embolism 
• 
Drug reaction to contrast, thrombolytic 
or anticoagulation 
• 
Embolism 
• 
Fever 
• 
Foreign body embolism 
 • 
Fistulation 
• 
General discomfort, tenderness or pain 
• 
Hemoglobinuria 
• 
Hemolysis 
• 
Hemoptysis 
• 
Hypo/Hypertension 
• 
Hypoxemia 
• 
Infection 
• 
Inflammatory response 
• 
Myocardial infarction 
• 
Nausea/vomiting 
• 
Neurological deficit 
• 
Organ impairment 
• 
Pericardial effusion 
• 
Perforation of pulmonary arteries 
• 
Peripheral nerve damage 
 • 
Pneumothorax 
• 
Pseudoaneurysm 

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• 
Pulmonary edema 
• 
Pulmonary infarction 
• 
Renal failure 
• 
Respiratory failure 
• 
Retroperitoneal hemorrhage 
• 
Right bundle branch block 
• 
Stroke/transient ischemic attack 
• 
Tachycardia 
• 
Valvular disruption/injury 
• 
Vascular spasm 
• 
Vasovagal reaction 
• 
Ventricular rupture 
• 
Vessel dissection/perforation 
• 
Vessel stenosis 
 
7.1.2 
DEVICE WARNINGS 
The following warnings are labeled for the FlowTriever2 Catheter:  
x 
Intended for single use only.  
x 
Do not re-sterilize or reuse this device 
x 
Should be   used   in   conjunction with   fluoroscopic   guidance and proper anticoagulation agents. 
x 
Examine the catheter before use to verify it is not damaged. 
x 
Use before the “Use By” date specified on the product packaging. 
x 
Avoid using excessive force to advance or retract against resistance. If excessive resistance occurs, retract 
and collapse the distal element into the catheter and remove the device. Excessive force against resistance 
may result in damage to the device or vessel perforation. 
x 
In the event of patient deterioration, remove FlowTriever2 Catheter/Triever device and assess situation. 
x 
Ensure that FlowTriever2 element is withdrawn into Triever Catheter prior to removal from patient to avoid 
vascular damage. 
x 
Do not use in blood vessels that have a history of therapeutic irradiation. Vessel perforation may occur. 
7.1.3 
 RISKS OF CT 
x 
High radiation exposure in cases of repeated examinations; possible increase in risk of cancer 
x 
Rise in serum creatinine levels 
x 
Nephropathy 
7.1.4 
POTENTIAL RISKS OF THE PROPOSED INVESTIGATION 
The risks associated with the FlowTriever2 Catheter are on the order of coronary endovascular interventions 
and catheter-directed embolectomies. Potential risks and complications include those resulting from 
anticoagulation and contrast dye, including bleeding, contrast-induced nephropathy, and anaphylactic 
reactions to iodine contrast. Potential vascular access complications include bleeding, hematoma, 
arteriovenous fistula, and pseudoaneurysm. The most serious complication resulting from catheter-directed 
procedures is perforation or dissection of a pulmonary artery, causing massive pulmonary hemorrhage and 
immediate death. The risk of perforation increases with smaller vessels. Other serious complications include 
pericardial tamponade, pneumothorax, cardiac rupture and cardiac arrest. Transient, periprocedural 
complications include arrhythmias when the catheter advances through the right heart, right heart block or 
bradycardia, worsening hypoxemia, and hemodynamic deterioration. The above risks are no greater with the 
use of the FlowTriever2 Catheter than that of any coronary endovascular intervention or catheter-directed 
embolectomy procedure. 
Malfunction of the device could result in cardiac damage and artery dissection/perforation of the artery; these 
are thought to be the most severe complications associated with the FlowTriever procedure. Manufacturing 
ĐŽŶƚƌŽůƐ ĂƌĞ ŝŶ ƉůĂĐĞ ƚŽ ĞŶƐƵƌĞ ĐŽŶƐŝƐƚĞŶƚ ƉƌŽĚƵĐƚ ƋƵĂůŝƚǇ ĂŶĚ ƚŽ ŵŝŶŝŵŝǌĞ ĚĞĨĞĐƚŝǀĞ ĚĞǀŝĐĞƐ ĞŶƚĞƌŝŶŐ
distribution. 
Under fluoroscopic guidance, the device is tracked over the guidewire into the pulmonary artery to the site of 
the pulmonary emboli. Use of fluoroscopic guidance for vascular access minimizes the risk of access failure and 

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vascular complications, such as vessel perforation and vessel trauma. To further minimize the risk of perforation 
or dissection, the FlowTriever2 Catheter will only be used in the main and lobar pulmonary artery branches and 
will not be attempted in smaller vessels (< 6 mm diameter). 
Mechanical thrombus retrieval from the pulmonary arteries can, in theory, result in dispersion of some residual 
thromboembolic material distal to the central obstruction to the periphery of the lungs. With fragmentation 
devices, the fundamental objective is to eliminate central thrombi and fragment them so that they migrate to 
more distal branches, thus alleviating main pulmonary obstruction, which allows both an improved perfusion 
and a reduction of elevated pulmonary arterial pressures right ventricular pressure overload. Worsening of 
hemodynamic parameters due to distal embolization can occur, however, available clinical data does not 
ĂƐƐŽĐŝĂƚĞ ƐĞƌŝŽƵƐ ĂĚǀĞƌƐĞ ƐĞƋƵĞůĂĞ ĚƵĞ ƚŽ ĚŝƐƚĂů ĞŵďŽůŝǌĂƚŝŽŶ ŝŶ W ƉĂƚŝĞŶƚƐ ƚƌĞĂƚĞĚ ǁŝƚŚ ĨƌĂŐŵĞŶƚĂƚŝŽŶ
devices. Since the primary mode of action of the FlowTriever2 Catheter is clot retrieval, the potential for distal 
showering of thromboemboli does exist, but with the synchronized thrombus removal mechanism of the 
&ůŽǁdƌŝĞǀĞƌϮĂƚŚĞƚĞƌĂŶĚĂƐƉŝƌĂƚŝŽŶĐĂƉĂďŝůŝƚǇŽĨƚŚĞdƌŝĞǀĞƌĂƚŚĞƚĞƌ͕ŝƚŝƐĂŶƚŝĐŝƉĂƚĞĚƚŽŽĐĐƵƌůĞƐƐĨƌĞƋƵĞŶƚůǇ
and to a lesser degree than devices that rely solely upon fragmentation. The minimal risk of distal embolization 
is outweighed by the anticipated benefits of the FlowTriever2 Catheter in the acute relief of the pulmonary 
arterial emboli. 
Finally, while the intent of FlowTriever2 intervention is not to remove the entire embolic load, the risk of clot 
remaining after the embolectomy procedure is mitigated by the physician’s ability to deliver thrombolytic to 
enhance both the impact of clot extraction and the body’s natural lytic system. Future thrombolytic therapy is 
not precluded following FlowTriever2 treatment. 
7.2 
RISK MITIGATION 
Awareness of the potential for serious complications is essential to the safe use of the FlowTriever2 Catheter. 
Additional risk mitigations include: 
x 
Careful patient selection based on study inclusion/exclusion criteria, 
x 
Use of study sites that have sufficient expertise and resources to manage adverse events and provide 
appropriate additional therapies if needed, 
x 
Specialized/experienced Investigators with appropriate training,  
x 
Timely reporting of adverse events, 
x 
Independent Clinical Events Committee, and  
x 
Informed consent process. 
7.3 
POTENTIAL BENEFITS 
There are no guaranteed benefits from participation in this study. In general, endovascular interventions (e.g., 
catheterization) are well-established in medical practice and are substantiated to minimize the risks to patients 
of: anesthesia complications, wound healing, bleeding and infection. The tissue and other bodily trauma 
associated with open surgical procedures are much greater compared to minimally invaƐŝǀĞƚĞĐŚŶŝƋƵĞƐ͘Ɛ
more tissue is exposed to air in an open surgical procedure, the risk of infection is greatly increased. As such, 
the medical option of an open surgical procedure is far inferior to the safer, less traumatic, endovascular 
procedure. The reduced tissue trauma may benefit the subject by reducing pain as well as faster recovery time. 
By minimizing tissue manipulation, the FlowTriever System may also benefit medical practice by reducing the 
operative time offering potential cost savings. 
Systemic administration of thrombolytic agents carries significant risk of bleeding, especially when predisposing 
conditions or comorbidities exist. Disruption of the emboli by the FlowTriever2 Catheter may enhance the 
effectiveness of thrombolytic agents by providing greater surface area contact of the therapeutic agent with 
the embolic mass. The aspiration of the emboli from the vasculature minimizes the potential for re-thrombosis 
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Information gained from the conduct of this Study may be of benefit to other persons with the same medical 
condition. 
7.3.1 
POTENTIAL BENEFITS OF THE PROPOSED INVESTIGATION 
Endovascular interventions (e.g. catheterization) are well-established in medical practice and are substantiated 
to minimize the risks to patients, including: anesthesia complications, wound healing, bleeding, and infection. 
FlowTriever intervention has an immediate impact on the vascular obstruction. The FlowTriever intervention is 
not reliant on the use of thrombolytics and therefore the FLARE-FT2 trial does not exclude patients with recent 
surgeries nor those at a high risk of catastrophic bleeding. 
7.3.2 
ASSESSMENT OF UNCERTAINTY 
There is a low degree of uncertainty regarding anticipated benefits of the clinical study since any amount of 
thrombus removal should be beneficial to the patient. 
7.4 
ALTERNATIVE TREATMENTS 
There is no obligation for a Subject to take part in this Study. Alternative treatments may include: 
x 
Medical Therapy: Includes the use of anticoagulation therapy alone and/or systemic thrombolytics. 
x 
Catheter-Directed Therapy: Pharmacomechanical delivery of intrapulmonary thrombolytics, with or 
without ultrasound assistance. 
x 
Mechanical Thrombectomy Device: An alternate FDA cleared catheter-based device designed to remove, 
fragment or dissolve blood clot. 
x 
Surgical Embolectomy: Surgical removal of the pulmonary embolism. 
The Investigator will inform the Subject as to what alternative methods are suitable and available. 
8 
ADVERSE EVENT AND PRODUCT COMPLAINT RECORDING/REPORTING 
Subject safety is of the utmost importance. Each Investigator has the responsibility for the safety of the subjects 
under his/her care. For purposes of understanding data and relevant confounders, assessment of clinical outcomes 
and/or SAEs possibly related or probably related to PE condition or complications thereof will be recorded. 
8.1 
COMPLICATIONS 
Complications should be reported on a per-subject basis and categorized according to the SIR Classification of 
Complications by Outcome as follows: 
x 
Minor Complications 
o 
EŽƚŚĞƌĂƉǇ͕ŶŽĐŽŶƐĞƋƵĞŶĐĞ 
o 
EŽŵŝŶĂůƚŚĞƌĂƉǇ͕ŶŽĐŽŶƐĞƋƵĞŶĐĞ;ŝŶĐůƵĚĞƐŽǀĞƌŶŝŐŚƚĂĚŵŝƐƐŝŽŶ for observation only) 
x 
Major Complications 
o 
ZĞƋƵŝƌĞƚŚĞƌĂƉǇ͕ŵŝŶŽƌŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ;чϰϴŚŽƵƌƐͿ 
o 
ZĞƋƵŝƌĞŵĂũŽƌƚŚĞƌĂƉǇ͕ƵŶƉůĂŶŶĞĚŝŶĐƌĞĂƐĞŝŶůĞǀĞůŽĨĐĂƌĞ͕ƉƌŽůŽŶŐĞĚŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ;хϰϴŚŽƵƌƐͿ 
o 
WĞƌŵĂŶĞŶƚĂĚǀĞƌƐĞƐĞƋƵĞůĂĞ 
o 
Death 

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8.2 
ADVERSE EVENTS (AE) 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated. (ISO 14155:2020 3.2) 
NOTE 1: This definition includes events related to the investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices 
or the comparator. 
Disease signs and symptoms that existed prior to study participation are not considered AEs unless the condition 
recurs after the subject has recovered from pre-ĞǆŝƐƚŝŶŐĐŽŶĚŝƚŝŽŶ͕ŽƌƚŚĞĐŽŶĚŝƚŝŽŶǁŽƌƐĞŶƐŝŶŝŶƚĞŶƐŝƚǇŽƌĨƌĞƋƵĞŶĐǇ
during the study. 
Collection of adverse events will start after the time that informed consent form is signed and subject is enrolled. 
Adverse events will be monitored throughout the study. Investigators must obtain all information available to 
determine the causality and outcome of the AE and to assess whether it meets the criteria for classification as a 
ƐĞƌŝŽƵƐĂĚǀĞƌƐĞĞǀĞŶƚƌĞƋƵŝƌŝŶŐŝŵŵĞĚŝĂƚĞŶŽƚŝĨŝĐĂƚŝŽŶƚŽƚŚĞSponsor or its designated representative. All reported 
AEs will be documented on the appropriate CRF and will include the event description (sign, symptom, or diagnosis), 
onset, resolution, seriousness, severity, cause and action taken. The Investigator must assess causality and severity 
for all AEs. 
All AEs will be followed by the Investigator until resolution or until the 30-day follow-up visit. 
8.2.1 
ADVERSE DEVICE EFFECT (ADE) 
An adverse device effect (ADE) is an AE related to the use of an investigational medical device. (ISO 14155:2020 3.1) 
NOTE 1͗ dŚŝƐ ĚĞĨŝŶŝƚŝŽŶ ŝŶĐůƵĚĞƐ ĂĚǀĞƌƐĞ ĞǀĞŶƚƐ ƌĞƐƵůƚŝŶŐ ĨƌŽŵ ŝŶƐƵĨĨŝĐŝĞŶƚ Žƌ ŝŶĂĚĞƋƵĂƚĞ ŝŶƐƚƌƵĐƚŝŽŶƐ ĨŽƌ ƵƐĞ͕
deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition also includes any event from use error or from intentional misuse of the investigational 
medical device. (ISO 14155:2020 3.1) 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. (ISO 14155:2020, 3.1) 
8.2.2 
SERIOUS ADVERSE EVENT (SAE) 
An SAE is an AE that: 
x 
Led to death 
x 
Led to serious deterioration in the health of the subject, users, or other persons as defined by one or more 
of the following: 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body function including chronic diseases, or 
o 
in-patient or prolonged hospitalization, or 
o 
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function.  
o 
fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
 
 (ISO 14155:2020 3.45) 

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Note 1 to entry:  Planned hospitalization for a pre-ĞǆŝƐƚŝŶŐĐŽŶĚŝƚŝŽŶ͕ŽƌĂƉƌŽĐĞĚƵƌĞƌĞƋƵŝƌĞĚďǇƚŚĞprotocol, 
without serious deterioration in health, is not considered an SAE. 
 
8.2.2.1 SERIOUS ADVERSE DEVICE EFFECT (SADE) 
ƐĞƌŝŽƵƐĂĚǀĞƌƐĞĚĞǀŝĐĞĞĨĨĞĐƚ;^ͿŝƐĂŶĂĚǀĞƌƐĞĚĞǀŝĐĞĞĨĨĞĐƚƚŚĂƚŚĂƐƌĞƐƵůƚĞĚŝŶĂŶǇŽĨƚŚĞĐŽŶƐĞƋƵĞŶĐĞƐ
characteristic of a serious adverse event. (ISO 14155:2020 3.44) 
8.2.3 
ANTICIPATED SERIOUS ADVERSE DEVICE EFFECT (ASADE) 
An anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome 
has been identified in the risk assessment. (ISO 14155:2020 3.51) 
8.2.4 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
An unanticipated adverse device effect (UADE) means any serious adverse effect on health or safety or 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 study protocol or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. (21 CFR 812.3 (s)) 
Similarly, according to ISO 14155:2020, an unanticipated serious adverse device effect (USADE) is a serious adverse 
effect which by its nature, incidence, severity or outcome has not been identified in the current risk assessment. (ISO 
14155:2020 3.51) 
8.3 
EVENT SEVERITY 
dŚĞƐĞǀĞƌŝƚǇŽĨĂŶĂĚǀĞƌƐĞĞǀĞŶƚŝƐĂƋƵĂůŝƚĂƚŝǀĞũƵĚŐŵĞŶƚŽĨƚŚĞĚĞŐƌĞĞŽĨŝŶƚĞŶƐŝƚǇ͕ĂƐĚĞƚĞƌŵŝŶĞĚďǇƚŚĞ
Investigator or as reported by the subject. The severity of the adverse event should be evaluated according to 
the following scale: 
x 
Mild: No limitatŝŽŶŽĨƵƐƵĂůĂĐƚŝǀŝƚŝĞƐ͕ŶŽƚŚĞƌĂƉǇŽƌŽŶůǇƐǇŵƉƚŽŵĂƚŝĐƚŚĞƌĂƉǇƌĞƋƵŝƌĞĚƚŽƚƌĞĂƚƚŚĞŝŶũƵƌǇ
or illness. 
x 
DŽĚĞƌĂƚĞ͗^ŽŵĞůŝŵŝƚĂƚŝŽŶŽĨƵƐƵĂůĂĐƚŝǀŝƚŝĞƐŽƌƐƉĞĐŝĨŝĐƚŚĞƌĂƉǇŝƐƌĞƋƵŝƌĞĚ͘ 
x 
Severe: Inability to carry out usual activities, hospitalization, emergency treatment, life threatening events, 
or death. 
The assessment of severity should be made independent of the relationship to the investigational device and 
therapy or the seriousness of the event. 
8.4 
EVENT RELATIONSHIP 
The Investigator will categorize the relationship of the adverse event as follows: 
x 
Study Disease-related: Event is clearly attributable to underlying disease state with no temporal 
relationship to the device, treatment or medication. 
x 
Concomitant Disease-related: Event is attributable to disease other than the study disease with no 
temporal relationship to the device, treatment or medication. 
x 
Procedure-related: Event has a strong temporal relationship to the procedure or treatment with the device 
deployment or any user handling. 
x 
Device-related: Event has a strong temporal relationship to the device and alternative etiology is less likely. 
o 
Primary Study Device: FlowTriever2 Catheter 

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o 
Ancillary Device: Any device other than the FlowTriever2 Catheter, such as the Triever Catheter, a 
guidewire, pressure monitoring catheter, or infusion catheter 
o 
Device Unknown: Device-related but unable to attribute a specific device relationship 
x 
tPA-related: Event is clearly attributable to tPA medication with no temporal relationship to the device or 
treatment. 
x 
Unrelated to the above categories: Event has no relationship to any of the above-mentioned categories. 
x 
Unknown: Event relationship is not known or unsure. 
8.5 
ADVERSE EVENT REPORTING 
Subjects will be carefully monitored during the study for possible adverse events. Any adverse event that occurs 
after the time of informed consent and a study specific exam or procedure through end of study participation will 
be fully evaluated by the Investigator. Appropriate treatment will be initiated, and the study follow-up will 
continue as completely as possible. 
The Investigator will document all observations and clinical findings of adverse events, including the nature, 
severity and relationship, on the appropriate CRFs.  
The Investigator ŝƐƌĞƋƵŝƌĞĚƚŽreport all UADEs/USADEs to the Sponsor within 24 hours after first learning of the 
event, and all SAEs within 5 business days after learning of the event. The Investigator must follow their local IRB 
policy for SAE/UADE/USADE reporting. 
The Investigator will send the completed SAE Report form and all available supporting documentation to the 
Sponsor.  
As additional information becomes available, the Investigator will record all adverse events (serious and non-
serious), adverse device effects (anticipated and unanticipated), device malfunction, product complaints or other 
reportable safety events on the appropriate CRFs. Copies of source documentation which contain significant 
information related to the event such as progress notes, consultations, nurse’s notes, operative reports and 
ƉĂƚŝĞŶƚƐƵŵŵĂƌŝĞƐĞƚĐ͘ĂƌĞƌĞƋƵŝƌĞĚĨŽƌĞǀĂůƵĂƚŝŽŶŽĨƚŚĞĞǀĞŶƚ͘ŽƉŝĞƐŽĨƐƵĐŚĚŽĐƵŵĞŶƚĂƚŝŽŶƐŚĂůůďĞŽďƚĂŝŶĞĚ
from the Investigator (de-identified as to the Subjects’ identity) and provided to the Sponsor. 
ZĞŐĂƌĚŝŶŐƐƵďũĞĐƚĚĞĂƚŚƐ͕ŝƚŝƐƌĞƋƵĞƐƚĞĚƚŚĂƚĂĐŽƉǇŽĨƚŚĞĚĞĂƚŚĐĞƌƚŝĨŝĐĂƚĞĂŶĚĂĐŽƉǇŽĨƚŚĞĂƵƚŽƉƐǇƌĞƉŽƌƚ͕ŝĨ
applicable, be sent to the Sponsor when available. Any other source documents related to the death should also 
be provided to the Sponsor͘/ŶƚŚĞĞǀĞŶƚƚŚĂƚŶŽƐŽƵƌĐĞĚŽĐƵŵĞŶƚƐĂƌĞĂǀĂŝůĂďůĞ͕ƚŚĞW/ŝƐƌĞƋƵŝƌĞĚƚŽĚĞƐĐƌŝďĞ
the circumstances of the Subject’s death in a letter, e-mail or other written communication. 
UADEs/USADEs have ƐƉĞĐŝĂůƌĞƉŽƌƚŝŶŐƌĞƋƵŝƌĞŵĞŶƚƐ͘dŚĞSponsor will notify the sites, IRBs and regulatory bodies 
as per specific regulations. 
In addition, the Sponsor ǁŝůůĐŽŵƉůǇǁŝƚŚDĞĚŝĐĂůĞǀŝĐĞZĞƉŽƌƚŝŶŐ;DZͿƌĞƋƵŝƌĞŵĞŶƚƐ͘ 
8.6 
DEVICE DEFICIENCY (DD) 
A Device Deficiency (DͿŝƐƚŚĞŝŶĂĚĞƋƵĂĐǇŽĨĂŵĞĚŝĐĂůĚĞǀŝĐĞǁŝƚŚƌĞƐƉĞĐƚƚŽŝƚƐŝĚĞŶƚŝƚǇ͕ƋƵĂůŝƚǇ͕ĚƵƌĂďŝůŝƚǇ͕
reliability, usability, safety or performance.  
NOTE 1͗ŝŶĐůƵĚĞŵĂůĨƵŶĐƚŝŽŶƐ͕ƵƐĞĞƌƌŽƌƐĂŶĚŝŶĂĚĞƋƵĂĐǇŝŶƚŚĞŝŶĨŽƌŵĂƚŝŽŶƐƵƉƉůŝĞĚďǇƚŚĞŵĂŶƵĨĂĐƚƵƌĞƌ
including labeling.  
NOTE 2: This definition includes device deficiencies related to the investigational medical device or the 
comparator. (ISO 14155:2020, 3.19) 

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8.7 
CLINICAL EVENTS COMMITTEE 
A Clinical Events Committee (CEC), an independent group of individuals knowledgeable in the appropriate medical 
specialties pertinent to the disease state being evaluated in this Study, will be responsible for the review and 
ǀĂůŝĚĂƚŝŽŶŽĨĂůůĂĚǀĞƌƐĞĞǀĞŶƚƐƚŚĂƚŽĐĐƵƌŽǀĞƌƚŚĞĐŽƵƌƐĞŽĨƚŚĞ^ƚƵĚǇĂŶĚƚŚĞƐƵďƐĞƋƵĞŶƚĐůĂƐƐŝĨŝĐĂƚŝŽŶŽĨƚŚĞƐĞ
events as related to the device or procedure. The CEC will review and adjudicate all adverse events according to the 
CEC Charter; they can ƌĞƋƵĞƐƚĂĚĚŝƚŝŽŶĂůƐŽƵƌĐĞĚŽĐƵŵĞŶƚĂƚŝŽŶĂŶĚĂŶǇŝŵĂŐŝŶŐŽďƚĂŝŶĞĚŝŶƐƵƉƉŽƌƚŽĨƚŚĞĂĚǀĞƌƐĞ
event to assist with adjudication. The CEC adjudicated results will overrule Investigator assessments. 
 
 

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9 
STATISTICS & DATA ANALYSIS 
9.1 
 SAMPLE SIZE CALCULATIONS 
The sample size of 50 subjects reflects sample size to confirm the FlowTriever2 Catheter performance. The sample 
ƐŝǌĞŽĨϱϬƐƵďũĞĐƚƐǁĂƐĞƐƚŝŵĂƚĞĚŝŶŽƌĚĞƌƚŽƉƌŽǀŝĚĞĂƚůĞĂƐƚϴϬйƉŽǁĞƌǁŝƚŚŽŶĞ-sided alpha = 0.05 for assuming 
&dϮ ƐĂĨĞƚǇ ĞǀĞŶƚ ƉƌŽƉŽƌƚŝŽŶƐ ŽĨ ϭϭй ǀƐ͘ ƚŚĞ ƉĞƌĨŽƌŵĂŶĐĞ ŐŽĂů ŽĨ Ϯϱй ĨƌŽŵ &>Z͘ ^ĞŶƐŝƚŝǀŝƚǇ ĂŶĂůǇƐŝƐ ĨŽƌ ƚŚŝƐ
confirmatory study will be performed on a sub-population of the 50 subjects that did not receive adjunctive 
thrombolytics. Descriptive statistics on safety and effectiveness will be provided for all patients.  
9.2 
 PRIMARY ENDPOINT - EFFECTIVENESS 
The primary effectiveness endpoint will include an evaluation of the mean pulmonary arterial pressure changes 
between pre- and post-procedure. 
9.3 
PRIMARY ENDPOINT - SAFETY 
The primary safety endpoint will include incidence of adjudicated Adverse Events including: 
x 
Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter 
x 
Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter 
x 
Intra-procedural device or procedure-related adverse events, including: 
o 
Clinical deterioration defined by hemodynamic or respiratory worsening 
o 
Pulmonary vascular injury related to FlowTriever2 Catheter 
o 
Cardiac injury related to FlowTriever2 Catheter 
9.4 
SECONDARY ENDPOINTS - EFFECTIVENESS 
The study’s secondary effectiveness endpoints will include:  
x 
The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure 
x 
Incidence of adjunctive thrombolytic use 
9.5 
SECONDARY ENDPOINTS - SAFETY 
Secondary safety endpoint will include incidence of adjudicated Adverse Events including:  
x 
All-Cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) 
x 
Device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) 
x 
Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from 
procedure -5 / +15 days) 
 
 

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10 
STUDY MANAGEMENT CONSIDERATIONS 
10.1 
QUALITY CONTROL AND QUALITY ASSURANCE 
ǀĞƌǇ ĞĨĨŽƌƚ ǁŝůů ďĞ ƚĂŬĞŶ ƚŽ ĞŶƐƵƌĞ ƚŚĞ ĂĐĐƵƌĂĐǇ ĂŶĚ ƌĞůŝĂďŝůŝƚǇ ŽĨ ĚĂƚĂ ŝŶĐůƵĚŝŶŐ ƚŚĞ ƐĞůĞĐƚŝŽŶ ŽĨ ƋƵĂůŝĨŝĞĚ
Investigators and appropriate study centers, review of protocol procedures with the Investigator and associated 
personnel before the Study commences, and periodic on-site monitoring visits by the Sponsor as deemed 
appropriate by the Sponsor. 
10.1.1 SPONSOR COMPLIANCE 
The Sponsor ŝƐƌĞƐƉŽŶƐŝďůĞĨŽƌŝŵƉůĞŵĞŶƚŝŶŐĂŶĚŵĂŝŶƚĂŝŶŝŶŐƋƵĂůŝƚǇĂƐƐƵƌĂŶĐĞĂŶĚĂƋƵĂůŝƚǇĐŽŶƚƌŽůƐǇƐƚĞŵƚŽ
ensure that the data generated are recorded and reported in accordance with established procedures. The Study 
will be organized, performed, and reported in compliance with this Clinical Protocol, Standard Operating Procedures, 
working practice documents, and applicable regulations and guidelines. The Sponsor also will confirm that the Study 
ŝƐƉĞƌĨŽƌŵĞĚŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚĂůůĂƉƉůŝĐĂďůĞƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ. 
The Sponsor will secure an agreement with all parties to allow direct access to all study- related sites, source 
documents, and reports for the purpose of monitoring and auditing by the Sponsor and/or its designee(s) and 
inspection by regulatory agencies. 
The Sponsor ǁŝůůĂƉƉůǇƋƵĂůŝƚǇĐŽŶƚƌŽůŵĞĂƐƵƌĞƐƚŽĂůůƐƚĂŐĞƐŽĨĚĂƚĂĐŽůůĞĐƚŝŽŶĂŶĚŚĂŶĚůŝŶŐƚŽĞŶƐƵƌĞƌĞůŝĂďŝůŝƚǇĂŶĚ
accuracy. In addition, the Sponsor will confirm that the data are processed correctly. 
Data from CRFs and other external data (i.e., core laboratory data) will be entered into a clinical database as specified 
in the Data Management Plan (DMP). Quality control and data validation procedures will be applied to ensure the 
validity and accuracy of the clinical database. 
The clinical database ǁŝůůďĞƌĞǀŝĞǁĞĚĂŶĚĐŚĞĐŬĞĚĨŽƌŽŵŝƐƐŝŽŶƐ͕ĂƉƉĂƌĞŶƚĞƌƌŽƌƐ͕ĂŶĚǀĂůƵĞƐƌĞƋƵŝƌŝŶŐĨƵƌƚŚĞƌ
ĐůĂƌŝĨŝĐĂƚŝŽŶŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚƚŚĞDW͘ĂƚĂƋƵĞƌŝĞƐƌĞƋƵŝƌŝŶŐĐůĂƌŝĨŝĐĂƚŝŽŶǁŝůůďĞĚŽĐƵŵĞŶƚĞĚĂŶĚƌĞƚƵƌŶĞĚƚŽ
the study site for resolution. Only authorized personnel will make corrections to the clinical database, and all 
ĐŽƌƌĞĐƚŝŽŶƐǁŝůůďĞĚŽĐƵŵĞŶƚĞĚŝŶĂŶĂƵĚŝƚƚƌĂŝů͘ŶŝŶƚĞƌŶĂůƋƵĂůŝƚǇĐŽŶƚƌŽůĂƵĚŝƚďǇĂƚĂDĂŶĂŐĞŵĞŶƚǁŝůůďĞ
performed and documented prior to database lock. 
During the course of the Study, an amendment to the protocol may be necessary. Only the Sponsor is allowed to 
amend this protocol. Any amendments or modifications must be approved by the research site’s IRB prior to 
research-study staff implementation, unless the modifications increase subject safety. The research sites will receive 
the following for their regulatory file, and if applicable, IRB submission: 
x 
A memorandum outlining the changes and justification for modifications 
x 
An updated protocol 
x 
Updated appendices (if necessary) 
x 
Changes to ICF template (if necessary) 
10.1.2 INVESTIGATOR COMPLIANCE 
The Principal Investigator assumes full responsibility for performance of the Study in accordance with the Clinical 
Research Agreement, this Clinical Protocol, ICH E6 GCP, 21 CFR Part 812, 21 CFR Part 50, 54 and 56, ISO 14155:2020 
ĂŶĚĂůůƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐĂƉƉůŝĐĂďůĞƚŽƚŚĞũƵƌŝƐĚŝĐƚŝŽŶƐŝŶǁŚŝĐŚƚŚĞ^ƚƵĚǇŝƐďĞŝŶŐĐŽŶĚƵĐƚĞĚ͘ 

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10.1.3 COMPLIANCE TO THE PROTOCOL  
The Sponsor ŝŶƚĞŶĚƐ ƚŽ ŵŽŶŝƚŽƌ Ăůů ƌĞƐĞĂƌĐŚ ƐŝƚĞƐ͘ DŽŶŝƚŽƌŝŶŐ ǁŝůů ďĞ ƉĞƌĨŽƌŵĞĚ ƵƐŝŶŐ ƋƵĂůŝĨŝĞĚ͕ ƚƌĂŝŶĞĚ
representatives. Except for a change that is intended to eliminate an immediate hazard to a Subject, the Clinical 
Protocol will be followed as described.  
A copy of the written approval from the IRB must be provided to the Sponsor prior to initiation of the Study. Any 
ĂŵĞŶĚŵĞŶƚ;ƐͿƚŚĂƚĂĨĨĞĐƚƚŚĞŝŶĨŽƌŵĞĚĐŽŶƐĞŶƚƌĞƋƵŝƌĞĂƌĞǀŝƐĞĚSponsor and IRB-approved informed consent 
before changes in study procedures are implĞŵĞŶƚĞĚ͘dŚĞƐĞƌĞƋƵŝƌĞŵĞŶƚƐƐŚŽƵůĚŝŶŶŽǁĂǇƉƌĞǀĞŶƚĂŶǇŝŵŵĞĚŝĂƚĞ
action from being taken by the Investigator or by the Sponsor to preserve the safety of any subjects included in the 
Study, as necessary. If an immediate change to the protocol is felt to be necessary by the Investigator and is 
implemented by him/her for safety reasons, the Sponsor should be notified immediately. 
The Investigator must provide reports on the progress, completion, termination, or discontinuation of the Study to 
the IRB(s) at appropriate intervals as designated by the Sponsor ĂŶĚƉĞƌ/ZƌĞƋƵŝƌĞŵĞŶƚƐ͘ 
10.1.4 PROTOCOL DEVIATIONS 
A protocol deviation is a divergence or non-adherence from the protocol-specific study procedures.  Protocol 
deviations should be recorded for all assessments not collected, and issues related to eligibility criteria. Any protocol 
deviation must be documented in CRFs and reported to the Sponsor in a timely manner. Protocol deviations will be 
evaluated to see if they impact the descriptive analysis for this confirmatory study. 
ZĞƉŽƌƚŝŶŐĚĞǀŝĂƚŝŽŶƐƚŽƚŚĞ/ZǁŝůůďĞĚĞƚĞƌŵŝŶĞĚďǇŝŶĚŝǀŝĚƵĂů/ZƌĞƉŽƌƚŝŶŐƌĞƋƵŝƌĞŵĞŶƚƐ͘ 
10.2 
SITE SELECTION 
The Sponsor or designee will assess each potential site to ensure the Investigator and his/her staff has the facilities 
ĂŶĚĞǆƉĞƌƚŝƐĞƌĞƋƵŝƌĞĚĨŽƌƚŚĞ^ƚƵĚǇ͘^ŝƚĞƐǁŝůůďĞƐĞůĞĐƚĞĚďĂƐĞĚƵƉŽŶĂƐŝƚĞĂƐƐĞƐƐŵĞŶƚ͕ĂƉƉƌŽƉƌŝĂƚĞĨĂĐŝůŝƚŝĞƐ͕ĂŶĚ
ƚŚĞ ƋƵĂůŝĨŝĐĂƚŝŽŶƐ ŽĨ ƚŚĞ Investigator(s). Individual Investigators will be evaluated by the Sponsor based on 
experience with the intended procedures and ability to conduct the Study according to the Clinical Protocol. 
Investigators and sites will be selected based upon the following factors: 
x 
Previous experience with clinical research and mechanical thrombectomy procedures 
x 
Experience in conducting clinical studies 
x 
Willingness to observe confidentiality at all times 
x 
Currently treating subjects who meet the inclusion/exclusion criteria  
x 
ďŝůŝƚǇƚŽĞŶƌŽůůĂŶĂĚĞƋƵĂƚĞŶƵŵďĞƌŽĨƐƵďũĞĐƚƐ 
x 
Ability to perform reƋƵŝƌĞĚĐůŝŶŝĐĂůƚĞƐƚŝŶŐ͕ŝŶĐůƵĚŝŶŐĂŶŐŝŽŐƌĂƉŚǇĂŶĚd 
x 
Ability and willingness to provide the Sponsor’s representatives access to the hospital records, study files, 
and subject files as they pertain to the study 
x 
Willingness to participate, including compliance with all aspects of the study  
x 
ĚĞƋƵĂƚĞƐƚĂĨĨŝŶŐƚŽĐŽŶĚƵĐƚƚŚĞƐƚƵĚǇ͘dŚŝƐŝŶĐůƵĚĞƐ͗ 
o 
Principal Investigator (PI): Responsible for overall clinical management of subjects enrolled at 
his/her institution. Assumes overall responsibility and accountability for the clinical team and for 
data obtained from each subject participating in the study. Ensures compliance with the protocol, 
applicable laws, and applicable regulations; ensures informed consents are signed, and reviews 
and signs CRFs indicating documents are accurate and complete. 
o 
Sub-Investigator (Sub-I): Responsible for study activities in coordination with PI and in accordance 
to the Clinical Protocol. Assume the responsibility of the PI should the PI resign from the study. A 
ƐŝƚĞŝƐŶŽƚƌĞƋƵŝƌĞĚƚŽŚĂǀĞĂƐƵď- Investigator.  

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o 
Study Coordinator (SC): Assists PI with study activities as delegated by the PI, including tracking 
subjects involved in the study, scheduling testing and follow- up visits, maintaining study records, 
completing CRFs to the Sponsor in a timely manner.  
 
Each Investigator who will participate in the investigation of the FlowTriever2 Catheter will sign a copy of the 
“Investigator’s Agreement” and approval of the institutional review board (“IRB”) will be obtained prior to beginning 
the study. 
 
No Investigator is permitted to begin clinical studies until Inari Medical has received a copy of the signed 
“Investigator’s Agreement.” 
 
No Investigator will be added to the investigation until he/she has signed the “Investigator’s Agreement”. 
10.3 
STUDY TRAINING 
Each investigational site will be trained to the Clinical Protocol. Investigator/site personnel will undergo training prior 
to performing any study-related procedures. All training must be documented.  
 
Training to the Clinical Protocol will include the following topics: 
x 
Study objectives  
x 
Protocol review 
x 
Delegation of authority for study-related tasks 
x 
Informed cŽŶƐĞŶƚƉƌŽĐĞƐƐ͕ŝŶĐůƵĚŝŶŐĂŶǇƌĞůĞǀĂŶƚ/ZͬŽŶĨŝĚĞŶƚŝĂůŝƚǇͬ,/WƌĞƋƵŝƌĞŵĞŶƚƐ 
x 
Case Report Forms and completion instructions 
x 
Documentation of protocol deviations  
x 
Adverse/serious adverse event reporting  
x 
Product malfunction reporting 
x 
IDE Instructions for Use and device accountability  
x 
Responsibilities and obligations of the Investigator/staff  
x 
General guidelines for good clinical practices 
x 
^ƚƵĚǇĚŽĐƵŵĞŶƚĂƚŝŽŶƌĞƋƵŝƌĞŵĞŶƚƐ;ĞƐƐĞŶƚŝĂůĚŽĐƵŵĞŶƚƐͿ 
 
Existing study site personnel who have been delegated new tasks and new study site personnel will undergo training 
to the Clinical Protocol, as appropriate. 
10.4 
PHYSICIAN DEVICE TRAINING 
ĂĐŚƉŚǇƐŝĐŝĂŶƐĞůĞĐƚĞĚƚŽƉĂƌƚŝĐŝƉĂƚĞŝŶƚŚŝƐƚƌŝĂůǁŝůůďĞƌĞƋƵŝƌĞĚƚŽŚĂǀĞĞǆƉĞƌŝĞŶĐĞƚƌĞĂting pulmonary embolism 
using the FlowTriever System. In addition, each physician will be trained on the use of the FlowTriever2 Catheter.     
10.5 
DEVICE ACCOUNTABILITY 
The investigational site shall supply the device from the Institution’s stock. Study-specific devices will not be provided 
to the site for the study. The Investigational Device Instructions for Use will be provided to the Principal Investigator 
and the Principal Investigator and Sub-Investigator(s) (if applicable) will be trained to the Investigational Device 
Instructions for Use prior to enrollment.  
 
Sites will document device accountability for any Inari Medical devices utilized during the index procedure. 

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10.6 
SITE INITIATION AND ADDITION OF SITE PERSONNEL 
A Site Initiation Visit (SIV) will be conducted by the Sponsor or designee, either in-person or via teleconference to 
ensure proper training of the Investigator and study staff members prior to participation in the study.  The SIV will 
ĐŽǀĞƌƚƌĂŝŶŝŶŐƚŽƚŚĞƐƚƵĚǇƉƌŽƚŽĐŽůĂŶĚĚĂƚĂĐŽůůĞĐƚŝŽŶ͕ĂƐǁĞůůĂƐƚŽĂŶǇĂƉƉůŝĐĂďůĞƌĞŐƵůĂƚŽƌǇƌĞƋƵŝƌĞŵĞŶƚƐ͕ĂŶĚ
will be documented in the study record.   
 
Prior to enrolling subjects at an investigational site, the following documentation must be provided to the Sponsor: 
x 
IRB approval for the Clinical Protocol 
x 
IRB and Sponsor approved study-specific Informed Consent Form for the study  
x 
Investigator(s’) curriculum vitae (CV) 
x 
Financial Disclosure(s) for the PI and Sub-I(s)  
x 
Signed Confidentiality Disclosure Agreement (CDA) 
x 
Signed Clinical Study Agreement (CSA), and if applicable, Sub-I Agreement(s) 
x 
Training documentation to verify the appropriate study staff has been trained on the protocol, device, CRFs 
and study conduct. 
 
Additional site personnel aĚĚĞĚƚŽƚŚĞƐƚƵĚǇĂĨƚĞƌƚŚĞ^/sǁŝůůďĞƌĞƋƵŝƌĞĚƚŽƵŶĚĞƌŐŽƉƌŽƚŽĐŽůƚƌĂŝŶŝŶŐ͕ƚŽďĞ
performed by the Sponsor, or designee, and documented in the study record. 
10.7 
SITE CLOSE-OUT 
Close-out visits will be conducted by the Sponsor or designee in-person or remotely to ensure compliance with the 
protocol, and other written instructions and regulatory guidelines. 
Final close-out visits at the sites will be conducted at the end of the Study.  
The purpose of the final visit is: 
x 
Collect any outstanding study data document 
x 
Ensure the Investigator’s files are accurate and complete  
x 
ZĞǀŝĞǁƌĞĐŽƌĚƌĞƚĞŶƚŝŽŶƌĞƋƵŝƌĞŵĞŶƚƐǁŝƚŚƚŚĞInvestigator 
x 
Make a final accounting of all study supplies shipped to the Investigator/Site 
x 
Provide for appropriate disposition of any remaining supplies 
x 
ŶƐƵƌĞƚŚĂƚĂůůĂƉƉůŝĐĂďůĞƌĞƋƵŝƌĞŵĞŶƚƐĂƌĞŵĞƚĨŽƌƚŚĞ^ƚƵĚǇ 
10.8 
DATA COLLECTION AND ELECTRONIC CASE REPORT FORMS (ECRF) 
Clinical study data will be collected using source document worksheets and eCRFs. A web-based electronic data 
capture system (EDC) will be used to record and manage study data. All eCRFs must be kept in good order and 
updated so they always reflect the latest observations on the subjects participating in the study. 
Electronic Case Report Forms (eCRFs) have been developed to collect all study-related information and data points. 
Inari Medical will provide eCRFs for each Subject enrolled in the Study to each investigational site. The appropriate 
eCRF will be completed after each Study visit. eCRF Completion Guidelines will be provided to the sites. 
The Investigator may keep a separate subject identification list showing enrollment numbers, names, and dates of 
birth to provide a local key for unambiguous identification of each subject included in the study.  This list will not be 
collected by the Sponsor.  

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The Investigator will sign the appropriate eCRF pages and source documentation. Pertinent eCRF corrections will be 
made electronically and signed electronically by the Investigator. An embedded audit trail will capture the date, time 
and user making entries and changes to the electronic data. 
Because it is important to have proper data collection in a timely manner, it is recommended that the Investigator 
or designee complete eCRFs within 5 buƐŝŶĞƐƐĚĂǇƐŽĨĚĂƚĂĂǀĂŝůĂďŝůŝƚǇ͘tŚĞŶƚŚĞŵŽŶŝƚŽƌŽƌĚĞƐŝŐŶĞĞƌĞƋƵĞƐƚƐ
ĂĚĚŝƚŝŽŶĂůĚĂƚĂŽƌĐůĂƌŝĨŝĐĂƚŝŽŶŽĨĚĂƚĂĨŽƌƚŚĞĞZ&;ƋƵĞƌŝĞƐͿ͕ƚŚĞƌĞƋƵĞƐƚŵƵƐƚďĞĂŶƐǁĞƌĞĚƐĂƚŝƐĨĂĐƚŽƌŝůǇĂƐƐŽŽŶĂƐ
possible. 
10.9 
STUDY MONITORING 
Inari Medical (the “Sponsor”) is respŽŶƐŝďůĞĨŽƌĞŶƐƵƌŝŶŐƚŚĂƚĂĚĞƋƵĂƚĞŵŽŶŝƚŽƌŝŶŐĂƚĞĂĐŚƐŝƚĞŝƐĐŽŵƉůĞƚĞĚƚŽ
ĞŶƐƵƌĞƚŚĞƌŝŐŚƚƐĂŶĚƐĂĨĞƚǇŽĨƐƵďũĞĐƚƐŝƐƉƌŽƚĞĐƚĞĚ͕ĂŶĚƚŚĞƋƵĂůŝƚǇĂŶĚŝŶƚĞŐƌŝƚǇŽĨƚŚĞĚĂƚĂĐŽůůĞĐƚĞĚĂŶĚ
submitted is in compliance with Title 21 CFR Part 812 Subpart C. Appropriately trained personnel (Monitors) 
appointed by the Sponsor will conduct monitoring visits according to the clinical Monitoring Plan. Monitors will 
consist of Sponsor ĐůŝŶŝĐĂůƐƚĂĨĨĂŶĚͬŽƌƋƵĂůŝĨŝĞĚĐŽŶƚƌĂĐƚƐĞƌǀŝĐĞƐ;Ğ͘Ő͕͘ZKͿĂƉƉŽŝŶƚĞĚďǇƚŚĞSponsor.  
^ƚƵĚǇDŽŶŝƚŽƌƐǁŝůůĐŽŶĚƵĐƚƐŝƚĞǀŝƐŝƚƐƚŽĞŶƐƵƌĞĂĐĐƵƌĂĐǇŽĨĚĂƚĂ͕ƚŝŵĞůŝŶĞƐƐŽĨĚĂƚĂƐƵďŵŝƐƐŝŽŶƐ͕ĂĚĞƋƵĂƚĞ
subject enrollment, investigational device accountability, compliance with applicable laws and regulations, 
compliance with the protocol, compliance with the signed Investigator Agreement, and compliance with IRB 
conditions and guidelines. Any non-ĐŽŵƉůŝĂŶĐĞ ǁŝƚŚ ƚŚĞƐĞ ŝƚĞŵƐ ƚŚĂƚ ŝƐ ŶŽƚ ĂĚĞƋƵĂƚĞůǇ ĂĚĚƌĞƐƐĞĚ ďǇ ƚŚĞ
Investigator/site staff is cause for the Sponsor to put the Investigator/site staff on probation or withdraw the 
InvestigatorͬƐŝƚĞƐƚĂĨĨĨƌŽŵƚŚĞƐƚƵĚǇ͘&ƌĞƋƵĞŶĐǇŽĨŵŽŶŝƚŽƌŝŶŐǁŝůůďĞďĂƐĞĚƵƉŽŶĞŶƌŽůůŵĞŶƚ͕ƐƚƵĚǇĚƵƌĂƚŝŽŶ͕
ĐŽŵƉůŝĂŶĐĞ͕ĂŶĚĂŶǇƐƵƐƉĞĐƚĞĚŝŶĐŽŶƐŝƐƚĞŶĐǇŝŶĚĂƚĂƚŚĂƚƌĞƋƵŝƌĞƐŝŶǀĞƐƚŝŐĂƚŝŽŶ͘ 
All subject treatment, follow-up visits and phone conversations/interviews will be fully documented either on the 
source document or in the subject’s medical records. Information entered into the CRFs will be verified against 
the source documents and subject’s medical records according to the monitoring plan. Additional subject medical 
ƌĞĐŽƌĚƌĞǀŝĞǁŵĂǇďĞƌĞƋƵŝƌĞĚĨŽƌĂĚũƵĚŝĐĂƚŝŽŶ͘^ŽƵƌĐĞĚŽĐƵŵĞŶƚƐŵĂǇďĞƉŚŽƚŽĐŽƉŝĞĚŝĨƌĞƋƵŝƌĞĚ͘dŚĞ
Monitor will also check the Investigator Site File (ISF) to ensure that all study related documents are current. 
10.9.1 MONITORING REPORTS 
After each monitoring visit, the Monitor will send to the Investigator an e-mail or letter summarizing the 
monitoring visit. A monitoring report will be sent to the Sponsor. The report will include: 
x 
Date of the monitoring visit  
x 
Monitor name 
x 
Site name  
x 
Investigator name 
x 
Individual names present for visit 
x 
/ƚĞŵƐƌĞǀŝĞǁĞĚĚƵƌŝŶŐƚŚĞǀŝƐŝƚ͕ĨŝŶĚŝŶŐƐ͕ĂŶĚĂŶǇƌĞƋƵŝƌĞĚĨŽůůŽǁ-up 
The Investigator will be responsible for ensuring that follow-ƵƉĂĐƚŝŽŶŝƚĞŵƐƌĞƋƵŝƌŝŶŐƌĞƐŽůƵƚŝŽŶĂƚƚŚĞƐŝƚĞĂƌĞ
completed in an accurate and timely manner. 
10.10 DIRECT ACCESS TO SOURCE DOCUMENTS 
By participating in this research study, the Investigator agrees to permit monitoring and auditing by the Sponsor 
and/or its designee(s) and inspection by applicable regulatory authorities. The Investigator also agrees to allow 
the Sponsor’s Monitors/Auditors/FDA Investigators to have direct access to (and copying of, if appropriate) 
his/her research- related study records (e.g., medical records, source documentation, and billing information) for 
review to ensure study integrity and data validation. 

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If an Investigator is notified of a pending investigation by a regulatory agency, standards organization, or other 
similar organization, he/she will inform the Sponsor promptly. 
10.11 ON-SITE AUDITS 
Representatives of the Sponsor may visit the study site(s) to conduct an audit of the Study in compliance with 
ƌĞŐƵůĂƚŽƌǇŐƵŝĚĞůŝŶĞƐĂŶĚĐŽŵƉĂŶǇƉŽůŝĐǇ͘dŚĞƐĞĂƵĚŝƚƐǁŝůůƌĞƋƵŝƌĞĂĐĐĞƐƐƚŽĂůůƐƚƵĚǇƌĞĐŽƌĚƐ͕ŝŶĐůƵĚŝŶŐƐŽƵƌĐĞ
documents, for inspection and comparison with the CRFs. Subject privacy will be respected. 
Similar auditing procedures may also be conducted by agents of any regulatory body reviewing the results of 
the Study in support of a regulatory submission. The Investigator agrees to immediately notify the Sponsor if 
he/she has been contacted by a regulatory agency concerning an upcoming inspection. 
10.12 RECORD STORAGE AND RETENTION 
10.12.1 INVESTIGATOR RECORD RETENTION 
The Investigator shall maintain all study documentation in his/her possession and/or control and institute 
measures to prevent accidental or premature destruction any data and/or documents related to the Study. 
After discontinuation of the Study, the Investigator shall retain study documentation for a minimum of three (3) 
years or in accordance with the GCP. 
No study document will be destroyed without prior written agreement between the Sponsor and the 
Investigator. Should the Investigator wish to assign the study records to another party or move them to another 
location, advance written notice must be given to the Sponsor. 
10.12.2 SPONSOR RECORD RETENTION 
The Sponsor will maintain all study documentation in its possession and/or contact and institute measures to 
prevent accidental or premature destruction of any data and/or documents related to the research Study. 
The Sponsor shall retain the study documentation for at least ten (10) years after formal discontinuation of Study 
or 10 years after the last FlowTriever2 Catheter has been placed on the market (whichever is longer). 
 
 

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11 
ETHICS AND CONFIDENTIALITY  
11.1 
ETHICAL CONDUCT OF THE STUDY 
This Study is to be conducted in accordance with U.S. and international standards for GCP, as described in 
the following documents: 
x 
ICH Harmonized Tripartite Guidelines for Good Clinical Practice 
x 
U.S. Code of Federal Regulations (CFR) regarding clinical studies (21 CFR including parts 812, 50, 54, and 56) 
x 
The Declaration of Helsinki concerning medical research in humans (64th WMA General Assembly, 
Fortaleza, October 2013) 
x 
ISO 14155 
The Investigator agrees by participating in the conduct of this protocol to adhere to the instructions and 
procedures described and to adhere to the principals of GCP. 
11.2 
INSTITUTIONAL REVIEW BOARDS (IRB) 
The Sponsor and/or Investigator must submit this protocol to the appropriate IRB. The informed consent form 
(ICF) used by the Investigator must be reviewed and approved by the Sponsor prior to submission to the 
appropriate IRB for approval. The Sponsor ŵƵƐƚĂůƐŽĂƉƉƌŽǀĞĂůů/ZƌĞƋƵĞƐƚĞĚĐŚĂŶŐĞƐƚŽƚŚĞ/&ƉƌŝŽƌƚŽ
finalization. 
This study must be approved by an appropriate IRB/EC at each registry site. Securing the approval is the 
responsibility of the Investigator, as defined by ICH E6, ISO 14155 and FDA regulations (21 CFR Part 56), prior 
to starting the study. 
The IRB and/or Investigator ŝƐƌĞƋƵŝƌĞĚƚŽĨŽƌǁĂƌĚƚŽƚŚĞSponsor a copy of the IRB approval to begin the Study. 
The Study (study number, protocol title, and version) documents reviewed (e.g., protocol, ICF, etc.) and the 
date of the review should be clearly stated on the written IRB approval. The Study will not start and subjects 
will not be enrolled until a copy of written and dated approval has been received by the Sponsor. 
Any amendment or modification to the protocol should be sent to the IRB. The IRB should also be informed of 
any event likely to affect the safety of subjects or the conduct of the Study. 
11.3 
STUDY PATIENT CONFIDENTIALITY 
The Investigator must ensure that the privacy of all patients, including their personal identity and all personal health 
information. In CRFs and other documents, patients will not be identified by their names, but by an individual 
identification code (i.e., patient identification number). 
Personal medical information may be reviewed for the purpose of verifying data recorded in the CRFs. A monitor or 
Sponsor designee may conduct source-document verification on behalf of the Sponsor͕ƚŚĞƋƵĂůŝƚǇĂƐƐƵƌĂŶĐĞƵŶŝƚ͕
or regulatory authorities. Personal medical information will always be treated as confidential and handled in 
compliance with the Health Insurance Portability and Accountability Act (HIPAA). 
 
 

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11.4 
INVESTIGATOR RESPONSIBILITIES 
Investigator responsibilities include, but are not limited to, the following: 
x 
Conducting the study in accordance with this investigational plan, signed agreement, and applicable 
regulations protecting the rights and safety of study patients 
x 
Ensuring that informed consent is obtained for each study patient in accordance with applicable regulations 
(e.g., ICH E6, ISO 14155, 21 CFR Part 50) 
x 
Ensuring that IRB/EC approval is secured prior to starting the study and ensuring continuing review and 
ĂƉƉƌŽǀĂůĂƐƌĞƋƵŝƌĞĚƚŚƌŽƵŐŚŽƵƚƚŚĞŝŶǀĞƐƚŝŐĂƚŝŽŶ 
x 
Ensuring all associates, colleagues, and employees assisting in the conduct of the study are informed about 
ƚŚĞŝƌŽďůŝŐĂƚŝŽŶƐ͕ĂƌĞĂĚĞƋƵĂƚĞůǇƋƵĂůŝĨŝĞĚĂŶĚƚƌĂŝŶĞĚ͕ĂŶĚŵĞĞƚƚŚĞŝƌĐŽŵŵŝƚŵĞŶƚƐ 
x 
DĂŝŶƚĂŝŶŝŶŐĂĚĞƋƵĂƚĞĂŶĚĂĐĐƵƌĂƚĞƌĞĐŽƌĚƐĂŶĚĞŶƐƵƌŝŶŐƚŚŽƐĞƌĞĐŽƌĚƐĂƌĞĂǀĂŝůĂďůĞĨŽƌŝŶƐƉĞĐƚŝŽŶĂƚĂŶǇ
time 
x 
Ensuring that conductinŐƚŚĞƐƚƵĚǇĚŽĞƐŶŽƚŐŝǀĞƌŝƐĞƚŽĂĐŽŶĨůŝĐƚŽĨŝŶƚĞƌĞƐƚ;ĨŝŶĂŶĐŝĂůĚŝƐĐůŽƐƵƌĞŝƐƌĞƋƵŝƌĞĚͿ 
11.5 
PUBLICATION POLICY 
Publications from the FT2 Study will be handled according to Standard Operating Procedures and as indicated in the 
CTA. 
Clinical study results will be maintained by the following means: 
x 
A final report, describing the results of all objectives and analysis, will be distributed to all Investigators, 
IRBs and the FDA 
x 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules stipulated  
x 
Submitting for publication the primary study results after the study ends  
x 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to the policies set 
forth by the corresponding journals and conferences  
x 
Making an individual study sites study data accessible to the corresponding Investigator after the 
ĐŽŵƉůĞƚŝŽŶŽĨƚŚĞƐƚƵĚǇ͕ŝĨƌĞƋƵĞƐƚĞĚ 
 
 
 

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12 
TERMS AND DEFINITIONS  
Term 
Definition 
Primary Safety Definitions 
Clinical Deterioration 
Clinical deterioration will include treatment-related events, such as unplanned 
endotracheal intubation, unexpected ƌĞƋƵŝƌĞŵĞŶƚ for mechanical ventilation, arterial 
ŚǇƉŽƚĞŶƐŝŽŶ;хϭŚŽƵƌŽƌƌĞƋƵŝƌŝŶŐvasopressors) or shock, cardiopulmonary 
resuscitation, persistent worsening in oxygenation, and emergency surgical 
embolectomy. 
Device Related Death 
Device-related death is defined as any death directly related to the device not 
performing as expected. Device-related death would include death from: 
x 
Vascular or cardiovascular injury  
x 
Device malfunction 
x 
Device-induced cardiac arrhythmia 
Life Threatening or 
Disabling Bleeding 
(VARC-2) 
x 
Fatal bleeding, OR 
x 
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial 
necessitating pericardiocentesis, or intramuscular with compartment syndrome, OR 
x 
Bleeding causing hypovolemic shock or severe hypotensiŽŶƌĞƋƵŝƌŝŶŐǀĂƐŽƉƌĞƐƐŽƌƐŽƌ
surgery, OR 
x 
Overt source of bleeding with drop in hemoglobin ш5 g/dL or whole blood or packed 
red blood cells (RBCs) ƚƌĂŶƐĨƵƐŝŽŶш4 units* 
Major Bleeding (VARC- 2) 
Overt bleeding that is: 
x 
Associated with a drop in the hemoglobin level of at least 3 g/dL, OR 
x 
ZĞƋƵŝƌĞƐƚƌĂŶƐĨƵƐŝŽŶŽĨϯƵŶŝƚƐŽĨǁŚŽůĞďůŽŽĚͬZ͕KZ 
x 
ĂƵƐĞƐŚŽƐƉŝƚĂůŝǌĂƚŝŽŶ͕ƉĞƌŵĂŶĞŶƚŝŶũƵƌǇ͕ŽƌƌĞƋƵŝƌŝŶŐƐƵƌŐĞƌǇ͕E 
x 
Does not meet criteria of life-threatening or disabling 
Minor Bleeding (VARC- 2) 
Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not 
ƋƵĂůŝĨǇĂƐůŝĨĞ-threatening or disabling bleeding or major bleeding. 
Pulmonary Vascular 
Injury 
Pulmonary vascular injury is defined as perforation or injury of a major pulmonary 
arterial branch during the ŝŶĚĞǆƉƌŽĐĞĚƵƌĞƌĞƋƵŝƌŝŶŐŝŶƚĞƌǀĞŶƚŝŽŶ͕ŝŶĐůƵĚŝŶŐďƵƚŶŽƚ
limited to blood transfusion, open or endovascular intervention, to avoid permanent 
injury. 
Cardiac Injury 
Cardiac injury is defined as any damage to the heart during the index procedure 
ƌĞƋƵŝƌŝŶŐŝŶƚĞƌǀĞŶƚŝŽŶ͕ŝŶĐůƵĚŝŶŐďƵƚŶŽƚůŝŵŝƚĞĚƚŽ blood transfusion, open or 
endovascular intervention, to avoid permanent injury. 
Additional Definitions 
Adverse Event (AE) 
An Adverse Event (AE) is an untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, 
users or other persons, whether or not related to the investigational medical device 
and whether anticipated or unanticipated (ISO 14155:2020, 3.2). 
NOTE 1: This definition includes events related to the investigational medical device. 
NOTE 2: This definition includes events related to the procedures 
involved. 
Serious Adverse Event 
(SAE) 
An AE that led to any of the following: 
x 
death, 
x 
serious deterioration in the health of the subject, users or other persons as defined by 
one or more of the following: 

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Term 
Definition 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body function, including 
chronic disease, or 
o 
in-patient or prolonged hospitalization, or 
o 
medical or surgical intervention to prevent life- threatening illness or injury 
or permanent impairment to a body structure or a body function, 
x 
fetal distress, fetal death or a congenital abnormality or birth defect including 
physical or mental impairment 
 
NOTE 1: Planned hospitalization for a pre-ĞǆŝƐƚŝŶŐĐŽŶĚŝƚŝŽŶ͕ŽƌĂƉƌŽĐĞĚƵƌĞƌĞƋƵŝƌĞĚ
by the CIP, without serious deterioration in health, is not considered an SAE. (ISO 
14155:2020, 3.45) 
Minor Complications (SIR 
Classification) 
Minor complications: 
x 
EŽƚŚĞƌĂƉǇ͕ŶŽĐŽŶƐĞƋƵĞŶĐĞ 
x 
EŽŵŝŶĂůƚŚĞƌĂƉǇ͕ŶŽĐŽŶƐĞƋƵĞŶĐĞ;ŝŶĐůƵĚĞƐŽǀĞƌŶŝŐŚƚĂĚŵŝƐƐŝŽŶ for observation 
only) 
Major Complications (SIR 
Classification) 
Major complications: 
x 
ZĞƋƵŝƌĞƚŚĞƌĂƉǇ͕ŵŝŶŽƌŚŽƐpitalization (ч 48 hours) 
x 
ZĞƋƵŝƌĞŵĂũŽƌƚŚĞƌĂƉǇ͕ƵŶƉůĂŶŶĞĚŝŶĐƌĞĂƐĞŝŶůĞǀĞůŽĨ care, prolonged hospitalization 
(>48 hours) 
x 
WĞƌŵĂŶĞŶƚĂĚǀĞƌƐĞƐĞƋƵĞůĂĞ 
x 
Death 
Adverse Device Effect 
(ADE) 
AE related to the use of an investigational medical device 
 
NOTE 1: dŚŝƐĚĞĨŝŶŝƚŝŽŶŝŶĐůƵĚĞƐƐƌĞƐƵůƚŝŶŐĨƌŽŵŝŶƐƵĨĨŝĐŝĞŶƚŽƌŝŶĂĚĞƋƵĂƚĞ
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 an error use or from 
intentional misuse of the investigational medical device. 
NOTE 3: this includes ‘comparator’ if the comparator is a medical device. (ISO 
14155:2020, 3.1) 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resuůƚĞĚŝŶĂŶǇŽĨƚŚĞĐŽŶƐĞƋƵĞŶĐĞƐ 
characteristic of a serious adverse event. (ISO 14155:2020, 3.44) 
Unanticipated Serious 
Adverse Device Effect 
(USADE) (pre-market 
term only)  
USADE is a serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current risk assessment. (ISO 14155:2020, 3.51) 
 
 
Anticipated Serious 
Adverse Device Effect 
(ASADE) (pre-market 
term only) 
ASADE is a serious adverse device effect which by its nature, incidence, severity or 
outcome has been identified in the risk assessment. (ISO 14155:2020, 3.51) 
Unanticipated Adverse 
Device Effect (UADE) 
(pre-market term only) 
Any serious adverse effect on health or safety or any life- threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death, was not 
previously identified in a nature, severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. (21 CFR 812.3(s)) 

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Term 
Definition 
Device Deficiency 
/ŶĂĚĞƋƵĂĐǇŽĨĂŵĞĚŝĐĂůĚĞǀŝĐĞǁŝƚŚƌĞƐƉĞĐƚƚŽŝƚƐŝĚĞŶƚŝƚǇ͕ƋƵĂůŝƚǇ͕ĚƵƌĂďŝůŝƚǇ͕
reliability, usability, safety or performance. 
 
NOTE 1: ĞǀŝĐĞĞĨŝĐŝĞŶĐŝĞƐŝŶĐůƵĚĞŵĂůĨƵŶĐƚŝŽŶƐ͕ƵƐĞĞƌƌŽƌƐĂŶĚŝŶĂĚĞƋƵĂĐǇŝŶƚŚĞ
information supplied by the manufacturer including labeling. 
NOTE 2: This definition includes device deficiencies related to the 
investigational medical device or the comparator. (ISO 14155:2020, 3.19) 
High-Risk PE 
Per ESC guidelines 2019: High-Risk PE determined by hemodynamic instability, PESI III-
V or sPESI ш1, RV Dysfunction, and Elevated cardiac troponins.  
Note Definition of hemodynamic instability, which delineates acute high-risk 
pulmonary embolism (one of the following clinical manifestations at presentation). 1. 
Cardiac Arrest: Need for cardiopulmonary resuscitation, 2. Obstructive Shock: Systolic 
BP < 90 mmHg or ǀĂƐŽƉƌĞƐƐŽƌƐƌĞƋƵŝƌĞĚƚŽĂĐŚŝĞǀĞĂWш 90 mmHg despite ĂĚĞƋƵĂƚĞ
filling status AND End-organ hypoperfusion (altered mental status; cold, clammy skin; 
oliguria/anuria; increased serum lactate), OR 3. Persistent Hypotension: Systolic BP < 
90 mmHg or systolic BP drop ш 40 mmHg, lasting longer than 15 min and not caused by 
new-onset arrhythmia, hypovolemia, or sepsis. 
Intermediate High-Risk 
PE 
Per ESC guidelines 2019: Intermediate High-Risk PE determined by no hemodynamic 
instability, PESI III- V or sPESI ш1, RV Dysfunction, and Elevated cardiac troponins. 
Intermediate Low-Risk 
PE 
Per ESC guidelines 2019: Intermediate Low-Risk PE determined by no hemodynamic 
instability, PESI III- V or sPESI ш1, and 1 or none of the following: RV Dysfunction; 
Elevated cardiac troponins. 
Patient/ Subject 
Participants in the study. 
Recurrent PE 
Symptomatic worsening from baseline of the embolism that was successfully treated 
with the index procedure with documentation of a change on CTPA or other suitable 
imaging modality, as determined by the CEC. 
 
 
 

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13 
REFERENCES 
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Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An 
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Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Hasenfuss G, Pruszczyk P, et al. Predictive value of 
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This document contains confidential information for use only by Inari Medical. This document is not to 
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Date: 2023.08.11 
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