FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Conditions: PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
Sponsor: Inari Medical

Inari Medical 
FlowTriever Retrieval/Aspiration System 
Version 8.0 
March 15, 2021 
 
 
 
 
 
 
FLASH Study (Protocol 18-002) 
CONFIDENTIAL 
Page 1 of 42 
 
 
FLowTriever All-Comer Registry for Patient 
Safety and Hemodynamics (FLASH) 
 
 
 
 
 
Device: FlowTriever® Retrieval/Aspiration System 
Protocol Number: 18-002 
Version: 8.0 
March 15, 2021 
 
 
Sponsor 
Inari Medical 
9 Parker, 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) / Ethics Committee (EC) or duly authorized representative of the U.S. 
Food and Drug Administration / Ministry of Health / Member State Medical Devices Regulatory Authority 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.  
 
 

Inari Medical 
FlowTriever Retrieval/Aspiration System 
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FLASH Study (Protocol 18-002) 
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CONTENTS 
PROTOCOL SIGNATURE PAGE ....................................................................................................................... 5 
SYNOPSIS ....................................................................................................................................................... 6 
ABBREVIATIONS .......................................................................................................................................... 10 
1 
INTRODUCTION AND BACKGROUND .................................................................................................. 11 
1.1 
Incidence and Fatality Rate for Pulmonary Embolism .............................................................. 11 
1.2 
Diagnosis of Pulmonary Embolism ............................................................................................ 12 
1.3 
Pulmonary Embolism Treatment & Risk Stratification ............................................................. 12 
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 
Pharmacologic Thrombolysis .............................................................................................. 14 
1.6.4 
Ultrasound-Accelerated Thrombolysis ............................................................................... 15 
1.6.5 
Percutaneous Pulmonary Artery Thromboembolectomy .................................................. 15 
2 
STUDY DEVICE ..................................................................................................................................... 16 
2.1 
Overview ................................................................................................................................... 16 
2.2 
Manufacturer ............................................................................................................................ 16 
2.3 
Indications for Use .................................................................................................................... 16 
3 
PRIOR INVESTIGATIONS ...................................................................................................................... 16 
3.1 
Design of the FLARE Study ........................................................................................................ 16 
3.2 
Study Results ............................................................................................................................. 17 
4 
STUDY OBJECTIVE................................................................................................................................ 18 
5 
OUTCOME VARIABLES ......................................................................................................................... 18 
5.1 
Primary Safety Endpoint Definition .......................................................................................... 18 
5.2 
Secondary Endpoints ................................................................................................................ 18 
5.2.1 
Secondary Safety Endpoints................................................................................................ 18 
5.2.2 
Secondary Effectiveness Endpoint ...................................................................................... 19 
5.2.3 
Utility Measures .................................................................................................................. 19 
6 
STUDY DESIGN..................................................................................................................................... 19 
6.1 
Study Population ....................................................................................................................... 20 
6.2 
Informed Consent ..................................................................................................................... 20 
6.3 
Point of Enrollment ................................................................................................................... 20 

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6.4 
Inclusion Criteria ....................................................................................................................... 20 
6.5 
Exclusion Criteria ....................................................................................................................... 21 
7 
ASSESSMENTS AND FOLLOW-UP SCHEDULE ...................................................................................... 21 
7.1 
Schedule of Assessments .......................................................................................................... 21 
7.2 
Baseline Assessments ............................................................................................................... 23 
7.3 
Index Procedure* ...................................................................................................................... 23 
7.4 
Bleeding Measures .................................................................................................................... 24 
7.5 
Follow-Up Assessments and Windows ..................................................................................... 24 
7.6 
Unscheduled Follow-up Visits ................................................................................................... 25 
7.7 
Withdrawals and Lost to Follow-up .......................................................................................... 25 
7.8 
COVID-19 Effect on Research .................................................................................................... 26 
8 
RISK ANALYSIS ..................................................................................................................................... 26 
8.1 
Risks to Patients ........................................................................................................................ 26 
8.2 
Risk Mitigation .......................................................................................................................... 26 
9 
SAFETY ASSESSMENT .......................................................................................................................... 26 
9.1 
Defining Adverse Events ........................................................................................................... 26 
9.2 
Reporting of Events ................................................................................................................... 27 
10 STATISTICS & DATA ANALYSIS ............................................................................................................. 28 
10.1 Sample Size ............................................................................................................................... 28 
10.2 Statistical Methodology ............................................................................................................ 28 
11 STUDY MANAGEMENT CONSIDERATIONS .......................................................................................... 28 
11.1 Data Management and Collection of Clinical Data ................................................................... 28 
11.2 Protocol Modifications .............................................................................................................. 29 
11.3 Protocol Deviations ................................................................................................................... 29 
11.4 Information for Study Personnel .............................................................................................. 29 
12 STUDY ADMINISTRATION .................................................................................................................... 29 
12.1 Site Initiation ............................................................................................................................. 29 
12.2 Site Monitoring Visits ................................................................................................................ 29 
12.3 Study Termination ..................................................................................................................... 30 
12.4 Data Handling and Recordkeeping ............................................................................................ 30 
12.4.1 
Completing, Signing and Archiving Case Report Forms ...................................................... 30 
12.4.2 
Data Management and Archiving ....................................................................................... 30 
12.4.3 
Direct Access to Source Data/Documentation ................................................................... 30 
13 ETHICS AND CONFIDENTIALITY ........................................................................................................... 31 
13.1 Informed Consent ..................................................................................................................... 31 

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13.2 Institutional Review Board (IRB) / Ethics Committee (EC) ........................................................ 31 
13.3 Study Patient Confidentiality .................................................................................................... 31 
13.4 Independent Medical Monitor .................................................................................................. 32 
13.5 Core Laboratory and Image Transfer ........................................................................................ 32 
13.6 Participating Institutions and Investigators .............................................................................. 32 
13.7 Investigator Responsibilities ..................................................................................................... 32 
14 ELECTRONIC DATA .............................................................................................................................. 32 
15 TERMS AND DEFINITIONS ................................................................................................................... 33 
16 REFERENCES ........................................................................................................................................ 36 
APPENDIX 1 
KNOWN RISKS OF THROMBECTOMY .................................................................................. 41 
SIGNATURE APPROVAL PAGE ..................................................................................................................... 42 
 
Listing of Tables 
Table 1. Elements of Various Bleeding Scales ............................................................................................................ 24 
 
Listing of Figures 
Figure 1. Incidence and Case-Fatality Rate for Pulmonary Embolism by Country .................................................... 11 
Figure 2. European Society of Cardiology Risk Stratification .................................................................................... 13 
Figure 3. Disposition of Patients in the FLARE Trial ................................................................................................... 17 
 
 

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PROTOCOL SIGNATURE PAGE 
 
 
 
 
Investigator Name 
 
Title 
 
 
 
Site Name 
 
Site Number 
 
 
I have read the protocol and agree that it contains all necessary details for carrying out this study. I will 
conduct the study as outlined therein.  
I will provide copies of the protocol and all information on the device relating to past non-clinical and 
clinical experience, which were furnished to me by the Sponsor, to all physicians and other study 
personnel responsible to me who participate in this study and will discuss this material with them to 
ensure that they are fully informed regarding the device and the conduct of the study. 
I agree to keep records on all patient information (e.g., source documents and informed consent forms) 
and all other information collected during the study, in accordance with local and national regulations. 
 
 
 
 
Investigator’s Signature 
 
 
Date 
 
 
 

Inari Medical 
FlowTriever Retrieval/Aspiration System 
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March 15, 2021 
 
 
 
 
 
 
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SYNOPSIS 
Protocol Number  
18-002 
Study Title 
FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) 
Study Device 
FlowTriever Retrieval/Aspiration System 
Regulatory Status 
The FlowTriever System is cleared for the treatment of Pulmonary Embolism under 
US Regulations 510(k) number K180466 and CE Mark 518259. The FlowTriever 
System is indicated for use in the peripheral vasculature and for the treatment of 
pulmonary embolism. 
Sponsor 
Inari Medical 
9 Parker, Suite 100 
Irvine, CA 92618 (USA) 
Study Objective 
The primary study objective is to evaluate the safety and effectiveness of the 
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 will be 
assessed in a real-world population, with eligibility criteria that closely approximate 
its use in clinical practice. 
Study Population 
This study will enroll up to 1000 patients (up to 800 in the US and up to 200 in 
Europe) with PE treated with FlowTriever. 
Number of Sites 
This study will be conducted at up to 100 Registry sites (up to 70 in the US, up to 30 
in Europe). 
Study Design 
The FLASH Registry is a prospective, single-arm, multicenter study of the 
FlowTriever System for intermediate-risk (submassive) and high-risk (massive) PE. 
Conservative Therapy 
Sub-study (US Only) 
Up to 300 additional patients with anticoagulation treatment as the initial planned 
primary treatment strategy for intermediate risk PE will be evaluated. Clinical 
assessments will be performed at Baseline, 48h, 30d, and 6m. 
Primary Endpoint 
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: 
• 
Device-related mortality through 48 hours after the index procedure, or 
• 
Major bleeding through 48 hours after the index procedure, or 
• 
Intra-procedural device or procedure-related adverse events, including: 
o 
Clinical deterioration defined by hemodynamic or respiratory worsening, or 
o 
Device-related pulmonary vascular injury, or 
o 
Device-related cardiac injury 
Secondary Endpoints 
Secondary Safety Endpoints: 
• 
Individual components of the MAE composite endpoint 
• 
Major access-site complications requiring open surgical or endovascular 
intervention or blood transfusion 
• 
All-cause mortality through 30 days 
• 
Device-related serious adverse events within 30 days 
 
 

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Secondary Endpoints 
Secondary Effectiveness Endpoints: 
• 
Reduction in pulmonary artery pressures during the procedure; 
• 
Hemodynamic improvements during the procedure, including cardiac index 
(CI) and stroke volume index (SVI), right ventricular stroke work index 
(RVSWI), pulmonary artery pulsatility index (PAPi) and total pulmonary 
vascular resistance (TPVR) 
• 
Reduction in right-ventricular/left-ventricular (RV/LV) ratio from baseline to 
30 days and 6 months; as measured by echocardiography 
Utility Measures: 
• 
Fluoroscopy time 
• 
Contrast used 
• 
Thrombectomy time 
• 
Estimated blood loss during the index procedure 
• 
Length of intensive care unit stay, if any 
• 
Length of total hospital stay 
Inclusion Criteria 
Patients must meet each of the following criteria to be included in the study: 
1. Age ≥ 18 years  
2. Clinical signs and symptoms consistent with acute PE 
3. Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at 
least one main or lobar pulmonary artery 
4. Scheduled for PE treatment with the FlowTriever System per the 
Investigator’s discretion* 
*US only:  Patients enrolled in the Conservative Therapy Sub-study are not required 
to meet this inclusion criteria but must instead be scheduled for primary 
anticoagulation therapy as the primary treatment strategy. 
Exclusion Criteria 
Patients will be excluded from the study for any of the following criteria:  
1. Unable to anticoagulate with heparin or alternative 
2. Diagnosis with a minor PE with a less than 0.9 RV/LV ratio  
3. Known sensitivity to radiographic contrast agents that, in the Investigator’s 
opinion, cannot be adequately pre-treated* 
4. Imaging evidence or other evidence that suggests, in the opinion of the 
Investigator, the patient is not appropriate for mechanical thrombectomy 
intervention (e.g., inability to navigate to target location or predominately 
chronic clot) * 
5. Life expectancy <30 days, as determined by the Investigator 
6. Current participation in another drug or device treatment study that, in the 
Investigator’s opinion, would interfere with participation in this study 
*US Only Patients enrolled in the Conservative Therapy Sub-study are not 
required to meet these exclusion criteria 
Analytic Datasets 
The analytic dataset will comprise all patients enrolled, where enrollment is 
defined when the FlowTriever System enters the patient’s vasculature or the 
patient is diagnosed with PE and the primary treatment strategy of anticoagulation 
is administered (Conservative Therapy Sub-study) and the patient provides consent 
to share his/her personal health information. 

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Follow-up Schedule 
Patients will have follow-up evaluations after the index procedure* at:  
• 
48 hours (± 36 hours)  
• 
30 days (± 15 days) 
• 
6 months (± 90 days) 
*US Only:  Conservative Therapy Sub-study patient follow up evaluations will occur 
after the primary treatment of anticoagulation is administered at Baseline. 
 
(US Only Patients) In addition to the follow-up schedule, approximately 100 
patients receiving treatment with the FlowTriever System and approximately 100 
patients receiving anticoagulation treatment will be asked to participate in ongoing 
data collection for 6 months utilizing an Apple iWatch. 
Medical Monitor 
An independent Medical Monitor will review adverse events and other important 
safety occurrences as specified in the Safety Manual. 
Global Principal 
Investigator 
Catalin Toma, M.D. 
Director, Interventional Cardiology 
Heart and Vascular Institute 
University of Pittsburgh Medical Center, Pittsburgh, PA 
 
Schedule of Assessments 
Assessment 
Baseline 
(≤ 48 hrs.) 
 Procedure* 
(Day 0) 
48 Hours‽ 
(± 36 hrs.) 
30 Days 
(± 15 days) 
6 Months 
(± 90 days) 
Inclusion/exclusion review 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History and Risk Factors 
X 
 
 
 
 
Clinical Diagnosis (CTEPH, CTED/Post PE 
Syndrome) 
X 
 
 
X 
X 
Current PE Condition 
X 
 
 
 
 
Clinical Condition on Arrival to ED/Hospital 
X 
 
 
 
 
Clinical Condition prior to treatment 
administration 
X 
 
 
 
 
Anticoagulation regimen 
X 
X 
X 
X 
X 
Clinical Labs: HGB, CBC, Troponin, BNP, Lactate, 
INR, Creatinine, D-Dimer 
X 
X 
X 
 
 
Echocardiogram (Required) 
X 
 
 
X 
X 
CTPA (Requested) † 
X 
 
 
 
 
mMRC Dyspnea Score (Required) 
X 
 
X 
X 
X 
Thrombectomy Time 
 
X 
 
 
 
Vitals 
X 
 
X 
X 
X 
Invasive hemodynamic measures with HGB, 
SvO2% (Required) 
 
2X Δ 
 
 
 
Pulmonary angiograms 
 
2X 
 
 
 
Bleeding measures 
 
X 
X 
 
 
FlowTriever Devices used 
 
X 
 
 
 
Access Site information 
 
X 
 
 
 
Procedure Summary (e.g. treatment location, 
EBL, Fluoro time, clot removal score, HR, 
pressures)  
 
X 
 
 
 

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Adjunctive therapy (thrombolysis and/or 
additional thrombectomy) 
X** 
X 
 
X 
 
6-minute walk test (Required) 
 
 
 
X 
X 
PEmb QOL (Required) 
 
 
 
X 
X 
Adverse event assessment 
 
X 
X 
X 
X 
Wearables assessment₲ 
 
 
X 
X 
X 
*Procedural assessments are not required nor will be captured for patients in the Conservative Therapy Sub-study. 
‽ The time to assessment clock starts after TrieverCatheter is removed for the final time. 
† CTPA imaging will be performed as per the local standard of care. If a CTPA is ordered, imaging data is requested.  
Δ Invasive hemodynamic measures will include RA, RV, and PA pressures from the tip of the pulmonary catheter, record the mixed venous PA sat (SvO2), RA 
pressure, and the PA pressures. Then, flush the catheter and draw the HGB sample from the PA and simultaneously record the heart rate, peripheral artery O2 sat 
(SaO2) and the oxygen level the patient is receiving.  These measurements are obtained pre-FlowTriever insertion and at least 5 minutes after removing the 
FlowTriever for the final time. 
₲ Data collection occurring from the 48-hour visit through the 6-month visit 
** For Conservative Therapy Sub-study, collect if adjunctive therapy was used at Baseline 
NOTE: Consenting can be done 48hr pre-index procedure OR within 7 days post index procedure.  Enrollment occurs when consent signed AND FlowTriever enters 
the body. For the US Only Patients, Conservative Therapy Sub-study, consenting can be done 48hr prior to the administration of anticoagulation therapy as the 
primary treatment strategy OR within 7 days after. Enrollment occurs when consent is signed AND the primary treatment strategy to administer anticoagulation 
has commenced.  
NOTE: Please collect COVID status at all visits as applicable on the supplemental EDC form. 
 
 
 

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ABBREVIATIONS 
Abbreviation 
Term 
AC 
Anticoagulation 
AE 
Adverse event 
AHA 
American Heart Association 
BSA 
Body surface area 
CDT 
Catheter-directed thrombolysis 
CO 
Cardiac output 
CRO 
Contract research organization 
CTED 
Chronic thromboembolic disease 
CTEPH 
Chronic thromboembolic pulmonary hypertension 
CTPA 
Computed tomographic pulmonary angiography 
DOAC 
Direct oral anticoagulant 
DVT 
Deep venous thrombosis 
ECMO 
Extracorporeal membrane oxygenation 
eCRFs 
Electronic case report forms 
ESC 
European Society of Cardiology 
EC 
Ethics Committee 
FDA 
Food and Drug Administration 
FLARE 
FlowTriever Clinical Embolectomy Clinical Study 
GDPR 
General Data Protection Regulation 2016/679 
H-FABP 
Heart type fatty acid binding 
HGB 
Hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
HIT 
Heparin-induced thrombocytopenia 
ICF 
Informed consent form 
IRB 
Institutional review board 
ITT 
Intent to treat 
LV 
Left ventricle 
MAE 
Major adverse events 
mMRC  
Modified Medical Research Council Dyspnea Scale 
PAPi 
Pulmonary Artery Pulsatility Index 
PE 
Pulmonary embolism 
PEmb-QOL 
Pulmonary Embolism Quality of Life 
PESI 
Pulmonary Embolism Severity Index 
PHI 
Protected Health Information 
PMT 
Percutaneous mechanical thrombectomy 
Post-PES 
Post-pulmonary embolism syndrome 
RV 
Right ventricle 
RV/LV 
Right ventricular to left ventricular diameter ratio 
RVSWI 
Right ventricular stroke work index 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SIV 
Site initiation visit 
sPESI 
Simplified Pulmonary Embolism Severity Index 

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Abbreviation 
Term 
SVI 
Stroke volume index 
TPVR 
Total pulmonary vascular resistance 
UAT 
Ultrasound-accelerated thrombolysis 
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). 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 study. At the same time, the case fatality rate 
dropped from approximately 7% to 4% over the same years in the US. By contrast, the fatality rate in China 
decreased from 25% in 1997 to less than 10% in 2008; a change likely accounted for by an increase in the rate of 
diagnosis of smaller PE and, possibly, improved treatment after recognition.2 
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 

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*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 probability of confirmed PE is 10%, 30%, and 65% in the low, intermediate, and high-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-diagnose small, 
subsegmental emboli of little clinical consequence.8 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 the hemodynamic consequences of the embolism, namely, acute right ventricular dysfunction. Right 
ventricular (RV) 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. 
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 2011 American Heart Association (AHA) Scientific Statement on Pulmonary 
Embolism classified 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 
systolic blood pressure <90 mm Hg lasting more than 15 minutes or requiring ionotropic 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 

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>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 25-50% for massive PE, 1% for low-risk PE, and somewhere in between for submassive PE. 
European Society of Cardiology. The 2014 European Society of Cardiology (ESC) guidelines 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. 
Figure 2. European Society of Cardiology Risk Stratification 
From Konstantinides et al.2 
*Markers of myocardial injury, e.g., elevated cardiac troponin, or heart type fatty acid-binding (H-FABP] 
plasma concentrations), or of right ventricular dysfunction, e.g., elevated natriuretic peptide plasma 
concentrations. 
 
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 
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. 

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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, massive 
pulmonary embolism occurs in less than 10% of cases.17 
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-risk patients is equally clear; anticoagulation alone 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 
thromboembolectomy was first conceived by Trendelenburg in 1908; while Kirschner was the first to publish the 
technique 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 mortality rate is more than 25%, 
although this figure must 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.  
1.6.3 Pharmacologic 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,35 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.36-41 The benefits were limited to short-term 
improvement in cardiac function, but the studies were not powered to detect mortality differences. For the first 

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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 cases included intracranial hemorrhage.16,42,43 These findings remained unchanged despite newer 
agents and better periprocedural patient management over the years. 
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 2009.44 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, massive PE. However, recent work suggests that even a catheter-directed approach may be 
associated with significant bleeding complications,45 although possibly at a lower rate than with systemic 
treatment.46 
1.6.4 Ultrasound-Accelerated Thrombolysis 
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.47 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.48 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-
directed thrombolysis, 12% with UAT vs. 10% with standard catheter-directed thrombolysis.21 The review, 
however, documented a trend toward improved survival with UAT; 4% vs. 9% in the UAT and 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-does, 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 1969.49 After that, other technologies were 
attempted, including fragmentation of proximal emboli,50,51 rheolytic thrombectomy,52-56 and the use of various 
pulmonary artery thromboembolectomy devices.57-59 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. 
 

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2 
STUDY DEVICE 
2.1 OVERVIEW 
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally 
invasive treatment of thromboemboli in the peripheral vasculature and the treatment of pulmonary embolism.  
The device was cleared in the US under 510(k) number K180466, May 17, 2018, and CE Mark on December 30, 
2020. The FlowTriever System is a Class II device in the US and a Class III device in Europe, intended for use in the 
peripheral vasculature and for the treatment of pulmonary embolism. 
2.2 MANUFACTURER 
Inari Medical  
9 Parker, Suite 100 
Irvine, CA 92618 (USA) 
2.3 INDICATIONS FOR USE 
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally 
invasive treatment of thromboemboli in the peripheral vasculature and the treatment of pulmonary embolism.  
The FlowTriever System is indicated for the non-surgical removal of emboli and thrombi from blood vessels; the 
injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The 
completion of the FLARE prospective clinical trial resulted in FDA clearance and CE Mark for the treatment of 
pulmonary embolism.  
3 
PRIOR INVESTIGATIONS 
The FlowTriever System was 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. 
3.1 DESIGN OF THE FLARE STUDY 
A maximum of 20 study sites were planned to participate in the study, and no single study site could enroll more 
than 25% of the total subjects. The study population comprised 106 subjects with acute submassive PE.  
Primary safety and  primary effectiveness performance goals (PG) were used in the study. For the safety PG, the 
results from seven studies with acute PE patients treated with a heparin control arm were used to develop a 
composite MAE rate. MAEs were defined when one or more of the following occurred within 48 hours: Device-
related mortality, major bleeding, treatment-related clinical deterioration, treatment-related pulmonary vascular 
injury, or treatment-related cardiac injury. Combining these composite MAE rates yielded an estimate of 16% with 
a 95% confidence interval of 6.7% to 25.8% after adjusting for heterogeneity among studies. The PG was chosen as 
the upper 95% confidence limit rounded down to two digits, for a safety PG of 25%. 
The primary effectiveness performance goal was the change in RV/LV ratio from baseline to 48 hours. The PG was 
based on heparin-treated subjects from four studies in which heparin was a control to an active pharmaceutical 
drug. Combining these results in a meta-analysis yielded a mean change from baseline of 12% with 95% confidence 
limits of 4% to 21% after adjusting for heterogeneity among studies, for an effectiveness PG of 12%. 

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Subjects were followed for 30 days post-procedure with CTPA at 48 hours and assessment of AEs through 30 days. 
The primary safety endpoint was assessed from the 48-hour MAE rate and the primary effectiveness endpoint 
from the change between the baseline and 48-hour CTPA imaging studies. 
The sample size for effectiveness was computed based on an estimated RV/LV ratio change from baseline. For 80% 
power to detect an RV/LV ratio greater than 0.12 using a one-sided alpha = 0.025, the sample size needs to be at 
least 62, 38, or 26 assuming a true RV/LV ratio of 0.20, 0.225 or 0.25, respectively. 
The sample size for safety was based on the PG of 25% for the composite endpoint. The true composite endpoint 
rate for the FlowTriever was expected to be about 13%, according to data from the historical studies used for the 
PG estimation. Additionally, rates of 15% and 17% were considered. For 80% power to detect a difference from the 
expected lower composite endpoint rates of 13%, 15%, and 17% compared to the performance goal with a one-
sided alpha = 0.05, 70, 103, and 167 subjects would be needed if the true rates were 13%, 15%, and 17%, 
respectively. Since a conservative sample size for safety was calculated to be 103, 103 was used as the sample size 
for this study, not adjusted for subjects receiving thrombolytics. It was assumed that approximately 15% of the 
subjects would receive thrombolytics so that 103/0.85=121.2 or up to 122 subjects could be enrolled. 
3.2 STUDY RESULTS 
The disposition of subjects in the FLARE trial is depicted in Figure 3. 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 3. Disposition of Subjects in the FLARE Trial 
 
 
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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For the primary safety endpoint, 4 subjects (3.8%) in the mITT population experienced one or more MAEs. The 
composite endpoint of 3.8% was statistically lower than the performance goal of 25% (p-value <0.0001), with an 
upper one-sided 95% confidence limit of 8.6%. The upper one-sided 95% confidence limit for the ITT population 
was 8.4%, which was significantly less than the performance goal of 25%. 
In sum, 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. 
4 
STUDY OBJECTIVE  
The primary study objective is to evaluate the safety and effectiveness of the 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 will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical 
practice. 
5 
OUTCOME VARIABLES 
5.1 PRIMARY SAFETY ENDPOINT DEFINITION 
The primary safety endpoint is the rate of Major Adverse Events (MAE). MAEs are defined as a composite when 
one or more of the following events occur: 
• 
Device-related mortality through 48 hours after the index procedure, or 
• 
Major bleeding through 48 hours after the index procedure, or 
• 
Intraprocedural device- or procedure-related adverse events, including: 
o 
Clinical deterioration defined by hemodynamic or respiratory worsening, or 
o 
Device-related pulmonary vascular injury, or 
o 
Device-related cardiac injury 
The components of the composite MAE endpoint will be assessed by the independent Medical Monitor. 
5.2 SECONDARY ENDPOINTS 
The secondary endpoints of the study will assess safety, effectiveness, and utility measures, as follows. 
5.2.1 Secondary Safety Endpoints 
• 
Individual components of the MAE composite endpoint 
• 
Major access site complications requiring open surgical or endovascular intervention or blood transfusion 
• 
All-cause mortality within 30 days 
• 
Device-related serious adverse events within 30 days 
 

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5.2.2 Secondary Effectiveness Endpoint 
• 
Reduction in pulmonary artery pressures during the procedure 
• 
Hemodynamic improvements during the procedure, including cardiac index (CI) and stroke volume index (SVI), 
right ventricular stroke work index (RVSWI), pulmonary artery pulsatility index (PAPi), and total pulmonary 
vascular resistance (TPVR)b 
• 
Reduction in right-ventricular/left-ventricular (RV/LV) ratio from baseline to 30 days and 6 months; as 
measured by echocardiography 
5.2.3 Utility Measures 
• 
Fluoroscopy time 
• 
Contrast used 
• 
Estimated blood loss during the index procedure 
• 
Thrombectomy Time 
• 
Length of intensive care unit stay, if any 
• 
Length of total hospital stay 
6 
STUDY DESIGN 
The FLASH Registry study is a prospective, single-arm, multicenter analysis of the FlowTriever System for 
intermediate-risk (submassive) and high-risk (massive) PE. The Registry will collect data on demographics, 
comorbidities, details from the PE diagnosis and treatment, and clinical outcomes through 6-month follow-up. 
Up to 1000 patients (up to 800 US, up to 200 Europe) with PE will be enrolled at up to 100 (up to 70 US, up to 30 
Europe) Registry sites. All patients who sign consent and are treated with the FlowTriever System will comprise the 
analytic dataset. 
Conservative Therapy Sub-study:  (US Patients Only) Up to 300 additional patients with anticoagulation treatment 
as the initial planned primary treatment strategy for intermediate risk PE will be evaluated. Clinical assessments 
will be performed at Baseline, 48 hours, 30 days, and 6 months. 
Conservative Therapy Sub-study: (US Patients Only) Approximately 150 of these patients should be considered 
intermediate-high risk. Enrollment will be limited to 60 patients per site. The Conservative Therapy Sub-study will 
 
b The Fick Method will be utilized to estimate cardiac output. Measurement of pulmonary artery oxygen saturation, peripheral arterial oxygen 
saturation by pulse oximetry or arterial line, and the hemoglobin concentration is required. Body surface area (BSA) will be approximated with 
the modified DuBois formula; BSA = 0.007184 x (height in cm)0.725 x (weight in kg)0.425. O2 consumption is approximated as body weight in kg x 3 
ml/kg. 
Cardiac output (CO) is estimated as the O2 consumption divided by the product of arterial-mixed venous O2 difference, hemoglobin 
concentration, and the constant 13.6. As an example, an 80 kg patient with a hemoglobin of 11 g/dL, a mixed venous (pulmonary artery) O2 
saturation of 60% and an arterial O2 saturation of 97% would have an estimated cardiac output of (80 kg x 3 ml/kg) / [(.97 - .60] x 13.6 x 11 
g/dL), or 210/ 53, or 4.34 L/min. If the BSA is 1.7, the cardiac index is 4.34/1.7, or 2.6. If the heart rate is 80, the SVI is 2,600 / 80 or 32.5 ml. 
RVSWI is calculated as the (mean pulmonary artery pressure – right atrial pressure) x stroke volume index x 0.136. 
PAPi is calculated as (pulmonary artery systolic – pulmonary artery diastolic) / right atrial pressure. 
TPVR is calculated as the mean pulmonary artery pressure / cardiac output. 

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collect data on demographics, comorbidities, details from the PE diagnosis and treatment, and clinical outcomes 
through 6-month follow-up.  
6.1 STUDY POPULATION 
The study will consist of up to 1000 patients (up to 800 US, up to 200 Europe) with intermediate-risk and high-risk 
PE, who meet the eligibility criteria and are appropriate candidates for treatment with the FlowTriever System. 
Conservative Therapy Sub-study (US Patients only): In addition to the up to 800 US patients enrolled who will 
receive treatment with the FlowTriever System, anticoagulation treatment will be evaluated on up to 300 patients 
diagnosed with intermediate-risk PE, who are not using mechanical thrombectomy as the primary treatment 
strategy. Approximately 150 of these patients should only be considered intermediate-low risk. 
6.2 INFORMED CONSENT 
Written, study-specific Informed Consent will be obtained from each patient 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 Informed Consent Form 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.  
6.3 POINT OF ENROLLMENT 
The FlowTriever System is not being used in an investigational manner and the patient will be treated with the 
device in the same manner regardless of whether the patient enrolls in the study. Therefore, the patient’s consent 
for treatment is covered under the institution’s internal procedures. To participate in the study, the patient must 
consent to share his/her de-identified personal health information (PHI) with the study sponsor. This allows sites 
to treat patients prospectively and consent patients after treatment. This can be helpful for sites when the 
research staff is unavailable to consent the patient prior to the index procedure (i.e., after hours, weekends, 
holidays). This practice is allowed provided there is no institutional prohibition against post-procedure consent. 
Pre-procedure consents are the preferred consenting method and should be obtained within 48 hours of the 
scheduled index procedure. When the informed consents are obtained retrospectively to the Index procedure, the 
consent must be obtained after the patient gains full capacity from anesthesia and within 7 days of the index 
procedure unless approved by a Legal Authorized Representative (LAR). 
If utilization of the FlowTriever System is planned, but the FlowTriever device does not enter the patient’s 
vasculature, the patient is not enrolled and as such, his/her data is not entered into the database. The patient is 
considered enrolled when 1the patient consents to the study and the device enters the patient or 2) the device 
enters the patient and the patient consents within 7 days. The timing of the two events, index procedure and 
consent, are interchangeable. 
Conservative Therapy Sub-study (US Patients Only): Point of enrollment will be defined as when 1) the patient is 
diagnosed with PE and the primary treatment strategy of anticoagulation is administered and 2) the patient 
consents to the study. The timing of treatment and consent are interchangeable.  
6.4  INCLUSION CRITERIA 
Patients must meet each of the following criteria to be included in the study: 
1. Age ≥ 18 years 

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2. Clinical signs and symptoms consistent with acute PE 
3. Echo, CTPA, or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar 
pulmonary artery 
4. Scheduled for PE treatment with the FlowTriever System per the Investigator’s discretion* 
*US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criterion 
but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.  
6.5 EXCLUSION CRITERIA 
Patients will be excluded from the study for any of the following criteria:  
1. Unable to anticoagulate with heparin or alternative 
2. Diagnosed with a minor PE with less than a 0.9 RV/LV ratio 
3. Known sensitivity to radiographic contrast agents that, in the Investigator’s opinion, cannot be adequately 
pre-treated* 
4. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not 
appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location or 
predominately chronic clot) * 
5. Life expectancy < 30 days, as determined by the Investigator 
6. Current participation in another investigational drug or device treatment study that, in the investigator’s 
opinion, would interfere with participation in this study 
*US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion 
criteria.  
7 
ASSESSMENTS AND FOLLOW-UP SCHEDULE  
7.1  SCHEDULE OF ASSESSMENTS 
The assessments conducted will be according to normal instructions and care of patients.  The Schedule of 
Assessments comprises recommended and required assessments.  Any departures from the follow-up schedule 
will be documented as a protocol deviation. Required assessments include invasive hemodynamic measurements 
with HGB during the index procedure*; Echo at baseline, 30 days, and 6 months; dyspnea mMRC score at 48 hours, 
30 days, and 6 months; and 6-minute walk test/PEmb QOL at 30 days and 6 months.  Missing any of these 
elements will be documented as a protocol deviation. 
*Invasive hemodynamic measurements are not required for patients in the Conservative Therapy Sub-study (US 
only) 
 
Wearables Assessment (US Patients Only): In addition to the follow-up schedule, approximately 100 patients 
receiving treatment with the FlowTriever System and approximately 100 patients receiving anticoagulation 
treatment will be asked to participate in ongoing data collection utilizing an Apple iWatch. Patients will be 
provided with a pre-configured Apple iWatch with cellular capabilities at the 48-hour visit. An iPhone is not 
required to participate. Patients who choose to participate will be expected to wear the Apple iWatch daily, with 
data collection occurring through their 6-month visit. Data to be collected will include but are not limited to blood 
oxygen saturation (Sp02), Heart Rate, and activity. Push notifications via SMS will also require the patient to 
respond to questions as applicable. Data collected via these means will not be provided to sites, routinely 
monitored, or used in the clinical decision-making process related to patient health. 
 

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Schedule of Assessments 
Assessment 
Baseline 
(≤ 48 hrs.) 
 
 Procedure* 
(Day 0) 
48 Hours‽ 
(± 36 hrs.) 
30 Days 
(± 15 days) 
 
6 Months 
(± 90 days) 
 
Inclusion/exclusion review 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History and Risk Factors 
X 
 
 
 
 
Clinical Diagnosis (CTEPH, CTED/Post PE 
Syndrome) 
X 
 
 
X 
X 
Current PE Condition 
X 
 
 
 
 
Clinical Condition on Arrival to ED/Hospital 
X 
 
 
 
 
Clinical Condition prior to treatment 
administration 
X 
 
 
 
 
Anticoagulation regimen 
X 
X 
X 
X 
X 
Clinical Labs: HGB, CBC, Troponin, BNP, Lactate, 
INR, Creatinine, D-Dimer 
X 
X 
X 
 
 
Echocardiogram (Required) 
X 
 
 
X 
X 
CTPA (Requested) † 
X 
 
 
 
 
mMRC Dyspnea Score (Required) 
X 
 
X 
X 
X 
Thrombectomy Time 
 
X 
 
 
 
Vitals 
X 
 
X 
X 
X 
Invasive hemodynamic measures with HGB, 
SvO2% (Required) 
 
2X Δ 
 
 
 
Pulmonary angiograms 
 
2X 
 
 
 
Bleeding measures 
 
X 
X 
 
 
FlowTriever Devices used 
 
X 
 
 
 
Access Site information 
 
X 
 
 
 
Procedure Summary (e.g. treatment location, 
EBL, Fluoro time, clot removal score, HR, 
pressures)  
 
X 
 
 
 
Adjunctive therapy (thrombolysis and/or 
additional thrombectomy) 
X** 
X 
 
X 
 
6-minute walk test (Required) 
 
 
 
X 
X 
PEmb QOL (Required) 
 
 
 
X 
X 
Adverse event assessment 
 
X 
X 
X 
X 
Wearables assessment₲ 
 
 
X 
X 
X 
* Procedural assessments are not required nor will be captured for patients in the Conservative Therapy Sub-study. 
‽ The time to assessment clock starts after TrieverCatheter is removed for the final time. 
† CTPA imaging will be performed as per the local standard of care. If a CTPA is ordered, imaging data is requested.  
Δ Invasive hemodynamic measures will include RA, RV, and PA pressures. From the tip of the pulmonary catheter, record the mixed venous PA sat (SvO2), RA 
pressure, and the PA pressures. Then, flush the catheter and draw the HGB sample from the PA and simultaneously record the heart rate, peripheral artery O2 sat 
(SaO2), and the oxygen level the patient is receiving.  These measurements are obtained pre-FlowTriever insertion and at least 5 minutes after removing the 
FlowTriever for the final time. 
₲ Data collection occurring from the 48-hour visit through the 6-month visit 
** (US Patients Only) For Conservative Therapy Sub-study, collect if adjunctive therapy was used at Baseline 
NOTE: Consenting can be done 48hr pre-index procedure OR within 7 days post-index procedure.  Enrollment occurs when consent is signed AND FlowTriever 
enters the body. For the Conservative Therapy Sub-study (US Patients Only), consenting can be done 48hr prior to the administration of anticoagulation therapy as 
the primary treatment strategy OR within 7 days after. Enrollment occurs when consent signed AND the primary treatment strategy to administer anticoagulation 
has commenced. 
NOTE: Please collect COVID status at all visits as applicable on the supplemental EDC form 

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7.2 BASELINE ASSESSMENTS 
An initial evaluation will be used to determine if a patient will be considered for enrollment. Assessments  include 
diagnostic testing that would have been done as part of a patient’s routine care. The following must be completed 
to evaluate for enrollment: 
• 
Review inclusion/exclusion to ensure patient meets criteria 
• 
Review of symptoms 
• 
Confirm PE on echocardiogram or CTPA 
 
If the consented patient meets all eligibility criteria and is scheduled for the thrombectomy procedure as the 
primary treatment strategy the patient will be enrolled in the study.  If the patient consents within 7 days after the 
thrombectomy procedure and meets all eligibility criteria, the patient will be considered enrolled.    
Patients (US Only) being treated with anticoagulation as the primary treatment strategy (instead of FlowTriever) 
may be invited to participate in the Conservative Therapy sub-study.  
The following assessments will be performed at the Baseline Visit within 48 hours of the index procedure. All data 
must be recorded in the patient’s case report forms (CRF): 
• 
Demographic information 
• 
Medical History and risk factors 
• 
Current PE condition 
• 
Clinical condition on arrival to ED/Hospital 
• 
Clinical condition prior to procedure 
• 
Anticoagulation regimen 
 
Clinical laboratory tests are expected to be performed at this visit to establish baseline levels. The panel of tests 
(including: HGB, CBC, Troponin, BNP, Lactate, INR, Creatinine, D-Dimer) standardly performed at the institution for 
patients with similar conditions related to PE should be considered.  
 
7.3 INDEX PROCEDURE*  
Thrombectomy using the FlowTriever System is considered the index procedure and the treatment phase of the 
study. The procedure is conducted under fluoroscopic/angiographic guidance. Refer to the Instructions for Use 
(IFU) for techniques and methods for device deployment. The following data are to be recorded on the patient’s 
Procedure CRF.  
• 
Thrombectomy Time 
• 
Number of FlowTriever devices used, with lot numbers 
• 
Pre- and post-procedure hemodynamics (Invasive hemodynamic measures will include RA, RV, and PA 
pressures.  From the tip of the pulmonary catheter, record the mixed venous PA sat (SvO2), RA pressure, and 
the PA pressures. Then, flush the catheter and draw the HGB sample from the PA and simultaneously record 
the heart rate, peripheral artery O2 sat (SaO2) and the oxygen level the patient is receiving.  These 
measurements are obtained pre-FlowTriever insertion and at least 5 minutes after removing the FlowTriever 
for the final time. 
• 
Pre- and post-procedure pulmonary angiograms 

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• 
Access site information 
• 
Procedure Summary information (e.g. treatment location, EBL, Fluoro time, clot removal score)  
• 
Procedure Bleeding Measures 
• 
Adjunctive therapy (thrombolysis and/or additional thrombectomy) 
• 
Anticoagulation regimen 
All procedural angiograms will be uploaded/sent to the sites core laboratory. 
7.4 BLEEDING MEASURES 
Various bleeding scales have been used to assess hemorrhagic complications after treatment for PE. The current 
study will capture elements of the commonly-utilized scales.62-65 This will allow comparisons of the rate of bleeding 
in the current study to that of other studies that have used a variety of bleeding scales. The elements that are 
included in several commonly employed bleeding scales are summarized in Table 1. Each element of each scale 
will be collected on the electronic case report forms (eCRFs) so that any of the bleeding scales can be 
retrospectively tabulated. Bleeding will be measured for 48 hours after conclusion of the index procedure. 
Table 1. Elements of Various Bleeding Scales 
Elements 
Bleeding Scale 
BARC 
PEITHO 
VARC 
TIMI 
GUSTO 
ISTH/SSC 
Clinically-overt bleeding 
 
 
 
X 
 
X 
Hemoglobin drop (g/dL)§ 
X 
 
X 
X 
X 
X 
Units of transfusion for bleeding§ 
X 
X 
X 
 
X 
X 
Hemodynamic compromise 
 
X 
 
 
X 
 
Requires surgical intervention 
X 
X 
X 
 
 
 
Life-threatening bleeding* 
X 
X 
X 
 
 
 
Fatal bleeding 
 
 
 
X 
 
X 
Intracranial hemorrhage 
X 
X 
X 
X 
X 
 
Intraocular bleed, impairment vision 
X 
 
 
 
 
 
Chest tube output 
X 
 
 
 
 
 
Bleeding is actionable† 
X 
 
X 
X 
 
X 
Bleeding is in a critical organ 
 
 
X 
 
 
X 
Compartment syndrome 
 
 
 
 
 
X 
* Includes cardiac tamponade, intracranial bleeding, bleeding requiring intravenous vasoactive agents 
†Defined by BARC as overt (clinically-evident or observed on imaging) bleeding that leads to discontinuation of a medication (e.g. antiplatelet 
or anticoagulant), local wound compression or other therapy, leads to hospitalization or prolonging of hospitalization, or to an unscheduled 
visit to a healthcare profession with laboratory or imaging assessment. Visits not prompting such assessments do not meet the criteria for 
BARC Type 2 bleeding. Defined by ISTH as hospital admission for bleeding, a physician-guided medical or surgical intervention for bleeding, or 
a change in antithrombotic therapy. 
§ The numerical hemoglobin drop and/or the number of units transfused will be recorded for all patients.  However, neither will be captured as 
a complication unless they also meet the VARC-2 definition.  Both will require a concurrent overt cause of bleeding AND either a ≥5g/dL Hgb 
drop or ≥2 units whole blood/RBC.  
 
7.5 FOLLOW-UP ASSESSMENTS AND WINDOWS 
Follow-up evaluation will be scheduled at 48 hours (±36 hours), 30 days (±15 days), and 6 months (±90 days) post-
procedure (or post anticoagulation administration for patients enrolled in the Conservative Therapy Sub-study. 
The following assessments and procedures will be performed at the 48-hour visit: 

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• 
Vitals 
• 
Dyspnea mMRC 
• 
Clinical Labs: HGB, CBC, Troponin, BNP, Lactate, INR, Creatinine, D-Dimer 
• 
Anticoagulation regimen 
• 
Bleeding Measures 
• 
AE observations that occurred since the last visit 
 
The following assessments and procedures will be performed at the 30-day and 6-month visits: 
• 
Vitals 
• 
Clinical Diagnosis (CTEPH, CTED/Post PE Syndrome) 
• 
Echocardiogram 
• 
Dyspnea mMRC 
• 
Anticoagulation regimen 
• 
6-Minute Walk Test 
• 
PEmb QOL 
• 
AE observations that occurred since the last visit 
 
7.6 UNSCHEDULED FOLLOW-UP VISITS 
This Registry study was designed to capture real-world data regarding the clinical use of the FlowTriever System 
and anticoagulation therapy. Therefore, the study will only record patient visits during the follow-up period that 
are related to the patient’s PE condition and treatment. If a patient returns to the site between scheduled follow-
up visits for matters related to the study, the visit will be treated as an unscheduled visit and the assessments 
completed at this visit will be done at the discretion of the Investigator*. CRF pages are provided for unscheduled 
visits with appropriate assessments and reason for the visit. 
* (US Only Patients) If a patient enrolled in the Conservative Therapy Sub-study requires an unscheduled visit for 
mechanical thrombectomy utilizing the FlowTriever System, pre-and post-hemodynamic measurements are 
required to be captured on the Unscheduled Visit CRF. 
7.7 WITHDRAWALS AND LOST TO FOLLOW-UP 
Participation is completely voluntary, and each patient is free to withdraw from the study at any time. An 
investigator also has the right to withdraw the patient from the study in the event of reasons concerning the 
health or well-being of the patient, or in the case of lack of cooperation. Should a patient decide to withdraw for 
any reason, or should the investigator decide to withdraw the patient, all efforts will be made to complete and 
report the observations up to the time of withdrawal as thoroughly as possible. A complete final evaluation at the 
time of the patient’s withdrawal must be made and an explanation given as to why the patient is withdrawing or 
being withdrawn from the study. 
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. 
If the FlowTriever procedure is aborted after entering the vasculature, the patient does not need to complete the 
follow-up assessments, however, patients who require conversion to open surgery due to incomplete FlowTriever 

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procedure will be followed for safety through 30 days, or until any treatment-related adverse events resolve, 
whichever is later.  Then the patient will be exited from the study.   
All efforts will be made to return patients for all follow-up visits.  Due diligence in reaching the patient must be 
made by two documented telephone contact attempts, emails, or regular postal mail letters.  After the above 
attempts are made, if no response is obtained, the final evaluation of the patient and study exit will be dated on 
the last visit at which study-related assessments were performed.  The Study Exit CRF page will be completed, and 
communication attempts will be documented. 
7.8  COVID-19 EFFECT ON RESEARCH 
This Registry study was designed to capture real-world data regarding the clinical use of the FlowTriever System 
(and anticoagulation treatment in the Conservative Therapy Sub-study). As a result of the COVID-19 pandemic, 
clinic practice patterns may have been affected and patient visits may have been postponed or eliminated.  In 
addition, some data may be collected from patients over the phone.  Our goal is to collect as much real-world data 
as possible while protecting everyone’s safety.  
8 
RISK ANALYSIS 
8.1 RISKS TO PATIENTS 
The FLASH Registry involves the use and disclosure of deidentified health information. It collects only information 
relevant to the patient’s PE condition and treatment.   
The Registry study involves the collection of specific information for research and educational purposes only. It 
does not specify how the FlowTriever System or anticoagulation will be used to treat PE, and decisions regarding a 
patient’s treatment are not influenced by the Registry study. Physicians participating in the Registry study are 
expected to review the indications, contraindications, warnings, precautions, and safety events described in the 
IFUs. As with any endovascular procedure or anticoagulation regimen, the treating physician is expected to counsel 
the patient on the risks and benefits specific to the planned treatment and to obtain the local, procedure-related, 
or treatment-related informed consent per institutional policies and procedures. 
8.2 RISK MITIGATION 
The Registry study was designed to capture real world data regarding the clinical use of the FlowTriever System 
(and anticoagulation treatment in the US Conservative Therapy Sub-study). The risks of providing this personal 
health information have been mitigated, as no personal information directly identifying the patient will not be 
collected for the Registry database.   At the time of participation, each participant will be assigned a unique study 
identification number. This number will be used in the database to identify the patient. .  All data handling will be 
in accordance with GDPR and HIPAA requirements and only de-identified information will be entered. 
9 
SAFETY ASSESSMENT 
9.1 DEFINING ADVERSE EVENTS 
An AE is any untoward medical occurrence or exacerbation of an existing medical condition subsequent to 
treatment with the FlowTriever. AEs are classified in several ways, including severity, relationship, and seriousness. 
• 
Severity (mild, moderate, severe) 

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- Mild: No limitation of usual activities, no therapy or only symptomatic therapy required to treat the injury 
or illness. 
- Moderate: Some limitation of usual activities or specific therapy is required. 
- Severe: Inability to carry out usual activities, hospitalization, emergency treatment, life-threatening events, 
or mortality. 
• 
Relationships (unrelated, device-related, procedure-related, drug-related, or relationship unknown) are 
defined below. 
Unrelated: The clinical event is completely independent of study procedure/study device and/or evidence 
exists that the event is definitely related to another etiology. 
Device-related: The event is directly related to the study device itself, as defined by its intended use. AEs 
will be considered unrelated to the device if the complication could have occurred if the device functioned 
entirely within its specifications. 
Procedure-related: Procedure-related events include all AEs that occur at any time of patient participation 
that was directly related to the procedure. The exception to this rule is an event that is device-related; such 
events should not also be classified as procedure-related. 
Drug-related: Event is attributable to thrombolytic or anticoagulant therapy. These events may occur from 
inadequate (thrombosis) or excessive therapy (bleeding). A drug-related AE cannot also be classified as 
device-related, but many will be classified as procedure-related, since the drug may be part and parcel of 
the index procedure or the event may have occurred within 30 days. 
Relationship unknown: The relationship to the study procedure/study device is not known. 
 
A Serious Adverse Event (SAE) is an event that meets at least one of the following: 
o 
Is fatal 
o 
Is life-threatening 
o 
Results in persistent or significant disability/incapacity 
o 
Results in permanent impairment of a body function or permanent damage to a body structure 
o 
Results in hospitalization or prolongs a hospitalization 
o 
Necessitates medical or surgical intervention to preclude permanent impairment of a body function or 
permanent damage to a body structure 
o 
Results in a congenital anomaly or birth defect 
o 
Serious deterioration of the health of the patient that resulted in chronic disease 
9.2 REPORTING OF EVENTS 
The FLASH Registry study was designed to capture real-world data regarding the clinical use of the FlowTriever 
System (and anticoagulation treatment in the Conservative Therapy Sub-study) and involves the collection of 
specific information for research and educational purposes only. It does not specify how the FlowTriever System or 
anticoagulation will be used to treat PE, and decisions regarding a patient’s treatment are not influenced by the 
study. This is a data collection study only; there is nothing investigational or experimental in the patient’s medical 
treatment.  

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Therefore, the study will only capture AEs related to the patient’s PE condition and its treatment. Reportable AEs 
include all events considered in the safety analyses (e.g., major bleedingc), all device- and/or procedure-related 
AEs, as well as any event resulting in mortality.  
The AEs will be captured on the Adverse Event CRF and should include, wherever possible, severity, duration, 
outcome, the Investigator’s description of the event, and his/her medical judgment as to the relationship of the AE 
(i.e., not related, related, or relationship unknown) to the study device, to the index procedure or any subsequent 
procedure(s), to a thrombolytic agent or anticoagulant, or  underlying disease. 
• 
Non-serious reportable AEs are to be submitted via the electronic data capture system (EDC) in a timely 
fashion. 
• 
Reportable SAEs must be reported to the Sponsor within 5 business days of the Investigator’s knowledge 
of the event. The event is reported in the EDC.  
 
Appendix 1 includes a list of possible SAEs associated with thrombectomy, including those events considered major 
device-related events and major morbidity. These events are considered reportable at all time points throughout 
the study and require submission to the Sponsor and the IRB/EC and regulatory authorities, as required. 
10 
STATISTICS & DATA ANALYSIS 
10.1  SAMPLE SIZE 
The sample size of up to 1000 patients (up to 800 US and up to 200 Europe) for the FlowTreiver System and up to 
an additional 300 patients for anticoagulation treatment reflects an adequate size to accrue data on real-world 
use, as assessed in up to 100 (up to 70 US, up to 30 Europe) registry sites. 
10.2 STATISTICAL METHODOLOGY 
This is an observational study and as such is not hypothesis-driven. The endpoints will be assessed for patients 
receiving treatment with the FlowTriever System with descriptive statistics. Continuous variables will report any 
combination of mean, median, Q1, Q3, IQR, minimum and maximum while the categorical variables will report 
frequency count and percentages (%). Additional ad-hoc and exploratory analyses for both the main study and US 
Conservative Therapy Sub-study will be separately defined in the Statistical Analysis Plans. 
11 
STUDY MANAGEMENT CONSIDERATIONS 
11.1 DATA MANAGEMENT AND COLLECTION OF CLINICAL DATA 
The Sponsor and/or designee will be responsible for the processing and quality control of the data. All source data, 
CRFs, copies of protocols and protocol amendments, correspondence, patient identification lists, informed consent 
forms, and other essential documents must be retained for a period of at least 2 years after study completion or 
closure. 
No study document or image will be destroyed without prior written agreement between the Sponsor and the 
Investigator prior to the conclusion of the retention period. 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. 
 
c For the purposes of this study, mild to moderate pain or ecchymosis at the access site do not require reporting as adverse events. 

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11.2 PROTOCOL MODIFICATIONS 
No changes from the final approved study protocol will be initiated without the IRB/EC prior written approval of 
the amendment. The Principal Investigator will acknowledge the amendment by signing the Protocol Signature 
Page. 
11.3 PROTOCOL DEVIATIONS 
A protocol deviation is the non-adherence to or divergence from the protocol-required study procedures. For 
example, the inclusion and exclusion criteria, improper or lack of consent, and lack of IRB/EC approval would all be 
considered protocol deviations. Non-compliance with required assessments or out of window visits will result in a 
protocol deviation. 
The Sponsor will address deviations and take appropriate corresponding action. Continued non-compliance with 
the study protocol may lead to termination of the Investigator’s participation in the study. 
11.4 INFORMATION FOR STUDY PERSONNEL 
The Sponsor or designee is responsible for explaining the protocol to all study staff, including the Investigator, and 
for ensuring their compliance with the protocol throughout the study. Additional information will be made 
available during the study when new staff become involved in the study, and as otherwise agreed upon with either 
the Investigator or the Sponsor or designee. 
The Investigator is responsible for giving information about the study to all staff members involved in the study or 
any element of patient management, both before starting the study and during  the study (e.g., when new staff 
become involved). The Investigator must ensure that all study staff members are qualified by education, 
experience, and training to perform their specific responsibilities. 
12 
STUDY ADMINISTRATION 
12.1 SITE INITIATION 
A Site Initiation Visit (SIV) may be conducted by the Sponsor or designee in-person or via teleconference to ensure 
proper training of the Investigator and study staff members regarding the study protocol and data collection, as 
well as to ensure regulatory requirements are fulfilled prior to enrollment of the first study patient at a site. 
12.2 SITE MONITORING VISITS 
Interim monitoring visits may be conducted by the Sponsor or designee in-person or remotely to ensure 
compliance with the protocol, and other written instructions and regulatory guidelines according to a study-
specific monitoring plan. 
The main responsibilities of the Monitor or designee are to ensure adherence to the protocol; to verify all data are 
correctly and completely recorded and reported; confirm that informed consent is obtained and recorded for each 
patient before any medical record or personal health information is shared with any study representatives. The 
Investigator and assisting staff must agree to cooperate with the Monitor or Sponsor representative to resolve any 
study-related action items, errors, or possible misunderstandings concerning the findings detected during these 
monitoring visits or data review. 

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12.3 STUDY TERMINATION 
Inari Medical and applicable regulatory authorities have the right to terminate the entire study or a specific study 
site at any time. Situations that could 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 
• 
Insufficient patient enrollment rates 
• 
Recurrent protocol deviations or other non-compliances 
• 
Inaccurate, incomplete, and/or untimely data recording on a recurrent basis 
• 
Lack of cooperation with monitoring visits (e.g., failure to adequately prepare for visits, address action 
items from one visit to the next, or provide access to medical records) 
12.4 DATA HANDLING AND RECORDKEEPING 
12.4.1 Completing, Signing and Archiving Case Report Forms 
Clinical study data will be collected using electronic case report forms (eCRFs). A web-based electronic data 
capture (EDC) database will be used to record and manage study data. eCRF completion guidelines and instructions 
for electronic data-entry will be developed in conjunction with the Sponsor and/or EDC vendor. All eCRFs must be 
kept in good order and updated so they always reflect the latest observations on the patients participating in the 
study. 
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. 
It is important to have proper data collection in a timely manner (approximately 5 business days of the study 
visit/assessment).  When the Sponsor or designee requests additional data or clarification of data for the eCRF, the 
request must be answered satisfactorily in a timely manner. 
12.4.2 Data Management and Archiving 
The Sponsor or designee will be responsible for the processing and quality control of the data. All imaging and 
wearable data collected for the study, eCRFs, copies of protocols and protocol amendments, correspondence, 
patient identification lists (kept by the Investigator), informed consent forms, and other essential documents must 
be retained for a period of at least 2 years after the study completion or closure.  
No study document or image 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. 
12.4.3 Direct Access to Source Data/Documentation 
The Investigator must maintain, at all times, the primary records (i.e., the original source of the data/source 
documents) of each patient’s data. Examples of source documents are hospital records, office visit records, 
examining physician’s findings or progress notes, consultant’s written opinion or notes, laboratory reports, imaging 
data, and worksheets that are used as the source. 

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The Investigator must keep a separate patient identification list showing enrollment numbers and names to allow 
unambiguous identification of each patient included in the study.  
The Sponsor, auditors, and health authority inspectors (or their agents) will be given direct access to source data 
and documentation (e.g., medical chart/records, laboratory test results, images) for source data verification, 
provided that patient confidentiality is maintained in accordance with local requirements. 
13 
ETHICS AND CONFIDENTIALITY  
13.1 INFORMED CONSENT 
Written informed consent will be obtained from each patient prior to the patient’s medical record or personal 
health information being shared with any study representative.  The patient’s willingness to participate in the 
study will be documented in writing in a study-specific Informed Consent Form, which will be signed and dated by 
the patient or Legally Authorized Representative. The Investigator will keep the original consent form and a copy 
will be given to the patient. It will be explained to the patients 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. Patients will be consented for 
the duration of the patient’s participation in the study.  
13.2 INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) 
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 ISO 14155-1 and FDA regulations (21 CFR Part 56), prior to starting 
the study.  
The Sponsor must receive a copy of the IRB/EC approval letter (or equivalent documentation) for the study 
protocol and Informed Consent Form before the study can be started at that site. 
The IRB/EC and Sponsor must approve any  changes to the protocol, as well as a change of Principal Investigator. 
Documentation of IRB/EC approval must be provided to the Sponsor. Records of all study review and approval 
documents must be maintained by the Investigator in the Study File/ Regulatory Binder and are patient to 
inspection by the Sponsor (or designee) or regulatory authority during or after completion of the study.  
The Investigator must notify the IRB/EC, as per their reporting guidelines, and the Sponsor when they  deviate 
from the protocol. The Sponsor must be notified of all relevant action taken by the IRB/EC and must receive a copy 
of all study-related correspondence between the Investigator and the IRB/EC. 
The IRB/EC must receive notification of study completion and a final report upon study completion or closure. A 
copy of these reports must be provided to the Sponsor. The Investigator must maintain an accurate and complete 
record of all submissions made to the IRB/EC. 
13.3 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 or image material submitted to the Sponsor, 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 Sponsor, the quality assurance 
unit, or regulatory authorities. Personal medical information will always be treated as confidential and handled in 

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compliance with the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection 
Regulation (GDPR). 
13.4 INDEPENDENT MEDICAL MONITOR 
An independent Medical Monitor, an independent physician who is not a participant in the study, will review AEs 
that occur throughout the course of the study. The activities of the Medical Monitor will be guided by the Safety 
Manual. The Medical Monitor will be responsible for classifying events by severity, relationship, and seriousness, 
as well as whether they meet MAE criteria related to the primary safety endpoint. For the Primary Endpoint, the 
Medical Monitor AE assessments will supersede those of the Investigators when there are differences. 
13.5 CORE LABORATORY AND IMAGE TRANSFER 
A core laboratory may be utilized in the study. The core laboratory will independently evaluate selected images 
collected at participating institutions.  
Irrespective of whether a core laboratory is utilized for pulmonary angiogram measurements of anatomic 
endpoints, de-identified, electronic pulmonary angiograms, echocardiographs, and CTPA images will be sent via 
secure electronic transfer to a secured imaging repository per US FDA/EU GDPR regulations. Where an electronic 
submission is not possible, deidentified images will be sent by other secure means per US FDA/EU GDPR 
regulations.  Copies of images  will be securely stored for a minimum of 2 years after the study has ended.  
13.6 PARTICIPATING INSTITUTIONS AND INVESTIGATORS 
Study sites and Investigators will be selected based on a variety of factors including, but not limited to, experience 
with endovascular techniques, access to required facilities and equipment, sufficient and adequately trained 
personnel, and availability of potential patients. The criteria used for determination will be documented.  
13.7 INVESTIGATOR RESPONSIBILITIES 
Investigator responsibilities include, but are not limited to, the following: 
• 
Conducting the study in accordance with this investigational plan, signed agreement, and applicable 
regulations protecting the rights and safety of study patients 
• 
Ensuring that informed consent is obtained for each study patient in accordance with applicable regulations 
(e.g., ISO 14155-1, 21 CFR Part 50) 
• 
Ensuring that IRB/EC approval is secured prior to starting the study and ensuring continuing review and 
approval as required throughout the investigation 
• 
Ensuring all associates, colleagues, and employees assisting in the conduct of the study are informed about 
their obligations, are adequately qualified and trained, and meet their commitments 
• 
Maintaining adequate and accurate records and ensuring those records are available for inspection at any 
time 
• 
Ensuring that conducting the study does not give rise to a conflict of interest (financial disclosure is required)  
14 
ELECTRONIC DATA 
Electronic data will only be accessible to authorized personnel with a unique user identifier and password for the 
EDC. Passwords will be set to expire periodically. Access to electronic study data will be provided to research 

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personnel upon completion of training. Read and write access will be provided to investigational sites but only for 
information and patient data at their site. The Sponsor and designee will have read-only access and can post 
queries for potential data-related discrepancies. 
(US Patients Only) Wearables: Electronic data collected via the Apple iWatch will be uploaded into a CFR Part 11 
compliant database daily via cellular data transfer. Data will only be accessible to authorized personnel with a 
unique user identifier and password.  
15 
TERMS AND DEFINITIONS  
Term 
Definition 
Primary Safety Endpoint Definitions 
Major adverse event (MAE) 
A composite endpoint triggered when one or more of the following events 
occur: 
• 
Device-related mortality within 48 hours, or  
• 
Major bleeding within 48 hours, or 
• 
Intraprocedural Device or procedure-related adverse events, including:  
o 
Clinical deterioration defined by hemodynamic or respiratory 
worsening, or  
o 
Device-related pulmonary vascular injury, or 
o Device-related cardiac injury. 
Intraprocedural 
Events occurring during the procedure or within 30 minutes of the FlowTriever 
Catheter being removed from the patient. 
MAE: Major Bleeding 
(≤48 hours) 
Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as 
intracranial, intraspinal, intraocular, retroperitoneal, intraarterial or pericardial, 
or intramuscular with compartment syndrome; and/or bleeding causing a fall in 
hemoglobin level of 5 g/dL (1.24 mmol/L) or more or leading to transfusion of 
two or more units of whole blood or red cells. 
MAE: Clinical Deterioration 
(Intraprocedural) 
Clinical deterioration is defined when new (not present at the start of the index 
procedure) hemodynamic or respiratory deterioration occurs. 
MAE: Hemodynamic 
Deterioration 
(Intraprocedural) 
When one or more of the following is definitely documented, with relation to 
both the severity and the duration of the event: 
• 
Hypotension with systolic blood pressure <90 mm Hg lasting at least 30 
minutes, unresponsive to fluid resuscitation, and requiring the addition of 
or increased dose of vasopressors 
• 
Fall in systolic blood pressure by 40 mm Hg or more, lasting at least 30 
minutes, and accompanied end-organ hypoperfusion (such as oliguria, 
mental status changes, ischemic extremities) 
• 
Cardiac arrest requiring cardiopulmonary resuscitation 
• 
Bradycardia lasting more than 10 minutes, accompanied by hypotension, 
and requiring pharmacologic intervention or insertion of a pacemaker 
• 
Ventricular tachycardia or fibrillation requiring pharmacologic intervention 
or defibrillation 
MAE: Respiratory 
Deterioration 
(Intraprocedural) 
A significant decline in respiratory function with one or more of the following is 
definitely documented with respect to the severity and the duration of the 
event: 

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Term 
Definition 
• 
Requirement for an increase in fraction of inspired oxygen requirements 
0.20 or greater, lasting longer than 30 minutes (e.g. from 0.21 to 0.41) 
• 
Need for intubation in a previously non-intubated subject 
MAE: Pulmonary Vascular 
Injury (Intraprocedural) 
Perforation or injury of a major pulmonary arterial branch requiring 
intervention to avoid permanent injury. 
MAE: Cardiac Injury 
(Intraprocedural) 
Any damage to the heart requiring intervention to avoid permanent injury. 
 
 
Additional Safety Definitions 
Adverse event (AE) 
An AE is any untoward medical occurrence or exacerbation of an existing medical 
condition subsequent to treatment with the FlowTriever.  
Device-related event 
The event is directly related to the study device itself, as defined by its intended 
use. AEs will be considered unrelated to the device if the complication could 
have occurred if the device functioned entirely within its specifications. 
Drug-related event 
Event is attributable to thrombolytic or anticoagulant therapy. These events may 
occur from inadequate (thrombosis) or excessive therapy (bleeding). A drug-
related AE cannot also be classified as device related, but many will be classified 
as procedure-related, since the drug may be part and parcel of the index 
procedure or the event may have occurred within 30 days. 
Minor bleeding 
All non-major bleeds will be considered minor bleeds. 
Procedure-related event 
Procedure-related events include all AEs that occur at any time of subject 
participation that was directly related to the procedure. The exception to this 
rule is an event that is device-related; such events should not also be classified as 
procedure-related. 
Reportable adverse event  
Reportable AEs include all events considered in the safety analyses, all device- 
and/or procedure-related AEs, as well as any event resulting in mortality.  
Serious adverse event (SAE) 
An adverse event that meets at least one of the following: is fatal; is life-
threatening; results in persistent or significant disability/incapacity; results in 
permanent impairment of a body function or permanent damage to a body 
structure; results in hospitalization or prolongs a hospitalization; or necessitates 
medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure; results in congenital 
anomaly or birth defect; results in chronic disease 
Other Definitions 
Asymptomatic PE 
Pulmonary embolism detected on an imagining study in a patient without 
clinical symptoms. 
CTED/Post PE Syndrome 
Chronic thromboembolic Disease: Per 2019 ESC Guidelines, some patients may 
present with normal pulmonary hemodynamics at rest despite symptomatic 
disease. If other causes of exercise limitation are excluded, these patients are 
considered as having chronic thromboembolic disease (CTED).  From 
Respiratory medicine journal on PE, (CTED) is characterized by similar symptoms 
and imaging findings to CTEPH but without pulmonary hypertension at rest. 

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CTEPH 
Chronic thromboembolic pulmonary hypertension:  Per 2019 ESC Guidelines, 
CTEPH is a disease caused by the persistent obstruction of pulmonary arteries 
by organized thrombi, leading to flow redistribution and secondary remodeling 
of the pulmonary microvascular bed.  The diagnosis of CTEPH is based on 
findings obtained after at least 3 months of effective anticoagulation, to 
distinguish this condition from acute PE. The diagnosis requires a mean PAP of 
≥25 mmHg along with a pulmonary arterial wedge pressure of ≤ 15 mmHg, 
documented at right heart catheterization in a patient with mismatched 
perfusion defects on V/Q lung scan. 
High-Risk PE 
Per ESC guidelines 2019: High-Risk PE determined by hemodynamic instability, 
PESI III-V or sPESI ≥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 vasopressors required to achieve a 
BP >_90 mmHg despite adequate 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 >_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 ≥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 ≥1, and 1 or none of the following: 
RV Dysfunction; Elevated cardiac troponins. 
Patient/ Subject 
Participants in the study. 
Proven PE 
Pulmonary embolism proven by a positive pulmonary angiogram, an 
unequivocally positive CT scan, a high-probability ventilation-perfusion scan, or 
autopsy. 
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 independent Medical 
Monitor. 
Suspected PE 
Pulmonary embolism suspected based on clinical symptoms and/or signs but for 
which definitive diagnosis has not been made by imaging or autopsy. 
Symptomatic PE 
Clinical pulmonary embolism symptoms and/or signs such as chest pain, 
dyspnea, hemoptysis, palpitations, or tachycardia. 
Wearable Technology 
(Wearables) US Patients Only 
From Dictionary.com, Wearable technology is a small computer or advanced 
electronic device that is worn or carried on the body.  For purposes of this 
study, the wearable technology being used is the Apple iWatch, which collects 
health metrics. 
 
 

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16 
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APPENDIX 1 KNOWN RISKS OF THROMBECTOMY  
 
Event Category 
Event 
Cardiac 
Myocardial infarction 
 
Congestive heart failure 
 
Arrhythmia 
 
Hypertension 
 
Hypotension 
Wound 
Wound infection 
 
Wound pain 
 
Wound dehiscence 
 
Serous wound drainage 
 
Lymphorrhea 
 
Hematoma 
 
Ecchymosis 
Peripheral vascular 
Vessel perforation 
 
False aneurysm formation 
 
Arterial dissection 
 
Mural thrombus formation 
 
Vessel occlusion 
 
Arteriovenous fistula 
 
Distal embolization 
Venous 
Deep venous thrombosis 
 
Pulmonary embolism 
 
Paradoxical embolization 
Cerebrovascular 
Transient ischemic attack 
 
Stroke 
 
Intracranial hemorrhage 
Pulmonary 
Exacerbation of chronic lung disease 
 
Respiratory failure 
Miscellaneous 
Sepsis 
 
Mortality 
 
 
 
 

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SIGNATURE APPROVAL PAGE  
FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) 
Protocol Number: 18-002 
Version: 8.0 
March 15, 2021 
 
 
This document contains confidential information for use only by Inari Medical. This document is not to be made 
available for review by unauthorized personnel. This document may not be reproduced without written 
permission. 
 
 
 
 
 
 
 
 
 
 
 
Signed:  
Keith Hebert 
Senior Director, Clinical Research 
Inari Medical 
 
 
March 18, 2021