Decorative Graphic
Important Notice
This Inari Medical website and all product offerings listed are tailored for the United States only. Please be aware that product availability and regulatory claims may vary in other regions we serve, including Europe, the Middle East, and Africa (EMEA), Asia-Pacific (APAC), and Latin America/Canada. Inari Medical is currently developing separate websites for our products tailored to these other global and regional markets.
Decorative Graphic
Transformational change in
the treatment of pulmonary embolism (PE)
FLASH℠ Registry
NCT03761173
FLASH is the largest prospective interventional registry of PE.
Jump to outcomes
Objective Graphic
Objective
  • Evaluate the safety and effectiveness of the FlowTriever system for treatment of PE in a real-world patient population
Objective Graphic
Design
  • Prospective, single-arm, multicenter registry: 1,000 patients (800 US + 200 Europe), 69 sites (50 US, 19 Europe)
Objective Graphic
Primary Endpoint
MAE Composite through 48h
  • Device-related mortality
  • Major bleeding
  • Intraprocedural device or procedure-related AEs, including clinical deterioration and device-related pulmonary vascular or cardiac injuries
Objective Graphic
Secondary Endpoints
and Clinical Outcomes
  • Individual components of the primary endpoint
  • Major access site complications
  • All-cause mortality through 30 days
  • Device-related serious adverse events through 30 days
  • Hemodynamic improvements during the procedure
  • Reduction in RV/LV ratio from baseline to 30 days and 6 months
  • 6-month clinical outcomes, including echocardiographic RV function assessment, dyspnea score, 6-minute walk test distance, quality of life score, and CTEPH/CTED diagnoses
Objective Graphic
Key Eligibility Criteria
  • Clinical signs and symptoms consistent with acute PE
  • Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
  • Intermediate- or high-risk PE
Objective Graphic
Duration of Patient Follow-up
  • Patients are assessed at 48-hours, 30-days, and 6-months
OUTCOMES FROM
THE FLASH REGISTRY
for the treatment of pulmonary embolism
with the FlowTriever system
Immediate
Hemodynamic
Improvement
800 patients enrolled
All-cause mortality at
30-day follow-up1
N=734
800 Patients Enrolled1
85%
Intermediate-High or
High-Risk Patients
32%
Lytics
Contraindication
65%
Concomitant
DVT
100mL median EBL
with the FlowSaver Blood Return System
(n=79)
Immediate hemodynamic improvement1
Mean PAP
Cardiac Index
Heart Rate
TPVR
Mean PAP (mm Hg)
Mean Cardiac Index (L/min/m2)
Mean Heart Rate (bpm)
Mean TPVR (mmHg min/L)
23%
reduction
19%
increase
12 bpm
decrease
20%
reduction
pre-procedure
N=779
post-procedure
N=767
pre-procedure
N=176*
post-procedure
N=159
pre-procedure
N=798
post-procedure
N=779
pre-procedure
N=683
post-procedure
N=621
*In patients with cardiac index <2.0 L/min/m2 at baseline
Excellent Safety Results1
1.8%
Major Adverse
Events (MAEs)
at 48 hours
0
Device Related
Deaths
at 30-day follow-up
<1.0%
All-Cause Mortality
at 30-day follow-up
Long-term Patient Benefits
at 6 months2
Chart
Normal RV Function
No or Mild Dyspnea
6-Minute Walk Test
% of patients with normal RV function
% of patients with no or mild dyspnea
Median distance (m)
Baseline
n=623
48 hrs
n=215
30 days
n=338
6 months
n=247
Baseline
n=475
48 hrs
n=392
30 days
n=396
6 months
n=343
48 hrs
n=75
30 days
n=308
6 months
n=243
*P<0.0001 compared to baseline
*P<0.0001 compared to baseline
P<0.001 trend test over time
1.0%
CTEPH 
n=581
Read the Peer-Reviewed
FLASH Results
Acute Outcomes
from the FLASH
Registry published in
EuroIntervention
See Results
6-month Outcomes
from the FLASH
Registry published
in JSCAI
See Results
Prevalence and Predictors
of Cardiogenic Shock in
Intermediate-Risk PE
published in JACC:CI
See Results
Outcomes from the high-risk
PE cohort of the FLASH
Registry published in JSCAI
See Results
Interim outcomes from
the FLASH Registry
published in CCI
See Results
References:
1. Toma C et al. Acute Outcomes for the Full US Cohort of the FLASH Mechanical Thrombectomy Registry in Pulmonary Embolism. EuroIntervention 2023;18:1201-1212.
2. Khandhar S et al. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-risk Pulmonary Embolism: 6-Month FLASH Registry Results. JSCAI 2023;2(4):101000.

Indications for Use:
The FlowTriever retrieval/aspiration system is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever retrieval/aspiration system is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever catheters are indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. Triever catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever catheters are also intended for use in treating clot in transit in the right atrium but not in conjunction with the FlowTriever catheters. The FlowSaver blood return system is used with Triever catheters for autologous blood transfusion.

Refer to IFU for complete Indications for Use, contraindications, warnings, and precautions.

Caution:
Federal (USA) law restricts this device to sale distribution and use by or on order of a physician.

All trademarks are property of their respective owners.