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Important Notice
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FlowTriever® system for acute
massive pulmonary embolism (PE)
FLAME Study
NCT04795167
FLAME is the largest prospective study of interventional
treatment in high-risk PE.
Jump to outcomes
Objective Graphic
Objective
  • Evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism who have received treatment with the FlowTriever system compared to a pre-specified meta-analytic performance goal
Design Graphic
Design
  • Prospective, multicenter, non-randomized, parallel group, observational study | Three Registries: FlowTriever, Context, and Prior Therapy
  • 115 subjects enrolled at 11 US sites following a successful interim analysis allowing early closure of the study
Primary Endpoint Graphic
Primary Endpoint
  • In-hospital composite of all-cause mortality, bailout, clinical deterioration, and major bleeding
Key Eligibility Graphic
Key Eligibility Criteria
High-risk pulmonary embolism with one or more of the following:
  • Systolic blood pressure <90 mmHg for at least 15 minutes or drop of >40 mmHg in systolic blood pressure for at least 15 minutes
  • Need for vasopressor support
  • Resuscitation after cardiac arrest with <30 minutes of CPR and Glasgow Coma Scale >8
Duration of Follow-Up Graphic
Duration of Patient Follow-up
  • Patients were followed through hospital discharge or were exited at 45 days if still in hospital
The largest prospective study of
interventional treatment in high-risk PE
A total of 115 high-risk PE patients were enrolled and treated with either FlowTriever or other contemporary therapies.
High-risk PE Patients
(n=115)
Context Arm*
(n=61)
FlowTriever Arm
(n=53)
Prior Treatment Arm
(n=1)
physician discretion
Flowchart
Patients treated with:
  • Systemic thrombolysis (68.9%)
  • Anticoagulation alone (23.0%)
  • Catheter directed thrombolytics (6.6%)
  • Surgical thrombectomy (1.6%)
Front-line FlowTriever
Non-high-risk PE patients who
received advanced therapy but
progressed to high-risk PE in the
same setting
Significantly Lower In-Hospital
Adverse Outcomes
Primary Endpoint†
Context Arm
(n=61)
Performance
Goal (Historical
Data)
(n=911)
FlowTriever Sytem
(n=53)
Graph 1
Low Mortality in High-Risk PE
All-Cause In-Hospital Mortality  
Context Arm
(n=61)
Performance
Goal (Historical
Data)
(n=607)
FlowTriever Sytem
(n=53)
Graph 2
Read the Peer-Reviewed FLAME Results
Outcomes in High-Risk Pulmonary Embolism
Patients Undergoing FlowTriever Mechanical Thrombectomy
or Other Contemporary Therapies
See Results
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*Context arm patients were treated with systemic thrombolysis (68.9%), anticoagulation alone (23.0%), CDT (6.6%) or surgical thrombectomy (1.6%)
†Composite primary endpoint consisted of in-hospital all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding.
P<0.01 vs. performance goal based on historical data.

Reference:
Silver MJ, et al. Outcomes in high-risk pulmonary embolism patients undergoing FlowTriever mechanical thrombectomy or other contemporary therapies: results from the FLAME study. Circ Cardiovasc Interv. 2023;16(10):e013406.

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.

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.

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