đź“‹ FDA Reference
flowtriever retrieval aspiration system
Inari Medical
Summary: The FlowTriever Retrieval Aspiration System is a medical device used for mechanical thrombectomy in patients with pulmonary embolism. It is primarily used by interventional radiologists and cardiologists to remove blood clots from the pulmonary arteries.
FDA Clearance Information
Pathway
510K
Number
K191710 ↗
Decision Date
September 5, 2019
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System was cleared via the FDA 510k pathway on September 5, 2019. Manufactured by Inari Medical, it is classified as a Class 2 device under product code QEW.
What It Is
The FlowTriever Retrieval Aspiration System is a mechanical thrombectomy device designed to remove thrombi from the pulmonary arteries. It works by using a combination of aspiration and mechanical retrieval to extract clots, thereby improving blood flow and reducing the risk of complications associated with pulmonary embolism. This device is particularly useful in cases where anticoagulation therapy alone is insufficient.
Clinical Applications
The device is commonly used in the treatment of intermediate- to high-risk pulmonary embolism, particularly in patients who are not candidates for thrombolytic therapy. It is typically employed in hospital settings by interventional radiologists and cardiologists. The system is beneficial for patients with a high clot burden or those experiencing hemodynamic instability due to pulmonary embolism.
Indications for Use
The FlowTriever System is indicated for use in patients with pulmonary embolism, specifically those who have large clots obstructing the pulmonary arteries. It is intended for cases where rapid clot removal is necessary to restore blood flow and reduce the risk of further complications.
Practical Considerations
The system is designed to be compatible with large-bore catheters, which allows for efficient clot retrieval. Clinicians should be trained in percutaneous techniques and familiar with the use of aspiration systems. Proper sizing and catheter selection are crucial for effective use.
Related Literature
The linked study discusses a novel case of cardiac tamponade following the use of the FlowTriever System for percutaneous pulmonary embolectomy. The study highlights the effectiveness of the device in reducing clot burden but also notes the potential for serious complications such as cardiac tamponade. Limitations include the case-specific nature of the findings, which may not be generalizable to all patient populations.
Linked Studies (14)
PubMed • 2026
Percutaneous Aspiration of a Large Mitral Valve Vegetation With Full-Body Protection: A Novel Approach.
JACC. Case reports
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Novel percutaneous aspiration thrombectomy in Fontan conduit obstruction with cardiogenic shock. Case report.
International journal of cardiology. Congenital heart disease
Case Report View Source →
PubMed • 2025
Early Experience Using Venous Sheath With Embolic Protection During Thrombectomy of Inferior Vena Cava and Complex Iliofemoral Deep Vein Thrombosis.
The American surgeon
Case Series View Source →
PubMed • 2024
Percutaneous pulmonary aspiration thrombectomy in an adolescent fontan patient using a large-bore system.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Other View Source →
PubMed • 2024
[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024
Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023
Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.
Circulation. Cardiovascular interventions
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023
Mechanical thrombectomy of inferior vena cava filter-associated caval thrombosis using FlowTriever and ClotTriever systems.
Journal of vascular surgery. Venous and lymphatic disorders
Other View Source →
PubMed • 2022
Percutaneous FlowTriever Retrieval/Aspiration System for Impending Paradoxical Embolism: A New Tool?
JACC. Cardiovascular interventions
View Source →
PubMed • 2022
A Novel Case of Cardiac Tamponade after Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System.
European journal of case reports in internal medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020
A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study.
JACC. Cardiovascular interventions
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2018
Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System.
Journal of vascular and interventional radiology : JVIR
View Source →Frequently Asked Questions
What is the FlowTriever Retrieval Aspiration System used for?
It is used for the mechanical removal of blood clots from the pulmonary arteries in patients with pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with pulmonary embolism requiring rapid clot removal from the pulmonary arteries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.