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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 typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K191368 ↗
Decision Date
June 17, 2019
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System was cleared via the FDA 510(k) pathway on June 17, 2019. It is manufactured by Inari Medical and is classified as a Class 2 device under product code QEW.
What It Is
The FlowTriever Retrieval Aspiration System is designed to mechanically remove blood clots from the pulmonary arteries. It uses a large-bore catheter to aspirate clots, providing a minimally invasive option for treating pulmonary embolism. The system is particularly useful in reducing clot burden in patients with intermediate- to high-risk pulmonary embolism, offering an alternative to thrombolytic therapy.
Clinical Applications
This device is commonly used in the interventional radiology and cardiology settings for patients presenting with pulmonary embolism. It is particularly beneficial in acute care settings such as hospitals where rapid intervention is necessary. The device is suited for patients who are at high risk for bleeding or in whom thrombolytic therapy is contraindicated.
Indications for Use
The FlowTriever system is indicated for patients with pulmonary embolism, specifically those who are at intermediate to high risk. It is used to mechanically remove clots from the pulmonary arteries, improving blood flow and reducing the risk of complications.
Practical Considerations
The FlowTriever system is available in various sizes to accommodate different patient anatomies and clot burdens. It is compatible with standard catheterization lab equipment. Clinicians should be trained in percutaneous thrombectomy techniques to use this device effectively.
Related Literature
The linked study discusses a case of cardiac tamponade following the use of the FlowTriever system for percutaneous pulmonary embolectomy. The study highlights the potential risks associated with the procedure, despite its effectiveness in clot removal. The findings underscore the importance of careful patient monitoring and selection. However, the study is limited by its focus on a single case, which may not be representative of typical outcomes.
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 mechanically removing 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 the treatment of pulmonary embolism, specifically in patients at intermediate to high risk.
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.