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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 to remove blood clots from the pulmonary arteries.
FDA Clearance Information
Pathway
510K
Number
K180466 ↗
Decision Date
May 17, 2018
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System was cleared through the FDA 510(k) pathway on May 17, 2018. 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 utilizes a large-bore catheter to aspirate and retrieve clots, providing a minimally invasive option for treating pulmonary embolism. This device is particularly useful in reducing clot burden in patients with intermediate- to high-risk pulmonary embolism.
Clinical Applications
The device is commonly used in interventional radiology and cardiology settings, particularly for patients presenting with acute pulmonary embolism. It is employed in hospital settings where rapid intervention is critical, such as in emergency departments or specialized cardiac care units. The system is suitable for patients who may not be candidates for thrombolytic therapy due to bleeding risks.
Indications for Use
The FlowTriever is indicated for use in patients with pulmonary embolism, specifically those at intermediate to high risk. It is designed to mechanically remove clots from the pulmonary arteries, improving blood flow and reducing the risk of further complications.
Practical Considerations
The device typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard catheterization lab equipment and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in endovascular techniques to use this system effectively.
Related Literature
The linked study discusses a case of cardiac tamponade following the use of the FlowTriever system for percutaneous pulmonary embolectomy. While the device effectively reduced clot burden, this rare complication highlights the importance of careful patient monitoring and selection. Limitations include the study's focus on a single case, which may not be generalizable.
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 primarily use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of pulmonary embolism, particularly 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.