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 clots from the pulmonary arteries.
FDA Clearance Information
Pathway
510K
Number
K182233 ↗
Decision Date
October 15, 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 October 15, 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 designed to perform mechanical thrombectomy for the removal of thrombi from the pulmonary arteries. It utilizes large-bore catheters to aspirate and retrieve clots, providing a minimally invasive option for treating pulmonary embolism. This 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
Clinically, the FlowTriever system is used in the interventional radiology and cardiology settings to treat patients with acute pulmonary embolism. It is particularly beneficial for patients who are at high risk for bleeding complications from thrombolytic drugs or those who have contraindications to such medications. The device is typically employed in hospital settings where rapid intervention is necessary to restore pulmonary blood flow and improve patient outcomes.
Indications for Use
The FDA indications for the FlowTriever system include the treatment of pulmonary embolism, specifically for patients with significant clot burden in the pulmonary arteries. It is intended for use in patients who require mechanical thrombectomy to alleviate symptoms and prevent further complications.
Practical Considerations
The FlowTriever system is available in various sizes to accommodate different patient anatomies and clot burdens. It is compatible with standard interventional radiology and cardiology equipment. Clinicians should be trained in the specific techniques for deploying and operating the device to ensure optimal outcomes.
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 potential risks associated with the procedure, despite its effectiveness in reducing clot burden. Limitations include the study's 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 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 commonly use this device for treating pulmonary embolism.
What are the FDA-cleared indications?
The device is indicated for the treatment of pulmonary embolism, particularly in patients with significant clot burden requiring mechanical thrombectomy.
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.