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 typically used by interventional radiologists and cardiologists to remove blood clots from the pulmonary arteries.
FDA Clearance Information
Pathway
510K
Number
K202345 ↗
Decision Date
December 18, 2020
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System by Inari Medical was cleared through the FDA 510(k) pathway on December 18, 2020. It is a Class 2 medical device under product code QEW.
What It Is
The FlowTriever Retrieval Aspiration System is a catheter-based device designed to remove blood clots from the pulmonary arteries. It combines mechanical thrombectomy with aspiration to effectively reduce clot burden in patients with pulmonary embolism. The system is minimally invasive and allows for percutaneous access, making it a valuable tool in acute settings.
Clinical Applications
This device is commonly used in the treatment of intermediate- to high-risk pulmonary embolism, particularly in patients who may not be candidates for thrombolytic therapy. It is typically employed in hospital settings by interventional radiologists and cardiologists. The device is used in catheterization labs where rapid intervention can significantly improve patient outcomes.
Indications for Use
The FlowTriever system is indicated for use in patients with pulmonary embolism, specifically those who have large clots obstructing blood flow in the pulmonary arteries. It is intended for patients who require mechanical intervention to restore normal circulation.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and is compatible with standard catheterization lab equipment. Clinicians should be trained in percutaneous techniques and be familiar with the device's operation to ensure optimal outcomes.
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, the study highlights a potential complication, emphasizing the need for careful patient monitoring. The study is limited by its focus on a single case, and further research is needed to assess the incidence of such complications.
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?
The device is used for mechanical thrombectomy to remove clots in patients with pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of pulmonary embolism to remove large blood clots 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.