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
K201541 ↗
Decision Date
December 4, 2020
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System, manufactured by Inari Medical, was cleared through the FDA 510k pathway on December 4, 2020. It is a Class 2 medical device.
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 large-bore catheters to aspirate and retrieve clots, providing a minimally invasive option for treating pulmonary embolism. The system is designed to reduce clot burden without the need for thrombolytic drugs, which can be beneficial in patients at risk for bleeding.
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, such as interventional radiology or cardiology suites. The primary users are interventional radiologists, cardiologists, and vascular surgeons who specialize in endovascular procedures.
Indications for Use
The FDA-cleared indications for the FlowTriever Retrieval Aspiration 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 are at intermediate to high risk and may benefit from mechanical clot removal.
Practical Considerations
The FlowTriever system is available in various catheter sizes to accommodate different patient anatomies and clot burdens. It is compatible with standard guidewires and introducer sheaths. Operators should be familiar with large-bore catheter techniques and have experience in managing potential complications such as vascular access site bleeding.
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 large-bore catheter use in the pulmonary vasculature. While the FlowTriever system is effective in reducing clot burden, clinicians should be aware of and prepared to manage possible complications. The study is limited by its focus on a single case, emphasizing the need for further research to better understand the risk profile of the device.
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 mechanical thrombectomy in patients with pulmonary embolism to remove clots from the pulmonary arteries.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of pulmonary embolism in patients with significant clot burden, particularly those 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.