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flowtriever retrieval aspiration system

Inari Medical

Summary: The FlowTriever Retrieval Aspiration System is a medical device used for the mechanical thrombectomy of pulmonary embolisms. It is typically used by interventional radiologists and cardiologists in hospital settings.

FDA Clearance Information

Pathway 510K
Decision Date June 17, 2018
Product Code QEW
Device Class Class 2
Evidence 14 studies

The FlowTriever Retrieval Aspiration System was cleared by the FDA via the 510(k) pathway on June 17, 2018. It is manufactured by Inari Medical and is classified as 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 a large-bore catheter to aspirate and retrieve clots, thereby reducing clot burden in patients with pulmonary embolism. This system offers a minimally invasive alternative to surgical embolectomy or systemic thrombolysis.

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 utilized in interventional radiology and cardiology departments within hospitals. The device is suitable for adult patients presenting with significant clot burden in the pulmonary arteries.

Indications for Use

The FDA has cleared the FlowTriever System for use in patients with pulmonary embolism, specifically for those requiring mechanical removal of thrombi from the pulmonary arteries. It is indicated for patients who are at intermediate to high risk due to clot burden.

Practical Considerations

The FlowTriever System is available in various catheter sizes to accommodate different patient anatomies and clot sizes. It is compatible with standard interventional radiology equipment and requires specific training for optimal use. Clinicians should be aware of the potential for complications such as vascular injury or bleeding.

Related Literature

The linked study discusses a case of cardiac tamponade following the use of the FlowTriever System for percutaneous pulmonary embolectomy. This highlights a potential complication, although the device is generally considered effective for reducing clot burden in pulmonary embolism. The study underscores the importance of careful patient selection and monitoring during the procedure.

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

Pulmonary Embolism With Syncope Treated With Inari FlowTriever®.

Cureus

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 →
ClinicalTrials.gov

FlowTriever2 Pulmonary Embolectomy Clinical Study

View Source →

Frequently Asked Questions

What is the FlowTriever Retrieval Aspiration System used for?

It is used for the mechanical thrombectomy of pulmonary embolisms, specifically to remove thrombi from the pulmonary arteries.

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, particularly in patients with significant clot burden who are 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.

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