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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 in hospital settings.

FDA Clearance Information

Pathway 510K
Decision Date July 27, 2018
Product Code QEW
Device Class Class 2
Evidence 14 studies

The FlowTriever Retrieval Aspiration System was cleared via the FDA 510(k) pathway on July 27, 2018. It is manufactured by Inari Medical and 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 in patients with pulmonary embolism. It operates by using a catheter-based system to aspirate and retrieve clots, thereby reducing the clot burden. This device is particularly useful for patients who are at intermediate to high risk and may not be candidates for thrombolytic therapy.

Clinical Applications

The FlowTriever system is commonly used in interventional radiology and cardiology to treat patients with acute pulmonary embolism. It is particularly beneficial in emergency settings where rapid clot removal is necessary to restore pulmonary circulation. The device is suitable for patients who have contraindications to anticoagulation or thrombolytic therapy, providing a mechanical alternative to pharmacological treatments.

Indications for Use

The FDA-cleared indications for the FlowTriever system include the treatment of pulmonary embolism, specifically in patients who are at intermediate to high risk. It is intended for use in scenarios where rapid clot removal is critical to patient outcomes.

Practical Considerations

The FlowTriever system is typically available in various sizes to accommodate different patient anatomies. It is compatible with standard catheterization techniques and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in mechanical thrombectomy techniques to use this device effectively.

Related Literature

The linked study discusses a case of cardiac tamponade following the use of the FlowTriever system for percutaneous pulmonary embolectomy. The study highlights the effectiveness of the device in reducing clot burden but also notes potential complications such as cardiac tamponade. Limitations include the focus on a single case, which may not represent broader clinical 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

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 removal of thrombi in patients with pulmonary embolism, particularly those at intermediate to high risk.

What specialties typically use this device?

Interventional radiologists and cardiologists primarily use this device in hospital settings.

What are the FDA-cleared indications?

The device is indicated for the treatment of pulmonary embolism, especially in patients who require rapid clot removal and may not be suitable for thrombolytic therapy.

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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