📊 Evidence-Based Reference

flowtriever retrieval aspiration system aspiration guide catheter retraction aspirator

Inari Medical

Summary: The FlowTriever Retrieval Aspiration System by Inari Medical is a device used for mechanical thrombectomy in pulmonary embolism interventions. Key evidence highlights its use in various thrombotic conditions with promising outcomes.

FDA Clearance Information

Pathway 510K
Decision Date November 22, 2016
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 November 22, 2016. It is manufactured by Inari Medical and is classified as a Class 2 device.

What It Is

The FlowTriever Retrieval Aspiration System is a mechanical thrombectomy device designed for the removal of thrombus in the pulmonary arteries. It operates by aspirating and retrieving thrombotic material, providing a minimally invasive treatment option for patients with pulmonary embolism.

Clinical Applications

This device is commonly used in clinical scenarios involving pulmonary embolism and other venous thrombotic conditions. It is particularly useful in cases where traditional anticoagulation or thrombolysis may be insufficient or contraindicated.

Evidence Summary

The available literature includes 7 studies, comprising case reports and other observational studies, published between 2022 and 2026. These studies explore the device's application in various thrombotic conditions.

Reported Outcomes

Published studies report successful thrombus retrieval and recanalization in patients with pulmonary embolism and other thrombotic conditions. The device has been used effectively in both adult and pediatric populations, demonstrating significant clinical improvement in hemodynamic parameters.

Safety Profile

Reported complications include potential risks associated with large-bore catheter use, such as vascular injury or bleeding. However, the studies reviewed did not report significant adverse events directly attributable to the device.

Evidence Limitations

The evidence is primarily based on case reports and small observational studies, which limits the generalizability of the findings. Larger, randomized controlled trials are needed to further validate the efficacy and safety 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

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 are the clinical indications for FlowTriever Retrieval Aspiration System?

The device is indicated for mechanical thrombectomy in pulmonary embolism and other venous thrombotic conditions.

What outcomes have been reported in clinical studies?

Studies report successful thrombus retrieval and improved hemodynamic stability in patients treated with the device.

What complications have been reported?

Reported complications include risks of vascular injury and bleeding, though significant adverse events were not commonly observed.

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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