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Inari Medical
FDA Clearance Information
The FlowTriever Retrieval Aspiration System was cleared by the FDA through the 510(k) pathway on April 30, 2021. It is manufactured by Inari Medical and classified as a Class 2 device.
What It Is
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Linked Studies (14)
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 →Novel percutaneous aspiration thrombectomy in Fontan conduit obstruction with cardiogenic shock. Case report.
International journal of cardiology. Congenital heart disease
Case Report View Source →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 →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 →[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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 →Percutaneous FlowTriever Retrieval/Aspiration System for Impending Paradoxical Embolism: A New Tool?
JACC. Cardiovascular interventions
View Source →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 →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 →Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System.
Journal of vascular and interventional radiology : JVIR
View Source →Frequently Asked Questions
What are the clinical indications for FlowTriever Retrieval Aspiration System?
The device is indicated for mechanical thrombectomy in venous thromboembolism, particularly in cases of pulmonary embolism.
What outcomes have been reported in clinical studies?
Studies have reported successful thrombus removal and improved hemodynamic stability in patients with pulmonary embolism and other complex thromboembolic conditions.
What complications have been reported?
Reported complications include risks of embolization and vascular injury, though detailed safety data is limited.