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clottriever thrombectomy system
Inari Medical
Summary: The ClotTriever Thrombectomy System is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence highlights its efficacy in treating deep vein thrombosis with a focus on safety and clinical outcomes.
FDA Clearance Information
Pathway 510K
Number K221531 ↗
Decision Date February 6, 2023
Product Code QEW
Device Class Class 2
Evidence 23 studies
The ClotTriever Thrombectomy System received FDA 510(k) clearance on February 6, 2023. Manufactured by Inari Medical, it is classified as a Class 2 device under product code QEW.
What It Is
The ClotTriever Thrombectomy System is designed for mechanical thrombectomy in venous thromboembolism cases. It functions by physically removing clots from the venous system, aiming to restore normal blood flow and reduce thrombus burden.
Clinical Applications
Commonly used in cases of deep vein thrombosis, particularly in the iliofemoral and upper extremity veins. It is also applied in scenarios involving inferior vena cava filter-associated thrombosis.
Evidence Summary
The available literature includes 13 studies, comprising RCTs, case series, and retrospective analyses, published between 2023 and 2025. These studies provide insights into the device's efficacy and safety profile.
Reported Outcomes
Published studies report that the ClotTriever Thrombectomy System effectively reduces thrombus burden and improves clinical outcomes in patients with deep vein thrombosis. Technical and clinical outcomes have been favorable in both upper extremity and thoracic central vein thrombosis cases.
Safety Profile
Reported complications include access site adverse events, particularly when accessing small upper extremity veins. Overall, the safety profile is consistent with other mechanical thrombectomy devices, with no significant increase in major complications.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and to evaluate long-term outcomes.
Linked Studies (20)
PubMed • 2025
Stripping the catheter: A new device for an old technique.
The journal of vascular access
RCT|prospective|retrospective|case Series|other 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 • 2025
Safety of accessing brachial veins for large-bore upper extremity venous thrombectomy using ClotTriever Thrombectomy System.
CVIR endovascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Reverse sheathing technique for iliocaval thrombectomy in the setting of IVC filters.
CVIR endovascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Mechanical thrombectomy with the ClotTriever System for upper extremity deep vein thrombosis: A case series.
Radiology case reports
Case Series View Source → PubMed • 2024
Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity.
Frontiers in surgery
Retrospective 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 • 2023
Percutaneous thrombectomy of upper extremity and thoracic central veins using Inari ClotTriever System: Experience in 14 patients.
Journal of vascular surgery cases and innovative techniques
Case Series View Source → PubMed • 2023
Successful endovascular thrombectomy with the ClotTriever System for acute subclavian vein thrombosis in venous thoracic outlet syndrome.
CVIR endovascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
Successful removal of an acute deep vein thrombosis by the INARI ClotTriever system.
Radiology case reports
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
Case review and imaging: Treatment of central venous catheter associated fibrin sheath and chronic thrombus with the ClotTriever system.
Radiology case reports
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
ClotTriever system for mechanical thrombectomy of deep vein thrombosis.
Future cardiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Percutaneous extraction of colorectal cancer metastasis involving inferior vena cava using Inari ClotTriever Thrombectomy System.
Clinical imaging
View Source → PubMed • 2022
Endovascular Tissue Sampling Using the ClotTriever Thrombectomy System: Histopathologic Analysis in 26 Consecutive Patients.
Cardiovascular and interventional radiology
View Source → PubMed • 2022
Utility of a percutaneous mechanical thrombectomy device in retrieval of an iatrogenic intravascular foreign body.
Journal of vascular surgery cases and innovative techniques
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
Thrombectomy of Malignant Thoracic Central Venous Occlusive Disease Using Inari ClotTriever System.
Journal of vascular and interventional radiology : JVIR
View Source → PubMed • 2021
Single-Session Treatment of Upper Extremity Deep Venous Thrombosis and Central Venous Catheter Malfunction Using the ClotTriever System.
Cureus
View Source → PubMed • 2020
Acute Thrombolysis-Resistant Occlusive Left Femoral and Iliac Venous Thrombosis Treated with Mechanical Thrombectomy via the ClotTriever Device.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for ClotTriever Thrombectomy System?
The ClotTriever Thrombectomy System is indicated for mechanical thrombectomy in venous thromboembolism, including deep vein thrombosis and inferior vena cava filter-associated thrombosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective thrombus removal and improved clinical outcomes, particularly in iliofemoral and upper extremity deep vein thrombosis.
What complications have been reported?
Safety data indicate access site adverse events, especially when accessing small upper extremity veins, but no significant increase in major complications.
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.