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clottriever thrombectomy system
Inari Medical
Summary: The ClotTriever Thrombectomy System is a mechanical device used for venous thrombectomy, primarily in cases of deep vein thrombosis. Key evidence highlights its efficacy in removing thrombi from large veins with a focus on safety and clinical outcomes.
FDA Clearance Information
Pathway 510K
Number K163549 ↗
Decision Date February 16, 2017
Product Code QEW
Device Class Class 2
Evidence 23 studies
The ClotTriever Thrombectomy System was cleared by the FDA via the 510(k) pathway on February 16, 2017. It is manufactured by Inari Medical and classified as a Class 2 device.
What It Is
The ClotTriever Thrombectomy System is a mechanical thrombectomy device designed to remove thrombi from large veins. It is intended for use in patients with venous thromboembolism, providing a minimally invasive option for thrombus removal.
Clinical Applications
Common clinical scenarios for the ClotTriever include treatment of deep vein thrombosis (DVT) in the iliofemoral and upper extremity veins. It is particularly useful in cases where anticoagulation therapy is insufficient or contraindicated.
Evidence Summary
The available literature includes 13 studies, comprising RCTs, case series, and other study types, conducted between 2023 and 2025. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the ClotTriever System effectively reduces thrombus burden in patients with deep vein thrombosis. Clinical outcomes include improved Villalta scores and reduced incidence of post-thrombotic syndrome. Technical success rates are high, with favorable clinical outcomes reported in multiple case series.
Safety Profile
Reported complications include access site adverse events, particularly when accessing small upper extremity veins. Other safety concerns involve potential complications associated with large-bore catheter use, though these are generally manageable.
Evidence Limitations
Evidence gaps include a lack of large-scale randomized controlled trials directly comparing the ClotTriever with other thrombectomy devices. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
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 is indicated for mechanical thrombectomy in patients with venous thromboembolism, particularly deep vein thrombosis in large veins.
What outcomes have been reported in clinical studies?
Studies report effective thrombus removal, improved clinical scores, and reduced post-thrombotic syndrome incidence.
What complications have been reported?
Safety data indicate access site complications and issues related to large-bore catheter use, though these are generally manageable.
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.