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clottriever thrombectomy system
Irani Medical
Summary: The ClotTriever Thrombectomy System is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence highlights its use in upper extremity and iliofemoral deep vein thrombosis with studies showing efficacy in clot removal.
FDA Clearance Information
Pathway
510K
Number
K210190 ↗
Decision Date
February 23, 2021
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 23, 2021. It is manufactured by Irani Medical and classified as a Class 2 device.
What It Is
The ClotTriever Thrombectomy System is a mechanical thrombectomy device designed for the removal of thrombi from the venous system. It is intended for use in patients with venous thromboembolism, providing a minimally invasive option for clot extraction.
Clinical Applications
Common clinical scenarios for the ClotTriever include treatment of upper extremity deep vein thrombosis and iliofemoral deep vein thrombosis. It is particularly useful in cases where anticoagulation therapy is insufficient or contraindicated.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, case series, and retrospective analyses, published between 2023 and 2025. These studies evaluate the device's efficacy and safety in various venous thrombosis contexts.
Reported Outcomes
Published studies report that the ClotTriever Thrombectomy System is effective in removing thrombi from the venous system, with significant improvements in symptoms and reduction in thrombus burden. In one study, the device showed comparable efficacy to anticoagulation in iliofemoral DVT treatment.
Safety Profile
Reported complications include access site adverse events, particularly when using small upper extremity veins. Other studies highlight the importance of proximal IVCF protection during procedures to prevent complications.
Evidence Limitations
Current evidence is limited by small sample sizes and a 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 is indicated for mechanical thrombectomy in cases of venous thromboembolism, including upper extremity and iliofemoral deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies report effective thrombus removal and symptom improvement, with some showing comparable results to anticoagulation therapy in certain DVT cases.
What complications have been reported?
Safety data indicate potential access site complications and the need for careful procedural planning to avoid adverse events, especially with IVCF-associated thrombosis.
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.