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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 outcomes.
FDA Clearance Information
Pathway 510K
Number K182531 ↗
Decision Date October 10, 2018
Product Code QEW
Device Class Class 2
Evidence 23 studies
The ClotTriever Thrombectomy System received FDA clearance through the 510(k) pathway on October 10, 2018. It is manufactured by Inari Medical and classified as a Class 2 device.
What It Is
The ClotTriever Thrombectomy System is a mechanical device designed for the removal of thrombi from venous systems. It is intended for use in patients with venous thromboembolism, specifically targeting large clots in deep veins.
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 observational studies, conducted between 2023 and 2025. These studies focus on the device's efficacy and safety in various venous thrombosis scenarios.
Reported Outcomes
Published studies report that the ClotTriever Thrombectomy System effectively reduces thrombus burden in patients with deep vein thrombosis. Technical and clinical outcomes have been positive, with improvements in symptoms and reduced incidence of post-thrombotic syndrome.
Safety Profile
Reported complications include access site adverse events, particularly when using large-bore catheters in small veins. However, overall safety profiles in the studies reviewed indicate a favorable risk-benefit ratio.
Evidence Limitations
Evidence gaps include a need for larger, multicenter trials to confirm findings and assess long-term outcomes. Some studies are limited by small sample sizes and lack of control groups, which may affect the generalizability of results.
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 in cases of deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal, symptom improvement, and reduced post-thrombotic syndrome incidence.
What complications have been reported?
Safety data indicate access site complications, especially with large-bore catheters in small veins, but overall safety is favorable.
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.