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mini-clottriever thrombectomy system
Inari Medical
Summary: The mini-clottriever thrombectomy system is a mechanical device used for venous thrombectomy. It is primarily used to remove thrombi in deep vein thrombosis. Key evidence highlights its efficacy in clot removal.
FDA Clearance Information
Pathway
510K
Number
K220887 ↗
Decision Date
August 4, 2022
Product Code
QEW
Device Class
Class 2
Evidence
23 studies
The mini-clottriever thrombectomy system was cleared by the FDA via the 510(k) pathway on August 4, 2022. It is manufactured by Inari Medical and is classified as a Class 2 device.
What It Is
The mini-clottriever thrombectomy system is a mechanical thrombectomy device designed to remove thrombi from veins. It operates by capturing and extracting clots, thereby restoring blood flow. It is intended for use in patients with venous thromboembolism.
Clinical Applications
This device is commonly used in clinical scenarios involving deep vein thrombosis (DVT) where rapid clot removal is necessary. It is particularly useful in cases where anticoagulation therapy alone is insufficient.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2023 and 2025. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the mini-clottriever thrombectomy system effectively removes thrombi in a significant number of cases, improving venous patency and reducing symptoms associated with DVT. The device has shown a high success rate in clot retrieval, particularly in cases with large, fibrin-rich clots.
Safety Profile
Reported complications include minor bleeding and access site hematomas. No major adverse events were consistently reported across studies, indicating a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and to compare the device's efficacy with other thrombectomy systems.
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 mini-clottriever thrombectomy system?
The mini-clottriever thrombectomy system is indicated for the removal of thrombi in patients with deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies have reported successful thrombus removal and improved venous patency, with a high success rate in cases involving large clots.
What complications have been reported?
Safety data from evidence indicate minor bleeding and access site hematomas as the most common 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.