📊 Evidence-Based Reference

clottriever thrombectormy system clottriever catheter clottriever sheath

Inari Medical

Summary: The ClotTriever Thrombectomy System by Inari Medical is a mechanical thrombectomy device used primarily for venous thrombus removal. Key evidence highlights its efficacy in treating deep vein thrombosis (DVT) with a focus on safety and procedural success.

FDA Clearance Information

Pathway 510K
Decision Date September 20, 2019
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 September 20, 2019. It is manufactured by Inari Medical and classified as a Class 2 device under product code QEW.

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 deep vein thrombosis (DVT) to restore venous flow and reduce thrombus burden.

Clinical Applications

The device is commonly used in clinical settings for the treatment of iliofemoral deep vein thrombosis, especially in cases where anticoagulation is insufficient or contraindicated. It is also utilized in scenarios requiring rapid thrombus removal to prevent complications such as post-thrombotic syndrome.

Evidence Summary

The available literature includes 10 studies, comprising randomized controlled trials, retrospective analyses, and case series, published between 2023 and 2024. These studies evaluate the device's efficacy and safety in treating venous thromboembolic conditions.

Reported Outcomes

Published studies report that the ClotTriever Thrombectomy System effectively reduces thrombus burden and improves venous patency in patients with deep vein thrombosis. Some studies highlight its superiority over anticoagulation alone in preventing post-thrombotic syndrome. The device has shown promising results in maintaining catheter patency and reducing restenosis risk.

Safety Profile

Reported complications include bleeding risks associated with the procedure, although these are generally lower compared to thrombolytic therapies. Some studies note minor procedural complications, but overall, the device is considered safe for clinical use.

Evidence Limitations

Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and compare the device's efficacy against 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 ClotTriever Thrombectomy System?

The ClotTriever Thrombectomy System is indicated for the treatment of deep vein thrombosis (DVT), particularly in cases where rapid thrombus removal is necessary or when anticoagulation is contraindicated.

What outcomes have been reported in clinical studies?

Clinical studies have reported effective thrombus removal, improved venous patency, and reduced incidence of post-thrombotic syndrome with the use of the ClotTriever Thrombectomy System.

What complications have been reported?

Reported complications include bleeding risks and minor procedural complications, though these are generally lower compared to thrombolytic therapies.

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.

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