đź“‹ FDA Reference

clottriever xl catheter

Inari Medical

Summary: The ClotTriever XL Catheter is a medical device used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and vascular surgeons to remove large clots from veins.

FDA Clearance Information

Pathway 510K
Decision Date April 27, 2023
Product Code QEW
Device Class Class 2
Evidence 23 studies

The ClotTriever XL Catheter by Inari Medical was cleared via the FDA 510(k) pathway on April 27, 2023. It is a Class 2 device under product code QEW.

What It Is

The ClotTriever XL Catheter is a specialized catheter designed for the removal of thrombi from large veins. It operates by mechanically capturing and extracting clots without the need for thrombolytic drugs, reducing the risk of bleeding complications. The device is engineered to accommodate larger clot burdens, making it suitable for extensive thrombotic events.

Clinical Applications

This device is commonly used in the treatment of deep vein thrombosis (DVT) in the iliac, femoral, and other large veins. It is typically utilized in hospital settings by interventional radiologists and vascular surgeons. The ClotTriever XL is particularly beneficial for patients who are at high risk for bleeding or have contraindications to thrombolytic therapy.

Indications for Use

The ClotTriever XL Catheter is indicated for patients with venous thromboembolism, particularly those with large clots in major veins. It is designed to safely and effectively remove thrombi, improving blood flow and reducing the risk of complications.

Practical Considerations

The ClotTriever XL Catheter is available in various sizes to accommodate different patient anatomies and clot sizes. It is compatible with standard vascular access techniques and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in mechanical thrombectomy procedures to ensure optimal 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 is the ClotTriever XL Catheter used for?

The ClotTriever XL Catheter is used for the mechanical removal of large blood clots from veins, particularly in cases of deep vein thrombosis.

What specialties typically use this device?

Interventional radiologists and vascular surgeons typically use this device in hospital settings.

What are the FDA-cleared indications?

The device is indicated for the removal of thrombi from large veins in patients with venous thromboembolism, especially those who cannot receive thrombolytic drugs.

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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