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clottriever xl catheter 41-102
Inari Medical
Summary: The ClotTriever XL Catheter 41-102 by Inari Medical is a mechanical thrombectomy device used for the removal of clots in venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K242557 ↗
Decision Date
September 27, 2024
Product Code
QEW
Device Class
Class 2
Evidence
23 studies
The ClotTriever XL Catheter 41-102 received FDA 510k clearance on September 27, 2024. Manufactured by Inari Medical, it is classified as a Class 2 medical device under product code QEW.
What It Is
The ClotTriever XL Catheter 41-102 is a specialized catheter designed for mechanical thrombectomy in the venous system. It works by capturing and removing thrombi (blood clots) from large veins, helping to restore normal blood flow. This device is particularly useful in treating conditions like deep vein thrombosis (DVT), where clots obstruct blood flow in the veins.
Clinical Applications
The ClotTriever XL is commonly used in hospital settings, particularly in interventional radiology and vascular surgery departments. It is suitable for patients with acute or chronic venous thromboembolism, including those with DVT. The device is used in procedures where rapid clot removal is necessary to prevent complications such as post-thrombotic syndrome.
Indications for Use
The FDA indications for the ClotTriever XL Catheter include the removal of thrombi from the venous system. It is intended for patients with conditions like deep vein thrombosis, where blood clots need to be mechanically extracted to restore venous blood flow.
Practical Considerations
The ClotTriever XL Catheter is designed to accommodate larger clots, making it suitable for extensive thrombus burdens. Clinicians should ensure compatibility with existing vascular access systems and be trained in mechanical thrombectomy techniques for optimal 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 is ClotTriever XL Catheter 41-102 used for?
It is used for the mechanical removal of blood clots from the venous system, 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 the venous system, particularly in patients with deep vein 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.