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clottriever bold catheter
Inari Medical
Summary: The ClotTriever BOLD catheter is a medical device used for mechanical thrombectomy in patients with deep vein thrombosis (DVT). It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K230494 ↗
Decision Date
April 18, 2023
Product Code
QEW
Device Class
Class 2
Evidence
23 studies
The ClotTriever BOLD catheter by Inari Medical was cleared by the FDA via the 510(k) pathway on April 18, 2023. It is a Class 2 device under product code QEW.
What It Is
The ClotTriever BOLD catheter is a component of the ClotTriever System, designed for percutaneous mechanical thrombectomy. It features a modified coring element that aids in the removal of thrombi from the venous system, specifically targeting deep vein thrombosis. This device allows for minimally invasive removal of clots, reducing the need for thrombolytic drugs.
Clinical Applications
The ClotTriever BOLD catheter is commonly used in the treatment of deep vein thrombosis, particularly in the lower extremities. It is utilized in hospital settings, often in interventional radiology or vascular surgery departments. The device is suitable for adult patients who present with significant venous thromboembolism and require mechanical intervention.
Indications for Use
The FDA has cleared the ClotTriever BOLD catheter for use in the treatment of deep vein thrombosis. It is intended for patients who have clots in their veins that need to be mechanically removed to restore normal blood flow.
Practical Considerations
The ClotTriever BOLD catheter is compatible with the ClotTriever System, and its design facilitates the removal of large clots without the need for adjunctive thrombolytic therapy. Clinicians should be familiar with catheter-based techniques and ensure proper sizing for the target vessels.
Related Literature
A single-center retrospective study evaluated the ClotTriever BOLD catheter's safety and efficacy in treating lower extremity DVT. The study reported preliminary success in procedural outcomes, indicating the device's potential effectiveness. However, limitations include the study's retrospective nature and limited sample size, necessitating further research for comprehensive validation.
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 BOLD catheter used for?
It is used for the mechanical removal of thrombi in patients with deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is cleared for the treatment of deep vein thrombosis, specifically for mechanically removing clots from veins.
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.