đź“Š Evidence-Based Reference
ClotTriever Thrombectomy System ClotTriever Catheter ClotTriever Sheath
Summary: The ClotTriever Thrombectomy System by Inari Medical is a mechanical thrombectomy device primarily used for venous thromboembolism. Key evidence highlights its efficacy in thrombus removal and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K173470 ↗
Decision Date ?
December 4, 2017
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
23 studies
The ClotTriever Thrombectomy System was cleared by the FDA via the 510(k) pathway on December 4, 2017. It is manufactured by Inari Medical and is classified as a Class 2 medical device.
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) and other venous thromboembolic conditions.
FDA-Cleared Indications
- Mechanical removal of thrombus from the peripheral vascular system.
- Treatment of thrombus in peripheral veins, including vessels affected by deep vein thrombosis.
- Use with compatible aspiration and thrombectomy components for removal of intravascular clot.
Clinical Applications
- Mechanical thrombectomy for selected patients with iliofemoral deep vein thrombosis.
- Mechanical thrombectomy for selected patients with upper-extremity venous thrombosis.
- Removal of thrombus from large peripheral veins when rapid clot extraction is clinically appropriate.
- Use during catheter-based treatment of venous thromboembolism in conjunction with venography and other supportive techniques.
Reported off-label uses
- Use in selected pulmonary embolism thrombectomy procedures, depending on the specific device labeling, anatomy and treatment strategy.
- Use for thrombosed dialysis grafts or fistulas as part of endovascular access salvage procedures.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of case series, retrospective studies, and randomized controlled trials, with a focus on the efficacy and safety of the ClotTriever System. The studies span from 2023 to 2024, providing a contemporary view of its clinical application.
Reported Outcomes
Published studies report that the ClotTriever System effectively removes thrombi in patients with deep vein thrombosis, with improvements in symptoms and reduced incidence of post-thrombotic syndrome. The device has shown favorable outcomes in both upper and lower extremity DVT cases.
Safety Profile
Reported complications include minor bleeding and access site hematomas, which are consistent with those observed in similar mechanical thrombectomy procedures. Overall, the device has a favorable safety profile with no major adverse events reported in the reviewed studies.
Evidence Limitations
The current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the long-term efficacy and safety of the ClotTriever System, as well as its comparative effectiveness against other thrombectomy devices.
Practical Considerations
- The system includes a thrombectomy catheter and compatible sheath; the required size depends on the target vessel, clot burden and access route.
- It is introduced through percutaneous venous access, commonly through the popliteal, femoral or internal jugular vein, with fluoroscopic or venographic guidance.
- Operators should assess vessel diameter, venous anatomy, caval or central venous obstruction, bleeding risk and the need for anticoagulation before treatment.
- The system is not a permanent implant and does not remain in the body after the procedure. MRI considerations generally apply to any retained devices, access-site materials or other implants rather than to the removed catheter itself.
- Potential complications include bleeding, hematoma, venous injury, embolization, contrast reaction, infection, recurrent thrombosis and complications related to sedation or anticoagulation.
Procedures that use this device
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 removal of thrombi in patients with deep vein thrombosis, particularly in the iliofemoral and upper extremity veins.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective thrombus removal and symptom improvement in patients treated with the ClotTriever System, with a reduction in post-thrombotic syndrome incidence.
What complications have been reported?
Reported complications include minor bleeding and access site hematomas, with no major adverse events noted in the reviewed studies.
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.