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clottriever sheath
Inari Medical
Summary: The ClotTriever Sheath by Inari Medical is a mechanical thrombectomy device for venous applications. It is primarily used for removing thrombi from large veins. Key evidence highlights its efficacy in reducing embolic events during thrombectomy.
FDA Clearance Information
Pathway
510K
Number
K233815 ↗
Decision Date
December 18, 2023
Product Code
QEW
Device Class
Class 2
Evidence
23 studies
The ClotTriever Sheath received FDA 510(k) clearance on December 18, 2023. Manufactured by Inari Medical, it is classified as a Class 2 device under product code QEW.
What It Is
The ClotTriever Sheath is a mechanical thrombectomy device designed for venous applications. It facilitates the removal of thrombi from large veins, utilizing a sheath mechanism to capture and extract clots effectively.
Clinical Applications
Commonly used in scenarios involving deep vein thrombosis (DVT) and inferior vena cava (IVC) thrombectomy, the ClotTriever Sheath is applied in procedures requiring efficient thrombus removal to restore venous patency.
Evidence Summary
The literature includes 8 studies, comprising RCTs, case series, and feasibility studies, conducted between 2024 and 2025. These studies evaluate the device's efficacy and safety in venous thrombectomy procedures.
Reported Outcomes
Published studies report that the ClotTriever Sheath is effective in reducing postoperative embolic events, with a high technical success rate of 100% and patency rates of 75% at 3 months and 71.4% at 6 months. The device demonstrates promising results in maintaining venous patency post-thrombectomy.
Safety Profile
Reported complications include subsegmental pulmonary embolisms and recurrent DVTs. The device's use in conjunction with IVC filters has shown a successful removal rate of prior filters in 5 out of 7 cases, indicating a favorable safety profile.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in the studies. Further research is needed to establish long-term outcomes and to evaluate the device's performance in diverse patient populations.
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 Sheath?
The ClotTriever Sheath is indicated for mechanical thrombectomy in venous thromboembolic conditions, such as deep vein thrombosis and inferior vena cava thrombosis.
What outcomes have been reported in clinical studies?
Clinical studies report a high technical success rate and significant reduction in embolic events, with patency rates of 75% at 3 months and 71.4% at 6 months.
What complications have been reported?
Reported complications include subsegmental pulmonary embolisms and recurrent DVTs, with a noted success in IVC filter removal in conjunction with the device.
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.