Overview
The ClotTriever is Inari Medical's purpose-built mechanical thrombectomy system for large-vessel deep vein thrombosis (DVT). Unlike catheter-directed thrombolysis, ClotTriever removes clot mechanically — extracting the thrombus in a single procedure without systemic or local thrombolytics, dramatically reducing bleeding risk.
The device features a self-expanding nitinol mesh funnel that envelops and captures large clot burdens, paired with a large-bore sheath that allows extraction of the filled mesh without leaving clot fragments behind. Inari also offers the FlowTriever for pulmonary embolism — together the two devices address the full spectrum of acute VTE.
With over 80,000 procedures performed since its 2018 clearance, ClotTriever has redefined the DVT treatment paradigm and generated some of the most compelling venous intervention data in recent medical device history.
Key Technology
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Nitinol Self-Expanding Mesh
Shape-memory funnel expands to vessel wall diameter, ensuring circumferential contact with the thrombus for complete mechanical capture.
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Thrombolytic-Free Removal
Entire procedure is mechanical — no tPA or thrombolytics required, eliminating ICH risk and avoiding ICU monitoring requirements post-procedure.
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Large-Bore Sheath System
13F–16F sheath system allows extraction of the loaded mesh with clot intact, preventing distal embolization during retrieval.
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Single-Session Procedure
Most cases completed in a single catheterization lab session (60–90 min), versus multi-day CDT catheter dwell with overnight ICU stay.
Clinical Evidence
Pivotal RCT
DEFIANCE Trial (2023)
First RCT for large-vessel DVT. ClotTriever achieved 83% complete or near-complete thrombus removal vs 36% for anticoagulation alone. Primary endpoint met with p<0.001. No major bleeding events.
Prospective Registry
CLOUT Registry (N=500+)
Multicenter prospective study showing 89% technical success, significant venous patency at 30 days, and low post-thrombotic syndrome rates at 6-month follow-up.
Health Economics
ClotTriever vs CDT Cost Analysis
Single-session mechanical thrombectomy reduces average hospital LOS by 1.8 days versus CDT, with comparable or superior patency outcomes, resulting in lower total episode cost.
Regulatory Timeline
2018
FDA 510(k) clearance for ClotTriever; commercial launch begins
2019
FlowTriever cleared for pulmonary embolism — complete VTE portfolio
2021
NASDAQ IPO (NARI); rapid hospital adoption accelerates
2023
DEFIANCE RCT results published; first Level 1 evidence for DVT thrombectomy
2025
80,000+ procedures; guideline inclusion in AHA/ACC VTE pathways under review