FlowTriever2 Catheter
Inari Medical, Inc.The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.
Intended Use
The FlowTriever2 Catheter is indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels, injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. It is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).
Technology
A single-use, sterile catheter device consisting of an outer Delivery Catheter and an inner catheter with a flexible shaft attached to a self-expanding wireform disk. It includes a Y-connector with rotatable hemostatic valve and stopcock. Radiopaque markers aid fluoroscopic visualization. The device is used with Triever Catheters for catheter deployment, aspiration, and clot removal. Materials include laser cut nitinol for the wireform disk and Pebax polymers for catheters. The device operates by advancing to the thrombus site, deploying the wireform disk to engage thrombus, then manually retracting to capture and aspirate the clot.
Performance
Performance was supported by the FLARE-FT2 clinical study, a multicenter prospective single-arm study with 50 patients evaluating safety and effectiveness for treating acute pulmonary embolism. Primary safety endpoint included incidence of serious adverse events within 48 hours (device-related mortality, major bleeding, device or procedure-related adverse events). Primary effectiveness endpoint was change in mean pulmonary arterial pressure. The study met its performance goals, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/14/2025
1 month - 2
FDA Approval
3/13/2025
Other devices from Inari Medical, Inc.
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