Mini-Clottriever Thrombectomy System

FDA-Cleared Indications

• For the removal of thrombus from peripheral blood vessels.
• For use in vessels with diameters appropriate for the specific device size and access system.
• The device is used under imaging guidance by trained physicians who determine whether mechanical thrombectomy is appropriate.

Clinical Applications

• Mechanical thrombectomy for selected patients with lower-extremity deep vein thrombosis.
• Endovascular removal of thrombus from peripheral venous vessels.
• Clot removal when rapid restoration of venous blood flow is clinically indicated.
• Use as part of a catheter-based treatment strategy, which may also include anticoagulation or other therapies.

Reported off-label uses

• Use in selected thrombosed dialysis grafts or fistulas may be reported in clinical practice, but the specific indication should be confirmed against current device labeling.
• Use in other peripheral venous or arterial thrombotic conditions outside the cleared labeling may be reported, but these applications should not be assumed to be FDA-cleared.

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.

Practical Considerations

• The Mini system is intended for smaller vessels than larger ClotTriever systems; the treating physician must select the device size and sheath based on vessel diameter and anatomy.
• The device is introduced through vascular access and used with fluoroscopic imaging. Venous access, commonly through the popliteal, femoral, or other suitable vein, depends on the location of the clot.
• It is a single-use catheter-based device and requires compatible access equipment, guidewires, and aspiration or blood-return management according to the manufacturer's instructions.
• MRI safety and conditions should be verified in the current manufacturer's labeling before scanning; an implanted or retained device should not be assumed to be MRI safe.
• Potential concerns include bleeding, hematoma, venous injury, vessel perforation, embolization, contrast reaction, recurrent thrombosis, and complications related to sedation or vascular access. Anticoagulation status and contraindications to endovascular treatment require individual assessment.