AngioJet Ultra Spiroflex Vg Thrombectomy Set Model 106608

FDA-Cleared Indications

• Mechanical removal of thrombus from the venous system.

Clinical Applications

• Endovascular mechanical thrombectomy for thrombus in the venous system.
• Removal of venous thrombus when catheter-based clot extraction is clinically appropriate.
• Treatment of selected patients with extensive venous thrombosis as part of an image-guided thrombectomy procedure.

Reported off-label uses

• Use in selected arterial thrombectomy procedures, depending on the specific catheter labeling and institutional practice.
• Use for selected pulmonary embolism thrombectomy procedures; applicability depends on the device's specific FDA labeling and should not be assumed from venous-system clearance.

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 device is intended for use by trained clinicians familiar with venous access, catheter-directed thrombectomy and image guidance.
• Device size and catheter configuration should be matched to the target vessel, clot burden and anatomy.
• The system requires a compatible console, saline supply and aspiration setup according to the manufacturer's instructions for use.
• MRI safety should be verified in the current device labeling; an implanted or indwelling thrombectomy catheter should not be considered MRI safe without specific confirmation.
• Potential complications include bleeding, vessel injury, embolization, hemolysis and kidney-related complications; anticoagulation, anatomy and patient-specific contraindications must be assessed before treatment.