AngioJet Ultra Avx Thrombectomy Set Model 105039

FDA-Cleared Indications

• Mechanical removal of thrombus from the venous system.
• Use during endovascular treatment of venous thrombotic disease when removal of obstructing thrombus is indicated.

Clinical Applications

• Endovascular mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
• Removal of thrombus from other labeled venous vessels when the vessel size and anatomy are compatible with the device.
• Catheter-based treatment of acute venous obstruction in an interventional radiology or vascular surgery setting.

Reported off-label uses

• Thrombectomy of selected dialysis grafts or fistulas, depending on the specific device labeling, access anatomy, and institutional practice.
• Treatment of selected pulmonary emboli with AngioJet systems or related device configurations; this should not be assumed to be on-label for this specific set.

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 used under fluoroscopic or other appropriate imaging guidance through vascular access, commonly in the femoral or other suitable venous access site.
• Vessel diameter, thrombus burden, lesion length, access route, and compatibility with the AngioJet console and catheter system must be confirmed in the current manufacturer instructions for use.
• The procedure may involve local anesthesia with moderate sedation; treatment time varies with clot burden and anatomy, and some patients require hospital observation or admission.
• The device is not automatically MRI safe. MRI conditions must be verified in the current labeling; the catheter and accessories should not be taken into the MRI environment unless specifically designated as MR Safe or MR Conditional.
• Potential complications include bleeding at the access site, vessel injury, residual or recurrent thrombosis, embolization, hemolysis, kidney injury, infection, arrhythmia in certain applications, and complications related to anticoagulation or sedation.