Cordis Aviator Peripheral Dilatation Catheter

FDA-Cleared Indications

• Dilatation of stenotic or obstructed peripheral blood vessels during percutaneous transluminal angioplasty.
• Treatment of peripheral vascular disease involving narrowed vessels of the limbs or other peripheral vascular beds.

Clinical Applications

• Balloon angioplasty of narrowed peripheral arteries.
• Treatment of peripheral vascular disease causing reduced blood flow to an extremity.
• Dilatation of a peripheral vascular lesion before or during placement of a vascular stent when clinically appropriate.
• Percutaneous treatment of selected stenoses in the leg or arm vessels.

Reported off-label uses

• Use in selected venous stenoses or occlusions, including lesions treated before venous stenting, may occur in clinical practice but should be evaluated against the device labeling and institutional policy.
• Use in vessel beds or lesion types outside the cleared labeling may be reported for balloon-catheter angioplasty, but requires physician judgment and appropriate consent.

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

• Select the balloon diameter and length based on the target vessel size, lesion length, and treatment plan.
• The catheter is used with compatible guidewires and introducer sheaths; compatibility should be confirmed before the procedure.
• It is advanced and positioned under fluoroscopic or other appropriate imaging guidance, then inflated to dilate the lesion.
• Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding at the access site, and restenosis.
• MRI safety depends on the specific catheter model and whether it remains in the patient; consult the current manufacturer labeling. A temporary angioplasty catheter is generally removed after treatment.