Cordis Powerflex Extreme PTA Balloon Catheter Cordis Powerflex Plus PTA Balloon Catheter Cordis Powerflex P3 PTA

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of peripheral vascular stenosis.
• Dilation of narrowed peripheral blood vessels to improve blood flow.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Treatment of peripheral vascular narrowing caused by atherosclerotic plaque or other stenotic disease.
• Dilation of a peripheral vascular lesion before or during a procedure intended to restore blood flow.
• Use in endovascular procedures performed by interventional radiology or vascular surgery teams.

Reported off-label uses

• Balloon dilation of selected venous stenoses, including lesions treated during venous intervention, when clinically appropriate.
• Lesion preparation before peripheral vascular stent placement.
• Balloon dilation of selected dialysis access stenoses.

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 catheter is available in multiple balloon diameters and working lengths; the selected size should match the target vessel and lesion.
• It is used with compatible guidewires, introducer sheaths, contrast, and inflation devices according to the applicable instructions for use.
• The balloon must be inflated within its labeled pressure limits. Overinflation or incorrect sizing can cause vessel injury, dissection, rupture, or other complications.
• MRI safety depends on the specific catheter model and whether it remains in the body; consult the current product labeling before MRI. The catheter is generally a temporary procedural device and is removed after treatment.
• Contraindications and precautions include inability to safely cross the lesion, significant uncorrected bleeding risk, contrast allergy, severe vessel calcification or tortuosity, and other conditions listed in the current labeling.