NC PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic or occluded peripheral arteries.
• Dilatation of peripheral vascular lesions in adults when balloon angioplasty is clinically indicated.
• Use in vessels appropriate for the catheter's labeled diameter, length, and pressure specifications.

Clinical Applications

• Balloon angioplasty of peripheral artery stenosis or occlusion.
• Treatment of iliac, femoropopliteal, and other labeled peripheral arterial lesions.
• Post-dilatation of a peripheral arterial stent when permitted by the device labeling.
• Lesion preparation before peripheral artery stenting or other endovascular treatment.

Reported off-label uses

• Angioplasty of dialysis access stenosis in an arteriovenous fistula or graft, when the specific catheter labeling does not include dialysis access use.
• Venous angioplasty for selected central or peripheral venous stenoses, when not included in the device labeling.

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 working length to match the target vessel and lesion; do not exceed the labeled inflation pressure or rated burst pressure.
• The catheter requires a compatible guidewire and vascular sheath or guiding catheter of the labeled size. Confirm crossing profile, shaft length, and access-site compatibility before use.
• The procedure is performed with fluoroscopic guidance, usually through femoral or radial arterial access depending on the target vessel; local anesthesia with or without moderate sedation is common.
• Contraindications and warnings include inability to cross the lesion, severe vessel tortuosity, uncorrected bleeding disorders, contrast allergy that cannot be managed, and risk of dissection, perforation, embolization, thrombosis, or restenosis.
• MRI safety depends on the final device labeling and whether the catheter remains in the patient. Review the manufacturer’s current instructions for use before MRI; do not assume the device is MR safe or MR conditional.