Dorado PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Dilation of stenotic segments in peripheral blood vessels during percutaneous transluminal angioplasty.
• Use in the peripheral vasculature to improve blood flow through narrowed vessel segments.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Treatment of narrowed lower-extremity vessels in patients with peripheral vascular disease.
• Dilation of peripheral venous stenoses when consistent with the device labeling and selected catheter configuration.
• Angioplasty of stenoses in dialysis access circuits, when the specific device labeling permits this application.

Reported off-label uses

• Treatment of selected stenoses in vascular territories or lesion types not specifically described in the device labeling.
• Use in complex or heavily calcified lesions beyond the labeled indications, based on operator judgment and institutional practice.

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 different balloon diameters and lengths; the selected size should match the target vessel and lesion.
• It is advanced over a compatible guidewire through an appropriately sized vascular sheath or access system under fluoroscopic imaging.
• The balloon must be inflated and deflated according to the device instructions for use. Excessive pressure or incorrect sizing can cause vessel injury.
• MRI safety depends on the exact catheter configuration and whether the device remains in the patient; consult the current manufacturer labeling before MRI.
• Contraindications and precautions include inability to cross the lesion, unsuitable vessel anatomy, severe uncorrected coagulation abnormalities, and allergy or intolerance to materials or contrast when relevant.