Advance 14rx Rapid Exchange PTA Balloon Catheter

FDA-Cleared Indications

• Dilation of stenotic or obstructed peripheral blood vessels during percutaneous transluminal angioplasty.
• Use in the peripheral vasculature when balloon dilation is clinically indicated.

Clinical Applications

• Balloon angioplasty of narrowed peripheral blood vessels.
• Dilation of venous stenoses or obstructions during endovascular treatment.
• Post-deployment expansion or optimization of a peripheral venous stent when balloon dilation is indicated.
• Treatment of impaired blood flow caused by venous narrowing or obstruction.

Reported off-label uses

• Balloon dilation of selected dialysis access stenoses when the device size and labeling are appropriate.
• Treatment of selected arterial lesions in clinical practice, although the specific vessel and indication should be confirmed against the current 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

• The catheter is designed for rapid exchange over a standard 0.014-inch guidewire; the required guidewire length and compatibility should be confirmed before use.
• Available balloon diameters and lengths vary by model. Select a size appropriate for the target vessel and follow the labeled rated burst pressure.
• The procedure is performed under fluoroscopic imaging, usually through vascular access such as the femoral or jugular vein, depending on the target anatomy.
• Do not overinflate the balloon. Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding, infection and recurrence of narrowing.
• MRI safety depends on the specific catheter model and whether it remains in the patient. Review the current manufacturer instructions for use; it is generally removed after angioplasty.