WAVE PTA Balloon Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic lesions in peripheral arteries.
• Treatment of peripheral arterial narrowing when balloon dilation is clinically indicated.
• Use in the peripheral vasculature through catheter-based endovascular access.

Clinical Applications

• Balloon angioplasty for peripheral arterial stenosis.
• Treatment of narrowed iliac, femoropopliteal, or other peripheral arteries when the catheter size and labeling are appropriate.
• Lesion preparation before placement of a peripheral vascular stent.
• Treatment of residual narrowing after another peripheral endovascular intervention.

Reported off-label uses

• Balloon angioplasty in dialysis access grafts or fistulas, when the specific device labeling does not include dialysis access and the treating clinician determines that off-label use is appropriate.

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 available balloon diameters, lengths, shaft configuration, guidewire requirements, and sheath compatibility must be confirmed in the current device labeling.
• The catheter is used with fluoroscopic imaging and requires vascular access, commonly through the common femoral artery or another appropriate peripheral access site.
• Balloon inflation pressure should remain within the labeled rated burst pressure; the balloon must be completely deflated before repositioning or removal.
• MRI safety depends on the device's current labeling and whether the catheter remains in the body; verify MR Safe, MR Conditional, or MR Unsafe status before scanning.
• Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding at the access site, restenosis, contrast reaction, and kidney injury.