Vipersphere PTA Balloon Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic lesions in peripheral vasculature.
• Dilation of stenoses within vascular stents when balloon angioplasty is clinically indicated.

Clinical Applications

• Balloon angioplasty of narrowed peripheral veins or arteries.
• Treatment of stenosis within a peripheral vascular stent.
• Endovascular dilation performed over a guidewire under fluoroscopic imaging.

Reported off-label uses

• Treatment of stenosis in hemodialysis arteriovenous fistulas or grafts when the specific catheter labeling does not include dialysis-access use.
• Angioplasty of selected central venous or iliac venous stenoses outside the device's specific labeled indications.

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 balloon size and length must match the target vessel and lesion; use only sizes listed in the current manufacturer instructions for use.
• The catheter must be compatible with the guidewire, introducer sheath, and vascular access system used for the procedure.
• The procedure is performed with fluoroscopic guidance, usually through percutaneous femoral or another suitable vascular access site.
• Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding, infection, and balloon rupture.
• MRI safety and conditional-use requirements depend on the complete device system and current labeling; confirm the manufacturer’s MRI information before scanning.