Bard Utraverse Small Vessel PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Use in percutaneous transluminal angioplasty of peripheral small vessels.
• Dilation of stenotic or obstructed peripheral arteries to improve blood flow.
• Use during endovascular treatment of peripheral vascular disease when balloon angioplasty is indicated.

Clinical Applications

• Balloon angioplasty of narrowed small peripheral arteries.
• Endovascular treatment of peripheral arterial stenosis or occlusion.
• Treatment of lower-extremity peripheral artery disease when the target vessel is appropriate for the catheter's size range.
• Adjunctive balloon dilation during a peripheral vascular intervention.

Reported off-label uses

• Use in selected venous angioplasty procedures, such as treatment of focal venous stenosis, may occur in clinical practice but is not necessarily covered by the device's small-vessel arterial labeling.
• Use in vessels or clinical situations outside the labeled size, anatomy, or indication may be considered off-label and should be based on clinician judgment, available evidence, and institutional policy.

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 length to match the target vessel and follow the product labeling for rated burst pressure and inflation technique.
• The catheter is used over a compatible guidewire under fluoroscopic or other appropriate imaging guidance, generally through percutaneous arterial access.
• Do not use if the device is damaged, expired, or incompatible with the planned guidewire, sheath, contrast medium, or inflation system.
• MRI safety depends on the specific catheter and whether any device components remain in the patient; confirm the current labeling before MRI.
• Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding, restenosis, and allergic or kidney-related complications from contrast.