Bard Atlas PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic peripheral arteries.
• Dilation of narrowed blood vessels to improve vascular lumen diameter and blood flow.

Clinical Applications

• Balloon angioplasty of peripheral arterial stenosis.
• Treatment of atherosclerotic narrowing in lower-extremity arteries.
• Treatment of peripheral vascular stenosis in patients with impaired blood flow.
• Use during endovascular procedures performed through a vascular access sheath and guidewire.

Reported off-label uses

• Balloon angioplasty of selected venous stenoses, including iliac or central venous narrowing, when determined appropriate by the treating physician.
• Adjunctive balloon dilation during some venous recanalization or venous-stenting procedures.

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 diameter and length must be selected to match the target vessel and the planned angioplasty technique; available sizes depend on the specific catheter configuration.
• The catheter is used with compatible guidewires, sheaths and other interventional equipment. Compatibility should be confirmed in the current instructions for use.
• Inflation and deflation should be performed under fluoroscopic guidance with the recommended inflation medium, pressure limits and technique.
• Risks include vessel dissection, perforation, thrombosis, embolization, bleeding at the access site, infection and allergic or kidney-related complications from contrast.
• MRI safety depends on the exact product and whether the catheter remains in the patient. The current labeling should be reviewed; an unused or removed catheter should not be assumed to be MRI relevant.