Bard Atlas PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Dilation of stenotic segments in veins during percutaneous transluminal angioplasty.
• Treatment of venous narrowing that can restrict blood flow, including stenosis associated with dialysis access circuits.

Clinical Applications

• Balloon angioplasty of venous stenosis.
• Treatment of narrowing in arteriovenous fistulas used for hemodialysis.
• Treatment of narrowing in hemodialysis arteriovenous grafts.
• Endovascular treatment of venous lesions when the selected catheter size is appropriate for the vessel and lesion.

Reported off-label uses

• Angioplasty of selected arterial stenoses, depending on the specific catheter model, labeling, anatomy, and clinical judgment.
• Treatment of venous stenosis outside dialysis access circuits when the use is not covered by the device's cleared 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

• Choose the balloon diameter and length based on the target vessel, lesion characteristics, and the manufacturer's sizing information.
• The catheter is used over a compatible guidewire and through an appropriately sized introducer sheath or access system.
• Inflation and deflation should follow the manufacturer's instructions; excessive pressure or oversizing can injure the vessel.
• Review contraindications, warnings, and device-specific compatibility information before use. The FDA record provided does not establish that the catheter is MR safe or MR conditional.
• The device is intended for trained clinicians familiar with vascular access, fluoroscopic guidance, balloon angioplasty, and management of complications such as dissection, rupture, thrombosis, or bleeding.