Atb All-Terrain Balloon PTA Dilatation Catheter

FDA-Cleared Indications

• Balloon dilation of stenotic or obstructed peripheral blood vessels during percutaneous transluminal angioplasty.
• Treatment of vascular obstructions when catheter-based vessel dilation is clinically indicated.

Clinical Applications

• Peripheral angioplasty for atherosclerotic narrowing in the lower-extremity arteries.
• Balloon dilation of peripheral arterial stenoses or occlusions that can be crossed with a guidewire.
• Treatment of peripheral vascular obstructions as part of an image-guided endovascular procedure.
• Dilation of selected peripheral venous stenoses when consistent with the device labeling and procedural plan.

Reported off-label uses

• Balloon angioplasty of venous stenoses, including selected iliac or central venous lesions, when the specific use is outside the device labeling.
• Adjunctive balloon dilation during selected venous recanalization or 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 catheter is available in different balloon diameters and working lengths; the selected size must match the target vessel and lesion.
• It is advanced over a compatible guidewire through percutaneous vascular access under fluoroscopic or other appropriate imaging guidance.
• The balloon must be inflated and deflated according to the current manufacturer instructions for use; excessive pressure or oversizing can injure the vessel.
• MRI safety depends on the exact catheter model and whether any components remain in the patient. Review the current labeling before MRI.
• Contraindications and precautions include inability to cross the lesion, unsuitable vessel anatomy, severe vessel injury risk, and clinical conditions that make angiography or anticoagulation unsafe.