Atb Advanced PTA Dilatation Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
• Dilatation of narrowed vessels when restoring or improving blood flow is clinically indicated.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Treatment of peripheral vascular disease caused by atherosclerotic narrowing.
• Dilatation of a narrowed vascular segment during an endovascular procedure.
• Use by interventional radiologists or vascular surgeons when balloon angioplasty is selected as part of revascularization.

Reported off-label uses

• Balloon angioplasty of selected venous stenoses, when judged appropriate by the treating clinician.
• Balloon preparation or post-dilatation during selected 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

• Select the balloon diameter and length according to the target vessel size, lesion length and degree of stenosis.
• Confirm compatibility with the intended guidewire, introducer sheath and other procedural equipment before use.
• Use fluoroscopic or other appropriate imaging guidance, with careful balloon inflation and deflation to reduce the risk of dissection, perforation or vessel rupture.
• The FDA record and supplied information do not establish MRI safety; review the current device labeling before MRI exposure.
• Contraindications, warnings and detailed operating instructions should be taken from the current Cook instructions for use and the patient's clinical condition.