Admiral Xtreme PTA Catheter

FDA-Cleared Indications

• Dilation of stenotic lesions in peripheral arteries.
• Treatment of peripheral vascular disease using percutaneous transluminal angioplasty.
• Improvement of blood flow through narrowed peripheral arterial segments.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Treatment of peripheral arterial disease affecting the lower extremities.
• Dilation of atherosclerotic arterial narrowing in appropriately selected patients.
• Percutaneous treatment of peripheral arterial lesions when vessel size and anatomy are suitable for the catheter.

Reported off-label uses

• Use in selected venous angioplasty procedures, depending on the catheter specifications and treating physician's judgment.
• Treatment of vascular stenoses outside the labeled peripheral arterial indications when clinically appropriate and supported by available evidence.

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 multiple balloon diameters and lengths; sizing should match the target vessel and lesion.
• It is used over a compatible guidewire and through an appropriately sized introducer sheath.
• Angiographic imaging is used to position the balloon and assess the result of angioplasty.
• Contraindications and precautions include inability to cross the lesion, unsuitable vessel anatomy, significant risk of vessel rupture, and known sensitivity to catheter materials or procedural contrast.
• MRI safety depends on the exact device configuration and labeling; confirm the current manufacturer instructions before an MRI examination.