Vaccess PTA Dilatation Catheter

FDA-Cleared Indications

• Dilatation of stenotic or narrowed peripheral blood vessels during percutaneous transluminal angioplasty.
• Treatment of vascular stenosis when widening the vessel is needed to improve blood flow.

Clinical Applications

• Balloon angioplasty of narrowed peripheral arteries.
• Treatment of peripheral vascular stenosis in the lower extremities.
• Image-guided catheter-based dilation of a narrowed vessel after guidewire access.
• Use in adult patients whose peripheral vascular narrowing requires endovascular treatment.

Reported off-label uses

• Use in selected venous stenoses or other vascular locations outside the device labeling may occur in clinical practice, but this should be determined by the treating specialist and institutional policy.

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 lengths; the selected size should match the target vessel and lesion.
• It is used over a compatible guidewire and through an appropriately sized introducer sheath.
• The procedure is performed with fluoroscopic or other suitable vascular imaging guidance, usually with local anesthesia and optional moderate sedation.
• The device should not be used when balloon angioplasty is contraindicated, including situations in which the access vessel, target lesion, or patient's condition makes catheter intervention unsafe.
• MRI safety depends on the specific device configuration and labeling; confirm the current manufacturer instructions before MRI. Do not assume the catheter is safe while it remains in the body.