Navajo PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
• Dilatation of narrowed peripheral arteries to improve blood flow.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Treatment of peripheral arterial narrowing caused by atherosclerotic or other vascular disease.
• Endovascular treatment of peripheral arterial stenosis in a catheterization laboratory.

Reported off-label uses

• Balloon angioplasty of selected stenotic or occluded venous segments may be performed in clinical practice, depending on the catheter's specifications and clinician judgment; this use may not be included in the FDA-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

• Available catheter and balloon dimensions must match the target vessel diameter, lesion characteristics and access route.
• The catheter should be used with compatible guidewires, introducer sheaths, inflation devices and contrast media according to the manufacturer's instructions.
• Potential complications include vessel dissection, perforation or rupture, thrombosis, embolization, bleeding and access-site injury.
• MRI safety depends on the specific device configuration and labeling; verify the manufacturer's current MRI information before scanning.
• Use is contraindicated or requires special caution when the target lesion, vessel anatomy, access route or patient condition makes catheter angioplasty unsafe.