Amphirion Deep 0 014 OTW PTA Balloon Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic or obstructed peripheral arteries.
• Dilation of peripheral vascular lesions to improve blood flow.
• Use with a compatible guidewire in an over-the-wire endovascular system.

Clinical Applications

• Balloon angioplasty of narrowed lower-extremity peripheral arteries.
• Treatment of peripheral arterial obstructions associated with peripheral arterial disease.
• Endovascular dilation of peripheral arterial lesions in patients with impaired limb blood flow.

Reported off-label uses

• Use in selected venous angioplasty procedures, such as treatment of venous stenosis, may occur in clinical practice but is not established here as an FDA-labeled indication.

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 must be matched to the lesion, vessel diameter, guidewire, introducer sheath, and other procedural equipment.
• Balloon inflation and deflation should follow the device instructions for use to reduce the risk of dissection, perforation, rupture, or other vessel injury.
• The record provided does not specify the available balloon diameters, lengths, rated burst pressure, or shaft dimensions; these should be confirmed in the current manufacturer labeling.
• MRI safety status is not established by the information provided. Review the current device labeling before MRI, particularly if the catheter remains in the body.
• Contraindications, warnings, and precautions should be reviewed in the current instructions for use; general concerns include inability to cross the lesion, severe vessel tortuosity, and risk of bleeding or contrast-related complications.