Modification to Amphirion Deep 0 014 OTW PTA Balloon Catheter

FDA-Cleared Indications

• Use during percutaneous transluminal angioplasty of narrowed peripheral blood vessels.
• Dilation of stenotic lesions in peripheral vessels when treatment with a balloon catheter is clinically appropriate.

Clinical Applications

• Balloon angioplasty of peripheral vascular stenoses.
• Dilation of narrowed vessels before or during peripheral vascular intervention.
• Lesion preparation before placement of a peripheral vascular stent when clinically indicated.
• Treatment of peripheral vascular narrowing in a catheterization laboratory or hospital-based interventional setting.

Reported off-label uses

• Use in selected venous stenoses, including dialysis-access or central venous narrowing, may occur in clinical practice but should be considered off-label unless specifically included in the applicable device labeling.
• Use in vessel territories, lesion types, or procedural techniques outside the FDA-cleared labeling is off-label and requires physician judgment, institutional review, and informed consent.

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 device uses an over-the-wire design and requires a compatible guidewire and vascular access system; clinicians should verify the catheter and guidewire specifications before use.
• Available balloon diameters and lengths vary by configuration, so the selected size must match the target vessel and lesion.
• Use fluoroscopic or other appropriate imaging guidance, careful lesion crossing, and controlled balloon inflation according to the manufacturer’s instructions for use.
• MRI safety depends on the exact device configuration and labeling; the device should not be considered MRI safe or MRI conditional without confirming the current manufacturer’s instructions.
• Contraindications and precautions include inability to safely cross the lesion, unsuitable vessel anatomy, severe access-site disease, and patient or lesion factors that increase the risk of dissection, perforation, thrombosis, or bleeding.