Amphirion Deep 0 014 OTW PTA Balloon Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic or obstructed peripheral blood vessels.
• Use in patients whose peripheral vessels require balloon dilation to restore or improve blood flow.

Clinical Applications

• Balloon angioplasty of narrowed peripheral arteries.
• Treatment of peripheral arterial disease caused by stenosis or obstruction.
• Dilation of a vascular lesion after a guidewire has been placed across the target segment.
• Use during catheter-based peripheral vascular interventions performed by appropriately trained clinicians.

Reported off-label uses

• Use in selected venous angioplasty procedures, depending on the balloon's labeled size, pressure limits, and the treating physician's judgment.

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 over-the-wire and requires a compatible guidewire for advancement and positioning.
• The available balloon diameters and lengths must match the target vessel and lesion; clinicians should follow the device labeling for inflation pressure and vessel-size limits.
• Careful preparation and handling are required to reduce the risk of catheter damage, balloon rupture, vessel injury, embolization, or incomplete deflation.
• MRI safety should not be assumed from the FDA clearance record. The current product labeling should be checked for MR conditions, and the device should be treated as having unknown MRI safety if that information is unavailable.
• Contraindications, access-site risks, anticoagulation requirements, and suitability for angioplasty depend on the patient's anatomy, lesion, comorbidities, and the manufacturer's instructions for use.