Modification to Amphirion Deep 0 014 OTW PTA Balloon Catheter

FDA-Cleared Indications

• Used for percutaneous transluminal angioplasty of stenotic or obstructed peripheral blood vessels.
• Intended to dilate narrowed vessels to improve blood flow.
• The available FDA record identifies the device as a percutaneous angioplasty catheter; it does not establish a separate indication for treating deep vein thrombosis itself.

Clinical Applications

• Balloon angioplasty of narrowed peripheral vessels.
• Dilation of obstructed vessel segments after guidewire placement.
• Treatment of peripheral vascular stenosis when catheter-based angioplasty is clinically appropriate.
• Use by interventional specialists during image-guided endovascular procedures.

Reported off-label uses

• Use in venous angioplasty for selected chronic venous outflow obstructions may occur in clinical practice, depending on the specific device labeling, vessel location, and physician 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 0.014-inch guidewire format is intended for use with compatible guidewires and catheter systems; confirm compatibility before the procedure.
• Available balloon diameters and lengths should be matched to the target vessel and lesion.
• The balloon requires careful advancement, positioning, inflation, deflation, and removal to reduce the risk of dissection, perforation, thrombosis, or embolization.
• The FDA record provided does not specify MRI compatibility. MRI safety should be confirmed from the current manufacturer instructions for use before scanning.
• Contraindications and precautions include inability to safely cross the lesion, significant vessel tortuosity, severe calcification, suspected vessel perforation, or other conditions listed in the current instructions for use.