Sterling OTW PTA Balloon Dilatation Catheter Model H74939032-Xxxxxx

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic peripheral arteries.
• Dilation of narrowed arterial segments in patients with peripheral vascular disease.
• Treatment of arterial stenoses using balloon inflation over a guidewire.

Clinical Applications

• Balloon angioplasty of peripheral arterial stenosis.
• Treatment of flow-limiting arterial narrowing in the lower extremities.
• Dilation of a stenosis during an endovascular peripheral vascular procedure.
• Use over a guidewire to position and inflate the balloon across a target arterial lesion.

Reported off-label uses

• Balloon dilation of selected venous stenoses may be reported in clinical practice, but use depends on the specific catheter labeling, vessel, and clinical circumstances.
• Use in vessels or lesion types outside the cleared labeling may occur in practice, but should be evaluated by the treating physician and is not an FDA-cleared indication for this device.

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 available in multiple balloon diameters and lengths; the treating physician selects a size based on the target vessel and lesion.
• It is an over-the-wire system and requires compatible guidewire access for advancement and positioning.
• Placement and inflation are performed with fluoroscopic or other appropriate imaging guidance, typically through arterial access such as the common femoral or radial artery, depending on the procedure.
• The device should be handled carefully to avoid balloon damage, loss of catheter integrity, vessel injury, dissection, perforation, thrombosis, or embolization.
• MRI safety depends on the exact model and whether the catheter remains in the patient; the specific product labeling should be reviewed before MRI. It is generally a temporary-use device and is removed after angioplasty.