Sterling Monorail PTA Balloon Dilatation Catheter Model H74939031-Xxxxxx

FDA-Cleared Indications

• Dilation of stenotic lesions in peripheral blood vessels during PTA.
• Treatment of peripheral vascular narrowing in vessels appropriate for the selected catheter and balloon size.

Clinical Applications

• Balloon angioplasty of peripheral arterial stenoses.
• Treatment of flow-limiting narrowing associated with peripheral artery disease.
• Dilation of selected lesions in the femoral, popliteal, and tibial arterial territories when the anatomy and device size are appropriate.
• Use with a compatible guidewire and vascular access system during image-guided endovascular treatment.

Reported off-label uses

• Balloon dilation of selected venous stenoses, such as iliac or central venous narrowing, may be performed in clinical practice but is not established here as a specific FDA-labeled indication.
• Use in other vascular territories or lesion types outside the device labeling may occur in specialized practice, based on physician judgment and available evidence.

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 working lengths; the selected size must match the target vessel and lesion.
• The monorail design is used over a compatible guidewire and requires appropriate introducer sheath and imaging equipment.
• Device handling, balloon inflation pressure, and lesion preparation should follow the current manufacturer instructions for use.
• MRI safety depends on the exact device configuration and labeling; verify the current Boston Scientific MRI information before scanning.
• Potential complications include dissection, perforation, thrombosis, embolization, bleeding at the access site, vessel recoil, and restenosis. Contraindications and warnings should be reviewed in the current labeling.