Foxcross 035 PTA Catheter 14 Mm x 20mm x 80 Cm Model 10342-20 Foxcross 035 PTA Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
• Treatment of vascular narrowing when balloon dilation is indicated to improve blood flow.

Clinical Applications

• Balloon angioplasty of stenotic peripheral arteries.
• Endovascular treatment of peripheral vascular disease involving narrowed vessels.
• Dilation of a peripheral vascular stenosis after the catheter is positioned across the lesion under imaging guidance.

Reported off-label uses

• Use in selected venous stenoses or occlusions may be reported in clinical practice, but this is outside the stated peripheral arterial angioplasty indication and should be evaluated by the treating specialist.

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 listed device has a 14 mm balloon diameter, 20 mm balloon length, and 80 cm catheter shaft; the balloon size should match the target vessel and lesion.
• The catheter is designed for use with a 0.035-inch guidewire system and compatible introducer sheath.
• Use fluoroscopic or other appropriate imaging guidance, and follow the manufacturer’s instructions for balloon preparation, inflation pressure, and handling.
• MRI safety depends on the complete device configuration and manufacturer labeling; confirm MR conditions before scanning because an implanted or retained catheter component may not be MR safe.
• Contraindications and precautions include inability to safely cross the lesion, unsuitable vessel size or anatomy, severe calcification, active infection at the access site, contrast allergy, and other factors identified in the current instructions for use.