Optimus 0 035 Inch PTA Balloon Dilatation Catheter

FDA-Cleared Indications

• Percutaneous transluminal angioplasty of stenotic or obstructed peripheral blood vessels.
• Treatment of vascular lesions that can be reached with a compatible 0.035-inch guidewire and balloon catheter.

Clinical Applications

• Balloon angioplasty of narrowed peripheral arteries.
• Endovascular treatment of peripheral arterial stenosis or obstruction.
• Dilation of vascular lesions during image-guided peripheral vascular intervention.

Reported off-label uses

• Balloon dilation of selected venous stenoses, such as iliac or central venous narrowing, when chosen by the treating physician.
• Adjunctive balloon dilation during selected venous stenting procedures.

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 designed for use with compatible 0.035-inch guidewires; the balloon diameter and working length must match the target vessel and lesion.
• The device is navigated under fluoroscopic or other appropriate imaging guidance, with controlled inflation to reduce the risk of dissection, rupture or other vessel injury.
• Patient selection should account for lesion location, vessel size, severe calcification, thrombus, tortuosity and the risk of embolization or perforation.
• MRI safety depends on the specific catheter configuration and whether any device component remains in the patient; consult the current manufacturer labeling before MRI.
• As a temporary angioplasty catheter, it is not intended to remain implanted. It is supplied for single use unless current labeling states otherwise.