Wallstent Venous Endoprosthesis with Unistep Plus Delivery System

FDA-Cleared Indications

• The FDA record lists an additional vendor location to supply manufacturing aids and components used in the manufacturing process of the devices.

Clinical Applications

Reported off-label uses

• Treatment of symptomatic iliac or central venous obstruction after appropriate imaging and clinical evaluation.
• Treatment of chronic venous outflow obstruction associated with post-thrombotic changes.
• Venous stenting following endovascular treatment of selected venous occlusions or stenoses.

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

• Select stent diameter and length according to the target vein, lesion dimensions, and the manufacturer's instructions for use.
• Placement requires fluoroscopic or other appropriate imaging guidance and controlled deployment through the Unistep Plus Delivery System.
• Review the current product labeling for delivery-system compatibility, access requirements, deployment technique, contraindications, and warnings.
• MRI conditions should be confirmed in the current device labeling before scanning; MRI safety may depend on the exact model, implant configuration, and scanner conditions.
• The supplied FDA indication does not establish a clinical indication for treating patients; clinical use must be verified against the current approved labeling and applicable regulatory documentation.