Wallstent TIPS Iliac Venous Endoprosthesis with Unistep Plus Delivery System

FDA-Cleared Indications

• The PMA supplement documents a change in the Wallstent delivery-system manufacturing process: a reduced cure time for the catheter-hub bond to the stainless-steel tube bond.
• The product is an iliac venous endoprosthesis intended for use as a venous stent to help maintain patency of the iliac vein.

Clinical Applications

• Endovascular placement of a self-expanding stent in an iliac vein with clinically significant obstruction or narrowing.
• Maintaining iliac-vein patency after catheter-based treatment of a venous obstruction.
• Treatment of iliac venous outflow obstruction when an iliac venous endoprosthesis is selected under the device labeling and applicable instructions for use.

Reported off-label uses

• Stenting of other large central veins, such as the inferior vena cava or common femoral vein, has been described in clinical practice for selected patients, but this may be outside the device labeling.
• Treatment of venous obstruction related to post-thrombotic disease or iliac vein compression may be performed in selected cases; the specific use should be confirmed against the current labeling.

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 stent is self-expanding and braided, so accurate vessel measurement, appropriate diameter and length selection, and controlled deployment are important.
• The Unistep Plus Delivery System is used for catheter-based delivery and deployment; access is commonly obtained through a peripheral vein, often the femoral vein, under fluoroscopic guidance.
• The FDA record supplied does not list specific stent sizes, sheath requirements, MRI conditions, or contraindications. These details must be confirmed in the current manufacturer instructions for use.
• Patients should be assessed for bleeding risk, venous access problems, active infection, thrombosis management needs, and the need for antithrombotic therapy after stent placement.
• Potential complications include bleeding or hematoma at the access site, venous thrombosis, stent migration, stent deformation or fracture, restenosis, perforation, and contrast-related reactions or kidney injury.