This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Zilver Vena Venous Self-Expanding Stent
PMA Applicant: Cook Ireland, Ltd.
Address: O'Halloran Road, National Technology Park, Limerick, Ireland
Approval Date: October 9, 2020
Approval Letter: Link to Approval Order

What is it? The Zilver Vena Venous Self-Expanding Stent is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). There are two parts: a small, spiral tube (stent) made of Nitinol (nickel-titanium) and an over-the-wire stent delivery system.

How does it work? The physician inserts a thin flexible tube (delivery system) with a stent loaded in its tip into the narrowed section of the iliofemoral vein. The physician releases the stent and it expands automatically. The stent increases blood flow from the leg by holding the vein wall open. The stent remains permanently implanted in the vein and acts as a support for the newly opened section of the blood vessel.

When is it used? The Zilver Vena Venous Self-Expanding Stent is used to reopen narrowed regions of iliofemoral veins caused by a collection of fibrous blood clots that can form along the walls of veins following deep-vein thrombosis (post-thrombotic syndrome) or caused by the squeezing of the vein between a bone and an overlying artery (iliofemoral compression). These conditions may limit blood flow from the leg and lead to swelling and pain in the leg when walking.

What will it accomplish? The Zilver Vena Venous Self-Expanding Stent acts as a support to hold open the narrowed iliofemoral vein and improve blood flow from the leg. In clinical studies, 89.9% of patients who received the Zilver Vena Venous Self-Expanding Stent continued to have an open iliofemoral vein after one year.

When should it not be used? The Zilver Vena Venous Self-Expanding Stent should not be used in patients who:

• have a lesion that prevents crossing or complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
• cannot receive specific blood thinning medications, such as aspirin or coumadin.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling
• Physician Labeling
• PMA Database Entry