News | Venous Therapies | February 22, 2021

FDA Clears Zilver Vena Venous Self-Expanding Stent

FDA Clears Zilver Vena Venous Self-Expanding Stent

February 22, 2021 — The U.S. Food and Drug Administration (FDA) recently cleared the Cook Medical Zilver Vena Venous Self-Expanding Stent to treat the iliofemoral vein. 

The device 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 (DVT, or 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.

The stent is made of nitinol (nickel-titanium) and comes on and over-the-wire stent delivery system.

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.

The 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. It also should not be used in patients who cannot receive specific blood thinning medications, such as aspirin or warfarin.

For more information on this device from the FDA website: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200023B.pdf

Product website: https://www.cookmedical.com/products/f3af274c-42cc-42cd-a0db-e5715ad57cc4/

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