FDA Clears Venous Stent for the Iliofemoral Veins

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently cleared Bard Peripheral Vascular's Venovo Venous Stent System intended to treat narrowed iliofemoral veins. 

The Venovo is used to reopen narrowed regions of iliofemoral vein caused by a collection of fibrous blood clots that can form along the lining of the veins following a deep vein thrombosis (post-thrombotic syndrome) or 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 of the leg and pain when walking.

The FDA said in the clinical study, 88.3 percent of patients who received stents continued to have an open iliofemoral vein after one year. Moreover, statistically significant improvements in pain and quality of life were observed from baseline to 12-months.

The stent has two components, a stent made of a nickel-titanium alloy (nitinol) tubing and an over-the-wire stent delivery catheter system. The physician rotates a thumb wheel on the delivery system to expose the stent which then self-expands automatically. The stent increases blood flow from the leg by holding the iliofemoral vein wall open. 

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm633970.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua