Becton Dickinson and Co. said the U.S. Food and Drug Administration approved the first-of-its-kind Venovo stent to restore blood flow in certain veins near the groin.
Venovo received regulatory approval to treat iliofemoral venous occlusive disease, which results from impaired blood flow in the iliofemoral vein due to certain diseases.
These diseases include acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome or a combination of all of these.
Chronic deep-vein thrombosis is characterized by a blood clot that scars the vein and does not allow blood to flow through effectively, and May-Thurner syndrome is caused when one of the veins in the pelvis is compressed by an artery, leading to a clot developing.
The Franklin Lakes, N.J.-based medical-device maker said the approval is based on data from the Vernacular trial, which involved 170 patients and demonstrated the safety and effectiveness of Venovo.